International Journal of Community Medicine and Public Health
Vol 4, No 5 (2017)  May 2017
http://www.ijcmph.com/index.php/ijcmph/issue/view/24

Review Articles
Ebola virus disease: epidemiology, clinical feature and the way forward
Lawan Gana Balami, Suriani Ismail, Saliluddin S. M., Garba S. H.
Abstract
The Ebola virus disease is a zoonotic, acute viral syndrome which occurs by infection with one the strains of the Ebola virus. It is primarily endemic in Africa however the recent outbreak in the year 2014 spanned from West Africa all the way to Europe and America. This shows the virus possess a global threat and should not be considered localized to only certain parts of the world. The social and economic impact of zoonotic diseases today is high as 80% of human pathogens are of zoonotic origin. Human to human transmission happens when there is contact with bodily fluids of infected humans during the infectious phase of the disease. This spread could be through nosocomial means or community spread. Poor knowledge of the syndrome among health care workers coupled with lack of funding and deficient resources has crippled their ability to diagnose and break the chain of transmission of the disease at its early stages. The virus undergoes pathogenesis by immune evasion, immune suppression, coagulopathy, and hypovolemic shock, multiple organ failure and death in up to 90% of cases. The unavailability of a cure or vaccine for this syndrome makes it a recurrent threat due to high risk behavior practiced in endemic countries such as bush meat consumption. Thus this study gives the reader a review of current literature on this deadly disease with the aim of increasing knowledge and aiding its prevention and control.

International Journal of Community Medicine and Public Health
Vol 4, No 5 (2017)  May 2017
http://www.ijcmph.com/index.php/ijcmph/issue/view/24

Outbreak of cholera at Dutsen-Abba Ward Zaria local government area, Kaduna State Nigeria 2015: the importance of hygienic practices
Baffa S. Ibrahim, Yahaya Mohammed, Rabi Usman, Ubong A. Okon, Uche I. Katchy, Abayomi A. Olufemi, Mercy Niyang, Bola Gobir, Oyeladun Funmi Okunromade
Abstract
Background: Cholera is an infection caused by Vibrio cholerae, which may lead to severe dehydration and death if not treated promptly. On August 31, 2015, the Kaduna Ministry of Health received a notification of increase cases of vomiting and diarrhoea at Dusten-Abba in Zaria. A response Team was sent to confirm the outbreak, describe the socio-demographic characteristics and identify possible risk factors for the outbreak.
Methods: We defined cases according to the world health organization (WHO) criteria. We conducted an unmatched case-control study and descriptive study. We retrieved line-listed cases at the ward facility. We interviewed cases at the facility and recruited controls from the community, and administered questionnaires to both cases and controls. We analysed data using Epi-Info7 and Microsoft Excel 2016.
Results: A total of 50 cases were recorded, with a median age of 20years and age range of 1 – 50 years. There were more females (68%) than males. Majority of cases (52%) were under 20 years, while all cases are below 50 years. Seven (7) deaths were recorded giving a Case Fatality Rate (CFR) of 14%. The CFR was higher in females (14.7%) than in males (12.5%). Index case was seen on August 29, 2015. The outbreak lasted five days. Last cases were seen on September 2, 2015. Highest number of cases seen in a day (23) was on third day of the outbreak. Only two cases (4%) had their samples tested using cholera RDT, and both tested positive. Drinking un-boiled water (OR: 12.67, 95%CI: 2.33–68.93), regular hand washing (OR: 0.22, 95% CI: 0.06–0.90) and proper waste disposal practices (OR: 0.07, 95% CI: 0.02–0.36) are factors we found to affect cholera infection during the outbreak.
Conclusions: Our investigation confirmed a cholera outbreak with a high CFR, especially among females. Poor hygienic practices among the populace seem to be the drivers for this outbreak.

International Journal of Community Medicine and Public Health
Vol 4, No 5 (2017)  May 2017
http://www.ijcmph.com/index.php/ijcmph/issue/view/24

Evaluation of primary immunization coverage among children in a rural block of district Rohtak, Haryana, India
Sahil Goyal, Vijay Kumar, Ritika Garg
Abstract
Background: Vaccination is the most important preventive and cost-effective intervention to decrease morbidity and mortality rates in children. Every year, vaccination averts an estimated 2-3 million deaths from diphtheria, tetanus, pertussis and measles. These are all life threatening diseases that disproportionately affect children. An estimated 1.5 million children die annually from diseases that can be prevented by immunization. In the past 50 years, vaccination has saved more lives worldwide than any other medical products or procedures. The objectives of the study were to evaluate primary immunization coverage along with 1st dose of Vitamin-A supplementation coverage, age-appropriate immunization and also to know the reasons for partial or non-immunization among children.
Methods: Community-based cross sectional study was conducted among 540 children in the rural area of Rohtak, Haryana during June 2015-May 2016. Information was collected from the mothers regarding immunization status of their children aged 12-23 months old and socio-demographic variables using a semi-structured interview schedule.
Results: 395 (73.15%) of 12-23 months old children were fully immunized and the rest 145 (26.85%) were partially immunized. The major reason for drop-out rate was found to be unawareness regarding need for immunization. Immunization coverage was found to be significantly associated with the presence of immunization card and literacy level of mothers.
Conclusions: Though the immunization coverage showed improvement through intensive immunization campaigns in recent years, still a lot needs to be done to increase awareness regarding importance of full immunization at the right time as mentioned in the National Immunization schedule (NIS).

International Journal of Community Medicine and Public Health
Vol 4, No 5 (2017)  May 2017
http://www.ijcmph.com/index.php/ijcmph/issue/view/24

Evaluation of measles immunization coverage in rural area of central India using WHO EPI 30 cluster survey method
Shailendra Meena, D. M. Saxena, Vishal Bankwar, Pratibha Meena
Abstract
Background: Measles is one of the most infectious diseases known to humankind and an important cause of death and disability among children worldwide. In 2010, the World Health Assembly set milestones towards global measles eradication, to be reached by 2015. One of the milestones is to Increase in routine coverage with the first dose of measles-containing vaccine (MCV1) for children aged 1 year to ≥90% nationally and ≥80% in every district.
Methods: A community based cross sectional study was carried out in rural area of Bhopal district, central India from September 2014 to November 2014. The WHO EPI 30-cluster survey methodology was used as sampling method. A pre designed and pre tested questionnaire was used to collect information on immunization coverage. Data was entered into Microsoft Excel and was analyzed by using EPI Info version 7.
Results: The mean age of study subjects was 17.7 months with SD of 3.64. Out of total 210 subjects 57.2% were boys and 42.8 % were girls. Our study findings suggest that 92% of the children were vaccinated for MCV1 vaccine and 8 % were not received MCV1 vaccine. The association of place of delivery with MCV1 vaccination status was found statistically significant (P <0.001).
Conclusions: We found high measles vaccination coverage in the field practice area as compared to other surveys. Main reasons found behind noncompliance were unawareness about Universal Immunization programme, lack of information about Measles and its complications, away from home on the session day, long distance of session site from home.

International Journal of Community Medicine and Public Health
Vol 4, No 5 (2017)  May 2017
http://www.ijcmph.com/index.php/ijcmph/issue/view/24

Knowledge, attitude and practices about tetanus toxoid immunisation amongst general population of an urban semi-slum area: a cross-sectional interview-based study from Western India
Pruthvi H. Patel, Aniruddha A. Malgaonkar, S. Kartikeyan
Abstract
Background: Members of the public are frequently unaware of tetanus immunisation schedules and its importance in preventing tetanus. This community-based, cross-sectional, complete enumeration, interview-based study was conducted to assess the knowledge, attitude and practices about tetanus toxoid immunisation amongst the general population in an urban semi-slum area located about 30 kms from Mumbai city in Western India.
Methods: Respondents comprised adult residents of either sex, who gave written informed consent to participate in the study. After obtaining approvals, the study was explained during routine home visits and the respondents were interviewed at a time convenient to them.  A direct face-to-face interview was conducted using a semi-structured proforma and their responses were recorded and statistically analysed.
Results: Of the 161 participants (90 males; 71 females), 16.15% were illiterates. 95.65% thought that a single tetanus toxoid injection was adequate to prevent tetanus while none knew that pregnant women are immunised to protect newborns against tetanus.  67.08% were unaware about the need for maintaining cold chain for storage of tetanus toxoid. 96.89% had received only one injection of tetanus toxoid, irrespective of the type of injury or previous immunisation status. The belief that an adult requires tetanus toxoid after every injury exhibited education-wise significant difference (p=0.02).
Conclusion: Sustained and focussed health education efforts are necessary to combat misconceptions regarding tetanus toxoid immunisation.

International Journal of Infectious Diseases
May 2017 Volume 58, p1-118
http://www.ijidonline.com/issue/S1201-9712(17)X0005-2

Perspective
International Society for Infectious Diseases: Position statement on the March for Science, April 22, 2017
Jonathan Cohen, Marc Mendelson
Published online: April 10, 2017
For more than thirty years, the International Society for Infectious Diseases (ISID) has been committed to the advancement of evidence-based scientific practices that further public health initiatives and the prevention of infectious diseases. On 22nd April 2017, people around the world will take part in the “March for Science” to demonstrate their support for informed reasoning. In light of the current political climate, which at times seeks to undermine scientific truths, ISID fully endorses the March for Science. We reaffirm our commitment to scientific progress with its goal of improving the health of all peoples.

ISID supports and promotes the exchange of information and best-practices amongst the international infectious disease community to aid research and inform local, national, and global policy decisions. The Society’s activities are at the forefront of evidence-based prevention and treatment of infectious diseases and the rapid identification of outbreak events. These activities rely upon support for the global scientific community, open lines of communication that are free of political constraint, and the unrestricted movement of scientists and healthcare professionals.

Policy makers, beholden to the public, must be informed of the latest scientific research as they create legislation, establish new programs, and allocate funding which directly and indirectly affects the health of their constituents. Science denialism and the mischaracterization of substantiated research poses a severe threat to the progress made by public health and medical professionals in the fight against infectious diseases. For example, the unequivocal success of vaccines cannot be denied as they have reduced the global burden of disease, particularly the mortality rate in children under five, and have eradicated both smallpox and rinderpest. The development of health policy based on peer-reviewed research and the founding of sufficiently funded agencies tasked with safeguarding human and environmental well-being, are hallmarks of modern public health. To prevent and control infectious diseases, we must remain vigilant in defending and sustaining these practices.

International Journal of Infectious Diseases
May 2017 Volume 58, p1-118
http://www.ijidonline.com/issue/S1201-9712(17)X0005-2

Dengue virus serological prevalence and seroconversion rates in children and adults in Medellin, Colombia: implications for vaccine introduction
Mabel Carabali, Jacqueline Kyungah Lim, Diana Carolina Velez, Andrea Trujillo, Jorge Egurrola, Kang Sung Lee, Jay S. Kaufman, Luiz Jacinto DaSilva, Ivan Dario Velez, Jorge E. Osorio
p27–36
Published online: March 8, 2017
Summary
Background
Dengue is an important public health problem worldwide. A vaccine has recently been licensed in some countries of Latin America and Asia. Recommendations for dengue vaccine introduction include endemicity and a high serological prevalence of dengue in the territories considering its introduction.
Methods
A community-based survey was conducted to estimate dengue seroprevalence and age-specific seroconversion rates in a community in Medellin, Colombia, using a dengue serological test (IgG indirect ELISA). Residents were selected at random and were first screened for dengue infection; they were then followed over 2.5 years.
Results
A total of 3684 individuals aged between 1 and 65 years participated in at least one survey. The overall dengue seroprevalence was 61%, and only 3.3% of seropositive subjects self-reported a past history of dengue. Among dengue virus (DENV)-naïve subjects with more than two visits (n = 1002), the overall seroconversion rate was 8.7% (95% confidence interval 7.3–10.4) per 1000 person-months, over the study period. Overall, the mean age of DENV prevalent subjects was significantly higher than the mean age of seroconverted subjects. Specifically, DENV seropositivity over 70% was observed in participants over 21 years old. Serotype-specific plaque-reduction neutralization tests (PRNT) revealed that all four dengue serotypes were circulating, with DENV4 being most prevalent.
Conclusions
These laboratory-based findings could inform dengue vaccine decisions, as they provide age-specific seroprevalence and seroconversion data, evidencing permanent and ongoing dengue transmission in the study area. This study provides evidence for the existing rates of secondary and heterotypic responses, presenting a challenge that must be addressed adequately by the new vaccine candidates.

Journal of Patient-Centered Research and Reviews
Volume 4, Issue 2 (2017)
http://digitalrepository.aurorahealthcare.org/jpcrr/

Original Research
Multiple Myeloma Vaccination Patterns in a Large Health System: A Pilot Study
Andinet Alemu, Maharaj Singh, Chris Blumberg, John O. Richards, Martin K. Oaks, and Michael A. Thompson
Abstract
Purpose
Common reasons for hospitalization and death in patients with multiple myeloma (MM) are infections. As patients with MM are living longer and are treated with immunomodulatory drugs, there is a need to immunize against vaccine-preventable diseases and ultimately determine the efficacy of these vaccines. We evaluated vaccination practice patterns in MM patients at our health system using electronic medical records and data analytics.
Methods
This institutional review board-approved study retrospectively reviewed patients with MM who visited the health system from May 2012 to May 2014. Data collected included demographics, influenza vaccination (FV) and pneumonia vaccination (PV) history, hospitalization episodes and associated costs, and duration of survival. Patients were considered PV-positive if vaccinated within 5 years prior to study. FV was defined as optimal (two FV in 2012–2014), suboptimal (one FV in 2012–2014) or none (in 2012–2014).
Results
Of 411 MM patients, 55% were male and 85% Caucasian. Nearly 58% received PV in the past 5 years. FV was 15% optimal, 52% suboptimal and 33% none. A total of 444 hospitalizations involving 204 patients were observed over 2-year follow-up. More than $23 million was incurred from hospitalizations in the 2-year study period. There was no statistically significant difference in all-cause hospitalization and overall survival by FV and PV status.
Conclusions
Despite recommendations of vaccination in multiple myeloma, our cohort had low rates of influenza and pneumonia vaccination. FV and PV status did not show any significant association with additional hospitalization or overall survival in this pilot study. Future prospective studies are needed to ascertain the immunological and clinical efficacy and effectiveness.

The Lancet
May 13, 2017 Volume 389 Number 10082 p1859-1952
http://www.thelancet.com/journals/lancet/issue/current

Editorial
Improving access to biosimilars in low-income countries
The Lancet
Published: 13 May 2017
DOI: http://dx.doi.org/10.1016/S0140-6736(17)31272-2
From September, 2017, WHO will accept applications for prequalification into their Essential Medicines List for biosimilar versions of two biologics: rituximab (for non-Hodgkin’s lymphoma) and trastuzumab (for breast cancer). This pilot project is an effort to increase access to these costly cancer treatments in low-income countries.

Biologics are medicines, usually antibodies, produced from living sources such as cells and blood, increasingly used to treat cancer as well as inflammatory diseases, such as arthritis and asthma. When patents for biologics expire, manufacturers can make biosimilar versions of the product with the same biological effect and characteristics as the original. Because their source is biological or living, one concern is that slight variations in manufacturing processes could alter the biosimilar.

The WHO Prequalification of Medicines Programme ensures that medicines purchased by international procurement agencies (eg, UNICEF) for distribution in low-income countries meet acceptable standards of quality, safety, and efficacy. The Lancet Commission on Essential Medicines recommended that the prequalification programme should expand the range of essential medicines, including biosimilars. With this welcome expansion, however, rigorous guidance and regulation for quality assurance will be required by WHO.

The incentive for governments to embrace biosimilars is to lower costs, which in turn should increase access and improve population health-care outcomes. However, the advent of biosimilars has not yet reduced costs as one might have expected from the generic drug experience. This might be because list prices for biosimilars are often not much cheaper, at around 70–85% of the list price of the original product; by contrast, generic drugs are usually markedly cheaper (20% of the originator’s price). Development of biosimilars is more costly and takes longer than for small-molecule generics. That said, countries such as Norway have achieved large price cuts by switching almost entirely to biosimilar versions and effectively tendering these switches. WHO prequalification will hopefully increase competition in the biosimilar market to further reduce the price and increase access to these medicines in low-income countries.

Lancet Global Health
Jun 2017 Volume 5 Number 6 e556-e632
http://www.thelancet.com/journals/langlo/issue/current

Articles
Community engagement and integrated health and polio immunisation campaigns in conflict-affected areas of Pakistan: a cluster randomised controlled trial
Muhammad Atif Habib, Sajid Soofi, Simon Cousens, Saeed Anwar, Najib ul Haque, Imran Ahmed, Noshad Ali, Rehman Tahir, Zulfiqar A Bhutta
Summary
Background
Pakistan faces huge challenges in eradicating polio due to widespread poliovirus transmission and security challenges. Innovative interventions are urgently needed to strengthen community buy-in, to increase the coverage of oral polio vaccine (OPV) and other routine immunisations, and to enhance immunity through the introduction of inactivated polio vaccine (IPV) in combination with OPV. We aimed to evaluate the acceptability and effect on immunisation coverage of an integrated strategy for community engagement and maternal and child health immunisation campaigns in insecure and conflict-affected polio-endemic districts of Pakistan.
Methods
We did a community-based three-arm cluster randomised trial in healthy children aged 1 month to 5 years that resided within the study sites in three districts of Pakistan at high risk of polio. Clusters were randomly assigned by a computer algorithm using restricted randomisation in blocks of 20 by an external statistician (1:1:1) to receive routine polio programme activities (control, arm A), additional interventions with community outreach and mobilisation using an enhanced communication package and provision of short-term preventive maternal and child health services and routine immunisation (health camps), including OPV (arm B), or all interventions of arm B with additional provision of IPV delivered at the maternal and child health camps (arm C). An independent team conducted surveys at baseline, endline, and after each round of supplementary immunisation activity for acceptability and effect. The primary outcome measures for the study were coverage of OPV, IPV, and routine extended programme on immunisation vaccines and changes in the proportion of unvaccinated and fully vaccinated children. This trial is registered with ClinicalTrials.gov, number NCT01908114.
Findings
Between June 4, 2013, and May 31, 2014, 387 clusters were randomised (131 to arm A, 127 to arm B, and 129 to arm C). At baseline, 28 760 children younger than 5 years were recorded in arm A, 30 098 in arm B, and 29 126 in arm C. 359 clusters remained in the trial until the end (116 in arm A, 120 in arm B, and 123 in arm C; with 23 334 children younger than 5 years in arm A, 26 110 in arm B, and 25 745 in arm C). The estimated OPV coverage was 75% in arm A compared with 82% in arm B (difference vs arm A 6·6%; 95% CI 4·8–8·3) and 84% in arm C (8·5%, 6·8–10·1; overall p<0·0001). The mean proportion of routine vaccine doses received by children younger than 24 months of age was 43% in arm A, 52% in arm B (9%, 7–11) and 54% in arm C (11%, 9–13; overall p<0·0001). No serious adverse events requiring hospitalisation were reported after immunisation.
Interpretation
Despite the challenges associated with the polio end-game in high-risk, conflict-affected areas of Pakistan, a strategy of community mobilisation and targeted community-based health and immunisation camps during polio immunisation campaigns was successful in increasing vaccine coverage, including polio vaccine coverage.
Funding
Bill & Melinda Gates Foundation.

New England Journal of Medicine
May 11, 2017  Vol. 376 No. 19
http://www.nejm.org/toc/nejm/medical-journal
Clinical Implications of Basic Research
Elizabeth G. Phimister, Ph.D., Editor

Zika Virus Vaccines — A Full Field and Looking for the Closers
Stephen J. Thomas, M.D.
N Engl J Med 2017; 376:1883-1886 May 11, 2017 DOI: 10.1056/NEJMcibr1701402

The Zika virus (ZIKV) epidemic, which started in 2015, is having a considerable effect on global public health, blood-product safety, and international travel and is further fueling the debate on elective termination of pregnancy. ZIKV infection is the latest infectious disease to reveal our limitations in preparing for and responding to biologic threats. The most profound consequence of the epidemic is the large number of congenital malformations that are known to be associated with or caused by ZIKV infection. Furthermore, as children who were exposed to ZIKV in utero grow older, new developmental abnormalities are being identified, extending the effects of the epidemic. According to a recent World Health Organization (WHO) report, 61 areas have reported ongoing ZIKV transmission since 2015, with 31 countries reporting congenital malformations that are potentially associated with infection. It is unclear whether ZIKV transmission will become endemic with seasonal peaks, like dengue, or be more episodic in nature.

There are no licensed antiviral drugs to prevent or treat ZIKV infection or disease, although groups are exploring the possibility of repurposing existing drugs and developing new compounds. There exists no licensed vaccine to prevent ZIKV infection. Once infection has occurred, diligent clinical monitoring and supportive care are the mainstays of treatment. Caring for patients with severe ZIKV disease manifestations, especially patients who were exposed in utero, is challenging for all involved and requires a substantial allocation of health care resources that are often limited in their availability. Because of these challenges, the WHO has called for development of a ZIKV vaccine, with an initial focus on protecting women of childbearing age.

Two recent reports describing the successful testing of experimental ZIKV vaccines in animal models — one by Pardi et al.1 and another by Richner et al.2 — are welcome news. Both groups engineered messenger RNAs (mRNAs) with sequences encoding the ZIKV precursor membrane (prM) glycoprotein and envelope (E) glycoprotein. The E protein is critical to viral attachment, entry, and replication in the infected host (Figure 1AFigure 1The ZIKV E Protein and a Nucleoside-Modified mRNA Vaccine Candidate.), which makes it a rational vaccine target. Neutralizing antibodies directed against the E protein have been identified as correlates of protection for vaccines directed against other flaviviruses, such as the Japanese encephalitis, yellow fever, and tickborne encephalitis viruses.3

Pardi et al. developed a nucleoside-modified mRNA vaccine candidate that was based on the prM–E sequence of a French Polynesian 2013 ZIKV strain and formulated the vaccine with lipid nanoparticles. A modified nucleoside was used to reduce indiscriminate innate immune responses after vaccination and to increase protein translation, and the lipid nanoparticles were designed to ensure prolonged protein expression. (Nucleoside molecules are the fundamental “building blocks” of nucleic acids like mRNA.) The authors vaccinated two different strains of mice (C57BL/6 and BALB/c), observed no acute safety events, and subsequently detected E-protein–specific binding IgG antibodies and neutralizing antibodies (Figure 1B). The C57BL/6 mice were also found to have antigen-specific CD4+ T cells after vaccination. The vaccinated mice were challenged with a Puerto Rican 2015 ZIKV strain 2 or 20 weeks after vaccination. All vaccinated mice were protected from viremia (i.e., their blood tested negative for ZIKV RNA). Nonhuman primates (macaque monkeys) were then vaccinated with one of three different doses (from 50 μg to 600 μg); they had no acute safety events and had development of E-protein–specific binding IgG antibodies and neutralizing antibodies, but without a dose effect. When five immunized monkeys and six control monkeys were challenged with Puerto Rican ZIKV 5 weeks after vaccination, all the control monkeys became infected, whereas four of the five vaccinated monkeys were protected from viremia; a single vaccinated monkey had transient low-level viremia 3 days after challenge.

Richner et al. used the prM–E sequence from a Micronesian 2007 ZIKV strain, the signal sequence from human IgE (IgEsig), a modified nucleoside, and enzymatically synthesized mRNA packaged in lipid nanoparticles in their experimental vaccine. They generated additional mRNA constructs by introducing mutations in or near viral DNA encoding the fusion loop of the E protein or by replacing the IgE signal sequence with one from Japanese encephalitis virus (JEVsig). These modifications were made to increase the efficiency of protein production and to minimize the generation of cross-reactive — and, in theory, potentially enhancing — ZIKV antibodies directed against the highly conserved and dominant flavivirus fusion-loop epitope. (“Enhancing” antibodies do not neutralize infection but instead cross-react with and enhance infection by viruses that share an epitope with the immunizing virus or viral antigen.)

On testing of the IgEsig–prM–E vaccine in mice (of strain AG129) either as a single dose or as a two-dose regimen, Richner et al. found E-protein–specific neutralizing antibodies. A higher dose (10 μg) outperformed a lower dose (2 μg) when administered as a single dose, and the two-dose regimens were superior to single-dose regimens. Six weeks after vaccination, the mice were challenged with a 1966 Malaysian ZIKV strain; all the mice that received the higher single dose or either two-dose regimen survived, and 60% of the mice that received the low single dose survived. Similarly, a two-dose, 10-μg regimen fully protected C57BL/6 mice against challenge with a 1984 Dakar ZIKV strain (none of these mice had viremia 5 days after challenge, and none died), whereas only 30% of the control mice survived.

BALB/c mice that were immunized and boosted with both wild-type and fusion-loop mutants of IgEsig–prM–E or JEVsig–prM–E candidates had production of similar neutralizing antibody titers. The JEVsig–prM–E vaccine provided complete protection against viremia when vaccinated mice were challenged with a 1984 Dakar ZIKV strain 13 weeks after vaccination; breakthrough viremia was observed in the group of mice that were vaccinated with IgEsig–prM–E. In vitro experiments revealed that the “fusion-loop” mutations reduced enhancing antibody production, and studies involving a mouse model of dengue antibody enhancement showed significantly lower morbidity and mortality in association with both the Esig–prM–E fusion-loop and JEVsig–prM–E fusion-loop vaccine candidates.

Data from studies in animals have now been described for numerous ZIKV vaccine candidates, which have been developed with the use of approaches that harness ZIKV DNA, protein subunit, adenovirus vectors, inactivated whole virions, and now mRNA.4-7 The candidates produced no acute safety signals, induced ZIKV-specific humoral or cellular immune responses, and conferred at least some protection against live virus challenge. The mRNA vaccine constructs reviewed here offer numerous potential advantages, including ease and cost of manufacturing, applicability across diverse pathogens, and a favorable safety profile. Vaccinology, however, constantly warns against extrapolating conclusions from animal experiments to humans.

In the case of ZIKV vaccines, most of the available data have been generated with the use of animals that have had no previous exposure to flaviviruses; these animals are not representative of most human populations, which will probably be immunized once a vaccine is available. Will preexisting immunity to flaviviruses (such as the dengue, yellow fever, West Nile, and Japanese encephalitis viruses) affect the safety or immunogenicity of a ZIKV vaccine? Disease enhancement resulting from the immunologic interplay between ZIKV infection or vaccination and other endemic flaviviruses has been proposed as a theoretical concern. This concern is based largely on data from in vitro studies and studies of small animals, but in vivo studies of ZIKV in nonhuman primates have not recapitulated these observations of “enhancement.” Prospective studies, most likely with large sample sizes, will be required in order to most appropriately explore the concept of immune enhancement in ZIKV infection.

Past successes with other flavivirus vaccines, together with more recently obtained ZIKV data, suggest that perhaps neutralizing antibodies will be required and are sufficient to confer protection against ZIKV. What is the immune profile required to protect a pregnant woman and her fetus from disease or to prevent long-term persistence of ZIKV in fluids such as semen?

Whole-virion inactivated vaccines (which I have experience in developing), live attenuated recombinant vaccines, and DNA vaccines against ZIKV are now being tested for safety in humans. ZIKV infection may be followed by adverse neurologic outcomes, such as the Guillain-Barré syndrome or acute myelitis. The pathophysiological processes underlying these less common clinical outcomes are incompletely understood, but it has been theorized that antibodies that develop in response to ZIKV infection also recognize and target the epitopes of antigens expressed by human nervous system tissues, which may appear similar to those on ZIKV. If this is the case, vaccine developers will need to closely monitor vaccine recipients for adverse events of potential neurologic origin.

Demonstrating safety in a small number of volunteers appears feasible; demonstrating that vaccine-induced immune responses are associated with clinical efficacy will be a much more formidable task. If a vaccine is found to be safe and efficacious, producing sufficient quantities to meet the projected global need (i.e., many millions of doses) may ultimately be the most difficult undertaking.

Despite the challenges, the pace of ZIKV vaccine research and development has been impressive. If past successes with flavivirus vaccines are a guide and ZIKV behaves more like the encephalitic flaviviruses and less like dengue there would be cause for optimism. However, history has shown that the race for a vaccine typically begins with many contenders at the start, of whom very few finish the race. This observation notwithstanding, the recently published data from Pardi et al. and Richner et al. represent an important step toward the goal of protecting people from ZIKV through active immunization.

PLoS Medicine
http://www.plosmedicine.org/
(Accessed 13 May 2017)

Perspective
Rotavirus vaccine will have an impact in Asia
Carl D. Kirkwood, A. Duncan Steele
Perspective | published 09 May 2017 PLOS Medicine
https://doi.org/10.1371/journal.pmed.1002298
Diarrhea remains the second leading infectious cause of death among children under five years of age, with more than half a million deaths each year. Rotavirus disease accounts for 25%–30% of all severe diarrhea cases [1]. While every child is at risk of rotavirus infection, the vast majority of rotavirus deaths occur in low- and middle-income countries, particularly in sub-Saharan Africa and South Asia, where access to treatment for severe rotavirus-related diarrhea may be limited or absent. Rotavirus immunization is well recognized as the best approach to protect children from mortality and morbidity caused by severe rotavirus disease.
In 2009, the World Health Organization (WHO) recommended that all countries should include rotavirus vaccines in their national immunization programs, particularly those with high child mortality due to diarrhea [2]. Currently, 84 countries have introduced rotavirus vaccines into their national immunization programs, including 41 Gavi-eligible countries with financial support for vaccine procurement. The uptake of rotavirus vaccines in sub-Saharan Africa and the Americas has been excellent; however, progress in Asia has been insignificant, with a notable lack of introductions into national immunization programs despite the well-characterized burden of rotavirus disease [3,4]. Rotavirus disease and hospitalization have been significantly reduced in high- and middle-income countries, with multiple vaccine-effectiveness studies documenting their powerful impact [5]. Moreover, recent vaccine-effectiveness studies in low-middle–and low-income countries in Latin America and Africa have shown dramatic reductions in rotavirus-associated morbidity and mortality [6–8]. Thus, the large infant population at risk in Asia is a priority for future rotavirus introduction efforts.

The reasons for delayed vaccine introduction likely vary by country, with multiple stages along the pathway to implementation posing hurdles, including evidence gathering, decision-making, planning, and introduction. The driver for introduction may also differ; for example, perceived health benefits may be the primary reason in one area, and economic benefits may be more important in another. However, the limited data from low-resource populations across Asia, which are needed to provide evidence of the clinical protection that rotavirus vaccination provides against severe diarrhea, have also likely stalled the uptake of rotavirus vaccines within these regions.

In a recent study in PLOS Medicine, John Victor and colleagues describe effectiveness of the human monovalent rotavirus vaccine, (Rotarix) in Bangladesh [9], providing evidence that should help to change the status quo in the region. Victor and colleagues’ study is the first to evaluate protection in infants in a low-resource population in Asia, using the WHO-recommended schedule at 6 and 10 weeks of age (i.e., the visits corresponding to the first and second dose of diphtheria–pertussis–tetanus-containing vaccine [DPT 1 and DPT 2]). The trial used a cluster-randomized village approach, comparing Rotarix vaccination integrated into the routine childhood immunization program in Bangladesh to the standard childhood immunizations without rotavirus vaccine but still utilizing oral rehydration salt (ORS) and other routine standard of care. The vaccine reduced severe acute rotavirus diarrhea by 41.4% (95% CI 23.2–55.2) among vaccinees. However, vaccine-induced protection appeared to wane from 45.2% in the first year of life to 28.9% during the second year, with the latter estimate not reaching statistical significance. Also, this study did not identify any measurable indirect protective effects despite being designed to capture the full effects of a rotavirus vaccination program.

Interestingly, these effectiveness rates generated through the programmatic implementation of the vaccine are consistent with the Phase III efficacy results for another rotavirus vaccine, RotaTeq, in Bangladesh, which demonstrated 42.7% (95% CI 10.4–63.9) efficacy against moderate-to-severe rotavirus diarrhea [10]. The results also align with the Phase III efficacy data for Rotarix in Malawi: 49.4% (95% CI 19.2–68.3) [11]; waning protection was also noted in this clinical trial setting in the second year of life [12]. Finally, an indigenous Indian vaccine (Rotavac) recently demonstrated 53.6% efficacy (95% CI 35.0–66.9) against moderate-to-severe rotavirus diarrhea in India [13]. Thus, rotavirus vaccines implemented in Asia are likely to have a similar impact to that observed in Bangladesh in Victor and colleagues’ study and in Gavi-eligible countries previously.

Concerns about the costs associated with rotavirus vaccines showing limited efficacy have been raised. A recent examination of the cost effectiveness of rotavirus immunization in Bangladesh highlighted that the vaccine is cost effective, even in the scenario of no Gavi financing support (personal communication, C. Pecenka to C. Kirkwood). Similar health economic analyses consistently indicate that rotavirus vaccines are very cost-effective interventions for low- and middle-income countries with a high diarrhea burden [14].

With increasing regional evidence of the benefits of vaccination, the introduction of rotavirus vaccines in national immunization programs should be a priority for countries in the Asian region. In recent progress, India commenced introduction of locally manufactured vaccine (Rotavac), using a staged rollout that commenced in March, 2016. The first four states introduced the rotavirus vaccine into the state-based immunization program and included active monitoring for programmatic and safety concerns as the vaccine was rolled out. Vaccine effectiveness is also being assessed. During 2017–2018, the government plans to roll out the vaccine into an additional five states, reaching approximately 50% of the Indian birth cohort. Another large country, Pakistan, commenced routine rotavirus immunization, with Gavi support, in January 2017 and plans to expand immunization over the coming months. Finally, Gavi recently approved support for Bangladesh to introduce rotavirus vaccine, which is anticipated to launch in 2018.

Therefore, the report by Victor and colleagues is timely and provides excellent evidence for the health benefits of rotavirus vaccines within a low-resource setting in Asia. The vaccine-effectiveness data highlight that introduction in settings of high rotavirus disease burden will result in a large public health benefit through a significant reduction in morbidity and mortality associated with rotavirus infection. As India, Pakistan, Bangladesh, and other countries in the region scale up the programmatic use of rotavirus vaccines, we should see dramatic reductions in childhood mortality due to diarrheal disease. Furthermore, as many countries transition from Gavi support and subsequently have to pay the full vaccine costs, we will see the advent of new safe, efficacious, and lower-cost rotavirus vaccines from manufacturers in India and elsewhere in the region, which will support the long-term sustainability of national immunization programs.

PLoS Neglected Tropical Diseases
http://www.plosntds.org/
(Accessed 13 May 2017)

Research Article
A third generation vaccine for human visceral leishmaniasis and post kala azar dermal leishmaniasis: First-in-human trial of ChAd63-KH
Mohamed Osman, Anoop Mistry, Ada Keding, Rhian Gabe, Elizabeth Cook, Sarah Forrester, Rebecca Wiggins, Stefania Di Marco, Stefano Colloca, Loredana Siani, Riccardo Cortese, Deborah F. Smith, Toni Aebischer, Paul M. Kaye, Charles J. Lacey
Research Article | published 12 May 2017 PLOS Neglected Tropical Diseases
https://doi.org/10.1371/journal.pntd.0005527

Zika virus-like particle (VLP) based vaccine
Hélène Boigard, Alexandra Alimova, George R. Martin, Al Katz, Paul Gottlieb, Jose M. Galarza
Research Article | published 08 May 2017 PLOS Neglected Tropical Diseases
https://doi.org/10.1371/journal.pntd.0005608

PLoS One
http://www.plosone.org/
[Accessed 13 May 2017]

Research Article
Cost-effectiveness of pneumococcal vaccination strategies for the elderly in Korea
Jung Yeon Heo, Yu Bin Seo, Won Suk Choi, Jacob Lee, Ji Yun Noh, Hye Won Jeong, Woo Joo Kim, Min Ja Kim, Hee Young Lee, Joon Young Song
Research Article | published 12 May 2017 PLOS ONE
https://doi.org/10.1371/journal.pone.0177342

PLoS One
http://www.plosone.org/
[Accessed 13 May 2017]

Taking stock of the social determinants of health: A scoping review
Kelsey Lucyk, Lindsay McLaren
Research Article | published 11 May 2017 PLOS ONE
https://doi.org/10.1371/journal.pone.0177306
Abstract
Background
In recent decades, the social determinants of health (SDOH) has gained increasing prominence as a foundational concept for population and public health in academic literature and policy documents, internationally. However, alongside its widespread dissemination, and in light of multiple conceptual models, lists, and frameworks, some dilution and confusion is apparent. This scoping review represents an attempt to take stock of SDOH literature in the context of contemporary population and public health.
Methods
We conducted a scoping review to synthesize and map SDOH literature, informed by the methods of Arksey and O’Malley (2005). We searched 5 academic and 3 grey literature databases for “social determinants of health” and “population health” or “public health” or “health promotion,” published 2004–2014. We also conducted a search on “inequity” or “inequality” or “disparity” or “social gradient” and “Canad*” to ensure that we captured articles where this language was used to discuss the SDOH. We included articles that discussed SDOH in depth, either explicitly or in implicit but nuanced ways. We hand-searched reference lists to further identify relevant articles.
Findings
Our synthesis of 108 articles showed wide variation by study setting, target audience, and geographic scope, with most articles published in an academic setting, by Canadian authors, for policy-maker audiences. SDOH were communicated by authors as a list, model, or story; each with strengths and weaknesses. Thematic analysis identified one theme: health equity as an overarching and binding concept to the SDOH. Health equity was understood in different ways with implications for action on the SDOH.
Conclusions
Among the vast SDOH literature, there is a need to identify and clearly articulate the essence and implications of the SDOH concept. We recommend that authors be intentional in their efforts to present and discuss SDOH to ensure that they speak to its foundational concept of health equity.

Science         
12 May 2017  Vol 356, Issue 6338
http://www.sciencemag.org/current.dtl

In Depth
Pinpointing HIV spread in Africa poses risks
By Jon Cohen
Science12 May 2017 : 568-569 Restricted Access
Researchers hash out ethical, legal issues raised by large sequence database of AIDS virus.
Summary
For the first time, researchers, ethicists, lawyers, and community representatives will meet to discuss balancing the public health benefits and the potential risks of creating a massive database of HIV sequences from people living in sub-Saharan Africa. The Phylogenetics and Networks for Generalised HIV Epidemics in Africa (PANGEA HIV) consortium for the past 4 years has been sequencing HIVs plucked from blood samples that were collected from 20 different clinical trials. The relationship between these sequences allows researchers to create family trees, or phylogenies, that can reveal transmission clusters and potentially offer novel ways for public health workers to intervene and try to slow HIV’s spread. But the meeting, which will be held in London, will also discuss the way these same data can cause harm. Phylogenetic HIV information has been used to prosecute people for transmitting HIV in several countries. What’s more, the clusters can also reveal behavior that’s often criminalized or stigmatized such as men having sex with men or people injecting drugs. PANGEA HIV anonymizes the data and takes several precautions to make sure that individuals cannot be identified. But these protections have been breached in the past, and the meeting will discuss how best to make sure that people who provide their HIV samples are not punished for participating in efforts that ultimately aim to help people control their infections and slow spread in communities.

Science         
12 May 2017  Vol 356, Issue 6338
http://www.sciencemag.org/current.dtl

Policy Forum
Myriad take two: Can genomic databases remain secret
By Christi J. Guerrini, Amy L. McGuire, Mary A. Majumder
Science12 May 2017 : 586-587 Full Access
Trade-secrecy laws clash with a right to one’s health data
Summary
An ongoing legal challenge to the business model of Myriad Genetics highlights how recent policy developments have contributed to a collision between individual interests in access to personal health data and commercial interests in trade secrecy. Following a landmark ruling by the U.S. Supreme Court invalidating its patents on BRCA1/2 genetic variants (1), which increase the risk of female breast and ovarian cancer, Myriad now faces efforts to dismantle the proprietary database of variants and their clinical interpretation that it began developing when it was the exclusive provider of BRCA1/2 tests. Although the competing claims that anchor this dispute are hard to reconcile, we see room for legal compromise and opportunity for policy innovations to incentivize companies to invest in test development while ensuring that their findings can be used by others.

Vaccine
Volume 35, Issue 23, Pages 3007-3152 (25 May 2017)
http://www.sciencedirect.com/science/journal/0264410X/35/23

Conference report
Strengthening and sustainability of national immunization technical advisory groups (NITAGs) globally: Lessons and recommendations from the founding meeting of the global NITAG network
Pages 3007-3011
Alex Adjagba, Noni E. MacDonald, Inmaculada Ortega-Pérez, Philippe Duclos, 2016 Global NITAG Network Meeting Participants
Abstract
National Immunization Technical Advisory Groups (NITAGs) provide independent, evidence-informed advice to assist their governments in immunization policy formation. However, many NITAGs face challenges in fulfilling their roles. Hence the many requests for formation of a network linking NITAGs together so they can learn from each other. To address this request, the Health Policy and Institutional Development (HPID) Center (a WHO Collaborating Center at the Agence de Médecine Préventive – AMP), in collaboration with WHO, organized a meeting in Veyrier-du-Lac, France, on 11 and 12 May 2016, to establish a Global NITAG Network (GNN). The meeting focused on two areas: the requirements for (a) the establishment of a global NITAG collaborative network; and (b) the global assessment/evaluation of the performance of NITAGs. 35 participants from 26 countries reviewed the proposed GNN framework documents and NITAG performance evaluation. Participants recommended that a GNN should be established, agreed on its governance, function, scope and a proposed work plan as well as setting a framework for NITAG evaluation.

Vaccine
Volume 35, Issue 23, Pages 3007-3152 (25 May 2017)
http://www.sciencedirect.com/science/journal/0264410X/35/23

Reviews
Immunological considerations regarding parental concerns on pediatric immunizations
Review Article
Pages 3012-3019
Francesco Nicoli, Victor Appay
Abstract
Despite the fundamental role of vaccines in the decline of infant mortality, parents may decide to decline vaccination for their own children. Many factors may influence this decision, such as the belief that the infant immune system is weakened by vaccines, and concerns have been raised about the number of vaccines and the early age at which they are administered. Studies focused on the infant immune system and its reaction to immunizations, summarized in this review, show that vaccines can overcome those suboptimal features of infant immune system that render them more at risk of infections and of their severe manifestations. In addition, many vaccines have been shown to improve heterologous innate and adaptive immunity resulting in lower mortality rates for fully vaccinated children. Thus, multiple vaccinations are necessary and not dangerous, as infants can respond to several antigens as well as when responding to single stimuli. Current immunization schedules have been developed and tested to avoid vaccine interference, improve benefits and reduce side effects compared to single administrations. The infant immune system is therefore capable, early after birth, of managing several antigenic challenges and exploits them to prompt its development.

Vaccine
Volume 35, Issue 23, Pages 3007-3152 (25 May 2017)
http://www.sciencedirect.com/science/journal/0264410X/35/23

Reviews
Improving adult immunization equity: Where do the published research literature and existing resources lead?
Review Article
Pages 3020-3025
Wendy Prins, Emily Butcher, Laura Lee Hall, Gary Puckrein, Bernard Rosof
Abstract
Evidence suggests that disparities in adult immunization (AI) rates are growing. Providers need adequate patient resources and information about successful interventions to help them engage in effective practices to reduce AI disparities. The primary purposes of this paper were to review and summarize the evidence base regarding interventions to reduce AI disparities and to scan for relevant resources that could support providers in their AI efforts to specifically target disparities. First, building on a literature review conducted by the U.S. Centers for Disease Control and Prevention, we searched the peer-reviewed literature to identify articles that either discussed interventions to reduce AI disparities or provided reasons and associations for disparities. We scanned the articles and conducted an internet search to identify tools and resources to support efforts to improve AI rates. We limited both searches to resources that addressed influenza, pneumococcal, hepatitis B, Tdap, and/or herpes zoster vaccinations. We found that most articles characterized AI disparities, but several discussed strategies for reducing AI disparities, including practice-based changes, communication and health literacy approaches, and partnering with community-based organizations. The resources we identified were largely fact sheets and handouts for patients and journal articles for providers. Most resources pertain to influenza vaccination and Spanish was the most prevalent language after English. More evaluation is needed to assess the health literacy levels of the materials. We conclude that additional research is needed to identify effective ways to reduce AI disparities and more resources are needed to support providers in their efforts. We recommend identifying best practices of high performers, further reviewing the appropriateness and usefulness of available resources, and prioritizing which gaps should be addressed.

Vaccine
Volume 35, Issue 23, Pages 3007-3152 (25 May 2017)
http://www.sciencedirect.com/science/journal/0264410X/35/23

Mapping information exposure on social media to explain differences in HPV vaccine coverage in the United States
Original Research Article
Pages 3033-3040
Adam G. Dunn, Didi Surian, Julie Leask, Aditi Dey, Kenneth D. Mandl, Enrico Coiera
Abstract
Background
Together with access, acceptance of vaccines affects human papillomavirus (HPV) vaccine coverage, yet little is known about media’s role. Our aim was to determine whether measures of information exposure derived from Twitter could be used to explain differences in coverage in the United States.
Methods
We conducted an analysis of exposure to information about HPV vaccines on Twitter, derived from 273.8 million exposures to 258,418 tweets posted between 1 October 2013 and 30 October 2015. Tweets were classified by topic using machine learning methods. Proportional exposure to each topic was used to construct multivariable models for predicting state-level HPV vaccine coverage, and compared to multivariable models constructed using socioeconomic factors: poverty, education, and insurance. Outcome measures included correlations between coverage and the individual topics and socioeconomic factors; and differences in the predictive performance of the multivariable models.
Results
Topics corresponding to media controversies were most closely correlated with coverage (both positively and negatively); education and insurance were highest among socioeconomic indicators. Measures of information exposure explained 68% of the variance in one dose 2015 HPV vaccine coverage in females (males: 63%). In comparison, models based on socioeconomic factors explained 42% of the variance in females (males: 40%).
Conclusions
Measures of information exposure derived from Twitter explained differences in coverage that were not explained by socioeconomic factors. Vaccine coverage was lower in states where safety concerns, misinformation, and conspiracies made up higher proportions of exposures, suggesting that negative representations of vaccines in the media may reflect or influence vaccine acceptance.

Vaccine
Volume 35, Issue 23, Pages 3007-3152 (25 May 2017)
http://www.sciencedirect.com/science/journal/0264410X/35/23

Challenges in conducting post-authorisation safety studies (PASS): A vaccine manufacturer’s view
Original Research Article
Pages 3041-3049
Catherine Cohet, Dominique Rosillon, Corinne Willame, Francois Haguinet, Marie-Noëlle Marenne, Sandrine Fontaine, Hubert Buyse, Vincent Bauchau, Laurence Baril
Abstract
Post-authorisation safety studies (PASS) of vaccines assess or quantify the risk of adverse events following immunisation that were not identified or could not be estimated pre-licensure. The aim of this perspective paper is to describe the authors’ experience in the design and conduct of twelve PASS that contributed to the evaluation of the benefit-risk of vaccines in real-world settings. We describe challenges and learnings from selected PASS of rotavirus, malaria, influenza, human papillomavirus and measles-mumps-rubella-varicella vaccines that assessed or identified potential or theoretical risks, which may lead to changes to risk management plans and/or to label updates. Study settings include the use of large healthcare databases and de novo data collection. PASS methodology is influenced by the background incidence of the outcome of interest, vaccine uptake, availability and quality of data sources, identification of the at-risk population and of suitable comparators, availability of validated case definitions, and the frequent need for case ascertainment in large databases. Challenges include the requirement for valid exposure and outcome data, identification of, and access to, adequate data sources, and mitigating limitations including bias and confounding. Assessing feasibility is becoming a key step to confirm that study objectives can be met in a timely manner. PASS provide critical information for regulators, public health agencies, vaccine manufacturers and ultimately, individuals. Collaborative approaches and synergistic efforts between vaccine manufacturers and key stakeholders, such as regulatory and public health agencies, are needed to facilitate access to data, and to drive optimal study design and implementation, with the aim of generating robust evidence

Vaccine
Volume 35, Issue 23, Pages 3007-3152 (25 May 2017)
http://www.sciencedirect.com/science/journal/0264410X/35/23

The impacts of email reminder/recall on adolescent influenza vaccination
Original Research Article
Pages 3089-3095
Kevin J. Dombkowski, Anne E. Cowan, Sarah L. Reeves, Matthew R. Foley, Amanda F. Dempsey
Abstract
Background
We sought to: (1) explore the feasibility of using email for seasonal influenza vaccination reminders to parents of adolescents and (2) assess influenza vaccination rates among adolescents whose parents were randomized to either receive or not receive email reminders.
Methods
Email addresses were obtained for parents of patients 10–18 years from 4 practices in Michigan. Addresses were randomized to either receive email reminders, or not. Reminder messages were sent during October 2012-March 2013 (Season 1) and October 2013-March 2014 (Season 2). Vaccination status was determined 60 days following the last email reminder for each season using the statewide Michigan Care Improvement Registry (MCIR); per protocol bivariate and multivariate logistic regression analyses were conducted to evaluate reminder notification.
Results
After email cleaning, testing, and matching with MCIR, approximately half of email addresses (2348 of 5312 in Season 1; 3457 of 6549 in Season 2) were randomized. Bivariate analyses found that influenza vaccination within 60 days after notification date was similar among those notified (34%) versus not notified (29%) in both Season 1 (p = 0.06) and Season 2 (39% vs. 37%, p = 0.20). However, multivariate models adjusted for season, site, and receipt of notification in two seasons found a higher likelihood of influenza vaccination among children that received notification (aOR = 1.28, 95% CI = 1.09, 1.51); in addition, differences in influenza vaccination were also observed between practice sites (range: p = 0.15 to p < 0.001).
Conclusions
We found that practice-based email influenza vaccine reminders to parents of adolescents are feasible, but not without complications. Our study demonstrates that email reminders from practices can yield increases in influenza vaccination rates among adolescents. Practices should consider email as an option for influenza reminders and establish business practices for collecting and maintaining patient email addresses.
This study is registered at http://www.ClinicalTrials.gov id #NCT01732315.

Vaccine
Volume 35, Issue 23, Pages 3007-3152 (25 May 2017)
http://www.sciencedirect.com/science/journal/0264410X/35/23

Awareness among adults of vaccine-preventable diseases and recommended vaccinations, United States, 2015
Original Research Article
Pages 3104-3115
Peng-jun Lu, Alissa O’Halloran, Erin D. Kennedy, Walter W. Williams, David Kim, Amy Parker Fiebelkorn, Sara Donahue, Carolyn B. Bridges
Abstract
Background
Adults are recommended to receive select vaccinations based on their age, underlying medical conditions, lifestyle, and other considerations. Factors associated with awareness of vaccine-preventable diseases and recommended vaccines among adults in the United States have not been explored.
Methods
Data from a 2015 internet panel survey of a nationally representative sample of U.S. adults aged ≥19 years were analyzed to assess awareness of selected vaccine-preventable diseases and recommended vaccines for adults. A multivariable logistic regression model with a predictive marginal approach was used to identify factors independently associated with awareness of selected vaccine-preventable infections/diseases and corresponding vaccines.
Results
Among the surveyed population, from 24.6 to 72.1% reported vaccination for recommended vaccines. Awareness of vaccine-preventable diseases among adults aged ≥19 years ranged from 63.4% to 94.0% (63.4% reported awareness of HPV, 71.5% reported awareness of tetanus, 72.0% reported awareness of pertussis, 75.4% reported awareness of HZ, 75.8% reported awareness of hepatitis B, 83.1% reported awareness of pneumonia, and 94.0% reported awareness of influenza). Awareness of the corresponding vaccines among adults aged ≥19 years ranged from 59.3% to 94.1% (59.3% HZ vaccine, 59.6% HPV vaccine, 64.3% hepatitis B vaccine, 66.2% pneumococcal vaccine, 86.3% tetanus vaccines, and 94.1% influenza vaccine). In multivariable analysis, being female and being a college graduate were significantly associated with a higher level of awareness for majority of vaccine-preventable diseases, and being female, being a college graduate, and working as a health care provider were significantly associated with a higher level of awareness for majority of corresponding vaccines.
Conclusions
Although adults in this survey reported high levels of awareness for most vaccines recommended for adults, self-reported vaccination coverage was not optimal. Combining interventions known to increase uptake of recommended vaccines, such as patient reminder/recall systems and other healthcare system-based interventions, and ensuring patients’ vaccination needs are assessed, are needed to improve vaccination of adults.

Vaccine
Volume 35, Issue 23, Pages 3007-3152 (25 May 2017)
http://www.sciencedirect.com/science/journal/0264410X/35/23

Economic impact of thermostable vaccines
Original Research Article
Pages 3135-3142
Bruce Y. Lee, Patrick T. Wedlock, Leila A. Haidari, Kate Elder, Julien Potet, Rachel Manring, Diana L. Connor, Marie L. Spiker, Kimberly Bonner, Arjun Rangarajan, Delphine Hunyh, Shawn T. Brown
Abstract
Background
While our previous work has shown that replacing existing vaccines with thermostable vaccines can relieve bottlenecks in vaccine supply chains and thus increase vaccine availability, the question remains whether this benefit would outweigh the additional cost of thermostable formulations.
Methods
Using HERMES simulation models of the vaccine supply chains for the Republic of Benin, the state of Bihar (India), and Niger, we simulated replacing different existing vaccines with thermostable formulations and determined the resulting clinical and economic impact. Costs measured included the costs of vaccines, logistics, and disease outcomes averted.
Results
Replacing a particular vaccine with a thermostable version yielded cost savings in many cases even when charging a price premium (two or three times the current vaccine price). For example, replacing the current pentavalent vaccine with a thermostable version without increasing the vaccine price saved from $366 to $10,945 per 100 members of the vaccine’s target population. Doubling the vaccine price still resulted in cost savings that ranged from $300 to $10,706, and tripling the vaccine price resulted in cost savings from $234 to $10,468. As another example, a thermostable rotavirus vaccine (RV) at its current (year) price saved between $131 and $1065. Doubling and tripling the thermostable rotavirus price resulted in cost savings ranging from $102 to $936 and $73 to $808, respectively. Switching to thermostable formulations was highly cost-effective or cost-effective in most scenarios explored.
Conclusion
Medical cost and productivity savings could outweigh even significant price premiums charged for thermostable formulations of vaccines, providing support for their use.

Vaccine
Volume 35, Issue 23, Pages 3007-3152 (25 May 2017)
http://www.sciencedirect.com/science/journal/0264410X/35/23

Cost effectiveness of a targeted age-based West Nile virus vaccination program
Original Research Article
Pages 3143-3151
Manjunath B. Shankar, J. Erin Staples, Martin I. Meltzer, Marc Fischer
Abstract
Background
West Nile virus (WNV) is the leading cause of domestically-acquired arboviral disease in the United States. Several WNV vaccines are in various stages of development. We estimate the cost-effectiveness of WNV vaccination programs targeting groups at increased risk for severe WNV disease.
Methods
We used a mathematical model to estimate costs and health outcomes of vaccination with WNV vaccine compared to no vaccination among seven cohorts, spaced at 10 year intervals from ages 10 to 70 years, each followed until 90-years-old. U.S. surveillance data were used to estimate WNV neuroinvasive disease incidence. Data for WNV seroprevalence, acute and long-term care costs of WNV disease patients, quality-adjusted life-years (QALYs), and vaccine characteristics were obtained from published reports. We assumed vaccine efficacy to either last lifelong or for 10 years with booster doses given every 10 years.
Results
There was a statistically significant difference in cost-effectiveness ratios across cohorts in both models and all outcomes assessed (Kruskal-Wallis test p < 0.0001). The 60-year-cohort had a mean cost per neuroinvasive disease case prevented of $664,000 and disability averted of $1,421,000 in lifelong model and $882,000 and $1,887,000, respectively in 10-year immunity model; these costs were statistically significantly lower than costs for other cohorts (p < 0.0001). Vaccinating 70-year-olds had the lowest cost per death averted in both models at around $4.7 million (95%CI $2–$8 million). Cost per disease case averted was lowest among 40- and 50-year-old cohorts and cost per QALY saved lowest among 60-year cohorts in lifelong immunity model. The models were most sensitive to disease incidence, vaccine cost, and proportion of persons developing disease among infected.
Conclusions
Age-based WNV vaccination program targeting those at higher risk for severe disease is more cost-effective than universal vaccination. Annual variation in WNV disease incidence, QALY weights, and vaccine costs impact the cost effectiveness ratios.

From Google Scholar & other sources: Selected Journal Articles, Newsletters, Dissertations, Theses, Commentary

Obstetrics & Gynecology
129():86S–87S, MAY 2017
Challenges to National Human Papillomavirus Vaccine Program Implementation in Developing Countries [18h]
T Shirazian, C Smith, J Fisher
Abstract
INTRODUCTION:
In 2012, an estimated 527,624 women were diagnosed with cervical cancer globally, and an estimated 265,653 women died from the disease. Of deaths attributed to cervical cancer, 90% occur in low and middle-income countries (LMIC) due to lack of access to screening and treatment. Vaccines protecting against the strains of human papillomavirus (HPV) causing cervical cancer have been available since 2006, but little is known about their national implementation in LMIC.
METHODS:
Using the PubMed database, literature was reviewed for any LMIC with national or pilot HPV programs. 2014 World Bank definitions and data were used to identify LMIC. In addition to the literature search, websites of organizations with information regarding cervical cancer programs, including Cervical Cancer Action, ICO Information Centre on HPV and Cancer, and PATH, were reviewed.
RESULTS:
Thirty LMIC were identified with national HPV programs. Four of the thirty began their programs in 2015 or 2016 with little data available. Fifteen countries do not report coverage rates or programmatic features, suggesting limited scope of their HPV national programs. Of eleven countries reporting coverage rates, these rates vary dramatically, from 5% to 99%. Of countries with available data, all of them target girls aged 9-17 but use a variety of school and clinic-based delivery methods. Only three of the thirty countries receive GAVI support for vaccine purchasing.
CONCLUSION:
Given the disproportionate burden of cervical cancer-related mortality in LMIC and the availability of the HPV vaccine, further research on the effectiveness of national HPV vaccine programs is warranted.
 
American Journal of Preventive Medicine
Available online 8 May 2017
In Press, Corrected Proof
Research Article
Feasibility of Text Message Influenza Vaccine Safety Monitoring During Pregnancy
Melissa S. Stockwell, MD, MPH, Maria Cano, MD, MPH, Kathleen Jakob, BSN, Karen R. Broder, MD, Cynthia Gyamfi-Bannerman, MD, MSc, Paula M. Castaño, MD, MPH
Abstract
Introduction
The feasibility and accuracy of text messaging to monitor events after influenza vaccination throughout pregnancy and the neonatal period has not been studied, but may be important for seasonal and pandemic influenza vaccines and future maternal vaccines.
Methods
This prospective observational study was conducted during 2013–2014 and analyzed in 2015–2016. Enrolled pregnant women receiving inactivated influenza vaccination at a gestational age Results
Most (80.2%, n=166) eligible women enrolled. Median gestational age was 8.9 (SD=3.9) weeks at vaccination. Response rates remained high (80.0%−95.2%). Only one Day 0–2 fever was reported. Women reported via text both pregnancy- and non-pregnancy−specific health events, not all associated with medical visits. Most pregnancy-specific events in the electronic medical record (EMR) were reported via text message. Of all enrollees, 84.9% completed the study (131 reported live birth, ten reported pregnancy loss). Two losses reported via text were not medically attended; there was one additional EMR-identified loss. Gestational age and weight at birth were similar between text message−reported and EMR-abstracted data and 95% CIs were overlapping for proportions of prematurity, low birth weight, small for gestational age, and major birth defects, as identified by text message−reported versus EMR-abstracted plus text message−reported versus EMR-abstracted data only.
Conclusions
This study demonstrated the feasibility of text messaging for influenza vaccine safety surveillance sustained throughout pregnancy. In these women receiving inactivated influenza vaccination during pregnancy, post-vaccination fever was infrequent and a typical pattern of maternal and neonatal health outcomes was observed.
 
American Journal of Preventive Medicine
Available online 8 May 2017
In Press, Corrected Proof
Feasibility of Text Message Influenza Vaccine Safety Monitoring During Pregnancy
MS Stockwell, M Cano, K Jakob, KR Broder
Abstract
Introduction
The feasibility and accuracy of text messaging to monitor events after influenza vaccination throughout pregnancy and the neonatal period has not been studied, but may be important for seasonal and pandemic influenza vaccines and future maternal vaccines.
Methods
This prospective observational study was conducted during 2013–2014 and analyzed in 2015–2016. Enrolled pregnant women receiving inactivated influenza vaccination at a gestational age Results
Most (80.2%, n=166) eligible women enrolled. Median gestational age was 8.9 (SD=3.9) weeks at vaccination. Response rates remained high (80.0%−95.2%). Only one Day 0–2 fever was reported. Women reported via text both pregnancy- and non-pregnancy−specific health events, not all associated with medical visits. Most pregnancy-specific events in the electronic medical record (EMR) were reported via text message. Of all enrollees, 84.9% completed the study (131 reported live birth, ten reported pregnancy loss). Two losses reported via text were not medically attended; there was one additional EMR-identified loss. Gestational age and weight at birth were similar between text message−reported and EMR-abstracted data and 95% CIs were overlapping for proportions of prematurity, low birth weight, small for gestational age, and major birth defects, as identified by text message−reported versus EMR-abstracted plus text message−reported versus EMR-abstracted data only.
Conclusions
This study demonstrated the feasibility of text messaging for influenza vaccine safety surveillance sustained throughout pregnancy. In these women receiving inactivated influenza vaccination during pregnancy, post-vaccination fever was infrequent and a typical pattern of maternal and neonatal health outcomes was observed.
 
Journal of Gynecological Research and Obstetrics
Published: 08 April, 2017
Research Article
Human Papilloma Virus vaccine–awareness and acceptability amongst medical students in a tertiary teaching hospital in South India
S Haritha, S Kumar, S Lakshminarayanan, P Dasari
Abstract
Objectives: To evaluate awareness and acceptability of HPV vaccine amongst medical students in a tertiary teaching hospital.
Materials and methods: This was a cross sectional descriptive study carried out in a tertiary hospital in South India in January 2015. A self-administered questionnaire in English was given to 310 undergraduate medical students after obtaining consent. Parameters studied included awareness and acceptability of HPV vaccine. Data was analysed using SPSS 16 software.
Results: Response rate in this study was 100%.40% of students were Conclusion: There is a lack of adequate knowledge regarding HPV prevention even among medical students. Health education and awareness campaigns on HPV prevention with more attention to the benefits of vaccination are necessary in order to improve acceptance of vaccination thereby preventing cervical cancer in future.
 
The Patient – Patient-Centered Outcomes Research
First Online: 04 May 2017
Systematic Review
Individual Preferences for Child and Adolescent Vaccine Attributes: A Systematic Review of the Stated Preference Literature
C Michaels-Igbokwe, S MacDonald, GR Currie
Abstract
Background
Discrete choice experiments are increasingly used to assess preferences for vaccines and vaccine service delivery.
Objectives
To synthesize and critically assess the application of discrete choice experiments in childhood/adolescent vaccines, to describe how discrete choice experiments have been applied to understand preferences, and to evaluate the use of discrete choice experiment data to inform estimates of vaccine uptake.
Methods
We conducted a systematic review of six electronic databases. Included studies were discrete choice experiments and conjoint analyses published from 2000 to 2016 related to childhood/adolescent vaccines where respondents were parents, children/adolescents, or service providers. Validity assessment was used to assess study quality and risk of bias.
Results
In total, 27 articles were included, representing 21 different studies. A majority of articles were published between 2011 and 2016. Vaccines studied included human papillomavirus (24%), influenza (19%), meningococcal vaccines (14%), childhood vaccines (14%), hypothetical vaccines (10%), hepatitis B (5%), and diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, and Haemophilus influenzae type b (5%). Most studies assessed parent preferences (67%). The most common attributes were risk (24%), degree/duration of protection (21%), and cost (15%). Commonly reported outcome measures were estimates of uptake (33%), willingness-to-pay (22%), and other marginal rates of substitution (14%). Validity assessments yielded high scores overall. Areas of weakness included low response rates, inefficient experimental design, and failure to conduct formative qualitative work and a pilot of the discrete choice experiment.
Conclusion
This is the first systematic review of childhood/adolescent vaccine-related discrete choice experiments. In future, special attention should be paid to ensuring that choice context and discrete choice experiment design are compatible to generate reliable estimates of uptake.

Clinical Infectious Disease
Published:  10 May 2017  cix444.
DOI: https://doi.org/10.1093/cid/cix444
Correspondence
The response of the peer review system to the Ebola and Zika virus epidemic 
Andreas Ronit, MD
Copenhagen University Hospital, Blegdamsvej 9B; DK-2100 Copenhagen Ø; Denmark E-Mail: ; Phone: (+45) 3545 0859, Fax: (+45) 3545 6648
Dear Editor,
An effective and rapid response to emerging infectious diseases, such as the West African Ebola Epidemic or the Zika Virus Epidemic, requires both availability and fast dissemination of data. Hence, a number of life science journals offer fast track publications and a few journals also allow publication of papers where data was uploaded in real-time before submission (i.e. preprints) [1,2]. The latter practice is common in the physical and formal science publications, but the majority of biomedical literature is still published using the conventional peer review system [3].
Last year a seminal study assessed time from submission to acceptance of papers indexed in PubMed [4]. The primary conclusion was that paper acceptance time had been stable for 30 years at a median of approximately 100 days. Data was made available online and could be stratified according to certain journal types which enabled further analyses of the peer review system within medical specialties [5].
However, applying text mining techniques on MEDLINE data exported from PubMed, specific diseases may be studied as well. To my knowledge, there are no reports of paper acceptance time stratified by diseases entity. In lieu of the effort made by some journals to create fast track systems for situations requiring a fast response, it would be informative to assess whether the peer review systems was able to respond with faster paper acceptance times to recent viral epidemics. A lower peer review time for these diseases compared to the average PubMed paper would be expected due to the urgency and, presumably, a larger number of fast track publications.
R code for extractions of timestamps in MEDLINE can be used as a template to study peer review times associated with other diseases. This code is available as supplementary material. In short, acceptance time was calculated for all publications containing a) EBOLA[MeSH] or EBOV[MeSH] and 1980-2013[year] (before the epidemic), b) EBOLA[MeSH] or EBOV[MeSH] and 2013-2017 [year] (during and after the epidemic), c) Zika[MeSH] and 2015-2017[year] (current epidemic), and d) herpes[MeSH] and 2013-2017[year] for reference.
Histograms depict paper acceptance time for the three first categories. Ebola papers from 1980 to 2013 required a median [IQR] of 94 days (54-103), whereas Ebola papers during the recent epidemic required 63 days (27-112), P These analyses are descriptive and may be confounded by several factors including journal and publication type (e.g. commentaries or editorials). Moreover, time stamps are not available for all articles and some journals use the revision date, rather than the submission date, to indicate the start date, creating bias towards lower acceptance time.
In conclusion, although the peer review system is under debate [4], it is reassuring that the scientific journals seem to be able to respond with faster review times to recent viral epidemics.
FUNDING
The study was conducted, analyzed, and written by the author without involvement of any commercial party.
COMPETING INTERESTS
AR: Travelling grants from Gilead.

Media/Policy Watch

This watch section is intended to alert readers to substantive news, analysis and opinion from the general media and selected think tanks and similar organizations on vaccines, immunization, global public health and related themes. Media Watch is not intended to be exhaustive, but indicative of themes and issues CVEP is actively tracking. This section will grow from an initial base of newspapers, magazines and blog sources, and is segregated from Journal Watch above which scans the peer-reviewed journal ecology.

We acknowledge the Western/Northern bias in this initial selection of titles and invite suggestions for expanded coverage. We are conservative in our outlook in adding news sources which largely report on primary content we are already covering above. Many electronic media sources have tiered, fee-based subscription models for access. We will provide full-text where content is published without restriction, but most publications require registration and some subscription level.

Forbes
http://www.forbes.com/
Accessed 13 May 2017
Yet Another Measles Outbreak Traces Directly To Antivaccine Autism Panic
6 May 2017
Emily Willingham,
Contributor
History repeats itself for the nth time in a decade as yet another community suffers through a measles outbreak that traces directly to antivaccine fervor and thoroughly debunked claims that vaccines cause autism. This time, the victims of this campaign of alternative facts are members of a Somali American community in Hennepin County, Minnesota. It’s the second measles outbreak in the last few years in this particularly vulnerable population.
This latest eruption of vaccine-preventable disease has left one in four infected children hospitalized. All but two of the 44 people diagnosed so far in the state’s largest measles outbreak in almost 30 years are unvaccinated. Clinicians warn that this event is still in the early stages.
These children are unvaccinated for the same reasons that children in a 2013 Wales outbreak were unvaccinated. And for the same reasons that an outbreak that began at Disneyland spread in 2015. And for the same reasons that a Texas megachurch experienced a measles outbreak in 2013. And for the same reasons as the 2016 outbreak that started in Arizona and spread. And for the same reasons as a 2008 outbreak that began in a pediatrician’s waiting room. And for the same reasons that Minnesota already experienced a measles outbreak back in 2011, in the same community…

The Guardian
http://www.guardiannews.com/
Accessed 13 May 2017
We need a revolution in mindsets at the top of the World Health Organization
Mukesh Kapila| 9 May 2017
…The irony is that never has medical science been so productive and yet health inequalities so wide. That is why continuing to do more of the same is not an option. While extra funding is always welcome, much more necessary is a revolution in mind-sets and attitudes. This means organisational innovation to drive universal health coverage, foster collaboration, strengthen national health capacities, and forge partnerships that respect health as a fundamental human right. Hence, the centrality of WHO.
While WHO has many successes under its belt, it is heavily criticised for its costly, many-layered, self-serving bureaucracy unresponsive to real country needs. World-class health expertise has been fleeing the numerous cubicles of its huge Geneva office. Even its traditional authority to set the norms and standards for things that impact on human health is challenged by centres of excellence elsewhere. Its suspicion of civil society has alienated the groups most vital to service delivery. Its archaic governance cannot or will not hold the organisation accountable. Member states have financially starved WHO because they don’t trust it, or have bypassed it by creating other international organisations that do higher-quality health work.
However, WHO is still a quintessential public good whose reform has become an expansive industry…

Huffington Post
http://www.huffingtonpost.com/
Accessed 13 May 2017
WHO Is The Driving Force To Reach All People With Vaccines
9 May 2017
By Brice Bicaba, Director of Disease Control for Burkina Faso
…More children are being immunized worldwide than ever before, with the highest level of routine coverage in history. In Burkina Faso, we are now able to reach 91 percent of all children with routine immunization. We were among the first countries in Africa to introduce a new vaccine for rotavirus, the cause of a deadly diarrhea, we eliminated polio and we are close to eliminating measles.
We appreciate the broader benefits that a well-performing immunization program brings to overall health care. When systems for vaccine procurement and delivery operate as a fully integrated component of a health system, they can drive the move towards universal health coverage.
There is more work to be done, especially in research and development. Many children are still dying from diseases because vaccines do not exist or they are too expensive.WHO remains committed to making new vaccines more accessible, faster. It is doing this by driving initiatives around an African vaccine regulatory forum and addressing the urgent need to expand clinical trial capacity and strengthen procedures to speed up licensing of new vaccines and technologies.
WHO continues to work through powerful public-private partnerships with international and national health leaders to make immunization more than the biggest success stories of modern medicine, but the greatest success story ever. With the success of the Meningitis Vaccine project, we’re well on our way.

New York Times
http://www.nytimes.com/
Accessed 13 May 2017
Ebola Outbreak Is Declared in Congo, With at Least 3 Dead
NAIROBI, Kenya — An Ebola outbreak has been declared in northern Democratic Republic of Congo and has killed at least three people in the past three weeks, the World Health Organization said on Friday.
The affected zone is in a forested area of Lower Uele Province, and it is close to the border with the Central African Republic, the W.H.O. said.
The outbreak is not linked to previous Ebola flare-ups in Congo, nor the one that tore through West Africa in 2014, killing more than 11,000 people, said Tarik Jasarevic, a W.H.O. spokesman. That outbreak was significant because it reached major cities and began in a part of Africa that had never seen Ebola before.
Mr. Jasarevic said that there had been a number of Ebola outbreaks in the Lower Uele region since 2000. Congo has had eight outbreaks of Ebola since 1976, according to the W.H.O.
May 12, 2017 – By KIMIKO de FREYTAS-TAMURA

Wall Street Journal
http://online.wsj.com/home-page?_wsjregion=na,us&_homepage=/home/us
Accessed 13 May 2017
World
Venezuela’s Maduro Replaces Top Health Official After Data Released
By Kejal Vyas
May 12, 2017 12:40 am ET
Move comes days after publication of figures showing sharp declines in public health
Venezuela President Nicolás Maduro replaced his top health official just days after her ministry reported a severe worsening in public health in a rare release of government statistics.
After withholding data since 2015, the Health Ministry in Venezuela this week published an epidemiological bulletin showing a 30% increase in infant mortality…

Washington Post
http://www.washingtonpost.com/
Accessed 13 May 2017
The Post’s View
Opinion
Another measles outbreak that didn’t have to happen
by Editorial Board May 9, 2017

WHAT CAN an advanced nation, with high-level medical care, say to the Somali American community of Minnesota, where an outbreak of measles, highly infectious and potentially deadly, is racing ahead because many people failed to get their children vaccinated, fearing a link to autism? This is what must be said: The fears are wrong, vaccinations save lives and this community must overcome distrust in order to overcome disease. There is no excuse for ignorance, not in Minnesota or anywhere else.

As Post reporter Lena H. Sun described in an article May 5, the Somali community in Minnesota is the largest in the United States. In 2008, parents raised concerns that their children were disproportionately receiving treatment for autism spectrum disorder. A University of Minnesota study in 2010 found that Somali children were about as likely as white children to be identified with autism, but Somali children with autism were more likely to have intellectual disabilities. Although extensive research has disproved the fears of a link between vaccination and autism, Ms. Sun reported that fear of vaccination became entrenched in the Somali community. Parents kept their children from inoculation with the highly effective measles, mumps and rubella vaccine. In 2004, 92 percent of Somali children in Minnesota were vaccinated, but by 2014 the rate plummeted to 42 percent, well below the 92 to 94 percent needed to protect a group.

Fears of vaccination deepened in Minnesota after Somali parents talked to Andrew Wakefield, the anti-vaccine activist who privately visited at least three times in 2010 and 2011. Mr. Wakefield’s 1998 study purporting to show a link between vaccines and autism was later identified as fraudulent. It was retracted by the medical journal that published it, and his medical license was revoked. Mr. Wakefield said he was invited to talk to the Somali community and is not at fault for what is happening. “I don’t feel responsible at all,” he told The Post.

The measles virus, which spreads through the air when a person coughs or sneezes, recently got a foothold among the unvaccinated children in Minnesota. According to the state health department, as of May 9 there were 50 cases, of whom 45 were unvaccinated. All but three are children. More cases are expected. Measles was once a scourge that infected 3 million to 4 million Americans annually, of whom 400 to 500 died. Because of the vaccine, the disease was almost completely eradicated in the United States by 2000. However, travelers have sometimes brought it from abroad; Somalia continues to have hundreds of suspected cases.

The vaccine is safe; two doses are about 97 percent effective at preventing measles. But the existence of groups of unvaccinated children, like those in Minnesota, are an outbreak waiting to happen. This is entirely unnecessary. The events in the Somali American community are not caused by a lack of medical technology or know-how, but rather by the rise of ignorance and fear. They provide a lesson to be spread far and wide: Do not give in to mindless irrationality about vaccines. They can save lives.

Milestones :: Perspectives

Julius Youngner, Polio Vaccine Pioneer, Dies at 96
New York Times, May 04, 2017 – By SAM ROBERTS
Julius Youngner, an inventive virologist whose nearly fatal childhood illness destined him to become a medical researcher and a core member of the team that developed the Salk polio vaccine in 1955, died on April 27 at his home in Pittsburgh. He was 96.
His death was confirmed by his son, Dr. Stuart Youngner.
Dr. Youngner was the last surviving member of the original three-man research team assembled by Dr. Jonas Salk at the University of Pittsburgh to address the polio scourge, which peaked in the United States in the early 1950s when more than 50,000 children were struck by it in one year. Three other assistants later joined the group.
Dr. Salk credited his six aides with major roles in developing the polio vaccine, a landmark advance in modern medicine, which he announced on April 12, 1955.
The announcement — that the vaccine had proved up to 90 percent effective in tests on 440,000 youngsters in 44 states — was greeted with ringing churchbells and openings of public swimming pools, which had been drained for fear of contagion. Within six years, annual cases of the paralyzing disease had declined from 14,000 to fewer than 1,000.

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Populism, Politics and Measles
New York Times, The Opinion Pages – Editorial 1 May 2017
One of the tragedies of these post-truth times is that the lies, conspiracy theories and illusions spread by social media and populist politicians can be downright dangerous. The denial of human responsibility for climate change is one obvious example; another is opposition to vaccination. A serious outbreak of measles in Italy and in some other European countries could well be the result of a drop-off in vaccinations caused by utterly misguided and discredited claims about their dangers.

Vaccines are among the greatest achievements of medical science, an easily and safely administered defense against once common and often deadly diseases like measles, polio, smallpox, whooping cough and cervical cancer. Yet fear of vaccines has spread over the past two decades, fueled in part by an infamous study published in the medical journal Lancet in 1998 and later retracted and completely discredited.

More recently, President Trump has added his voice to vaccine skepticism, like this utterly unfounded and irresponsible tweet: “Healthy young child goes to doctor, gets pumped with massive shot of many vaccines, doesn’t feel good and changes – AUTISM. Many such cases!” In Italy, the populist Five Star Movement (M5S) led by the comedian Beppe Grillo has campaigned actively on an anti-vaccination platform, likewise repeating the false ties between vaccinations and autism.

To these and other skeptics, the measles outbreak in Italy should sound a piercing alarm. As of April 26, the Italian Ministry of Health had reported 1,739 cases of the disease, compared with 840 in all of 2016 and only 250 in 2015. Of those stricken, 88 percent had not been vaccinated. The danger was not only to them: 159 of the cases were health care workers infected by patients. Yet studies show that 97 percent of people who receive the recommended two doses of MMR (measles, mumps and rubella) vaccine are fully protected. Most people today would not remember a time when measles — or mumps, or polio — were commonplace.

M5S may not be responsible for the entire outbreak, since vaccine skepticism predates the party’s rise. Yet the percentage of 2-year-olds given vaccinations has steadily fallen in recent years, from 88 percent in 2013 to 86 percent in 2014 and 85.3 percent in 2015. The World Health Organization regards 95 percent as the level to achieve “herd immunity,” at which point the disease poses no threat to the entire community.

Combating vaccine skepticism is not easy, because even the countless studies by innumerable health groups affirming that there is no link between vaccines and autism have failed to penetrate the fog spread by Mr. Grillo and his ilk. The Italian measles outbreak, unfortunate as it is, does give health authorities an opportunity to strengthen their case by pointing to concrete evidence of what inevitably follows when vaccinations drop off.

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Regional Director commits continuing support to Romania to stop measles outbreak and improve immunization performance
WHO Europe, 03-05-2017
…The ongoing outbreak in Romania has spread across the country since January 2016, affecting people of all ages and causing over 4800 cases, including 23 deaths as of 28 April 2017. The highest burden has fallen on children, including 888 infants too young to be vaccinated. Of all cases, 96.6% were not vaccinated. Today, Romania is facing critical vaccine shortages or delays, including of the measles, mumps and rubella (MMR) vaccine, along with a substantial drop in immunization coverage.

At the policy dialogue event, Prime Minister Sorin Grindeanu, spoke of the government’s commitment to resolve the current vaccine supply shortage and ensure predictability, flexibility and continuity of supply in the future: “It’s a situation that can no longer be tolerated or accepted. It’s inadmissible for multiple vaccine shortage crises to occur in Romania each year.

This situation has caused suffering to those families whose children died of measles. There are no excuses for these tragedies, nor for the fact that for certain vaccines only 1 in 2 children are immunized”.

Minister of Health, Dr Florian Bodog, outlined the government’s plans to accelerate the response to the current measles outbreak through a far-reaching countrywide vaccination campaign. In the longer term the minister committed to:
:: establish an effective vaccine management system;
:: amend legislation regarding the purchasing of vaccines to keep the process transparent and predictable;
:: develop a multi-year plan for assessing the need for vaccines;
:: simplify pricing mechanisms;
:: build a national stock of vaccines for exceptional situations.

In early April 2017, the Ministry of Health introduced a new law on vaccination for public debate, which would make vaccination mandatory for kindergarten or school enrollment.

“We are open to dialogue and determined to work together to adopt the necessary legislative changes, adapting our legislation to the problems and conditions of our society,” stressed Dr Laszlo Attila, head of the Public Health Committee of the Senate of Romania during the policy dialogue on immunization…

Emergencies

Public Health Emergencies of International Concern (PHEIC) [to 6 May 2017]

POLIO
Public Health Emergency of International Concern (PHEIC)
Polio this week as of 25 April 2017
:: The Strategic Advisory Group of Experts on immunization (SAGE) convened last week in Geneva.  On polio eradication, the group noted the progress achieved in the remaining endemic countries.  Recognizing an ongoing global supply constraint of inactivated polio vaccine (IPV), the group urged countries to adopt a fractional-dose approach (1/5th of a full dose), noting that several countries which had implemented this approach are able to meet their national vaccine requirements for its populations, and to prioritize supply to routine immunization rather than to outbreak response.  SAGE also reviewed long-term immunization policy options for the post-certification world and put forward key recommendations for this period.  A summary report from the meeting is available here.

:: The report from the 13th Meeting of the International Health Regulations Emergency Committee on the international spread of poliovirus and available on www.polioeradication.org.  The Committee concluded that the current epidemiological situation continued to remain a Public Health Emergency of International Concern, and recommended the extension of the Temporary Recommendations for a further three months.[see below]

Country Updates [Selected Excerpts]
New cases or environmental samples reported across the monitored country/region settings: Afghanistan, Pakistan, Nigeria, Lake Chad Basin. Guinea and West Africa, and Lao People’s Democratic Republic have been removed from the monitored geographies list.
Pakistan
:: Seven new WPV1 positive environmental samples were reported in the past week, all collected in April, from Islamabad, Pishin (Balochistan), Peshawar (Khyber Pakhtunkhwa), and Sindh (three from greater Karachi and one from Sukkur in northern Sindh).

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Statement of the 13th IHR Emergency Committee regarding the international spread of poliovirus
WHO statement 2 May 2017
[Excerpts; text bolding by Editor]
The thirteenth meeting of the Emergency Committee under the International Health Regulations (2005) (IHR) regarding the international spread of poliovirus was convened via teleconference by the Director General on 24 April 2017.

The Emergency Committee reviewed the data on wild poliovirus (WPV1) and circulating vaccine­derived polioviruses (cVDPV). The Secretariat presented a report of progress for affected IHR States Parties subject to Temporary Recommendations. The following IHR States Parties presented an update on the implementation of the WHO Temporary Recommendations since the Committee last met on 7 February 2017: Afghanistan, Pakistan, Nigeria, and Equatorial Guinea. The committee also invited the Russian Federation and the Netherlands to provide information about polio events in their respective territories.

Wild polio
Overall the Committee was encouraged by continued steady progress in all three WPV1 infected countries, Pakistan, Afghanistan, and Nigeria, and the fall in the number of cases globally. While falling transmission in these three countries decreased the risk of international spread, the consequences should spread occur would represent a significant set-back to eradication and a risk to public health….

Vaccine derived poliovirus
The committee noted that there were no new outbreaks of cVDPV, and no new cases in the three current cVDPV2 outbreaks (Borno and Sokoto in northern Nigeria, and in Quetta Pakistan). However, these outbreaks highlighted the presence of vulnerable under immunized populations in countries with endemic transmission. The committee noted the comprehensive response to these outbreaks.

The Russian Federation provided an update on the actions taken following the detection of VDPV2s in two children from the Chechen Republic and Moscow, but the committee noted there were still some important gaps in the information and the final classification of the case is therefore pending. However, the surveillance and immunization activities taken in response to this event were welcomed, and there appears to be very little risk of international spread.

In Lao PDR, the most recent case of cVDPV had onset in January 2016, and based on the most recent outbreak response assessment and the criteria of the committee, the country is no longer considered as infected, but remains vulnerable.

Conclusion
The Committee unanimously agreed that the risk of international spread of poliovirus remains a Public Health Emergency of International Concern (PHEIC), and recommended the extension of revised Temporary Recommendations for a further three months…

…Based on the advice concerning WPV1 and cVDPV, and the reports made by Afghanistan, Pakistan, Nigeria, and Equatorial Guinea, the Director General accepted the Committee’s assessment and on 2 May 2017 determined that the events relating to poliovirus continue to constitute a PHEIC, with respect to WPV1 and cVDPV. The Director General endorsed the Committee’s recommendations for countries falling into the definition for ‘States infected with WPV1, cVDPV1 or cVDPV3 with potential risk for international spread’, ‘States infected with cVDPV2’ and for ‘States no longer infected by WPV1 or cVDPV, but which remain vulnerable to re-infection by WPV or cVDPV’ and extended the Temporary Recommendations as revised by the Committee under the IHR to reduce the risk of international spread of poliovirus, effective 2 May 2017.

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WHO Grade 3 Emergencies  [to 6 May 2017]
Iraq  – No new announcements identified
Yemen – No new announcements identified
Nigeria – No new announcements identified
South Sudan  – No new announcements identified
The Syrian Arab Republic  – No new announcements identified

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WHO Grade 2 Emergencies  [to 6 May 2017]
Cameroon  – No new announcements identified.
Central African Republic  – No new announcements identified.
Democratic Republic of the Congo – No new announcements identified.
Ethiopia – No new announcements identified.
Libya – No new announcements identified.
Myanmar – No new announcements identified.
Niger  – No new announcements identified.
Ukraine  – No new announcements identified.

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UN OCHA – L3 Emergencies
The UN and its humanitarian partners are currently responding to three ‘L3’ emergencies. This is the global humanitarian system’s classification for the response to the most severe, large-scale humanitarian crises. 
Iraq
:: Iraq: Mosul Humanitarian Response Situation Report No. 31 (24 April to 30 April 2017) [EN/AR/KU]
:: Support provided to Yazidi survivors of kidnapping and sexual violence [EN/AR/KU]
Report Published on 30 Apr 2017

Syrian Arab Republic
:: 5 May 2017 Leo Messi Foundation helps UNICEF get Syrian children back into the classroom

UN OCHA – Corporate Emergencies
When the USG/ERC declares a Corporate Emergency Response, all OCHA offices, branches and sections provide their full support to response activities both at HQ and in the field.
Somalia
:: Somalia: Drought Response – Situation Report No. 6 (as of 30 April 2017)
:: Humanitarian Bulletin Somalia April 2017 | Issued on 4 May 2017

Ethiopia
:: 2 May 2017 Ethiopia Weekly Humanitarian Bulletin, 01 May 2017

Nigeria – No new announcements identified.

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Editor’s Note:
We will cluster these recent emergencies as below and continue to monitor the WHO webpages for updates and key developments.
 

EBOLA/EVD [to 6 May 2017]
http://www.who.int/ebola/en/
4 May 2017
Leaders gather in Guinea to celebrate Ebola vaccine successes
“The world is far better prepared for another Ebola outbreak,” said Dr Margaret Chan, Director-General of the World Health Organization, today at a celebratory event to recognize the Governments and people of the three most-affected countries for their contribution to the control of the Ebola outbreak in 2014-15.

Dr Chan joined the President of the Republic of Guinea, HE Professor Alpha Conde, His Excellency Minister of Health, Dr Abdourahmane Diallo, and representatives from the Governments of Liberia and Sierra Leone, in celebrating the successful development of the world’s first vaccine against Ebola. Dr Matshidiso Moeti, Regional Director of WHO’s Office of the African Region, was also present at this celebration.

“This truly remarkable achievement is thanks to collaborative efforts of the Government of Guinea, health workers, local and international scientists, public and private entities, international donors and, above all, the thousands of people who consented to be vaccinated in this vaccine trial,” she said.

In December 2016, The Lancet published results of the WHO-led Guinea ring vaccination trial, showing that the world’s first Ebola vaccine provides substantial protection. Among more than 11 000 people who were vaccinated in the trial, no cases of Ebola virus disease occurred.

Building on the work done to fast-track the development and testing of this vaccine, WHO established the R&D Blueprint to help cut the time in future for the development of new vaccines and treatments against new and emerging infectious diseases including Lassa Fever and MERS Coronavirus.

Dr Chan presented certificates to selected individuals for their remarkable contribution to the vaccine trial as well as the control of the Ebola outbreak in Guinea, Liberia and Sierra Leone.
:: Opening remarks by WHO Director-General at the Ebola vaccines for Guinea and the world event

WHO & Regional Offices [to 6 May 2017]

Somalia launches second cholera vaccination campaign in Baidoa
3 May 2017 – WHO and the Federal Ministry of Health of Somalia launched the first round of a preventative oral cholera vaccination campaign (OCV) today in Baidoa at the Baidoa Regional Hospital, targeting 224 000 persons aged 1 year and older.

The launch was attended by the President of South West State H.E. Sharif Hassan Sheikh Adan, Somalia’s Minister of Health and Social Services H.E. Dr Fawziya Abikar, WHO Representative for Somalia Dr Ghulam Popal and state Minister of Health Issak Ali Subag along with the community, local leaders and representative of UN and NGO partners.

The vaccination campaign is in response to a major cholera outbreak in Somalia that began in January 2017. Since the beginning of the year, a total of 31 674 cases and 618 deaths have been reported in Somalia. Of these, 18 608 cases and 415 deaths have been reported in the South West State, which is nearly 60% of all AWD/ cholera cases reported in the country.

The start of the rainy season has brought some respite to the community where clean water sources are scare, however, the effects of the drought in Somalia have had its harsh impact. Lack of access to clean water and hygiene, food insecurity and malnutrition caused by drought have increased cases of cholera in the area.

The vaccination campaign is conducted in 2 rounds and will conclude before the start of Ramadan. The cholera vaccine does not replace traditional preventative measures such as access to clean water and safe hygiene practises. Supplementing the cholera vaccine, water treatment tablets were distributed to the community during the campaign by the WASH cluster.

H.E. Dr Fawziya Abikar thanked WHO for supporting the Ministry of Health in introducing oral cholera vaccines in the country. “This is an important step to prevent the further spread of cholera and we are thankful to WHO and partners for their continued support in containing this outbreak,” she said.

The OCV campaign in Baidoa follows a successful vaccination campaign that was implemented in 7 high-risk districts in Banadir, Hiraan and Lower Jubba regions. A concurrent vaccination campaign has also started in Jowhar in Middle Shebelle region this week, targeting 239000 vulnerable persons aged 1 year and above.

Dr Ghulam Popal reiterated WHO’s commitment to support cholera response efforts across the country. “We are working with health authorities at all levels and humanitarian partners to limit this outbreak,” he said.

The vaccination campaigns are supported by the Global Task Force on Cholera Control, GAVI the Vaccine Alliance, UNICEF, Sweden and health partners in its various stages of planning and implementation. WHO is also engaged in planning, organization and monitoring of the campaigns.

Disease outbreak news [DONs]

:: Unexplained cluster of deaths – Liberia  5 May 2017
:: Hepatitis E – Niger 5 May 2017
:: Human infection with avian influenza A(H7N9) virus – China  1 May 2017

Highlights
Noncommunicable diseases: the slow motion disaster
May 2017 — Of all the major health threats to emerge, none has challenged the very foundations of public health so profoundly as the rise of chronic noncommunicable diseases. Heart disease, cancer, diabetes, and chronic respiratory diseases, once linked only to affluent societies, are now global, and the poor suffer the most.

“Fight antibiotic resistance… it’s in your hands”
May 2017 – World Hand Hygiene Day, marked globally on 5 May, highlights the importance of hand hygiene in health care. The slogan of this year’s campaign illustrates the important relationship between good infection prevention and control practices like washing your hands and preventing antibiotic resistance.

Drowning: confronting the silent killer in the Philippines
May 2017 – In the Philippines, an average of 3276 deaths per year from accidental drowning and submersion were recorded in 2006–2013. To address this, WHO, the Philippine Department of Health, local government units, and Bloomberg Philanthropies undertook a drowning prevention project.

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Weekly Epidemiological Record, 5 May 2017, vol. 92, 18 (pp. 229–240)
:: Progress towards measles elimination – African Region, 2013–2016 :: Monthly report on dracunculiasis cases, January– March 2017

GIN April 2017 pdf, 1.21Mb 1 May 2017

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WHO Regional Offices
Selected Press Releases, Announcements
WHO African Region AFRO
:: High-level meeting on Ebola Vaccines gets underway in Conakry, Guinea [undated]
WHO Regional Director for Africa Dr Matshidiso Moeti and the Director-General of WHO, Dr Margaret Chan are in Conakry, Guinea to participate in the high-level meeting on Ebola Vaccines for Guinea and the World
:: In Kenya, the path to elimination of malaria is lined with good preventions – 02 May 2017

WHO Region of the Americas PAHO
:: Traffic speed management key to saving lives, making cities more livable (05/04/2017)
:: Hand hygiene is key to safe care and prevention of antibiotic resistance (05/04/2017)

WHO South-East Asia Region SEARO
No new announcements identified.

 WHO European Region EURO
:: Hand hygiene a key defence in Europe’s fight against antibiotic resistance 04-05-2017
:: Highlighting nurses and midwives’ commitment to delivering the highest quality care 04-05-2017
:: Regional Director commits continuing support to Romania to stop measles outbreak and improve immunization performance 03-05-2017
:: WHO Regional Director for Europe highlights key health aspects for SDG implementation at the first Regional Forum on Sustainable Development 03-05-2017
:: Georgia hosts meeting on improving antenatal care in eastern Europe and central Asia 02-05-2017

WHO Eastern Mediterranean Region EMRO
:: Antimicrobial resistance: now a political priority  May 2017

WHO Western Pacific Region
:: Slow down to save lives  5 May 2017

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CDC/ACIP [to 6 May 2017]
http://www.cdc.gov/media/index.html

Press Release
Friday, May 05, 2017
CDC updates guidance on interpretation of Zika testing results for pregnant women
Recommendations focus on women who live in or frequently travel to areas with a CDC Zika travel notice
The Centers for Disease Control and Prevention (CDC) today issued a Health Alert Notice with updated guidance for healthcare professionals to interpret Zika test results for women who live in, or frequently travel (daily or weekly) to areas with a CDC Zika travel notice.

This change is being made because CDC’s Zika testing guidance for pregnant women relies, in part, on a test [Zika virus Immunoglobulin M (IgM) ELISA] to detect Zika antibodies or proteins that the body makes to fight Zika infections. New data suggest that Zika virus infection, similar to some other flavivirus infections, may result in Zika antibodies staying in the body for months after infection for some individuals. As a result, results of these tests may not be able to determine whether women were infected before or after they became pregnant.

Specifically, CDC recommends the following guidance for healthcare professionals evaluating women without symptoms who had potential Zika exposure—particularly women who live in or frequently travel (daily or weekly) to areas with CDC Zika travel notices. Use of these tests may be helpful, but may not always be conclusive, in distinguishing how recent the infection is.

:: Screen pregnant women for risk of Zika exposure and symptoms of Zika. Test pregnant women promptly, using nucleic acid testing (NAT), if they develop symptoms at any point during pregnancy or if their sexual partner tests positive for Zika virus infection;
:: Consider NAT testing at least once during each trimester of pregnancy to detect evidence of Zika virus, unless a previous test has been positive;
:: Consider testing specimens obtained during amniocentesis to detect evidence of Zika virus if amniocentesis is performed for other reasons;
:: Counsel all pregnant women each trimester about the limitations of Zika testing.’’…

MMWR News Synopsis for May 4, 2017
Progress Toward Measles Elimination — African Region, 2013–2016
CDC Media Relations (404) 639-3286
To eliminate measles by 2020, countries in the region and partners need to 1) achieve ≥95% two-dose measles vaccine coverage through improved immunization services, including introducing a second vaccine dose of measles into routine immunization schedules; 2) improve vaccine campaign quality by preparing 12–15 months in advance, and using related preparation and assessment tools; 3) fully perform necessary disease surveillance for elimination purposes; 4) conduct annual district-level risk assessments; and 5) establish commissions to verify measles elimination. Countries in the World Health Organization African Region show progress and setbacks toward a regional goal of measles elimination by 2020. The number of new cases annually in the region has decreased by 63% from 2013 to 2016. However, not enough children are receiving the recommended two doses of vaccine to provide full protection against measles. The majority of children in the region not being fully protected against measles reside in four countries: Nigeria, Ethiopia, the Democratic Republic of the Congo, and Angola; these countries also account for the majority of the region’s measles cases each year. Only half of all African Region countries have introduced a second vaccine dose against measles. For the region to eliminate measles by 2020, efforts are needed for countries to achieve ≥95% two-dose coverage.

Announcements

PATH [to 6 May 2017]
http://www.path.org/news/index.php
Press release | May 01, 2017
Biovac and PATH announce partnership to develop novel vaccine against newborn infection
South African manufacturer will be the first in a low-resource country to develop a vaccine against Group B Streptococcus vaccine, a leading cause of severe infection in infants
Durban, South Africa, 2 May 2017—The South Africa–based Biovac Institute (Biovac) and PATH, an international health organization, are pleased to announce the launch of a collaborative partnership to develop a novel vaccine against Group B Streptococcus (GBS), supported by a grant from the Bill & Melinda Gates Foundation. The partnership was announced today at the Innovation Effect Africa symposium held alongside the World Economic Forum event in Durban.
Biovac, a public-private partnership based in Cape Town, will be one of only three companies in the world and the only developing-country vaccine manufacturer to develop a novel conjugate vaccine against GBS….

Announcement | May 01, 2017
PATH Statement on the US Fiscal Year 2017 Appropriations Bill
PATH Applauds Congress for Protecting Vital Health Programs

Press release | May 01, 2017
Powering African innovation for health and economic growth
Leaders convene ahead of the World Economic Forum on Africa to accelerate investment in African-led innovation

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Human Vaccines Project [to 6 May 2017]
http://www.humanvaccinesproject.org/media/press-releases/
03 May, 2017
Jose-Maria Fernandez Joins The Human Vaccines Project Board Of Directors
NEW YORK, May 3, 2017 /PRNewswire-USNewswire/ — The Human Vaccines Project, a nonprofit public-private partnership focused on decoding the immune system to improve human health, today announced the board appointment of Jose-Maria Fernandez, managing partner at Altamar Credit, Altamar Capital Partners LLC. Fernandez brings extensive experience in economics, finance and capital markets to the post. He formerly served as Director General of the Spanish Treasury.
“Jose-Maria brings deep expertise in financial markets in the US and Europe. Engaging him as part of our team will strengthen our current board as we continue to expand our project and reach,” said Wayne C. Koff, president and CEO of the Human Vaccines Project. “Along with his background in business leadership and finance, he brings a strong personal commitment to seeing biomedical research expand and improve to advance global public health.”…

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Global Fund [to 6 May 2017]
http://www.theglobalfund.org/en/news/?topic=&type=NEWS;&country=
News
Global Fund Accelerates Efforts To End Epidemics
04 May 2017
KIGALI, Rwanda – At its 37th Meeting, the Board of the Global Fund to Fight AIDS, Tuberculosis and Malaria took significant steps toward increasing impact and maximizing effectiveness in its goal of ending epidemics, which will achieve greater health security and long-term prosperity.
Taking on serious challenges like expanding impact in public health as more countries transition toward domestic funding, the Board addressed numerous issues on how to continue to expand prevention, treatment and care for people affected by HIV, TB and malaria in the coming years.
The Global Fund is embedding into its work the principles and practices of a new policy on sustainability, transition and co-financing. It aims to leverage additional sources of funding, strengthen domestic investment and co-financing of core interventions, while planning for long-term transition.

In his final address to the Board, outgoing Executive Director Mark Dybul weaved together global dynamics as he pointed to a clear direction for the Global Fund: working together collaboratively, optimizing portfolio management, improving program quality and efficiency, and constantly looking for ways to maximize the impact of funds in countries where we invest. Dr. Dybul completes a four-year term on 31 May 2017. Marijke Wijnroks, currently Chief of Staff, will serve as Interim Executive Director until the Board selects a replacement for Dr. Dybul.

The Board confirmed an Executive Director Nomination Committee with nine members to oversee the search for the Global Fund’s next Executive Director. The Global Fund anticipates soliciting applications for the position beginning in early June, and intends to select a new Executive Director at the Board’s next meeting in November 2017…

News
Global Fund Board Selects New Chair and Vice-Chair
03 May 2017
KIGALI, Rwanda – The Board of the Global Fund to Fight AIDS, Tuberculosis and Malaria selected Aida Kurtović as its new Chair, after serving as Vice-Chair for the past two years. The Board also selected Ambassador John Simon as incoming Vice-Chair.
Kurtović, who is from Bosnia and Herzegovina, was selected for a two-year term during a Board meeting that is being hosted by the government of Rwanda…
As Chair of the Board, Kurtović succeeds Norbert Hauser of Germany, whose term began in April 2015.
Ambassador John Simon, selected as Vice-Chair of the Board, is a distinguished government official with special expertise in innovative finance, and is currently founder and managing partner of Total Impact Capital, an impact investing firm. He has served as United States Ambassador to the African Union, and as Executive Vice President of the Overseas Private Investment Corporation (OPIC)…

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UNAIDS [to 6 May 2017]
http://www.unaids.org/
Selected Press Releases & Updates
Update
PEPFAR is on track to deliver yet more results
04 May 2017
Since its establishment in 2003, the United States President’s Emergency Plan for AIDS Relief (PEPFAR) has saved millions of lives. In 2016, around 11.5 million people living with HIV had access to antiretroviral treatment through PEPFAR-funded programmes, including 1.1 million children. Nearly 2 million babies born to women living with HIV were born HIV-free, and 6.2 million orphans and other vulnerable children received care and support.
In addition, PEPFAR funding supported more than 11.7 million voluntary medical male circumcision procedures to help prevent HIV acquisition and one million adolescent girls and young women were reached through the DREAMS initiative in 10 countries in sub-Saharan Africa.
And PEPFAR is on track to continue to deliver yet more results. Through a series of consultations over the past three months, PEPFAR has completed planning for its 2017 funding cycle to support more than 30 countries through Country Operational Plans…

Update
Generating evidence to ensure HIV is part of social protection
04 May 2017
Widely used in developed countries to maintain living standards and address transient poverty, social protection has now become an essential element of modern development efforts. Social protection in developing countries encompasses a range of programmes designed to help lift people out of poverty and prevent, manage and overcome situations that adversely affect their well-being.
To ensure that HIV is considered and integrated appropriately into social protection programmes, UNAIDS and partners have developed an HIV and social protection assessment tool. The tool has been designed to analyse social protection schemes and establish whether they take into account the needs of people at higher risk of contracting HIV and people living with and affected by the virus…

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IVI  [to 6 May 2017]
http://www.ivi.int/
IVI Annual Report 2015
May 2017
[Excerpt from introductory letter from IVI Director General Jerome H. Kim, MD]
…IVI is the first international organization hosted by the Republic of Korea, which has since seen the establishment of several international organizations and UN offices. We are pleased to South Korea’s partner in international cooperation efforts, particularly in global health. We also appreciate the long-standing support and trust of our other key funders, Sweden and the Bill & Melinda Gates Foundation.
Shortly after my appointment, it was universally agreed that IVI was in need of revitalization so we underwent a strategic refresh in 2015. With support from the Boston Consulting Group (BCG), we reviewed and reevaluated our core capabilities and redefined our direction. The eight-month long process resulted in major organizational and strategic changes for the organization:
:: Revised mission statement to reflect our expanded focus on new and emerging diseases of global health importance such as MERS.
:: Articulation of a more clear direction that builds on our best-in-class product development and translational capabilities.
:: Renewed focus on diseases where we have exceptional expertise and experience, such as cholera, typhoid, dengue, hepatitis E, and MERS.
:: Reorganized scientific structure designed to facilitate cross-departmental communication and to focus talent against highest priority activities.
:: Streamlined core cost structure that ensures financial sustainability and operational efficiency.
:: Renewed focus on strengthening relationships with key funders and stakeholders to ensure IVI will be at the forefront of efforts to develop affordable vaccines for global health…

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Wellcome Trust [to 6 May 2017]
https://wellcome.ac.uk/news
Opinion / Published: 3 May 2017
Is public mistrust of expertise damaging research?
What does the world think about ‘experts’ – and how does that make you feel? We’re exploring the role of expertise in research, policy making and wider society in our four-week #ExpertDebate.
Over the past couple of years, there seems to have been a pushback in society on ‘experts’, whether it’s politicians saying that people have had enough of experts, or a rejection of scientific consensus on issues such as climate change, vaccination, or evidence-based decision-making.
We think this could be hindering the environment for research to thrive. So we’re holding a four-week debate on Facebook (opens in a new tab) and Twitter (opens in a new tab) to explore the role of expertise, find out what the issues are and see what, if anything, Wellcome as an organisation might be able to do to help…

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European Medicines Agency [to 6 May 2017]
http://www.ema.europa.eu/ema/
05/05/2017
New guide on biosimilar medicines for healthcare professionals
Increasing understanding of biosimilar medicines
The European Medicines Agency (EMA) and the European Commission have published an information guide for healthcare professionals on biosimilar medicines. Biosimilars are biological medicines that are highly similar in all essential aspects to a biological medicine that has already been authorised.
The objective of the guide is to provide healthcare professionals with reference information on both the science and regulation underpinning the use of biosimilars.
“Today, biosimilars are an integral part of the effective biological therapies available in the EU,” said Professor Guido Rasi, EMA’s Executive Director. “Given the role of healthcare professionals on the front line of patient care, it is vital that they have access to reliable information on these medicines: what they are and how they are developed, approved and monitored.”…

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Journal Watch

   Vaccines and Global Health: The Week in Review continues its weekly scanning of key peer-reviewed journals to identify and cite articles, commentary and editorials, books reviews and other content supporting our focus on vaccine ethics and policy. Journal Watch is not intended to be exhaustive, but indicative of themes and issues the Center is actively tracking. We selectively provide full text of some editorial and comment articles that are specifically relevant to our work. Successful access to some of the links provided may require subscription or other access arrangement unique to the publisher.

If you would like to suggest other journal titles to include in this service, please contact David Curry at: david.r.curry@centerforvaccineethicsandpolicy.org

American Journal of Infection Control
May 01, 2017 Volume 45, Issue 5, p463-582, e45-e52
http://www.ajicjournal.org/current

Brief Reports
Seasonal influenza vaccination among Chinese health care workers
Paul H. Lee, Benjamin J. Cowling, Lin Yang
p575–578
Published online: September 21, 2016
Highlights
:: 13% of Chinese healthcare workers (HCWs) received influenza vaccination in 2014-2015.
:: 98% of doctors and 99% of nurses maintained their vaccination practice over 4 seasons.
:: Doctors aged ≥45 and worked in surgical departments were more likely to be vaccinated.
:: Nurses who received influenza training and recommended high-risk patients to be vaccinated were more likely to be vaccinated.
We conducted a study to examine the knowledge, attitudes, and opinions of health care workers (HCWs) and the factors associated with receipt of influenza vaccination in HCWs during August 2015 in 3 hospitals in Jiangsu Province, China. Among the 173 doctors and 220 nurses included in this study, the proportions who received vaccination for the 2014-2015 season were 14% and 13%, respectively. Ninety-eight percent of doctors and 99% of nurses maintained their vaccination practice over 4 seasons.

American Journal of Public Health
Volume 107, Issue 5 (May 2017)
http://ajph.aphapublications.org/toc/ajph/current

AJPH POLICY – REFUGEES
Evaluation of Measles-Mumps-Rubella Vaccination Among Newly Arrived Refugees
American Journal of Public Health: May 2017, Vol. 107, No. 5: 684–686.
Deborah Lee, Michelle Weinberg, Stephen Benoit
Abstract
Objectives. To assess US availability and use of measles-mumps-rubella (MMR) vaccination documentation for refugees vaccinated overseas.
Methods. We selected 1500 refugee records from 14 states from March 2013 through July 2015 to determine whether overseas vaccination records were available at the US postarrival health assessment and integrated into the Advisory Committee on Immunization Practices schedule. We assessed number of doses, dosing interval, and contraindications.
Results. Twelve of 14 (85.7%) states provided data on 1118 (74.5%) refugees. Overseas records for 972 (86.9%) refugees were available, most from the Centers for Disease Control and Prevention’s Electronic Disease Notification system (66.9%). Most refugees (829; 85.3%) were assessed appropriately for MMR vaccination; 37 (3.8%) should have received MMR vaccine but did not; 106 (10.9%) did not need the MMR vaccine but were vaccinated.
Conclusions. Overseas documentation was available at most clinics, and MMR vaccinations typically were given when needed. Further collaboration between refugee health clinics and state immunization information systems would improve accessibility of vaccination documentation.

American Journal of Tropical Medicine and Hygiene
Volume 96, Issue 5, 2017
http://www.ajtmh.org/content/current

Perspective Pieces
Motorcycles, Cell Phones, and Electricity Can Dramatically Change the Epidemiology of Infectious Disease in Africa
Authors: Jean-Christophe Lagier, Cheikh Sokhna and Didier Raoult
https://doi.org/10.4269/ajtmh.16-0290
Abstract
Some observations and recent publications demonstrated, particularly in Africa, the potential influence that low-cost motorcycles, cell phones, and even widespread electrification could have on the evolution of infectious diseases, particularly zoonoses. Our reflections support the conclusion that we should focus on the real-time surveillance systems including alerting systems leading to a rapid and flexible response rather than the strongly limited modeling of infectious diseases because of the continuous evolution of microorganisms, as well as changes in the environment and human habits that are unpredictable.

BMC Cost Effectiveness and Resource Allocation
http://resource-allocation.biomedcentral.com/
(Accessed 6 May 2017)

Review
Economic evaluations of vaccines in Canada: a scoping review
Ellen R. S. Rafferty, Heather L. Gagnon, Marwa Farag and Cheryl L. Waldner
Published on: 5 May 2017
Abstract
Background
This study aims to summarise and describe the evolution of published economic evaluations of vaccines in Canada, thereby outlining the current state of this expanding and meaningful research.
Methods
Using Arksey and O’Malley’s scoping review framework we assembled relevant research from both academic and grey literature. Following abstract and full-text review we identified 60 articles to be included in the final analysis.
Results
We found that since 1988 there has been a steady increase in the number of economic evaluations on vaccines in Canada. Many of these studies focus on the more recently licensed vaccines, such as influenza (16.7%), human papillomavirus (15.0%) and pneumococcal disease (15.0%). Since 2010 economic evaluations of vaccines have shown increased adherence to economic evaluation guidelines (OR = 4.6, CI 1.33, 18.7), suggesting there has been improvement in the consistency and transparency of these studies. However, there remains room for improvement, for instance, we found evidence that studies who stated a conflict of interest are more likely to assert the vaccine of interest was cost-effective (OR = 7.4; CI 1.04, 17.8). Furthermore, most reports use static models that do not consider herd immunity, and only a few evaluate vaccines post-implementation (ex-post) and traveller’s vaccinations.
Conclusion
Researchers should examine identified research gaps and continue to improve standardization and transparency when reporting to ensure economic evaluations of vaccines best meet the needs of policy-makers, other researchers and the public.

BMC Infectious Diseases
http://www.biomedcentral.com/bmcinfectdis/content
(Accessed 6 May 2017)

Research article
Assessing real-time Zika risk in the United States
Confirmed local transmission of Zika Virus (ZIKV) in Texas and Florida have heightened the need for early and accurate indicators of self-sustaining transmission in high risk areas across the southern United S…
Lauren A. Castro, Spencer J. Fox, Xi Chen, Kai Liu, Steven E. Bellan, Nedialko B. Dimitrov, Alison P. Galvani and Lauren Ancel Meyers
BMC Infectious Diseases 2017 17:284
Published on: 4 May 2017

BMC Medicine
http://www.biomedcentral.com/bmcmed/content
(Accessed 6 May 2017)

Research article
Application of real-time global media monitoring and ‘derived questions’ for enhancing communication by regulatory bodies: the case of human papillomavirus vaccines
Priya Bahri, Julianna Fogd, Daniel Morales and Xavier Kurz
BMC Medicine 2017 15:91
Published on: 2 May 2017
Abstract
Background
The benefit-risk balance of vaccines is regularly debated by the public, but the utility of media monitoring for regulatory bodies is unclear. A media monitoring study was conducted at the European Medicines Agency (EMA) concerning human papillomavirus (HPV) vaccines during a European Union (EU) referral procedure assessing the potential causality of complex regional pain syndrome (CRPS) and postural orthostatic tachycardia syndrome (POTS) reported to the authorities as suspected adverse reactions.
Methods
To evaluate the utility of media monitoring in real life, prospective real-time monitoring of worldwide online news was conducted from September to December 2015 with inductive content analysis, generating ‘derived questions’. The evaluation was performed through the validation of the predictive capacity of these questions against journalists’ queries, review of the EMA’s public statement and feedback from EU regulators.
Results
A total of 4230 news items were identified, containing personal stories, scientific and policy/process-related topics. Explicit and implicit concerns were identified, including those raised due to lack of knowledge or anticipated once more information would be published. Fifty derived questions were generated and categorised into 12 themes. The evaluation demonstrated that providing the media monitoring findings to assessors and communicators resulted in (1) confirming that public concerns regarding CRPS and POTS would be covered by the assessment; (2) meeting specific information needs proactively in the public statement; (3) predicting all queries from journalists; and (4) altering the tone of the public statement with respectful acknowledgement of the health status of patients with CRSP or POTS.
Conclusions
The study demonstrated the potential utility of media monitoring for regulatory bodies to support communication proactivity and preparedness, intended to support trusted safe and effective vaccine use. Derived questions seem to be a familiar and effective format for presenting media monitoring results in the scientific-regulatory environment. It is suggested that media monitoring could form part of regular surveillance for medicines of high public interest. Future work is recommended to develop efficient monitoring strategies for that purpose.

Bulletin of the World Health Organization
Volume 95, Number 5, May 2017, 313-388
http://www.who.int/bulletin/volumes/95/5/en/

EDITORIALS
Tuberculosis and antimicrobial resistance – new models of research and development needed
Grania Brigden, José Luis Castro, Lucica Ditiu, Glenda Gray, Debra Hanna, Marcus Low, Malebona Precious Matsoso, Greg Perry, Melvin Spigelman, Souyma Swaminathan, Els Torreele & Sidney Wong http://dx.doi.org/10.2471/BLT.17.194837

Tuberculosis is a disease that needs more investment in research and development. More people – 1.4 million in 2015 – die from tuberculosis every year than from human immunodeficiency virus (1.1 million deaths; 400 000 die from combinations of these infections) and malaria (429 000 deaths). Despite a current global caseload of 580 000 people infected with drug-resistant tuberculosis,1 current levels of investment – 620 million United States dollars – in research and development are at their lowest since 2008.2 Over the past decade, only two new drugs have been licensed; bedaquiline and delamanid. Tuberculosis cannot be cured by a single drug, but requires at least three different classes of antibiotic for treatment. Drug-resistant tuberculosis – bacilli resistant to two or more of the available antibiotics – is a persistent problem and is projected to account for 25% of deaths from all drug-resistant pathogens in the future.3

In 2010, the World Health Organization’s (WHO’s) Consultative Expert Working Group on Research and Development was established to examine current financing and incentives for research and development and to propose new approaches addressing unmet medical needs. Delegates at this month’s World Health Assembly will continue discussions to implement the recommendations from the group’s 2012 report on global financing and coordination of research and development.4

A United Nations (UN) General Assembly session on antimicrobial resistance and the UN High Level panel on Access to Medicines,5 as well as reports from the United Kingdom of Great Britain and Northern Ireland3 and the German government6 have all looked at new research and development models to incentivize research for drug-resistant infections.

Several nongovernmental organizations, medical research councils, civil society representatives and the South African government have recently developed a new funding framework to support research and development of tuberculosis treatments – the 3P Project (pull, pool and push). This initiative (i) uses a pull incentive, by rewarding research through prizes; (ii) pools intellectual property and data; and (iii) uses push incentives through research grants.7 The 3P project is a collaborative research initiative that aims to support the discovery and development of a one-month treatment regimen that can be used to cure all cases of tuberculosis. The project’s funding model will ensure that a new regimen is affordable and accessible to all those in need. The 3P Project incentivizes researchers by providing cash prizes for compounds that meet predefined product characteristics and are ready to enter phase I clinical trials. Coupling this financial reward with an obligation to pool the compounds data and intellectual property, the 3P Project will then fund the development of treatment combinations. The project will thus de-link the costs of research and development from the final cost of the treatment and sales as defined by the UN Political declaration of the high-level meeting of the General Assembly on antimicrobial resistance;8 ensuring treatment affordability.

Bulletin of the World Health Organization
Volume 95, Number 5, May 2017, 313-388
http://www.who.int/bulletin/volumes/95/5/en/

RESEARCH
Equity trends in ownership of insecticide-treated nets in 19 sub-Saharan African countries
Cameron Taylor, Lia Florey & Yazoume Ye http://dx.doi.org/10.2471/BLT.16.172924

Evaluation of a social franchising and telemedicine programme and the care provided for childhood diarrhoea and pneumonia, Bihar, India
Manoj Mohanan, Soledad Giardili, Veena Das, Tracy L Rabin, Sunil S Raj, Jeremy I Schwartz, Aparna Seth, Jeremy D Goldhaber-Fiebert, Grant Miller & Marcos Vera-Hernández http://dx.doi.org/10.2471/BLT.16.179556

PERSPECTIVES
National drug policy reform for noncommunicable diseases in low-resource countries: an example from Bangladesh
Sheikh Mohammed Shariful Islam, Md Tauhidul Islam, Anwar Islam, Anthony Rodgers, Clara K Chow & Aliya Naheed http://dx.doi.org/10.2471/BLT.15.161117

 
Current Opinion in Infectious Diseases
June 2017 – Volume 30 – Issue 3
http://journals.lww.com/co-infectiousdiseases/pages/currenttoc.aspx

PAEDIATRIC AND NEONATAL INFECTIONS
Placental transfer of antibody and its relationship to vaccination in pregnancy
Calvert, Anna; Jones, Christine E.
Current Opinion in Infectious Diseases . 30(3):268-273, June 2017.
Abstract:
Purpose of review: Vaccination in pregnancy boosts maternal vaccine-specific antibody concentration and therefore increases transplacental transfer of antibody to optimize protection of the infant. The purpose of this review is to describe what is known about placental transfer of antibody in the context of vaccination in pregnancy, focussing on the recent literature and areas of debate, particularly about the timing of vaccination.
Recent findings: There is a debate about the timing of pertussis vaccination in pregnancy with some studies reporting that vaccination in the third trimester results in higher pertussis antigen-specific IgG concentrations in cord blood and others finding that the concentration is higher following vaccination in the second trimester. The impact of timing of vaccination on antibody avidity in cord blood has also been investigated and one study suggests that avidity may be increased following vaccination at 27–30+6 gestational weeks compared with later vaccination.
Summary: Understanding placental transfer of antibody is vital in informing maternal vaccination strategy. There has been recent research about the timing of pertussis vaccination in pregnancy that has implications for the timing of both current and future vaccines to be used in pregnancy.

Infectious Diseases of Poverty
http://www.idpjournal.com/content
[Accessed 6 May 2017]

Commentary
Commentary: restarting NTD programme activities after the Ebola outbreak in Liberia
Brent C. Thomas, Karsor Kollie, Benjamin Koudou and Charles Mackenzie
Infectious Diseases of Poverty 2017 6:52
Published on: 1 May 2017
Abstract
It is widely known that the recent Ebola Virus Disease (EVD) in West Africa caused a serious disruption to the national health system, with many of ongoing disease focused programmes, such as mass drug administration (MDA) for onchocerciasis (ONC), lymphatic filariasis (LF) and schistosomiasis (SCH), being suspended or scaled-down. As these MDA programmes attempt to restart post-EVD it is important to understand the challenges that may be encountered. This commentary addresses the opinions of the major health sectors involved, as well as those of community members, regarding logistic needs and challenges faced as these important public health programmes consider restarting. There appears to be a strong desire by the communities to resume NTD programme activities, although it is clear that some important challenges remain, the most prominent being those resulting from the severe loss of trained staff.

JAMA
May 2, 2017, Vol 317, No. 17, Pages 1707-1812
http://jama.jamanetwork.com/issue.aspx
Special Issue on COI

Viewpoint
Conflict of InterestWhy Does It Matter?
Harvey V. Fineberg, MD, PhD
In this Viewpoint, the former president of the Institute of Medicine discusses the importance of conflicts of interest to the integrity of the medical profession, and the importance of policies to manage conflicts of interest that are specific, clear, public, comprehensible, and fair.

Editorials
The Complex and Multifaceted Aspects of Conflicts of Interest
William W. Stead, MD

Conflict of Interest and Medical Journals
Phil Fontanarosa, MD, MBA; Howard Bauchner, MD

Why There Are No “Potential” Conflicts of Interest
Matthew S. McCoy, PhD; Ezekiel J. Emanuel, MD, PhD
This Viewpoint argues that “potential” conflicts of interest (COIs) are actual COIs that are effectively managed, and calls for clear terminology to describe the severity of COIs and how they are identified and managed.

Addressing Bias and Conflict of Interest Among Biomedical Researchers
Lisa Bero, PhD
JAMA. 2017;317(17):1723-1724. doi:10.1001/jama.2017.3854
This Viewpoint explores the differences between financial and nonfinancial conflicts of interest, the effects of both on research bias, and the importance of managing each in ways that reduce bias.

Role of Leaders in Fostering Meaningful Collaborations Between Academic Medical Centers and Industry While Also Managing Individual and Institutional Conflicts of Interest
Philip A. Pizzo, MD; Thomas J. Lawley, MD; Arthur H. Rubenstein, MBBCH
JAMA. 2017;317(17):1729-1730. doi:10.1001/jama.2017.2573
This Viewpoint discusses the important role that leaders of academic medical centers (AMCs) play in fostering collaborations with industry while managing individual and institutional conflicts of interest (COI).

Managing Conflicts of Interest in Industry-Sponsored Clinical ResearchMore Physician Engagement Is Required
Joanne Waldstreicher, MD; Michael E. Johns, MD
JAMA. 2017;317(17):1751-1752. doi:10.1001/jama.2017.4160
This Viewpoint discusses the conflicts of interest that arise from industry’s dual obligations to patients and shareholders and outlines progress academic medical centers and others have made managing conflicts of interest in industry-sponsored clinical research.

Conflict of Interest and Legal Issues for Investigators and Authors
Joseph P. Thornton, JD
JAMA. 2017;317(17):1761-1762. doi:10.1001/jama.2017.4235
This Viewpoint discusses the duty of authors to report potential conflicts of interest, the legal and professional consequences of omissions, and processes for investigating allegations of failure to disclose conflicts of interest.

JAMA Pediatrics
May 2017, Vol 171, No. 5, Pages 407-500
http://archpedi.jamanetwork.com/issue.aspx

Viewpoint
Preparing for Emerging Infectious Diseases
Lisa Saiman, MD, MPH; Amy S. Arrington, MD, PhD; Michael Bell, MD
JAMA Pediatr. 2017;171(5):411-412. doi:10.1001/jamapediatrics.2016.4947
This Viewpoint argues for increased preparedness in the pediatric community for emerging infectious diseases

Journal of Community Health
Volume 42, Issue 3, June 2017
http://link.springer.com/journal/10900/42/3/page/1

Original Paper
Variation in Human Papillomavirus Vaccine Uptake and Acceptability Between Female and Male Adolescents and Their Caregivers
Kristin L. Johnson, Meng-Yun Lin, Howard Cabral…

Original Paper
Community BMI Surveillance Using an Existing Immunization Registry in San Diego, California
Amanda R. Ratigan, Suzanne Lindsay, Hector Lemus…

Original Paper
Factors Related to Pertussis and Tetanus Vaccination Status Among Foreign-Born Adults Living in the United States
Liliana Sánchez-González, Alfonso Rodriguez-Lainz…

Journal of Pediatrics
May 2017 Volume 184, p1-246
http://www.jpeds.com/current

The Editors’ Perspectives
Pediatric clinical trials—number needed to recruit
Denise M. Goodman
p1–2
Published in issue: May 2017
Abstract
As pediatricians we often extrapolate findings from adult clinical trials to comparable pediatric populations, acknowledging that this is an imperfect approach while bemoaning the lack of adequately powered pediatric trials. There are many reasons for the difficulties in completing clinical trials in children. For instance, the prevalence of certain conditions may be lower, and outcomes different, than for adults. By way of example, mortality is not infrequently used as an end point for adult studies of intensive care unit patients, but mortality in the pediatric intensive care unit is low and thus, an insensitive marker by which to assess the success of many interventions. In addition, there are special considerations in advancing studies in the vulnerable population of children, including a more complex informed consent process and potential reluctance on the part of parents as surrogate decision makers.

In this context, any empiric data regarding the execution of clinical trials in children is helpful. In this volume of The Journal, Schandelmaier et al report on premature discontinuation of clinical trials in children. They drew from studies approved by 6 research ethics committees in 3 countries. By using this approach they minimized issues with incomplete registration and reporting bias that might be present using trial registries or publications as the basis for examining trials. They also waited for as long as 10 years or more to ensure that recruitment and publication could be accomplished. These investigators found that 40% of pediatric trials, compared with 29% ofadult clinical trials, are prematurely discontinued, with slow recruitment the most common reason across the board. After controlling for other trial characteristics, such as source of funding, they found, however, that being a pediatric trial was not in andof itself an independent risk factor for discontinuation. This suggests that other features of trial implementation, such as planned recruitment targets and adequate funding, may be more important.

These findings underscore the importance of robust clinical trial design, including a realistic recruitment strategy, an adequately sized pool of potential enrollees, and sufficient support for patient screening and consenting. The evidence needed to support good clinical decision making rests on rigorous science and a disciplined approach to trial implementation. We owe both the patients we treat and those who generously participate in clinical trials no less.

Journal of Pediatrics
May 2017 Volume 184, p1-246
http://www.jpeds.com/current
The Editors’ Perspectives

Original Articles
Racial and Ethnic Disparities in Parental Refusal of Consent in a Large, Multisite Pediatric Critical Care Clinical Trial
Joanne E. Natale, Ruth Lebet, Jill G. Joseph, Christine Ulysse, Judith Ascenzi, David Wypij, Martha A.Q. Curley for the Randomized Evaluation of Sedation Titration for Respiratory Failure (RESTORE) Study Investigators
p204–208.e1
Published online: March 3, 2017
Abstract
Objective
To evaluate whether race or ethnicity was independently associated with parental refusal of consent for their child’s participation in a multisite pediatric critical care clinical trial.
Study design
We performed a secondary analyses of data from Randomized Evaluation of Sedation Titration for Respiratory Failure (RESTORE), a 31-center cluster randomized trial of sedation management in critically ill children with acute respiratory failure supported on mechanical ventilation. Multivariable logistic regression modeling estimated associations between patient race and ethnicity and parental refusal of study consent.
Result
Among the 3438 children meeting enrollment criteria and approached for consent, 2954 had documented race/ethnicity of non-Hispanic White (White), non-Hispanic Black (Black), or Hispanic of any race. Inability to approach for consent was more common for parents of Black (19.5%) compared with White (11.7%) or Hispanic children (13.2%). Among those offered consent, parents of Black (29.5%) and Hispanic children (25.9%) more frequently refused consent than parents of White children (18.2%, P < .0167 for each). Compared with parents of White children, parents of Black (OR 2.15, 95% CI 1.56-2.95, P<.001) and Hispanic (OR 1.44, 95% CI 1.10-1.88, P = .01) children were more likely to refuse consent. Parents of children offered participation in the intervention arm were more likely to refuse consent than parents in the control arm (OR 2.15, 95% CI 1.37-3.36, P < .001).
Conclusions
Parents of Black and Hispanic children were less likely to be approached for, and more frequently declined consent for, their child’s participation in a multisite critical care clinical trial. Ameliorating this racial disparity may improve the validity and generalizability of study findings.
Trial registration
ClinicalTrials.gov: NCT00814099.