Vaccines and Global Health: The Week in Review is a weekly digest  summarizing news, events, announcements, peer-reviewed articles and research in the global vaccine ethics and policy space. Content is aggregated from key governmental, NGO, international organization and industry sources, key peer-reviewed journals, and other media channels. This summary proceeds from the broad base of themes and issues monitored by the Center for Vaccine Ethics & Policy in its work: it is not intended to be exhaustive in its coverage. You are viewing the blog version of our weekly digest, typically comprised of between 30 and 40 posts below all dated with the current issue date

.– Request an Email Summary: Vaccines and Global Health : The Week in Review is published as a single email summary, scheduled for release each Saturday evening before midnight (EDT in the U.S.). If you would like to receive the email version, please send your request to david.r.curry@centerforvaccineethicsandpolicy.org.

– pdf version:  A pdf of the current issue is available here: Vaccines and Global Health_The Week in Review_28 April 2018

– blog edition: comprised of the approx. 35+ entries posted below.

– Twitter:  Readers can also follow developments on twitter: @vaxethicspolicy.
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– Links:  We endeavor to test each link as we incorporate it into any post, but recognize that some links may become “stale” as publications and websites reorganize content over time. We apologize in advance for any links that may not be operative. We believe the contextual information in a given post should allow retrieval, but please contact us as above for assistance if necessary.

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David R. Curry, MS
Executive Director
Center for Vaccine Ethics and Poli

Milestones :: Perspectives
 
World Immunization Week, 24-30 April 2018

Protected Together  #VACCINESWORK

Milestones :: Perspectives

Dr. Paul Offit Receives 2018 Albert B. Sabin Gold Medal

WASHINGTON, D.C. – April 24, 2018 – Tonight, the Sabin Vaccine Institute (Sabin) will honor Dr. Paul Offit with the 2018 Albert B. Sabin Gold Medal. Sabin will recognize Dr. Offit for his contributions as co-inventor of an oral rotavirus vaccine and his leadership as one of the United States’ most vocal and dedicated advocates for immunization…

…Dr. Offit’s contributions to protecting human health extend beyond the laboratory and for many years he has been a strong public advocate for childhood immunizations. Dr. Offit drives efforts to improve public understanding of vaccines through speaking engagements, media appearances and his books. Dr. Offit’s many books make science accessible to lay audiences worldwide, highlighting the history of immunization, tackling vaccine myths and reinforcing the message that science is not a matter of faith but a matter of fact.

“Paul’s contributions as a vaccinologist and advocate have improved the health of children in every corner of the world,” said Amy Finan, chief executive officer of the Sabin Vaccine Institute. “His scientific accomplishments are rivaled only by his impact as a dedicated advocate for immunization. Paul truly exemplifies Albert Sabin’s commitment to ensuring every child is protected from preventable disease. It is an honor to present Paul with this year’s Albert B. Sabin Gold Medal.”

“It’s an honor to join the distinguished ranks of Albert B. Sabin Gold Medal recipients,” said Dr. Offit. “Though our research may have focused on different diseases, we all share Dr. Sabin’s commitment to reducing human suffering. We have accomplished so much, discovering and introducing several vaccines that have reshaped the world as we know it, but vaccines will always be a victim of their own success. As once-common diseases disappear, it is increasingly important to stand as vaccine champions. I thank the Sabin Vaccine Institute for recognizing my research and advocacy with tonight’s award, and for its efforts to expand immunization globally.”…

Milestones :: Perspectives

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Editor’s Note:
In last week’s edition, we published the full text of the initial report on the WHO SAGE meeting held 17-18 April 2018 in Geneva, including the revised SAGE recommendation on use of dengue vaccine [see link just below]. We should have also immediately explored whether Sanofi had made any response to this revised guidance and should have published any such response in tandem. We provide the full text of the Sanofi media release dated 19 April 2018 below.
 
Revised SAGE recommendation on use of dengue vaccine
19 April 2018
 
Sanofi Pasteur communication on SAGE recommendation about Dengvaxia® dengue vaccine
19th April 2018 – Today, the Strategic Advisory Group of Experts (SAGE) on Immunization communicated an updated recommendation on Dengvaxia® dengue vaccine to the World Health Organization (WHO).

:: The new SAGE recommendation confirms the public health value of Dengvaxia and its     potential to reduce the overall burden of dengue in high endemic populations.

:: For dengue-endemic countries that would like to use Dengvaxia as part of their integrated dengue control and prevention strategy, SAGE recommends as a preferred option pre-vaccination screening in which only previously dengue infected individuals are vaccinated. As will be made clear in forthcoming published documents from SAGE, current available sero-tests or Rapid Diagnostic Tests (RDT) could be considered in high transmission settings until better tests are available. We maintain our efforts to develop a dengue RDT that can reliably assess prior dengue infection as an aid to vaccination.

:: SAGE also acknowledges the public health value of vaccinating without pre-vaccination screening in very high endemic settings (80% seroprevalence at 9 years of age).

This guidance from the SAGE will help to inform an updated World Health Organization position on the vaccine expected to be published in the coming months. The WHO’s mandate is to promote global public health, and their positions on new vaccines provide guidance to countries to make decision on public program implementation, based on their specific disease burden and epidemiology.

The SAGE updated their recommendation on the vaccine taking into account the results of a supplementary analysis of clinical data on the vaccine, for which findings were communicated publically last year by Sanofi.

These new data1, which were finalized and shared by Sanofi at the end of November 2017 and submitted to a peer-reviewed medical journal, contribute to the scientific understanding of how this vaccine can be used optimally in dengue prevention efforts at individual and population levels. They show that for people 9 years of age or older who had a dengue infection prior to vaccination, which includes most of the people living in high transmission areas2, the vaccine provides sustained protective benefit up to 5 years after the first injection which highlights the public health value of the vaccine in high endemic settings. These findings also represent the first clinical evidence that the vaccine’s long-term safety profile in individuals 9 years and older differs according to prior dengue infection exposure. Sanofi has proposed a label update for the vaccine that takes these new findings into account. The label update is currently under review or has been accepted already by some of the regulatory agencies in the countries where the vaccine is either approved today or under regulatory consideration.

We are confident in Dengvaxia’s safety and its proven potential to reduce dengue disease burden in endemic countries. As we previously communicated in November, in our new analysis, the risk and severity of cases in vaccinated individuals not previously infected with dengue was similar to those observed in unvaccinated individuals previously infected. Over five years, in vaccinated individuals not previously infected this increased risk was of 0.2% for vaccinated vs unvaccinated individuals. The severe dengue symptoms observed were a temperature over 38°C for 2 days or more coupled with symptoms such as bruising and abnormal laboratory findings. All fully recovered after symptomatic treatment.

At Sanofi, we have worked to provide an innovative vaccine against dengue in spite of the challenges posed by this complex infection. Dengue can be caused by 4 distinct dengue viruses capable of making a person sick up to four times in a lifetime. Most dengue infections are ‘silent’ which means people have dengue but do not feel ill. However, in rare cases, dengue can be severe, leading to a range of clinical symptoms that require hospital treatment and can deteriorate into a life-threatening form of the disease called dengue hemorrhagic fever. Severe dengue can occur at any of the four infections yet, for reasons not fully understood by the scientific community, secondary dengue infections lead more often to severe dengue than a first infection with the virus3. Therefore, prevention of subsequent dengue infections has the potential to significantly reduce the human suffering, as well as the economic impact caused by dengue every year4.

Dengue continues to represent a significant public health challenge for countries where almost half the world’s population lives today. An estimated 390 million dengue infections are reported annually; about 100 million of which cause overt illness2. Dengue is spread by mosquitoes that bite during the daytime which contributes to rapid spread of the disease during the rainy season and can often result in overburdened community healthcare services and societal disruption and anxiety.

The global strategy for dengue prevention and control was adopted by the WHO member states in 2012 aiming to reduce the mortality associated with dengue by 50% and the morbidity or illness caused by dengue by 25% by the Year 2020. To achieve this goal, the WHO recommends that countries adopt an integrated approach to dengue infection prevention and disease management5.

Sanofi shares the same goal as the WHO and endemic countries to significantly reduce global dengue burden. The WHO recognizes the important role of vaccination together with vector control, robust disease surveillance and proper medical management in addressing dengue burden.  Appropriate introduction of Dengvaxia as part of such an integrated approach has the potential to significantly reduce overall dengue burden, particularly leading to lower impact of severe dengue on human lives and healthcare expenditures in highly endemic countries. Sanofi continues our long-term commitment to global dengue burden reduction. We developed the first approved vaccine to fight this complex infection and we will continue to work with the international public health community and endemic countries, to ensure the best usage of the vaccine to increase protection for populations at risk of subsequent dengue infections, potentially more debilitating.

1 http://www.who.int/immunization/diseases/dengue/q_and_a_dengue_vaccine_dengvaxia_use/en/
2
World Health Organization.  Dengue and severe dengue. Fact sheet No 117.  www.who.int/mediacentre/factsheets.fs117 updated April 2017.  Last accessed May 2017
3
Mizumoto, K., Ejima, K., Yamamoto, T. & Nishiura, H. On the risk of severe dengue during secondary infection: a systematic review coupled with mathematical modeling. J. Vector Borne Dis. 51, 153–164 (2014)
4 http://www.who.int/immunization/sage/meetings/2016/april/1_Background_Paper_Dengue_Vaccines_2016_03_17.pdf
5
World Health Organization. Dengue guidelines for diagnosis, treatment, prevention and control. WHO/HTM/NTD/DEN/2009.1.http://whqlibdoc.who.int/publications/2009/9789241547871_eng.pdf

Milestones :: Perspectives

EMA launches public consultation on revised guideline on clinical evaluation of vaccines

26/04/2018
Updated rules for clinical development of vaccines
The European Medicines Agency (EMA) has released a revised guideline on the clinical evaluation of vaccines for a six-month public consultation.
Stakeholders are invited to send their comments by 30 October 2018 to vwp@ema.europa.eu using the template provided in the guideline.
Vaccination is one of the greatest breakthroughs in modern medicine. According to the World Health Organization (WHO), immunisation saves an estimated two to three million lives every year and protects against many dangerous diseases, including, for example, cervical cancer, diphtheria, hepatitis B, measles, mumps, pertussis (whooping cough), and tetanus. Additionally, vaccines can help limit the spread of antibiotic resistance as vaccination is a very effective way to stop people and animals getting infected, thereby preventing the need for antibiotics.
Vaccines undergo a rigorous scientific review to ensure that they are safe and effective. The updated guideline introduces additional safeguards for European Union citizens and ensures that the evaluation is in line with the most up-to-date scientific knowledge and technological developments.
EMA’s draft guideline includes specific considerations for clinical trials with vaccines in special populations, such as pregnant women or the elderly.
The revised version of the guideline also adds considerations to priming and boosting strategies, including the option of heterologous prime-boost, which entails administration of one type of vaccine first followed by a different type of vaccine for the same pathogen later. The need to develop vaccine for pathogens that may cause future epidemics and for which conducting clinical trials outside of outbreaks might be problematic, is also addressed.
Once the revised guideline is adopted by the Committee for Medicinal Products for Human Use (CHMP), the current guideline on the clinical evaluation of new vaccines and the Annex on summaries of product characteristics (SmPCs) for vaccines will no longer apply.

Milestones :: Perspectives

Vaccination in humanitarian emergencies

Humanitarian emergencies, regardless of type and cause, have a number of common risk factors for communicable diseases inextricably linked to excess risk of morbidity and mortality which can come from vaccine–preventable diseases.

Vaccine-preventable disease outbreaks occurring in humanitarian emergencies highlighted the need for a comprehensive and evidence-based decision-making framework for vaccination in humanitarian emergencies. In 2013, “Vaccination in acute humanitarian emergencies: a framework for decision making” was developed by the World Health Organization (WHO). The ultimate aim of the framework is to assist the user to thoughtfully, deliberately, ethically, and rationally determine whether or not the delivery of one or more vaccines to specific target populations during the acute phase of an emergency would result in an overall saving of lives, a reduction in the population burden of disease, and generally more favourable outcomes than would otherwise be the case.

Revised and extended guidance/content
Through a series of consultations with partners in 2016 the revised and extended guidance is now available:
:: Vaccination in acute humanitarian emergencies: a framework for decision making
:: Vaccination in humanitarian emergencies implementation guide
:: Country case studies pdf, 240kb

eTool
An eTool based on the framework for decision making has been developed. The intended audience for the eTool includes UNICEF and WHO staff, government and partner agencies who are expected to work together to reach a decision regarding the need and strategies of implementing one or more vaccines in a given humanitarian emergency.
:: Download Mac version  zip, 69.27Mb
:: Download Windows version  zip, 67.03Mb
:: Instructions on installing the tool  pdf, 321kb

eLearning course
An eLearning course has been developed in collaboration with UNICEF, it is intended to provide a methodology and tools to immunization programme managers for vaccination during humanitarian emergencies. It takes 2 – 2.5 hours to complete this course. A certificate is available following the successful completion of all five modules.
:: UNICEF site for eLearning

Humanitarian Mechanism
A “Humanitarian Mechanism” has been developed by WHO, UNICEF, Médecins Sans Frontières, and Save the Children to enable civil society organizations, governments and UN agencies to quickly procure affordable vaccine supplies on behalf of populations facing humanitarian emergencies and who do not have such access. The mechanism is available for use as of 1 May 2017.
:: Accessing Affordable and Timely Supply of Vaccines for use in Humanitarian Emergencies: the Humanitarian Mechanism pdf, 126kb

Milestones :: Perspectives

UNICEF – Twelve things you didn’t know about immunization

Reaching every child: Nearly 13 million children went unvaccinated in 2016

Vaccines keep children alive and healthy by protecting them against disease. Yet in 2016, an estimated 1.4 million children under five died from vaccine-preventable diseases. Approximately one-fourth of deaths among children under 5 were from¬ pneumonia, diarrhoea and measles, and could have been mostly prevented by vaccines. Globally 1 in 7 children – over 19 million – missed out on routine vaccines, including 13 million who have never been vaccinated, putting them and their communities at risk of disease and death. Low immunization coverage compromises gains in all other areas of health for mothers and children. The poorest, most vulnerable children who need immunization the most continue to be the least likely to get it.

UNICEF and its partners are working to ensure that the lives of all children are protected. But, if vaccination is not prioritized, some of the most marginalized children will miss out on their right to benefit from immunization, which could mean the difference between life and death.

Despite these challenges, vaccines are protecting more children than ever before. Behind their phenomenal success lies the hard work of health workers who go from village-to-village to vaccinate children, even though they encounter fear and suspicion.
“Last year, it is estimated that vaccines saved the lives of as many as 3 million children. That’s 3 million future doctors, teachers, artists, community leaders, mothers and fathers alive today thanks to millions of frontline health workers who walk for hundreds of miles to remote locations, through jungles and across seas to reach every child,” said Robin Nandy, UNICEF’s Chief of Immunization. “We continue to work with governments on the ground, including in places affected by conflict, in support of these unsung heroes who take on this extremely dangerous work to save lives.”

Twelve key facts on vaccines today

1. Two-thirds of unvaccinated children live in fragile countries or those affected by conflict. Between 2010 and 2016, Syria saw the sharpest decline in vaccinated children, with coverage* falling by 38 percentage points over this period. Second is Ukraine where coverage decreased by 33 percentage points.

2. A number of countries have seen a significant increase in the number of vaccinated children since 2010, driving most of the gains in immunization coverage this decade, including India, Ethiopia, Democratic Republic of the Congo, Bangladesh, Philippines, Mexico, United Republic of Tanzania, Vietnam, Turkey and Sudan. In India, the number of unvaccinated children** reduced by 45 per cent, from 5.3 million in 2010 to 2.9 million in 2016.

3. As of 2016, six countries accounted for half of the world’s unimmunized children*: Nigeria (18%); India (15%); Pakistan (7%); Indonesia (5%); Ethiopia (4%); and Democratic Republic of the Congo (3%).

4. The top 10 countries where vaccination coverage*, in percentage points, has increased between 2010 and 2016 are Palau (29%), Malta (21%), Democratic Republic of the Congo (19%), Comoros (17%), Azerbaijan (16%), Ethiopia (16%), Timor-Leste (13%), Barbados (11%), Costa Rica (9%) and India (9%).

5. In 2017, Yemen witnessed one of the worst cholera epidemics on record with over a million suspected cases, almost 29 per cent of them among are children under five. Around 5.2 million people received two doses of the oral cholera vaccine in South Sudan, Somalia, Mozambique, Malawi, Sierra Leone, Philippines, Nigeria, Chad, Haiti, Cameroon, Zambia and Bangladesh during cholera outbreaks or as part of preventive campaigns.

6. Diphtheria, a disease that is only rarely seen thanks to immunization, is making a come-back. In response to an outbreak among Rohingya refugees – in which three out of four people affected were children – UNICEF supported several large vaccination campaigns in southern Bangladesh, reaching close to half a million children.

7. In 1988, there were 350,000 cases of polio a year. Since then, over 2.5 billion children have been vaccinated against the disease. Today, the world is closer than ever to eradicating polio, with only 22 cases in two countries last year. More than 400 million children will be vaccinated this year.

8. The lives of an estimated 20 million children have been saved through measles immunization between 2000 and 2016.

9. A billion people will be vaccinated against Yellow fever in Africa by 2026 – almost half of them children under 15 years of age. Since 2001, the production of the yellow fever vaccine has quadrupled from 20 million to 80 million doses annually, and is expected to increase in the coming years.

10. As of 2016, an estimated 86 per cent of children less than one year of age were fully vaccinated against diphtheria, tetanus and pertussis, compared to 52 per cent some 30 years ago.

11. In 2017, UNICEF procured 2.4 billion vaccine doses worth $1.3 billion, reaching 45 per cent of the world’s children.

12. Thanks to vaccines, maternal and neonatal tetanus, which is extremely deadly amongst newborns, has been eliminated in all but 15 countries. Ethiopia, Haiti and Philippines eliminated the disease in 2017.

Emergencies

 
POLIO
Public Health Emergency of International Concern (PHEIC)
Polio this week as of 24 April 2018 [GPEI]
:: In January, children in Raqqa city, Syria, received polio vaccines for the first time in two years as families return to their homes.
:: The GPEI Post-Certification Strategy (PCS), which is aimed at ensuring the availability of core functions to sustain a polio-free world after global certification (such as outbreak response capacity, surveillance, immunization and containment), is now available to read on our website. The PCS will be presented to Member States at the World Health Assembly (WHA) in May.
:: Recommendations and meeting outcomes from the recent Strategic Advisory Group of Experts on immunization (SAGE) meeting are now published. Among other things, the group reviewed and endorsed the main elements of the PCS, and reviewed proposed recommendations relating to global containment and immunization policies for countries hosting polio essential facilities (PEFs).
:: The Polio Oversight Board has released a statement welcoming and actively supporting steps being taken by the international community to prevent and stop sexual misconduct. The full statement may be read here.
 
Summary of newly-reported viruses this week:
Pakistan: One new wild poliovirus type 1 (WPV1)  positive environmental sample has been reported, in Khyber Pakhtunkhwa province.
The Democratic Republic of the Congo: One case of circulating vaccine-derived poliovirus type 2 (cVDPV2) reported, from Haut Katanga province.
Nigeria: Circulating vaccine-derived poliovirus type 2 (cVDPV2) has been confirmed, following isolation of the virus from three environmental samples collected between 10 January and 20 March, from two environmental sites in Jigawa state.
Somalia: Circulating vaccine-derived poliovirus type 3 (cVDPV3) has been confirmed, following isolation of the virus from four environmental samples collected between 8-22 March, from two environmental sites in Banadir province.

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WHO Grade 3 Emergencies  [to 28 April 2018]
Yemen 
:: WHO scales up support to mitigate child malnutrition in Yemen  18 April 2018

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WHO Grade 2 Emergencies  [to 28 April 2018]

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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. 
Syrian Arab Republic
:: Syrian Arab Republic: The Humanitarian Crisis in Syria as of 23 April 2018 [EN/AR]

Yemen  
:: Yemen Humanitarian Update Covering 17 – 23 April 2018 | Issue 12

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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
:: OCHA Somalia Flash Update #2 – Humanitarian impact of heavy rains | 26 April 2018
 
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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.

MERS-CoV [to 28 April 2018]
http://www.who.int/emergencies/mers-cov/en/
Maps and epicurves
:: Epicurve of confirmed global cases of MERS-CoV   png, 213kb  20 April 2018
:: Global map of countries with confirmed cases of MERS-CoV  gif, 2.42Mb  20 April 2018
 
Yellow Fever  [to 28 April 2018]
http://www.who.int/csr/disease/yellowfev/en/
:: Dr Tedros, WHO Director-General, launches the EYE Strategy in Africa
26 April 2018
On 10 April 2018, as part of the Eliminate Yellow fever Epidemics (EYE) Strategy regional kick-off meeting in Abuja, Dr. Tedros Adhanom Ghebreyesus, WHO Director-General, together with Professor Isaac Folorunso Adewole, Nigeria’s Minister of Health, and other partners called African countries to reinforce their engagement to eliminate yellow fever epidemics by 2026…

WHO & Regional Offices [to 28 April 2018]
 
Weekly Epidemiological Record, 27 April 2018, vol. 93, 17 (pp. 221–228)
Control of cutaneous leishmaniasis in Afghanistan: achievements and challenges

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WHO Regional Offices
Selected Press Releases, Announcements
WHO African Region AFRO
Selected Featured News
:: World Malaria Day 2018; Ready to Beat Malaria   28 April 2018
:: Strengthen Health System to achieve universal health coverage – Dr Moeti  25 April 2018
:: Immunization partners launch week-long campaign across Africa 24 April 2018

WHO Region of the Americas PAHO
:: ‘Malaria Champions of the Americas’ contest seeks nominations for best efforts in malaria capacity building (04/25/2018)
:: Uruguayan footballer Edinson Cavani joins PAHO to promote vaccination (04/25/2018)
:: Vaccination Week in the Americas launches in Cuba for the first time (04/23/2018)

WHO South-East Asia Region SEARO
:: Reach every child, adolescent and pregnant woman in the WHO South-East Asia Region with life-saving vaccines By Dr Poonam Khetrapal Singh, WHO Regional Director for South-East Asia
 
WHO European Region EURO
:: Photo story – “Leaving no one behind – saving lives through immunization” exhibit 28-04-2018
:: European Immunization Week – vaccination is a right and responsibility for all 23-04-2018

WHO Eastern Mediterranean Region EMRO
:: World Immunization Week 2018: Protected Together, #VaccinesWork  23 April 2018
:: Investing in the health of Syrians is an investment in the future of Syria, WHO says  23 April 2018

WHO Western Pacific Region
:: Viet Nam ready to eliminate malaria  HA NOI, 25 APRIL 2018 –
:: Micronesia achieves regional goal for reducing hepatitis B in children  SUVA, Fiji, 24 April 2018

CDC/ACIP [to 28 April 2018]

http://www.cdc.gov/media/index.html
https://www.cdc.gov/vaccines/acip/index.html

MMWR News Synopsis for April 26, 2018
Three Rotavirus Outbreaks in the Postvaccine Era — California, 2017
While rotavirus vaccination is the best way to reduce rotavirus disease in the United States, outbreaks may continue to occur as the vaccine does not confer full protection, especially against mild disease. Efforts to improve rotavirus vaccination coverage should continue. Rotavirus disease, a cause of severe diarrhea in young children, has substantially declined since the introduction of rotavirus vaccine in the United States in 2006. However, rotavirus disease still occurs in a winter-spring seasonal pattern. This study examined three rotavirus outbreaks in California in 2017. Most of the cases were associated with mild to moderate illness, although one fatality was reported in an unvaccinated child with underlying complications. Rotavirus outbreaks may continue to occur because the vaccine does not confer full protection, especially against mild disease. However, vaccination of eligible infants is the best way to reduce rotavirus disease.

ECDC – European Centre for Disease Prevention and Control  [to 28 April 2018]

https://ecdc.europa.eu/en/home
27 Apr 2018
Communicable disease threats report, 22-28 April 2018, week 17
Publication series: Communicable Disease Threats Report (CDTR)
Time period covered: 22-28 April 2018
The ECDC Communicable Disease Threats Report (CDTR) is a weekly bulletin for epidemiologists and health professionals on active public health threats. This issue covers the period 22-28 April 2018 and includes updates on dengue, chikungunya, seasonal influenza, yellow fever, gonorrhoea and cholera.

Announcements
 
 
BMGF – Gates Foundation  [to 28 April 2018]
http://www.gatesfoundation.org/Media-Center/Press-Releases
APRIL 23, 2018
Global Financing Facility Replenishment Event to Be Co-hosted by Governments of Norway and Burkina Faso, World Bank Group, and Bill & Melinda Gates Foundation
Event in Oslo in November aims to urgently raise funds to save the lives of 38 million women, children and adolescents in 50 countries
OSLO, NORWAY, April 23, 2018 – Every year in 50 countries across the world, more than 5 million mothers and children die from preventable causes, and countries lose billions of dollars to poor health and nutrition. The estimated annual financing shortfall is about US$33 billion on a global level. To end preventable maternal, newborn and child deaths by 2030, countries are acting now to fill the funding gap by investing in the Global Financing Facility (GFF).
The Governments of Norway and Burkina Faso, the World Bank Group, and the Bill & Melinda Gates Foundation announced today that they will co-host the GFF replenishment event on November 6, 2018, in Oslo, Norway. The Government of Norway, one of the initiators of and largest investors in the GFF, will also host a conference focused on development finance, in partnership with the GFF, on November 5, 2018, the day before the GFF replenishment event…

 
CEPI – Coalition for Epidemic Preparedness Innovations  [to 28 April 2018]
http://cepi.net/
Governance
Overview of CEPI Board and Scientific Advisory Committee members

EDCTP    [to 28 April 2018]
http://www.edctp.org/
The European & Developing Countries Clinical Trials Partnership (EDCTP) aims to accelerate the development of new or improved drugs, vaccines, microbicides and diagnostics against HIV/AIDS, tuberculosis and malaria as well as other poverty-related and neglected infectious diseases in sub-Saharan Africa, with a focus on phase II and III clinical trials
Latest news
25 April 2018
A growing malaria R&D portfolio: grants and calls 2014-2018
The fight against malaria requires a concerted effort of many and various partners. EDCTP wholeheartedly supports the fight for a world free of malaria that goes back more than 100 years. To end malaria much effort through a combination of…

European Medicines Agency  [to 28 April 2018]
http://www.ema.europa.eu/ema/
27/04/2018
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 April 2018
Three medicines recommended for approval
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended three medicines for approval at its April 2018 meeting.
The CHMP recommended granting a marketing authorisation for Biktarvy (bictegravir / emtricitabine / tenofovir alafenamide), for the treatment of HIV-1 infection.
One hybrid medicine, Dzuveo (sufentanil) received a positive opinion for the treatment of pain. Hybrid applications rely in part on the results of pre-clinical tests and clinical trials for a reference product and in part on new data.
The Committee recommended for approval the generic medicine Carmustine Obvius (carmustine), for the treatment brain tumours, non-Hodgkin’s lymphoma and Hodgkin’s disease…

26/04/2018
Updated rules for clinical development of vaccines
EMA launches public consultation on revised guideline on clinical evaluation of vaccines …
[See Milestones/Perspectives above for more detail]

25/04/2018
Ten years promoting high-quality scientific research in paediatric medicines
Registration opens for workshop of the European Network of Paediatric Research at EMA (Enpr-EMA), 7–8 June 2018 … \

23/04/2018
European Immunization Week 2018: Statement of Guido Rasi, Executive Director, European Medicines Agency
Protected together, #VaccinesWork
Vaccines matter for each of us: yearly, they prevent 2.7 million people from contracting measles, one million from getting whooping cough and two million babies from getting tetanus.
They eradicated smallpox. They stopped polio, a dreadful disease affecting millions of children, in almost all countries in the world.
Despite these hard facts, many Europeans are hesitant when it comes to immunising themselves or their children.
Between 2016 and 2017, data from the European Centre for Disease Prevention and Control (ECDC) show that the number of people affected by measles more than tripled in the European Union (EU). Of these, 86% were not vaccinated. Since the beginning of 2017, 50 people have died from this disease, although it can be easily prevented through vaccination.
Some parents are actively choosing not to vaccinate their child. This has consequences both for the individuals and for public health. In some communities, vaccination coverage has dropped below 95%, the rate needed to shield the population.
This poses serious risks to vulnerable groups, such as very small babies, people with an immune disorder or people who receive treatment against cancer. They cannot be vaccinated themselves, but are protected when people they come in contact with are vaccinated.
By deciding not to use vaccination, people put themselves, their children and those around them at risk.
Our job at the European Medicines Agency (EMA) is to ensure that only vaccines that are safe and effective are used in the EU. EMA has strict rules for the authorisation of vaccines across Europe. Once they are in use, EMA continuously monitors their safety, so any adverse effects can be promptly detected, investigated and managed.
Immunisation keeps you safe, but at the same time it is a responsibility towards those close to you.
EMA therefore supports European Immunization Week .
We have produced a video together with the community of patients, consumers, doctors, nurses and pharmacists we work with across the EU, who took the time to explain why vaccination matters. Let’s listen to them and reflect.

 
European Vaccine Initiative  [to 28 April 2018]
http://www.euvaccine.eu/news-events
25 April 2018
World Malaria Day 2018: EVI calls for further stepping up investments
European Vaccine Initiative reports positive clinical trial results for two malaria vaccines and calls for further increase in…
 
 
FDA [to 28 April 2018]
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
What’s New for Biologics
Maternal vaccination with pertussis vaccine containing only one immunity-stimulating component provides protection against disease in baboon model
Posted: 4/26/2018

IVAC  [to 28 April 2018]
https://www.jhsph.edu/research/centers-and-institutes/ivac/index.html
Latest Updates
April 24-30th: Share messages from IVAC’s World Immunization Week 2018 Social Media Toolkit
 
 
MSF/Médecins Sans Frontières  [to 28 April 2018]
http://www.doctorswithoutborders.org/news-stories/press/press-releases
Press release
MSF: USTR Special 301 Report Calls Out Countries for Protecting Public Health
NEW YORK, APRIL 27, 2018—The Office of the United States Trade Representative (USTR) released its annual “Special 301 Report” today, which reviews countries based on their intellectual property (IP) rights protection and enforcement. Countries that are deemed by the U.S. to not protect IP strongly enough are placed on this watch list.

 
NIH  [to 28 April 2018]
http://www.nih.gov/news-events/news-releases
April 25, 2018
Anti-HIV drug combination does not increase preterm birth risk, study suggests
— NIH-funded study could allay concerns about regimens containing TDF.

NIH statement on World Malaria Day 2018
April 25, 2018 — NIH reaffirms its commitment to conduct and support innovative scientific research needed to end malaria.

Sabin Vaccine Institute  [to 28 April 2018]
http://www.sabin.org/updates/pressreleases
April 27, 2018
Statement on New Universal Flu Vaccine Development Grand Challenge
The new $12 million Ending the Pandemic Threat: A Grand Challenge for Universal Influenza Vaccine Development from the Bill & Melinda Gates Foundation and Lucy and Larry Page is an important and necessary step toward finding a game-changing solution to end the threat of flu, according to experts at the Sabin Vaccine Institute (Sabin), a leading advocate for expanding vaccine access and uptake across the world. This challenge invites researchers from any discipline to submit innovative ideas for safe, effective, affordable flu vaccines.
Sabin Vaccine Institute has 25 years of experience catalyzing vaccine innovation through collaboration and partnerships. Bruce Gellin, M.D., M.P.H., Sabin’s president of Global Immunization and lead on influenza efforts, welcomed today’s announcement with the following statement:
“The Grand Challenge is a strong example of how we can invigorate influenza research and stimulate interest to accelerate the development of a long-lasting, universal flu vaccine. The Gates Foundation and Page Family are right to encourage innovative approaches by the world’s best thinkers across a variety of disciplines— beyond the traditional flu community…

Dr. Paul Offit Receives 2018 Albert B. Sabin Gold Medal
WASHINGTON, D.C. – April 24, 2018 – Tonight, the Sabin Vaccine Institute (Sabin) will honor Dr. Paul Offit with the 2018 Albert B. Sabin Gold Medal. Sabin will recognize Dr. Offit for his contributions as co-inventor of an oral rotavirus vaccine and his leadership as one of the United States’ most vocal and dedicated advocates for immunization.
[See Milestones, Perspectives above for more detail]
 

UNAIDS [to 28 April 2018]
http://www.unaids.org/en
27 April 2018
Reaching people who inject drugs with HIV services in Finland

Urgent work ahead for Start Free Stay Free AIDS Free

26 April 2018
The injustices faced by transgender women in Peru

Mobile phones provide massive potential to move towards e-health systems
Read

25 April 2018
UNAIDS ambassadors speak out to stop discrimination
Read

Egyptian medical students meet to address stigma and discrimination in health-care settings
Read

UNICEF  [to 28 April 2018]
https://www.unicef.org/media/
Selected Press Releases
17 April 2018
Ten things you didn’t know about malaria
New York, 25 April 2018 – Every two minutes, a child dies of malaria .
Malaria is a preventable and treatable disease that remains, in many regions of the world, a major public health problem . Ninety-one countries currently experience ongoing malaria transmission. Almost half the world’s population – about 3.2 billion people – are at risk of malaria. In 2016 alone, 216 million new cases of malaria were reported, and approximately 445,000 people died of the disease – most of them children.

Twelve things you didn’t know about immunization
Vaccines keep children alive and healthy by protecting them against disease. Yet in 2016, an estimated 1.4 million children under five died from vaccine-preventable diseases. Approximately one-fourth of deaths among children under 5 were from¬ pneumonia, diarrhoea and measles, and could have been mostly prevented by vaccines. Globally 1 in 7 children – over 19 million – missed out on routine vaccines, including 13 million who have never been vaccinated, putting them and their communities at risk of disease and death. Low immunization coverage compromises gains in all other areas of health for mothers and children. The poorest, most vulnerable children who need immunization the most continue to be the least likely to get it.
[See Milestones, Perspectives above for full text]

 
Vaccine Confidence Project  [to 28 April 2018]
http://www.vaccineconfidence.org/
26 Apr, 2018
Rise in vaccine hesitancy related to pursuit of purity
Heidi Larson
Immunization Week 24-30 April 2018   “Protected Together”
Interview published in HORIZON — The rise of alternative health practices and a quest for purity can partly explain the falling confidence in vaccines which is driving outbreaks of preventable diseases such as measles
 

Vaccine Education Center – Children’s Hospital of Philadelphia  [to 28 April 2018]
http://www.chop.edu/centers-programs/vaccine-education-center
April 2018
Newsletter – Vaccine Update for Providers
The March webinar, Current Issues in Vaccines, is available online for viewing. During the event, Dr. Offit discussed the following topics:
:: Novel hepatitis B vaccine: ACIP recommendations
:: : Updates on vaccine efficacy and disease burden
:: HPV: Updates on vaccine safety and long-term efficacy
:: Meningococcal disease: Revised data on risk for college students

Wellcome Trust  [to 28 April 2018]
https://wellcome.ac.uk/news
Q&A / Published: 23 April 2018
Why do we need vaccines?
Vaccines are one of our most effective health interventions, but are often misunderstood. In this Q&A, we explain what they are, how they work and why they are important.

 
The Wistar Institute   [to 28 April 2018]
https://www.wistar.org/news/press-releases
Press Release   Apr. 27 2018
Wistar and Ben Franklin Technology Partners of Southeastern Pa. Forge Collaboration to Accelerate Technology Commercialization
Wistar and Ben Franklin Technology Partners of Southeastern Pennsylvania, a nonprofit conglomerate of partners providing direct/seed funding, mentorship and networks to strengthen enterprise development, have signed a Memorandum of Understanding (MoU) to accelerate the advancement of early-stage life sciences start-ups coming out of Wistar…

::::::

DCVMN – Developing Country Vaccine Manufacturers Network  [to 28 April 2018]
http://www.dcvmn.org/
28 April 2018
Regional workshop: Optimization of vaccines’ manufacturing, containers and testing for global supply
7 May 2018 to 10 May 2018
Hyderabad / India
 
PhRMA    [to 28 April 2018]
http://www.phrma.org/press-room
April 27, 2018
PhRMA Welcomes 2018 Special 301 Report
Applauds Administration for Combatting Discriminatory Pricing and Intellectual Property Barriers Abroad
Washington, D.C.— The Pharmaceutical Research and Manufacturers of America (PhRMA) welcomed the 2018 Special 301 Report, including a new section devoted to pharmaceutical market access barriers, released today by U.S. Trade Representative (USTR) Robert Lighthizer. The Report highlights serious threats America’s biopharmaceutical innovators face in countries around the world, including with trading partners like Canada, Japan, Colombia and others…
PhRMA’s Special 301 submission asked USTR to name Korea, Canada and Malaysia Priority Foreign Countries, a designation reserved for economies with the most onerous and egregious intellectual property or market access practices that have the greatest impact on U.S. products. Earlier this year, USTR secured a commitment under the U.S.–Korea Free Trade Agreement (KORUS) that Korea will end some discriminatory pricing and reimbursement policies. USTR today downgraded Canada from the Watch List to the Priority Watch List and committed to an Out-of-Cycle review of Malaysia’s intellectual property system.
The USTR report also places a priority on solving longstanding problems in India, Indonesia, Chile and other countries, and heading off emerging threats in Colombia and Saudi Arabia…

Industry Watch    [to 28 April 2018]
:: Zoetis to Expand Animal Vaccine Research and Manufacturing in Suzhou, China
April 26, 2018
   Company begins construction of state-of-the-art vaccine manufacturing and research and development facilities in Suzhou to support growth
   Operations to focus on development and manufacturing of vaccines for pigs, cattle and fish and companion animals tailored to the animal health needs of China

:: Pfizer Granted FDA Breakthrough Therapy Designation for TRUMENBA® (Meningococcal Group B Vaccine) for the Prevention of Invasive Meningococcal B Disease in Children Ages 1 to 9 Years
April 23, 2018

Reports/Research/Analysis/Commentary/Conferences/Meetings/Book Watch/Tenders

Vaccines and Global Health: The Week in Review has expanded its coverage of new reports, books, research and analysis published independent of the journal channel covered in Journal Watch below. Our interests span immunization and vaccines, as well as global public health, health governance, and associated themes. If you would like to suggest content to be included in this service, please contact David Curry at: david.r.curry@centerforvaccineethicsandpolicy.org
 

Working Together to Protect All with Vaccines
CSIS | Katherine Bliss
Report  April 24, 2018 : 5 pages
PDF: https://csis-prod.s3.amazonaws.com/s3fs-public/publication/180424_Bliss_WorkingTogetherVaccines_Web.pdf?__DFQvD9A6M6.5QRq_mflhb0t_Z3dMCs

In the United States, global immunization programs have enjoyed consistent bipartisan support over the past two decades. The U.S. Agency for International Development (USAID) and the U.S. Centers for Disease Control and Prevention (CDC) provide financial and technical support for bilateral programs to strengthen countries’ immunization campaigns, including supply chain management and data analysis. The USAID Maternal and Child Health account also supports Gavi, the Vaccine Alliance, a public-private partnership financing vaccine programs in eligible lower and lower-middle income countries. The United States was one of the original six donors to Gavi and has consistently supported the alliance, which reports that it has immunized 640 million children and saved 9 million lives since its founding in 2000. Indeed, the 2018 omnibus budget passed by Congress in March provides $290 million for the vaccine partnership. That amount is $15 million above the FY2017 enacted level, a clear testament to political support for global immunization programs in a budget cycle when almost all other global health programs held steady at FY2017 levels in the face of an administration request 34 percent below the previous year.

Recent research suggests that in addition to preventing disease and protecting health, immunizations also contribute to poverty alleviation, supporting broader global economic development goals. In February, Health Affairs published a study arguing that, between 2016 and 2030, vaccines administered through public programs will prevent 36 million deaths and prevent 24 million people worldwide from becoming impoverished as a result of dealing with the catastrophic health costs associated with illness and death. This research builds on earlier data from 2016 showing that every $1 invested in vaccines saves $16 in health care costs associated with illness.

World Immunization Week, which in 2018 runs from April 24 to 30 and highlights the theme, “Protected Together, #VaccinesWork,” offers a moment to reflect on the positive support global immunization programs enjoy within an otherwise fractious political environment and the global successes to which U.S.-supported programs have contributed. Podcast Episode

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 2018 Volume 46, Issue 5, p479-600
http://www.ajicjournal.org/current

Message from APIC
Newly revised guide to clinically important microbes—available in print and digital formats
Published in issue: May 2018

American Journal of Infection Control
May 2018 Volume 46, Issue 5, p479-600
http://www.ajicjournal.org/current

Major Articles
Lessons from the domestic Ebola response: Improving health care system resilience to high consequence infectious diseases
Diane Meyer, Tara Kirk Sell, Monica Schoch-Spana, Matthew P. Shearer, Hannah Chandler, Erin Thomas, Dale A. Rose, Eric G. Carbone, Eric Toner
p533–537
Published online: December 15, 2017

American Journal of Preventive Medicine
May 2018 Volume 54, Issue 5, p611-726, e83-e98
http://www.ajpmonline.org/current

Research Articles
Pneumococcal Vaccine Coverage in Adults Aged 19–64 Years, Newly Diagnosed With Chronic Conditions in the U.S.
Tanaz Petigara, Dongmu Zhang
Published online: March 15, 2018
Open Access

BMC Infectious Diseases
http://www.biomedcentral.com/bmcinfectdis/content
(Accessed 28 April 2018)

Research article
Evaluating clinical effectiveness of 13-valent pneumococcal conjugate vaccination against pneumonia among middle-aged and older adults in Catalonia: results from the EPIVAC cohort study
Benefits using the 13-valent pneumococcal conjugate vaccine (PCV13) in adults are controversial. This study investigated clinical effectiveness of PCV13 vaccination in preventing hospitalisation from pneumonia…
Authors: Angel Vila-Corcoles, Olga Ochoa-Gondar, Cinta de Diego, Eva Satue, María Aragón, Angel Vila-Rovira, Frederic Gomez-Bertomeu, Ramon Magarolas, Enric Figuerola-Massana, Xavier Raga, Mar O. Perez and Frederic Ballester
Citation: BMC Infectious Diseases 2018 18:196
Published on: 27 April 2018

BMC Infectious Diseases
http://www.biomedcentral.com/bmcinfectdis/content
(Accessed 28 April 2018)

Research article
Assessment of an optimized manufacturing process for inactivated quadrivalent influenza vaccine: a phase III, randomized, double-blind, safety and immunogenicity study in children and adults
GSK has modified the licensed monovalent bulk manufacturing process for its split-virion inactivated quadrivalent influenza vaccine (IIV4) to harmonize the process among different strains, resulting in an incr…
Authors: Carine Claeys, Mamadou Drame, José García-Sicilia, Khalequ Zaman, Alfonso Carmona, Phu My Tran, Mariano Miranda, Federico Martinón-Torres, Franck Thollot, Michael Horn, Tino F. Schwarz, Ulrich Behre, José M. Merino, Iwona Sadowska-Krawczenko, Henryk Szymański, Peter Schu…
Citation: BMC Infectious Diseases 2018 18:186
Published on: 18 April 2018

BMC Medical Ethics
http://www.biomedcentral.com/bmcmedethics/content
(Accessed 28 April 2018)

Research article
‘Screening audit’ as a quality assurance tool in good clinical practice compliant research environments
With the growing amount of clinical research, regulations and research ethics are becoming more stringent. This trend introduces a need for quality assurance measures for ensuring adherence to research ethics …
Authors: Sinyoung Park, Chung Mo Nam, Sejung Park, Yang Hee Noh, Cho Rong Ahn, Wan Sun Yu, Bo Kyung Kim, Seung Min Kim, Jin Seok Kim and Sun Young Rha
Citation: BMC Medical Ethics 2018 19:30
Published on: 25 April 2018

BMC Pregnancy and Childbirth
http://www.biomedcentral.com/bmcpregnancychildbirth/content
(Accessed 28 April 2018)

Research article
Tolerability of trivalent inactivated influenza vaccine among pregnant women, 2015
Thailand recommends influenza vaccination among pregnant women. We conducted a cohort study to determine if the prevalence of adverse events following immunization (AEFIs) with influenza vaccine among Thai pre…
Authors: Suvanna Asavapiriyanont, Wanitchaya Kittikraisak, Piyarat Suntarattiwong, Darunee Ditsungnoen, Surasak Kaoiean, Podjanee Phadungkiatwatana, Nattinee Srisantiroj, Tawee Chotpitayasunondh, Fatimah S. Dawood and Kim A. Lindblade
Citation: BMC Pregnancy and Childbirth 2018 18:110
Published on: 23 April 2018

BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles
(Accessed 28 April 2018)

Research article
Examining the spatiotemporal evolution of vaccine refusal: nonmedical exemptions from vaccination in California, 2000–2013
Vaccine hesitancy continues to be an issue throughout the United States, as numerous vaccine hesitant parents are choosing to exempt their children from school-entry vaccination requirements for nonmedical rea…
Authors: Paul L. Delamater, Timothy F. Leslie and Y. Tony Yang
Citation: BMC Public Health 2018 18:458
Published on: 24 April 2018

BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles
(Accessed 28 April 2018)

Research article
Altruism, Scepticism, and collective decision-making in foreign-born U.S. residents in a tuberculosis vaccine trial
The current vaccine against tuberculosis, BCG, is effective when given in most TB-endemic countries at birth but has diminished efficacy against pulmonary TB after 15–20 years. As a result, new booster vaccine…
Authors: Sienna R. Craig, Timothy Lahey, Apoorva Dixit and C. Fordham von Reyn
Citation: BMC Public Health 2018 18:535
Published on: 23 April 2018

BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles
(Accessed 28 April 2018)

Study protocol
Impact evaluation of a community engagement intervention in improving childhood immunization coverage: a cluster randomized controlled trial in Assam, India
To improve immunization coverage, most interventions that are part of the national immunization program in India address supply-side challenges. But, there is growing evidence that addressing demand-side facto…
Authors: Santanu Pramanik, Arpita Ghosh, Rituu B. Nanda, Marlou de Rouw, Philip Forth and Sandra Albert
Citation: BMC Public Health 2018 18:534
Published on: 23 April 2018

BMC Research Notes
http://www.biomedcentral.com/bmcresnotes/content
(Accessed 28 April 2018)

Research note
Assessment of temperatures in the vaccine cold chain in two provinces in Lao People’s Democratic Republic: a cross-sectional pilot study
All childhood vaccines, except the oral polio vaccine, should be kept at 2–8 °C, since the vaccine potency can be damaged by heat or freezing temperature. A temperature monitoring study conducted in 2008–2009 …
Authors: Tomomi Kitamura, Viraneth Bouakhasith, Kongxay Phounphenghack, Chansay Pathammavong, Anonh Xeuatvongsa, Masataro Norizuki, Hironori Okabayashi, Yoshio Mori, Munehito Machida and Masahiko Hachiya
Citation: BMC Research Notes 2018 11:261
Published on: 27 April 2018

Contemporary Clinical Trials
Volume 68  Pages 1-146 (May 2018)
https://www.sciencedirect.com/journal/contemporary-clinical-trials/vol/68/suppl/C

Study Design, Statistical Design, Study Protocols
Design and statistical considerations for studies evaluating the efficacy of a single dose of the human papillomavirus (HPV) vaccine
Original research article
Pages 35-44
Joshua N. Sampson, Allan Hildesheim, Rolando Herrero, Paula Gonzalez, … Mitchell H. Gail
Abstract
Cervical cancer is a leading cause of cancer mortality in women worldwide. Human papillomavirus (HPV) types 16 and 18 cause about 70% of all cervical cancers. Clinical trials have demonstrated that three doses of either commercially available HPV vaccine, Cervarix ® or Gardasil ®, prevent most new HPV 16/18 infections and associated precancerous lesions. Based on evidence of immunological non-inferiority, 2-dose regimens have been licensed for adolescents in the United States, European Union, and elsewhere. However, if a single dose were effective, vaccine costs would be reduced substantially and the logistics of vaccination would be greatly simplified, enabling vaccination programs in developing countries. The National Cancer Institute (NCI) and the Agencia Costarricense de Investigaciones Biomédicas (ACIB) are conducting, with support from the Bill & Melinda Gates Foundation and the International Agency for Research on Cancer (IARC), a large 24,000 girl study to evaluate the efficacy of a 1-dose regimen. The first component of the study is a four-year non-inferiority trial comparing 1- to 2-dose regimens of the two licensed vaccines. The second component is an observational study that estimates the vaccine efficacy (VE) of each regimen by comparing the HPV infection rates in the trial arms to those in a contemporaneous survey group of unvaccinated girls. In this paper, we describe the design and statistical analysis for this study. We explain the advantage of defining non-inferiority on the absolute risk scale when the expected event rate is near 0 and, given this definition, suggest an approach to account for missing clinic visits. We then describe the problem of estimating VE in the absence of a randomized placebo arm and offer our solution.

Current Opinion in Infectious Diseases
June 2018 – Volume 31 – Issue 3
http://journals.lww.com/co-infectiousdiseases/pages/currenttoc.aspx

PAEDIATRIC AND NEONATAL INFECTIONS
The impact of malnutrition on childhood infections
Walson, Judd L.; Berkley, James A.
Current Opinion in Infectious Diseases. 31(3):231-236, June 2018.
Abstract:
Purpose of review
Almost half of all childhood deaths worldwide occur in children with malnutrition, predominantly in sub-Saharan Africa and South Asia. This review summarizes the mechanisms by which malnutrition and serious infections interact with each other and with children’s environments.
Recent findings
It has become clear that whilst malnutrition results in increased incidence, severity and case fatality of common infections, risks continue beyond acute episodes resulting in significant postdischarge mortality. A well established concept of a ‘vicious-cycle’ between nutrition and infection has now evolving to encompass dysbiosis and pathogen colonization as precursors to infection; enteric dysfunction constituting malabsorption, dysregulation of nutrients and metabolism, inflammation and bacterial translocation. All of these interact with a child’s diet and environment. Published trials aiming to break this cycle using antimicrobial prophylaxis or water, sanitation and hygiene interventions have not demonstrated public health benefit so far.
Summary
As further trials are planned, key gaps in knowledge can be filled by applying new tools to re-examine old questions relating to immune competence during and after infection events and changes in nutritional status; and how to characterize overt and subclinical infection, intestinal permeability to bacteria and the role of antimicrobial resistance using specific biomarkers.

Globalization and Health
http://www.globalizationandhealth.com/
[Accessed 28 April 2018]

Research
Global landscape assessment of screening technologies for medicine quality assurance: stakeholder perceptions and practices from ten countries
The spread of substandard and falsified (SF) medical products constitutes a growing global public health concern. Some countries use portable, handheld screening technologies (STs) in the field to accelerate detection of SF medicines and reduce the number of medicine samples that undergo costly and time-consuming confirmatory analysis.
Authors: Lukas Roth, Ameena Nalim, Beth Turesson and Laura Krech
Citation: Globalization and Health 2018 14:43
Published on: 25 April 2018

Globalization and Health
http://www.globalizationandhealth.com/
[Accessed 28 April 2018]

Research
Health in Yemen: losing ground in war time
The effect of the ongoing war in Yemen on maternal and child health (MCH) has not been comprehensively assessed. Providing a situational analysis at the governorate level is critical to assist in planning a re…
Authors: Charbel El Bcheraoui, Aisha O. Jumaan, Michael L. Collison, Farah Daoud and Ali H. Mokdad
Citation: Globalization and Health 2018 14:42
Published on: 25 April 2018

Globalization and Health
http://www.globalizationandhealth.com/
[Accessed 28 April 2018]

Research
Defining the global health system and systematically mapping its network of actors
The global health system has faced significant expansion over the past few decades, including continued increase in both the number and diversity of actors operating within it. However, without a stronger unde…
Authors: Steven J. Hoffman and Clarke B. Cole
Citation: Globalization and Health 2018 14:38
Published on: 17 April 2018

Humanitarian Exchange Magazine
Number 71  March 2018
https://odihpn.org/magazine/humanitarian-response-urban-areas/

Humanitarian response in urban areas
Humanitarian crises are increasingly affecting urban areas either directly, through civil conflict, hazards such as flooding or earthquakes, urban violence or outbreaks of disease, or indirectly, through hosting people fleeing these threats. The humanitarian sector has been slow to understand how the challenges and opportunities of working in urban spaces necessitate changes in how they operate. For agencies used to working in rural contexts, the dynamism of the city, with its reliance on markets, complex systems and intricate logistics, can be a daunting challenge. Huge, diverse and mobile populations complicate needs assessments, and close coordination with other, often unfamiliar, actors is necessary.

International Journal of Community Medicine and Public Health
Vol 5, No 5 (2018)  May 2018
http://www.ijcmph.com/index.php/ijcmph/issue/view/38

Original Research Articles
Urban immunization: a story of meticulous policy implementation
This cross sectional study aimed to assess the full immunization and reasons for partial or no immunization in children less than two years of age in a metropolitan overcrowded area. Total 246 children were enrolled after applying complete enumeration method of sampling. Parents were interviewed by home to home visit and data recorded through immunization card/recall method.
Meena Kakeri, Rakesh Balaji Waghmare
DOI: 10.18203/2394-6040.ijcmph20181720

International Journal of Epidemiology
Volume 47, Issue 2, 1 April 2018, Pages 359
https://academic.oup.com/ije/issue/47/2

Miscellaneous
Quadrivalent human papillomavirus vaccination in boys and risk of autoimmune diseases, neurological diseases and venous thromboembolism
Morten Frisch; Andréa Besson; Kim Katrine Bjerring Clemmensen; Palle Valentiner-Branth; Kåre Mølbak …
International Journal of Epidemiology, Volume 47, Issue 2, 1 April 2018, Pages 634–641, https://doi.org/10.1093/ije/dyx273

Journal of Community Health
Volume 43, Issue 3, June 2018
https://link.springer.com/journal/10900/43/3/page/1

Original Paper
Barriers and Facilitators of HPV Vaccination in the VFC Program
Wayne S. Fleming, Kristin K. Sznajder, Margaret Nepps…

Journal of Community Health
Volume 43, Issue 3, June 2018
https://link.springer.com/journal/10900/43/3/page/1

Original Paper
Human Papilloma Virus Vaccination Among Adolescents in a Community Clinic Before and After Intervention
Varman, C. Sharlin, C. Fernandez, J. Vasudevan… Pages 455-458

Journal of Community Health
Volume 43, Issue 3, June 2018
https://link.springer.com/journal/10900/43/3/page/1

Original Paper
Male Undergraduates’ HPV Vaccination Behavior: Implications for Achieving HPV-Associated Cancer Equity
Hee Yun Lee, Katherine Lust, Suzanne Vang, Jay Desai

Journal of Pediatrics
May 2018 Volume 196, p1-334
http://www.jpeds.com/current

Original Articles
Education of parents and providers is needed to optimize life-saving immunizations for children with sickle cell disease
Sarah S. Long
Published in issue: May 2018

Journal of Pediatrics
May 2018 Volume 196, p1-334
http://www.jpeds.com/current

Pneumococcal and Meningococcal Vaccination among Michigan Children with Sickle Cell Disease
Abram L. Wagner, Nijika Shrivastwa, Rachel C. Potter, Sarah K. Lyon-Callo, Matthew L. Boulton
Published online: March 16, 2018

Journal of Public Health Management & Practice
May/June 2018 – Volume 24 – Issue 3
https://journals.lww.com/jphmp/pages/currenttoc.aspx

Research Full Report
Planning and Implementing Immunization Billing Programs at State and Local Health Departments: Barriers and Possible Solutions
Corriero, Rosemary; Redmon, Ginger
Journal of Public Health Management and Practice. 24(3):248-254, May/June 2018.

The Lancet
Apr 28, 2018 Volume 391 Number 10131 p1637-1748  e19
http://www.thelancet.com/journals/lancet/issue/current

Editorial
Addressing decreasing vaccine coverage in the EU
The Lancet
In recent years, the European Union (EU) has seen large outbreaks of vaccine-preventable diseases such as measles due to declining vaccine coverage, supply shortages, and growing vaccine hesitancy. To address the challenges facing vaccination programmes, the European Commission set an ambitious goal: to put together a Recommendation to strengthen cooperation against vaccine-preventable diseases in EU countries. A roadmap for the Recommendation was published on Dec 4, 2017, and was opened for public consultation for 4 weeks. The European Academies Science Advisory Council (EASAC) and the Federation of European Academies of Medicine (FEAM) publicly responded to the roadmap on April 19.

EASAC and FEAM warned the European Commission against a one-size-fits-all approach. They state that solutions to improve vaccine coverage need to be tailored to each member state, and that the proposal to align and coordinate vaccination schedules in the member states will most likely be “an enormous and futile effort”. The Recommendation should recognise that not all vaccines are of equal relevance for public health and individual protection, and should include a priority list for vaccines that are in high need. It should present strategies to invest in research and innovation for vaccines that need improvement. Furthermore, to tackle vaccine hesitancy with optimal communication approaches, the input of social scientists will be essential. EASAC and FEAM also call for the establishment of a European vaccination card and registry, to track vaccination status across the EU, and a monitoring system for vaccine shortage.

The Recommendation has the potential to be momentous, bringing together EU member states in a common goal towards better vaccine coverage. As we went to press, a proposal for the Recommendation was scheduled to be published on April 26. The European Commission should take heed of the medical community’s feedback to clarify the scope and aims of the proposal, or risk continuing to lose the gains for public health brought by immunisation in Europe.

Lancet Global Health
May 2018 Volume 6 Number 5 e469-e592
http://www.thelancet.com/journals/langlo/issue/current

Editorial
#VaccinesWork… don’t they?
The Lancet Global Health
One hundred years ago in April 1918, as American soldiers landed on European soil in the final months of World War I, so did a virus detected a month earlier at an army training facility in Kansas, USA, accelerating what would be the first wave of the 1918 flu pandemic. The exact origin of the pandemic is not known, but the culprit is: it was an influenza A(H1N1) virus, the kind that would again emerge and spread worldwide in 2009, causing this time a reported (and probably underestimated) 19 000 deaths. Global health has come a long way since then: the development of influenza vaccines, including a potentially universal one granting protection against all flu strains, and preparation for pandemic influenza are now integral parts of health and security efforts. Yet 100 years later, influenza prevention is not free of debate and controversy, and neither is the field of vaccines and immunisation.

Vaccination has contributed tremendously to global health. Since the creation of the Expanded Programme on Immunization in 1974, it has saved countless lives and improved the living conditions of millions of people. So as we near the end of the Decade of Vaccines, with its promise of universal access to immunization by 2020 via the Global Vaccine Action Plan (GVAP), it seems almost paradoxical that global coverage of such a successful and cost-effective tool is showing only sluggish progress. Results of the 2017 report from WHO’s Strategic Advisory Group of Experts on Immunization (SAGE) on implementation of the GVAP were concerning, as slow improvement in vaccination coverage, misalignment of strategies and funding, and external threats to progress were evoked. SAGE will meet this April as part of its twice-yearly schedule and while there may be some progress to celebrate, pressures on vaccination efforts will certainly continue to permeate the discussions.

Conflicts, instability, and humanitarian disasters are especially challenging and disrupt efforts to reach those most in need of vaccines. Examples abound in today’s geopolitical state of affairs and among the most heart-wrenching is the situation of the Rohingyas stranded in Cox’s Bazaar and Bandarban, Bangladesh, where as Delan Devakumar describes in a Comment in this issue, the risks of the monsoon season are coupled with outbreaks of measles and diphtheria. In east Ghouta, in spite of an emergency vaccination campaign against measles, rubella, tuberculosis, hepatitis, and polio, Syrian refugees remain vulnerable to diseases. Weakened health systems such as Venezuela’s are susceptible to resurgence of diseases that threaten decade-long regional efforts, such as measles elimination in the Americas. Venezuela also shares a border with Brazil, where a high risk of urban yellow fever transmission has prompted a nationwide vaccination campaign.

Another impediment to progress is true political commitment to an issue that has complex budgetary implications, particularly in countries where economic progress is such that they are transitioning out of international financial assistance. One example is Nigeria, which, following rebasing, qualifies out of GAVI in spite of paltry immunisation coverage indicators and the continuing threat of polio. In this case, GAVI’s board has agreed to an exceptional support plan beyond 2020, and Bill Gates announced in March that he would support the country’s immunisation efforts by paying up a US$76 million loan from Japan. The question is whether ad-hoc interventions of this type would be repeated with other transitioning countries.

Vaccination efforts are also clearly aligned with the Universal Health Coverage (UHC) agenda, but financing and service delivery plans on the road to UHC might affect the way immunisation programmes and services are prioritised, adding uncertainty. Beyond budgetary considerations, vaccine policies must strike the right balance between imposing vaccination or giving a choice, to parents in particular, in environments where vaccine skepticism can be high. Recent laws making several childhood vaccines mandatory in France and Italy have generated much debate and highlighted the reality that the power of vaccines can be threatened in countries on the full spectrum of national incomes, and not only where lack of access is due to lack of resources.

There is no doubt that vaccines work: they save lives, they are the best investment a country could make for its citizens. Yet immunisation only really works when all the pressures on coverage, those mentioned above and many more, are relieved in a collective effort. The theme of this year’s World Immunization Week on April 24–30, “Protected Together, #VaccinesWork” is a good reminder of that.

Lancet Global Health
May 2018 Volume 6 Number 5 e469-e592
http://www.thelancet.com/journals/langlo/issue/current

Articles
National and regional under-5 mortality rate by economic status for low-income and middle-income countries: a systematic assessment
Fengqing Chao, Danzhen You, Jon Pedersen, Lucia Hug, Leontine Alkema

Lancet Infectious Diseases
May 2018  Volume 18 Number 5 p475-582  e147-e182
http://www.thelancet.com/journals/laninf/issue/current

Editorial
Plotting a route to a universal influenza vaccine
The Lancet Infectious Diseases

Lancet Infectious Diseases
May 2018  Volume 18 Number 5 p475-582  e147-e182
http://www.thelancet.com/journals/laninf/issue/current

Review
Effectiveness of national and subnational infection prevention and control interventions in high-income and upper-middle-income countries: a systematic review
Lesley Price, Jennifer MacDonald, Lynn Melone, Tracey Howe, Paul Flowers, Kay Currie, Evonne Curran, Valerie Ness, Debbie Waddell, Sarkis Manoukian, Agi McFarland, Claire Kilpatrick, Julie Storr, Anthony Twyman, Benedetta Allegranzi, Jacqui Reilly
Summary
Evidence-based guidance for national infection prevention and control (IPC) programmes is needed to support national and global capacity building to reduce health-care-associated infection and antimicrobial resistance. In this systematic review we investigate evidence on the effectiveness of IPC interventions implemented at national or subnational levels to inform the development of WHO guidelines on the core components of national IPC programmes. We searched CENTRAL, CINAHL, Embase, MEDLINE, and WHO IRIS databases for publications between Jan 1, 2000, and April 19, 2017. 29 studies that met the eligibility criteria (ie, economic evaluations, cluster-randomised trials, non-randomised trials, controlled before-and-after studies, and interrupted time-series studies exploring the effective of these interventions) were categorised according to intervention type: multimodal, care bundles, policies, and surveillance, monitoring, and feedback. Evidence of effectiveness was found in all categories but the best quality evidence was on multimodal interventions and surveillance, monitoring, and feedback. We call for improvements in study design, reporting of research, and quality of evidence particularly from low-income countries, to strengthen the uptake and international relevance of IPC interventions.

Lancet Respiratory Medicine
May 2018 Volume 6 Number 5 p315-402   e16-e18
http://www.thelancet.com/journals/lanres/issue/current

Editorial
Fake medicines: fighting on all fronts
The Lancet Respiratory Medicine

The illegal market in fake medicines is a growing threat and is harming patients the world over—this was the headline of Fight the Fakes, an event at University College London (UCL) on March 16, 2018, which aimed to provoke action on the urgent global issue of falsified and substandard medicines.

A recent WHO report estimated that about 1 in 10 medical products circulating in countries of low and middle income is either substandard or falsified. Fake drugs are being produced by organised criminals who can turn large profits. Factories are set up that can create packaging and medication inserts that perfectly resemble the real drugs; this packaging is then filled with cheaply made tablets or solutions that contain no active ingredient whatsoever, or in some cases contain dangerous substances. All too often, these harmful counterfeits find their way into pharmacies and clinics in countries of low and middle income. At the Fight the Fakes event, Michael Deats of WHO showed footage of a raid on a fake medicines factory in West Africa; glass bottles were being filled with “antimicrobials” to be dispensed to children with lung infections, but the liquid being decanted from filthy plastic canisters not only contained no active ingredient, it was also heavily contaminated with Escherichia coli.

Antimicrobials and antimalarials are the most commonly reported fake drugs. A modelling study based on data from the WHO report estimated that between 79 000 and 169 000 children might be dying each year from pneumonia because they are being treated with fake antibiotics. Data on all classes of drugs are patchy, but a 2013 study of pharmacies in 19 countries found that 9·1% of tuberculosis drugs sampled did not contain enough active ingredient or failed disintegration tests. Failure rate was 16·6% in Africa, 10·1% in India, and 3·9% in other middle-income countries.

Speaking at the Fight the Fakes event, Professor Ibrahim Abubakar (UCL) noted that in the case of tuberculosis, as well as some other infectious diseases, fake drugs do not just cause harm to the individual patient, but they also contribute to the development of resistant strains that can affect society as a whole.

A second WHO report on surveillance and monitoring of substandard and falsified drugs identified three main drivers of the problem in countries of low and middle income: constrained access to safe and affordable medical products, lack of good governance, and weak technological capacity. For these drivers to be addressed, political will and public awareness will be required.

Higher-income countries face a slightly different set of problems. Lynda Scammell of the MHRA said that the incidence of fake drugs making their way into the official supply chain in the UK (ie, being dispensed by the NHS) is very low; however, a growing number of people are buying medicines online. Often, these drugs are bought from websites that look legitimate, but the supply chain is opaque, increasing the risk of falsified or substandard drugs being taken. Additionally, prescription-only medications are frequently bought online without any consultation or appropriate medical advice.

Substandard medical devices bought online are also a problem; Scammell cited syphilis testing kits that always give a negative result or dental drills with a tendency to fall apart in the middle of procedures. Both of these are examples of products seized during Operation Pangea, co-ordinated by INTERPOL, which aims to tackle the illegal sale of medicines and devices online. As well as seizing packages as they come through customs, Pangea targets internet service providers for illegal medicine websites and the payments systems that they use.

The conversation around the complex issue of fake medicines can often be rather sterile, focusing on the need for supply chain oversight, country-level surveillance, and public awareness campaigns. Although these are all important weapons in the fight, it is important to remember that this is a human issue that brings misery and suffering to people daily. In his presentation, Michael Deats showed video footage of five children from a rural area of the Democratic Republic of Congo who were among 1000 young people admitted to hospital with the same set of symptoms: dystonia, paralysis of the upper limbs, and protruding tongue. He explained that an investigation by Medecins Sans Frontieres eventually found that all the children had been given yellow tablets labelled as diazepam, which had been prescribed to treat malarial convulsions; however, when tested, the tablets were found to contain haloperidol, an antipsychotic, which had been purposefully mislabelled as diazepam to sell it. 11 of the children died. This shocking example highlights that this is an urgent issue that is not receiving the attention it deserves.

Lancet Respiratory Medicine
May 2018 Volume 6 Number 5 p315-402   e16-e18
http://www.thelancet.com/journals/lanres/issue/current

Articles
Efficacy, immunogenicity, and safety evaluation of an MF59-adjuvanted quadrivalent influenza virus vaccine compared with non-adjuvanted influenza vaccine in children: a multicentre, randomised controlled, observer-blinded, phase 3 trial
Timo Vesikari, Judith Kirstein, Grace Devota Go, Brett Leav, Mary Ellen Ruzycky, Leah Isakov, Marianne de Bruijn, Janine Oberye, Esther Heijnen

New England Journal of Medicine
April 26, 2018  Vol. 378 No. 17
http://www.nejm.org/toc/nejm/medical-journal

Original Article
Azithromycin to Reduce Childhood Mortality in Sub-Saharan Africa
Jeremy D. Keenan, M.D., M.P.H., Robin L. Bailey, M.D., Sheila K. West, Ph.D., Ahmed M. Arzika, M.S., John Hart, M.D., Jerusha Weaver, M.P.H., Khumbo Kalua, M.B., B.S., M.Med., Ph.D., Zakayo Mrango, M.D., M.P.H., Kathryn J. Ray, M.S., Catherine Cook, M.P.H., Elodie Lebas, R.N.,
Kieran S. O’Brien, M.P.H., Paul M. Emerson, Ph.D., Travis C. Porco, Ph.D., M.P.H., and Thomas M. Lietman, M.D. for the MORDOR Study Group*
Abstract
Background
We hypothesized that mass distribution of a broad-spectrum antibiotic agent to preschool children would reduce mortality in areas of sub-Saharan Africa that are currently far from meeting the Sustainable Development Goals of the United Nations.
Methods
In this cluster-randomized trial, we assigned communities in Malawi, Niger, and Tanzania to four twice-yearly mass distributions of either oral azithromycin (approximately 20 mg per kilogram of body weight) or placebo. Children 1 to 59 months of age were identified in twice-yearly censuses and were offered participation in the trial. Vital status was determined at subsequent censuses. The primary outcome was aggregate all-cause mortality; country-specific rates were assessed in prespecified subgroup analyses.
Conclusions
Among postneonatal, preschool children in sub-Saharan Africa, childhood mortality was lower in communities randomly assigned to mass distribution of azithromycin than in those assigned to placebo, with the largest effect seen in Niger. Any implementation of a policy of mass distribution would need to strongly consider the potential effect of such a strategy on antibiotic resistance. (Funded by the Bill and Melinda Gates Foundation; MORDOR ClinicalTrials.gov number, NCT02047981.)

PLoS Medicine
http://www.plosmedicine.org/
(Accessed 28 April 2018)

Perspective
From surviving to thriving: What evidence is needed to move early child-development interventions to scale?
Mark Tomlinson
| published 24 Apr 2018 PLOS Medicine
https://doi.org/10.1371/journal.pmed.1002557

Public Health
May 2018 Volume 158, p1-202
http://www.publichealthjrnl.com/current
Special issue on Migration: A global public health issue
Edited by Sian M Griffiths, Roger YN Chung

Editors’ Choice
Migration: a core public health ethics issue
Wild, A. Dawson
Published online: March 29, 2018
Migration is a core issue of public health ethics and must take a case-based approach: seeking to identify the specific ethical dimensions and vulnerabilities in each particular context. Public health as a practice, built upon the core value of justice, requires the protection and promotion of migrants’ well-being (even if this produces tension with immigration services). Ethical analysis should take all phases of migration into account: before, during and after transit. We argue that migration policies, at least as they relate to migrants’ well-being, should be founded upon a shared humanity, respect for human rights and on the idea that effective public health cannot and should not be confined within the borders and to the citizens of any host country.

Public Health
May 2018 Volume 158, p1-202
http://www.publichealthjrnl.com/current
Special issue on Migration: A global public health issue
Edited by Sian M Griffiths, Roger YN Chung

Themed papers
Migrant children within Europe: a systematic review of children’s perspectives on their health experiences
Curtis, J. Thompson, H. Fairbrother
p71–85
Published online: April 4, 2018