PLoS One
http://www.plosone.org/
[Accessed 7 Dec 2019]

Visual inspection of vaccine storage conditions in general practices: A study of 75 vaccine refrigerators
Anika Thielmann, Marie-Therese Puth, Birgitta Weltermann
Research Article | published 03 Dec 2019 PLOS ONE
https://doi.org/10.1371/journal.pone.0225764

PLoS One
http://www.plosone.org/
[Accessed 7 Dec 2019]

Withdrawn medicines included in the essential medicines lists of 136 countries
Onella Charles, Igho Onakpoya, Simran Benipal, Hannah Woods, Anjli Bali, Jeffrey K. Aronson, Carl Heneghan, Nav Persaud
Research Article | published 02 Dec 2019 PLOS ONE
https://doi.org/10.1371/journal.pone.0225429
Abstract
Background
Essential medicines lists and related policies are intended to meet the priority health needs of populations and their implementation is associated with more appropriate use of medicines. The World Health Organization (WHO) recommends that countries carefully select the medicines to be included in their national essential medicines lists. Lists that are used to prioritize access to important treatments should not include medicines that have been withdrawn elsewhere because of an unfavourable benefit-to-harm balance; however, countries still list and use medicines that have been withdrawn worldwide. The objective of this study was to determine whether the national essential medicines lists of 137 countries include medicines that have been withdrawn in other countries.
Methods and findings
We performed an audit of national essential medicines lists for medicines that had been withdrawn. Medicines withdrawn from worldwide markets between 1953 and 2014 were identified using a systematic review of published literature and regulatory documents. The reviewers used sources including the WHO’s database of drugs, PubMed, and the websites of regulatory agencies to obtain information regarding adverse effects associated with the medicines, the year of first withdrawal, markets of withdrawal, and the level of evidence supporting each withdrawal. We recorded the number of countries with a withdrawn medicine included in their national medicines list, the number of withdrawn medicines included in each nation’s list, and the number of national essential medicines including each withdrawn medicine. 97 medicines were withdrawn in at least one country but still included in one more national essential medicines list. Of 137 countries with a national essential medicines list, 136 lists included at least one withdrawn medicine, with 54% of the lists containing 5 or fewer withdrawn medicines, and 27% including 10 or more withdrawn medicines. 11 medicines were withdrawn worldwide but still included on at least one national essential medicines list. Countries with longer essential medicines lists had more withdrawn medicines included in their lists.
Conclusions
This study found that withdrawn medicines are included in all but one national essential medicines list, representing a need for more stringent processes for selecting and removing medicines on these lists. Countries may wish to apply special scrutiny to medicines withdrawn in other nations when selecting medicines to include on their lists

PLoS One
http://www.plosone.org/
[Accessed 7 Dec 2019]

Trust, and distrust, of Ebola Treatment Centers: A case-study from Sierra Leone
Paul Richards, Esther Mokuwa, Pleun Welmers, Harro Maat, Ulrike Beisel
Research Article | published 02 Dec 2019 PLOS ONE
https://doi.org/10.1371/journal.pone.0224511

Public Health
Volume 177 Pages A1-A4, 1-144 (December 2019)
https://www.sciencedirect.com/journal/public-health/vol/177/suppl/C

Research article Abstract only
What the public think about participation in medical research during an influenza pandemic: an international cross-sectional survey
N. Gobat, C.C. Butler, J. Mollison, N.A. Francis, … A. Nichol
Pages 80-94

Public Health
Volume 177 Pages A1-A4, 1-144 (December 2019)
https://www.sciencedirect.com/journal/public-health/vol/177/suppl/C

Research article Abstract only
A systematic approach to map the adolescent human papillomavirus vaccine decision and identify intervention strategies to address vaccine hesitancy
S. Marshall, L.J. Sahm, A.C. Moore, A. Fleming
Pages 71-79

Science
06 December 2019 Vol 366, Issue 6470
http://www.sciencemag.org/current.dtl

Research Articles
A generalized HIV vaccine design strategy for priming of broadly neutralizing antibody responses
By Jon M. Steichen, Ying-Cing Lin, Colin Havenar-Daughton, Simone Pecetta, Gabriel Ozorowski, Jordan R. Willis, Laura Toy, Devin Sok, Alessia Liguori, Sven Kratochvil, Jonathan L. Torres, Oleksandr Kalyuzhniy, Eleonora Melzi, Daniel W. Kulp, Sebastian Raemisch, Xiaozhen Hu, Steffen M. Bernard, Erik Georgeson, Nicole Phelps, Yumiko Adachi, Michael Kubitz, Elise Landais, Jeffrey Umotoy, Amanda Robinson, Bryan Briney, Ian A. Wilson, Dennis R. Burton, Andrew B. Ward, Shane Crotty, Facundo D. Batista, William R. Schief
Science06 Dec 2019 Restricted Access
A repertoire-guided germline-targeting approach for development of broadly neutralizing anti-HIV antibodies is explored.

Tropical Medicine & International Health
Volume 24, Issue 12 Pages: i-iv, 1341-1475 December 2019
https://onlinelibrary.wiley.com/toc/13653156/current

Reviews
Experimental infections in humans—historical and ethical reflections
W. G. Metzger, H.‐J. Ehni, P. G. Kremsner, B. G. Mordmüller,
Pages: 1384-1390
First Published: 26 October 2019
Abstract
Vaccine efficacy and prophylactic treatment of infections are tested best when the vaccinated or treated individual is challenged through deliberate infection with the respective pathogen. However, this trial design calls for particular ethical caution. Awareness of the history of challenge trials is indispensable, including trials that were problematic or even connected to abuse. We briefly introduce historical aspects of experimental infections in humans and the ethical debate around them and give estimates of the numbers of volunteers participating in human experimental infection models. Challenge models can offer a great chance and benefit for the development of medical interventions to fight infectious diseases, but only when they are appropriately controlled and regulated.

Vaccine
Volume 38, Issue 1 Pages 1-100 (3 January 2020)
https://www.sciencedirect.com/journal/vaccine/vol/38/issue/1

Selected Content
Research article Full text access
Perceived trust in the health system among mothers and nurses and its relationship to the issue of vaccinations among the Arab population of Israel: A qualitative research study
Nour Abed Elhadi Shahbari, Anat Gesser-Edelsburg, Gustavo S. Mesch
Pages 29-38

Vaccine
Volume 38, Issue 1 Pages 1-100 (3 January 2020)
https://www.sciencedirect.com/journal/vaccine/vol/38/issue/1

Research article Full text access
Factors associated with the willingness of primary caregivers to avail of a dengue vaccine for their 9 to 14-year-olds in an urban community in the Philippines
Ma. Sophia Graciela L. Reyes, Karen Mae G. Lee, Adrianna Michelle L. Pedron, Jennel Mae T. Pimentel, Paul Adrian V. Pinlac
Pages 54-62

Vaccine
Volume 38, Issue 1 Pages 1-100 (3 January 2020)
https://www.sciencedirect.com/journal/vaccine/vol/38/issue/1

Research article Full text access
Differential determinants and reasons for the non- and partial vaccination of children among Nigerian caregivers
Ryoko Sato
Pages 63-69

Value in Health
December 2019 Volume 22, Issue 12, p1345-1470
https://www.valueinhealthjournal.com/issue/S1098-3015(19)X0012-1

ECONOMIC EVALUATION
Cost-Effectiveness Analysis for Influenza Vaccination Coverage and Timing in Tropical and Subtropical Climate Settings: A Modeling Study
Mu Yue, Borame L. Dickens, Joanne Su-yin Yoong, Mark I-Cheng Chen, Yot Teerawattananon, Alex R. Cook
p1345–1354
Published online: August 19, 2019

Value in Health
December 2019 Volume 22, Issue 12, p1345-1470
https://www.valueinhealthjournal.com/issue/S1098-3015(19)X0012-1

ECONOMIC EVALUATION
Cost-Effectiveness Analysis for Influenza Vaccination Coverage and Timing in Tropical and Subtropical Climate Settings: A Modeling Study
Mu Yue, Borame L. Dickens, Joanne Su-yin Yoong, Mark I-Cheng Chen, Yot Teerawattananon, Alex R. Cook
p1345–1354
Published online: August 19, 2019

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

Frontiers in Microbiology
Accepted: 29 Nov 2019.
Review Article
Recent progress in vaccine development against chikungunya virus
L Zhang, S Gao, S Song -, 2019
Chikungunya fever (CHIKF) is an acute infectious disease which is mediated by mosquito-transmitted chikungunya virus (CHIKV). People who infected with CHIKV could cause high fever, severe joint pain, skin rash and headache. In recent years, this disease has become one of the global public health problems. However, there is no licensed vaccine available to prevent CHIKV. Accumulating research data have provided novel approaches and new directions for the development of CHIKV vaccines. Our review focuses on the recent progress of CHIKV vaccines studies. The potential vaccine candidates are classified into seven types: inactivated vaccine, subunit vaccine, live-attenuated vaccine, recombinant virus-vectored vaccine, virus-like particle vaccine, chimeric vaccine and nucleic acid vaccine. These studies will shed important insights into future development of CHIKV vaccines.

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.

The Atlantic
http://www.theatlantic.com/magazine/
Accessed 7 Dec 2019
[No new, unique, relevant content]

BBC
http://www.bbc.co.uk/
Accessed 7 Dec 2019
[No new, unique, relevant content]

The Economist
http://www.economist.com/
Accessed 7 Dec 2019
[No new, unique, relevant content]

Financial Times
http://www.ft.com/home/uk
[No new, unique, relevant content]

Forbes
http://www.forbes.com/
Accessed 7 Dec 2019
[No new, unique, relevant content; new website has no search function]

Foreign Affairs
http://www.foreignaffairs.com/
Accessed 7 Dec 2019
[No new, unique, relevant content]

Foreign Policy
http://foreignpolicy.com/
Accessed 7 Dec 2019
[No new, unique, relevant content]

The Guardian
http://www.guardiannews.com/
Accessed 7 Dec 2019
[No new, unique, relevant content]

New Yorker
http://www.newyorker.com/
Accessed 7 Dec 2019
[No new, unique, relevant content]

New York Times
http://www.nytimes.com/
Accessed 7 Dec 2019
[No new, unique, relevant content]

Washington Post
https://www.washingtonpost.com/
Accessed 7 Dec 2019
[No new, unique, relevant content]

Think Tanks et al

Brookings
http://www.brookings.edu/
Accessed 7 Dec 2019
[No new relevant content]

Center for Global Development
http://www.cgdev.org/page/press-center
Accessed 7 Dec 2019
[No new relevant content]

CSIS
https://www.csis.org/
Accessed 7 Dec 2019
Podcast Episode
The New Threat – Making Sense of Vaccine-Derived Polio
December 3, 2019 | By Nellie Bristol

Council on Foreign Relations
http://www.cfr.org/
Accessed 7 Dec 2019
[No new relevant content]

Kaiser Family Foundation
https://www.kff.org/search/?post_type=pre ss-release
[No new relevant content]

Milestones :: Perspectives :: Research

Measles

UNICEF delivers over 260,000 vaccines and medical supplies to fight measles outbreaks in Samoa, Fiji and Tonga
Delivers 115,500 doses of measles vaccines to worst-affected Samoa
SUVA, 28 November 2019: UNICEF is supporting the Governments of Samoa, Fiji and the Kingdom of Tonga to respond to the current measles outbreak in the Pacific region. As of 28 November, almost 300,000 vaccines and medical supplies have been delivered to reach those populations most at-risk in Samoa, Fiji, the Kingdom of Tonga, Vanuatu, Cook Islands, Nauru, Niue, Tokelau and Tuvalu.

UNICEF is responding to the outbreak together with the World Health Organisation (WHO) and other partners. UNICEF’s response is being conducted with the support of the Australian Department of Foreign Affairs and Trade (DFAT) and New Zealand’s Ministry of Foreign Affairs and Trade (MFAT).

SAMOA
The Government of Samoa officially declared a state of emergency on 15 November 2019. UNICEF has delivered a total of 115,500 doses of measles vaccines to Samoa since 1 October, including the required diluent, syringes and safety boxes, as well as sufficient supplies of Vitamin A.

The national Measles Vaccination Campaign began on 20 November 2019 with mobile outreach vaccination sites and teams, and special vaccine booths. Since the launch of the campaign, the Ministry of Health has successfully vaccinated more than 33,500 individuals in both Upolu and Savai’i.

UNICEF has delivered six 42 sqm tents, which will be used as vaccination sites or isolation wards for patients with measles. Six specially designed refrigerators and three emergency trolleys will also be provided to the Ministry of Health, to ensure the cold chain is maintained and vaccines are effective when given at vaccination sites.

FIJI
Fiji declared a measles outbreak on 7 November 2019. Since 1 October, UNICEF has delivered a total of 135,000 doses of measles vaccines with required diluent, syringes and safety boxes. An additional 200,000 vaccines are en route to Fiji.

KINGDOM OF TONGA
A measles outbreak was also declared in the Kingdom of Tonga on 24 October 2019. Since 1 October, UNICEF has delivered a total of 12,000 measles vaccines including required diluent, syringes and safety boxes, to Tonga. Two refrigerators, for the vaccine cold chain, will also be provided along with an additional 6,000 doses of vaccines.

UNICEF and WHO have jointly prepared a communication toolkit and resources to be used for measles prevention, which has been shared with all Pacific Island governments, including Samoa, Fiji and the Kingdom of Tonga. The toolkit is a regional resource, which countries can use and adapt to their country’s needs. It includes a range of communication products targeting three main audiences: travellers, general public and health workers.

::::::

4,500 children under the age of five died from measles in the Democratic Republic of the Congo so far this year
Statement by UNICEF Representative in the DRC Edouard Beigbeder
KINSHASA, 27 November 2019 – “Since the beginning of the year, more than 5,000 people have died due to measles, over 90 per cent of them children under the age of five.

“While the Ebola outbreak, which has claimed more than 2,000 lives in the Eastern DRC, has commanded sustained international attention, measles, which has claimed more than twice as many lives, continues to be underreported.

“Violence and insecurity, lack of access to healthcare and shortages of vaccines and medical kits in the worst-affected areas have meant that thousands of children have missed out on vaccinations, with potentially deadly consequences. Cultural beliefs and traditional healthcare practices also often get in the way of vaccinating children against measles and treating those with symptoms.

“Despite the many challenges, we have the tools and the knowledge to prevent measles with a safe, effective and affordable vaccine. The key is to reach every single child, no matter where they are.

“UNICEF and partners are conducting measles vaccination campaigns in the worst-affected areas and supplying clinics with medicine to treat symptoms. So far, we have distributed 1,317 medical measles kits – containing antibiotics, rehydration salts, Vitamin A and other medicines – to affected health zones to treat children with complications.

“Yet these measures can only ever be a short-term solution, as significant investment in strengthening DRC’s national vaccination programme and wider health care systems is crucial to guarantee the health and wellbeing of the country’s children.”

::::::

Measles – Global situation
Disease outbreak news = WHO
27 November 2019
Many countries around the world are experiencing measles outbreaks. As of 5 November 2019, there have been 440,263 confirmed cases reported to WHO through official monthly reporting by 187 Member States in 2019.

The following is a brief update on the global measles situation based on information shared by Member States with WHO. Note that this is an evolving situation and data is constantly updated. Data below are based on the latest information available to WHO.

African Region
Large measles outbreaks are being reported in several countries in the region. Outbreaks are ongoing in Madagascar and Nigeria ; although the rate of new cases is decreasing, cases are still being reported weekly. As of 17 November 2019, a total of 250,270 suspected cases with 5,110 associated deaths have been reported by the Democratic Republic of the Congo, an increase in more than 8,000 cases compared to the previous week. All provinces are affected, and a national outbreak response vaccination campaign is ongoing in phases and should be completed by the end of the year. As of 13 November, Guinea had 4,690 suspected measles cases, 1,091 of which were confirmed. Outbreak vaccination response activities are underway. As of 17 November 2019, Chad had reported 25,596 suspected cases in 94% of their districts; outbreak response vaccination is planned.

Eastern Mediterranean Region
From 1 January through 17 November 2019, Lebanon reported 1,060 confirmed cases of measles1 (For more information, please see Disease Outbreak News (DON) published on measles in Lebanon on 22 October 2019). As of 8 November 2019, current outbreaks of concern include Yemen with 5,847 confirmed cases, Sudan with 3,659 confirmed cases, Somalia with 2,795 cases, Pakistan with 1,978 confirmed cases, Tunisia with 1,367 cases, and Iraq with 1,222 cases of measles.

European Region
Many countries in Europe experienced large outbreaks in 2019. From 1 January through 5 November 2019, Ukraine has reported 56,802 cases, followed by Kazakhstan with 10,126 cases, Georgia with 3,904 cases, Russian Federation with 3,521 cases, Turkey with 2,666 cases, and Kyrgyzstan with 2,228 cases of measles. Some of these outbreaks (e.g. Georgia, Russian Federation, Turkey) have resolved.

Region of the Americas
From 1 January through 9 November 2019, Brazil reported 11,887 confirmed cases of measles, with the majority of cases in Sao Paulo. A vaccination response is underway.

During the same time, Venezuela reported 520 measles cases with no new case being reported in the last 14 weeks. Colombia has reported 215 cases which were likely acquired in Venezuela. In the United States, two large sustained outbreaks in New York State have also been declared over; however, small outbreaks are still occurring in other states within the United States. 2

South-East Asia Region
From 1 January through 18 November, Bangladesh has reported 4,181 confirmed cases of measles. Much of the current, growing outbreak is centered in Rohingya refugee camps in Cox’s Bazaar; vaccination efforts continue. Myanmar has had 5,286 cases though their outbreak appears to be resolving after two rounds of outbreak response immunization. A nationwide vaccination campaign for children aged 9-65 months is ongoing. There is a need to also vaccinate previously unreached adults to stop the current ongoing transmission.

During the same time, Thailand reported 4,852 cases, and a vaccination campaign targeting children between 1-12 years of age is ongoing; however, there is a need to conduct vaccination campaigns for susceptible populations born between 1984 to 2000 as well as migrant populations in industrial areas, people participating in travel and tours company and such other establishments.

Western Pacific Region
Outbreaks in the Philippines and Viet Nam earlier in 2019 drove the increase in cases in the Region, but new cases are decreasing in these countries. As of 20 November 2019, current outbreaks include New Zealand with 2,084 confirmed cases, of which 80% are in the Auckland region 3 ; Cambodia has 490 cases with cases occurring in all provinces.

From 1 January through 23 November 2019, multiple countries in the Pacific Islands are experiencing outbreaks including Tonga (310 cases), Fiji (10 cases)4 , and American Samoa (2 cases). As of 26 November, the Samoa Ministry of Health confirmed a total of 2,437 cases and 32 associated deaths, with 243 new cases reported within the last 24 hours 5 . These islands are conducting outbreak response activities and mitigation measures, including vaccination campaigns.

Public health response
WHO and partners coordinate their support to Member States for the following activities:
:: Enhancing preparedness for measles outbreak response
:: Strengthening public trust in vaccines
:: Strengthening surveillance, risk assessment and outbreak investigations
:: Improving clinical management of measles cases
:: Implementing outbreak response immunization activities
:: Evaluating outbreak response activities

WHO has established a measles outbreaks Incident Management Support system to coordinate its support to affected countries.

WHO risk assessment
Measles is a highly contagious viral disease which affects susceptible individuals of all ages and remains one of the leading causes of death among young children globally, despite the availability of safe and effective measles-containing vaccines. It is transmitted via droplets from the nose, mouth, or throat of infected persons. Initial symptoms, which usually appear 10–12 days after infection, include high fever, usually accompanied by one or several of the following: runny nose, conjunctivitis, cough and tiny white spots on the inside of the mouth. Several days later, a rash develops, starting on the face and upper neck and gradually spreads downwards. A patient is infectious four days before the start of the rash to four days after the appearance of the rash. Most people recover within 2–3 weeks.

Even with implementation of routine immunization, measles continues to circulate globally due to suboptimal vaccination coverage and population immunity gaps. Any community with less than 95% population immunity is at risk for an outbreak. If an outbreak response is not timely and comprehensive, the virus will find its way into more pockets of vulnerable individuals and potentially spread within and beyond the affected countries.

The impact on public health will persist until the ongoing outbreaks are controlled, routine immunization coverage is continuously high (≥ 95%) and immunity gaps in the population are closed. As long as measles continues to circulate anywhere in the world, no country can be assured to avoid importation. However, countries can protect their populations through high vaccine coverage achieved primarily through routine immunization programmes, and where necessary through supplemental immunization activities designed to assure that susceptible individuals are vaccinated.

WHO advice
Immunization is the most effective preventive measure against measles. Two doses of measles-containing-vaccine are recommended to ensure immunity.

While there is no specific antiviral treatment for measles,prompt provision of vitamin A is recommended by WHO for all children infected with measles. It is critical to quickly recognize and treat complications of measles in order to reduce mortality and severity of disease.

WHO urges all Member States to do the following:
:: Maintain high measles vaccination coverage (≥ 95%) with two doses of measles-containing-vaccine, in every district;
:: Offer vaccination to individuals who do not have proof of vaccination or immunity against measles, and who are at risk of infection and transmission of the virus, such as healthcare workers, people working in tourism and transportation, and international travelers;
:: Strengthen epidemiological surveillance for cases of ‘fever with rash’ for timely detection of all suspected cases of measles in public and private healthcare facilities;
:: Ensure that collected blood samples from suspect measles cases appropriately tested by laboratories within five days;
:: All countries need to provide a rapid response to imported measles cases to prevent the establishment or re-establishment of endemic transmission;
:: Recognize complications early and provide comprehensive treatment to reduce the severity of disease and avoid unnecessary deaths.
:: Administer vitamin A supplementation to all children diagnosed with measles to reduce the complications and mortality (two doses of 50, 000 IU for a child less than 6 month of age, 1,00,000 IU for children between 6 and12 months of age or 2,00,000 IU for children 12-59 months, immediately upon diagnosis and on the following day.
:: Ensure health care workers are vaccinated in order to avoid infections acquired in a health care setting.

Milestones :: Perspectives :: Research

Policy/Regulation

Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators
National Academies of Sciences, Engineering, and Medicine; doi.org/10.17226/25594.
Alastair Wood and Patricia Cuff, Editors
November 2019 :: 160 pages
Open Access – PDF: https://www.nap.edu/login.php?record_id=25594&page=https%3A%2F%2Fwww.nap.edu%2Fdownload%2F25594
Description
Globalization is rapidly changing lives and industries around the world. Drug development, authorization, and regulatory supervision have become international endeavors, with most medicines becoming global commodities. Drug companies utilize global supply chains that often include facilities in countries with inconsistent regulations from those of the United States, perform pivotal trials in multiple countries to support registration submissions in various jurisdictions, and subsequently market their medicines throughout most of the world. These companies operate across borders and require individual national regulators to ensure that drugs authorized for use in their countries are safe and effective, and appropriate for their health care system and their population. This process involves significant resources and often duplicative work. It is important to consider how this process can be improved in order to better allocate resources, time, and efforts to improve public health.
Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators considers the role of mutual recognition and other reliance activities among regulators in contributing to enhancing public health. This report identifies opportunities for leveraging reliance activities more broadly in order to potentially impact public health globally. Key topics in this report include the job of medicines regulators in today’s world, what policy makers need to know about today’s regulatory environment, stakeholder views of recognition and reliance, as well as removing impediments and facilitating action for greater recognition and reliance among regulatory authorities.

Emergencies

Ebola – DRC+
Public Health Emergency of International Concern (PHEIC)

Ebola Outbreak in DRC 69: 26 November 2019
Situation Update
In the week of 18 to 24 November 2019, seven new confirmed EVD cases were reported from four health zones in two affected provinces in Democratic Republic of the Congo. The majority of the confirmed cases in this week came from Mabalako Health Zone (57%; n=4).

Violence and civil unrest in the week have led to the suspension of Ebola response activities in some areas of Beni, Butembo, and Oicha health zones. On 26 November 2019, some response personnel were temporarily relocated from Beni, though most remain in place to continue responding. The immediate focus will be on maintaining the safety and welfare of response personnel while preserving essential response activities in these places.

The disruptions to the response and lack of access to Ebola-affected communities is threatening to reverse recent progress. As seen previously during this outbreak, such disruptions limit contact tracing, surveillance, and vaccination efforts, and they often result in increased transmission…

::::::

Dead and injured following attacks on Ebola responders in the Democratic Republic of the Congo
Attacks in eastern Democratic Republic of the Congo
28 November 2019 News release
Two attacks in eastern Democratic Republic of the Congo (DRC) have killed 4 workers responding to the Ebola outbreak and injured 5 others.
The attacks occurred overnight on a shared living camp in Biakato Mines and an Ebola response coordination office in Mangina.
We are heartbroken that people have died in the line of duty as they worked to save others,” said Dr Tedros Adhanom Ghebreyesus, World Health Organization Director-General. “The world has lost brave professionals.”
The dead include a member of a vaccination team, two drivers and a police officer. No WHO staff are among those killed, one staff member was injured.
“My heart goes out to the family and friends of the first responders killed in these attacks,” said Dr Matshidiso Moeti, WHO Regional Director for Africa. “We are doing everything possible to bring the injured and front-line workers in the impacted areas to safety. These constant attacks must stop. We will continue to work with the DRC Government, partners and MONUSCO to ensure the security of our staff and other health workers.”…

::::::

New England Journal of Medicine
Online November 27, 2019
DOI: 10.1056/NEJMoa1910993
Original Article
A Randomized, Controlled Trial of Ebola Virus Disease Therapeutics
Sabue Mulangu, M.D., Lori E. Dodd, Ph.D., Richard T. Davey, Jr., M.D., Olivier Tshiani Mbaya, M.D., Michael Proschan, Ph.D., Daniel Mukadi, M.D., Mariano Lusakibanza Manzo, Ph.D., Didier Nzolo, M.D., Antoine Tshomba Oloma, M.D., Augustin Ibanda, B.S., Rosine Ali, M.S., Sinaré Coulibaly, M.D., Adam C. Levine, M.D., Rebecca Grais, Ph.D., Janet Diaz, M.D., H. Clifford Lane, M.D., Jean-Jacques Muyembe-Tamfum, M.D., and the PALM Writing Group for the PALM Consortium Study Team*
Abstract
Background
Although several experimental therapeutics for Ebola virus disease (EVD) have been developed, the safety and efficacy of the most promising therapies need to be assessed in the context of a randomized, controlled trial.
Methods
We conducted a trial of four investigational therapies for EVD in the Democratic Republic of Congo, where an outbreak began in August 2018. Patients of any age who had a positive result for Ebola virus RNA on reverse-transcriptase–polymerase-chain-reaction assay were enrolled. All patients received standard care and were randomly assigned in a 1:1:1:1 ratio to intravenous administration of the triple monoclonal antibody ZMapp (the control group), the antiviral agent remdesivir, the single monoclonal antibody MAb114, or the triple monoclonal antibody REGN-EB3. The REGN-EB3 group was added in a later version of the protocol, so data from these patients were compared with those of patients in the ZMapp group who were enrolled at or after the time the REGN-EB3 group was added (the ZMapp subgroup). The primary end point was death at 28 days.
Results
A total of 681 patients were enrolled from November 20, 2018, to August 9, 2019, at which time the data and safety monitoring board recommended that patients be assigned only to the MAb114 and REGN-EB3 groups for the remainder of the trial; the recommendation was based on the results of an interim analysis that showed superiority of these groups to ZMapp and remdesivir with respect to mortality. At 28 days, death had occurred in 61 of 174 patients (35.1%) in the MAb114 group, as compared with 84 of 169 (49.7%) in the ZMapp group (P=0.007), and in 52 of 155 (33.5%) in the REGN-EB3 group, as compared with 79 of 154 (51.3%) in the ZMapp subgroup (P=0.002). A shorter duration of symptoms before admission and lower baseline values for viral load and for serum creatinine and aminotransferase levels each correlated with improved survival. Four serious adverse events were judged to be potentially related to the trial drugs.
Conclusions
Both MAb114 and REGN-EB3 were superior to ZMapp in reducing mortality from EVD. Scientifically and ethically sound clinical research can be conducted during disease outbreaks and can help inform the outbreak response. (Funded by the National Institute of Allergy and Infectious Diseases and others; PALM ClinicalTrials.gov number, NCT03719586. opens in new tab.)

::::::

Investigational Drugs Reduce Risk of Death from Ebola Virus Disease – NIH
Study Leaders Publish Results from NIH-DRC-WHO Clinical Trial of Four Experimental Therapies.
November 27, 2019
The investigational therapeutics mAb114 and REGN-EB3 offer patients a greater chance of surviving Ebola virus disease (EVD) compared to the investigational treatment ZMapp, according to published results from a clinical trial conducted in the Democratic Republic of the Congo (DRC). The new report also shows that early diagnosis and treatment are associated with an increased likelihood of survival from EVD.
The results appear online this week in the New England Journal of Medicine. An announcement made on August 12, 2019, noted that the study leaders halted the trial early, on August 9, 2019, as recommended by an independent data and safety monitoring board based on its review of preliminary data from 499 study patients. The preliminary analysis found that both mAb114 and REGN-EB3 performed better than ZMapp. The fourth drug, remdesivir, performed similarly to ZMapp. Today’s publication provides a comprehensive analysis of the full dataset from nearly 200 additional patients enrolled in the clinical study.
The clinical trial known as PALM, short for “Pamoja Tulinde Maisha,” a Kiswahili phrase that translates to “together save lives,” was organized by an international research consortium coordinated by the World Health Organization (WHO). It is led and funded by the DRC’s National Institute for Biomedical Research (INRB) and Ministry of Health, and the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health. Professor Jean-Jacques Muyembe-Tamfum, M.D., Ph.D., director-general of the INRB and head of the DRC’s Ebola response, and Richard T. Davey, Jr., M.D., deputy director of NIAID’s Division of Clinical Research, are co-principal investigators for the study.
“Response teams have faced unprecedented challenges in ongoing efforts to save lives and control the outbreak of Ebola in a highly insecure region of the Democratic Republic of the Congo,” said NIAID Director Anthony S. Fauci, M.D. “Although effective treatments alone will not end this outbreak, the PALM study findings identify the first efficacious treatments for Ebola virus disease and therefore mark a significant step forward in improving care for Ebola patients. We thank the study team for their extraordinary efforts to conduct this landmark trial.”
The study enrolled 681 people with Ebola virus disease between November 2018 and August 2019 at four Ebola treatment centers (ETCs) in the cities of Beni, Butembo, Katwa and Mangina. Staff from The Alliance for International Medical Action (ALIMA), International Medical Corps (IMC), Médecins Sans Frontières/Doctors Without Borders (MSF) and the DRC Ministry of Health implemented the trial at the ETCs with support from Congolese staff, the World Health Organization, the Frederick National Laboratory for Cancer Research and The Mitchell Group.
The study was designed to compare mortality among patients who received one of three investigational Ebola drugs with that from a control group of patients who received the investigational monoclonal antibody cocktail ZMapp, developed by Mapp Biopharmaceutical, Inc. The other therapies were mAb114, a single monoclonal antibody product developed for clinical use by NIAID’s Vaccine Research Center and the INRB and licensed to Ridgeback Biotherapeutics and Mapp Biopharmaceutical; REGN-EB3, a monoclonal antibody cocktail developed by Regeneron Pharmaceuticals, Inc.; and remdesivir, an antiviral drug developed by Gilead Sciences, Inc. The Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services, also has provided support for the development of REGN-EB3, ZMapp and mAb114.
The four therapies are administered as intravenous infusions. REGN-EB3 and mAb114 are administered as single infusions and ZMapp and remdesivir are administered as infusions over multiple days. Study participants also received optimized supportive care, including oral and/or intravenous fluids, electrolyte replacement, monitoring of oxygen levels and blood pressure (with supportive measures as needed), blood transfusions, pain management, and antibiotics and antimalarials as indicated….
All four study drugs were generally well tolerated. There were a total of four serious adverse events that were judged to be potentially related to the experimental drugs. Three of these were in two of the patients who received ZMapp. One was in a patient who received remdesivir.
The authors note that despite encouraging findings regarding mAb114 and REGN-EB3, approximately one-third of patients who received these therapeutics died, highlighting the potential to improve upon these results, whether through further optimization of supportive care, combination therapy using agents with complementary mechanisms of action or other strategies.
“Despite unprecedented challenges — including an unstable electrical power grid and evacuations of staff and patients from treatment centers due to violent attacks — the PALM trial demonstrates that scientifically rigorous and ethically sound clinical research can be conducted during disease outbreaks,” said H. Clifford Lane, M.D., NIAID deputy director for Clinical Research and Special Projects. “We thank the patients and the medical staff in the field and at the treatment sites for their participation and exceptional commitment to the trial.”

::::::
::::::

POLIO
Public Health Emergency of International Concern (PHEIC)

Polio this week as of 20 November 2019
:: A four-day regional emergency preparedness workshop is currently underway in Lomé, Togo, for senior public health officials to strengthen the capabilities within West African countries to respond to polio outbreaks. Read more about the workshop.
:: “It was good to know that a country like India could eradicate polio. It gives us hope that Pakistan can do it too, and we will soon be polio free.” These are the words of Aziz Memon, a Rotarian who has dedicated his life to fight polio in Pakistan. Read about his journey.

Summary of new viruses this week (AFP cases and ES positives):
:: Pakistan— five WPV1 cases, two cVDPV2 cases and one cVDPV2 positive environmental sample;
:: Democratic Republic of the Congo (DR Congo)- five cVDPV2 cases;
:: Benin – four cVDPV2 cases;
:: Ghana— four cVDPV2 cases and two cVDPV2 positive environmental samples;
:: Philippines – three cVDPV2 cases and five cVDPV2 positive environmental samples;
:: Togo – two cVDPV2 cases.

::::::

More than 3.1 million Iraqi children to be vaccinated against polio
Baghdad, 26 November 2019 – Health authorities in Iraq, in partnership with the World Health Organization (WHO) and UNICEF, have launched a campaign to reach more than 3.1 million children under-5 years of age with lifesaving polio vaccine.

The 5-day campaign aims to target children in 65 districts in the governorates of Baghdad, Babylon, Diwaniya, Diyala, Muthanna, Thi-Qar, Missan and Basra.

“Over the years, WHO, the Ministry of Health and UNICEF have worked hard to improve immunization coverage in the country. Therefore, it is important that we keep building on our work by making sure that children are vaccinated against childhood preventable diseases like polio and we keep Iraq polio free,” said Dr Adham Ismail, WHO Representative for Iraq. “During this second phase of the campaign, we want to reach all the children under 5 regardless of their previous vaccination status with oral polio vaccine leaving no one out no matter where they are,” added Dr Adham…

::::::
::::::

Editor’s Note:
WHO has posted a refreshed emergencies page which presents an updated listing of Grade 3,2,1 emergencies as below.

WHO Grade 3 Emergencies [to 30 Nov 2019]

Democratic Republic of the Congo
:: Dead and injured following attacks on Ebola responders in the Democratic Republic of the Congo 28 November 2019
:: Ebola Outbreak in DRC 69: 26 November 2019

Mozambique floods – No new digest announcements identified
Nigeria – No new digest announcements identified
Somalia – No new digest announcements identified
South Sudan – No new digest announcements identified
Syrian Arab Republic – No new digest announcements identified
Yemen – No new digest announcements identified

::::::

WHO Grade 2 Emergencies [to 30 Nov 2019]

Afghanistan – No new digest announcements identified
Angola – No new digest announcements identified
Burkina Faso [in French] – No new digest announcements identified
Burundi – No new digest announcements identified
Cameroon – No new digest announcements identified
Central African Republic – No new digest announcements identified
Ethiopia – No new digest announcements identified
HIV in Pakistan – No new digest announcements identified
Iran floods 2019 – No new digest announcements identified
Iraq – No new digest announcements identified
Libya – No new digest announcements identified
Malawi floods – No new digest announcements identified
Measles in Europe – No new digest announcements identified
MERS-CoV – No new digest announcements identified
Myanmar – No new digest announcements identified
Niger – No new digest announcements identified
occupied Palestinian territory – No new digest announcements identified
Sudan – No new digest announcements identified
Ukraine – No new digest announcements identified
Zimbabwe – No new digest announcements identified

::::::

WHO Grade 1 Emergencies [to 30 Nov 2019]

Chad – No new digest announcements identified
Djibouti – No new digest announcements identified
Kenya – No new digest announcements identified
Mali – No new digest announcements identified
Namibia – viral hepatitis – No new digest announcements identified
Tanzania – No new digest announcements identified

::::::
::::::

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 – No new digest announcements identified
Yemen – No new digest announcements identified

::::::

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.
Editor’s Note:
Ebola in the DRC has bene added as a OCHA “Corporate Emergency” this week:
CYCLONE IDAI and Kenneth – No new digest announcements identified
EBOLA OUTBREAK IN THE DRC – No new digest announcements identified

::::::
::::::

WHO & Regional Offices [to 30 Nov 2019]
28 November 2019
News release
WHO launches Online Training on Climate and Health in the UN climate negotiations

28 November 2019
News release
Dead and injured following attacks on Ebola responders in the Democratic Republic of the Congo

28 November 2019
News release
5 Key Actions for COP25 to Bolster Global Health

28 November 2019
News release
Pollution Pods at COP25 show climate change and air pollution are two sides of the same coin

27 November 2019
News release
Innovative WHO HIV testing recommendations aim to expand treatment coverage
The World Health Organization (WHO) has issued new recommendations to help countries reach the 8.1 million people living with HIV who are yet to be diagnosed, and who are therefore unable to obtain lifesaving treatment.

“The face of the HIV epidemic has changed dramatically over the past decade,” said Dr Tedros Adhanom Ghebreyesus. “More people are receiving treatment than ever before, but too many are still not getting the help they need because they have not been diagnosed. WHO’s new HIV testing guidelines aim to dramatically change this.”

HIV testing is key to ensuring people are diagnosed early and start treatment. Good testing services also ensure that people who test HIV negative are linked to appropriate, effective prevention services. This will help reduce the 1.7 million new HIV infections occurring every year.

The WHO guidelines are released ahead of World AIDS Day (1 December), and the International Conference on AIDS and Sexually Transmitted Infections in Africa (ICASA2019) which takes place in Kigali, Rwanda on 2-7 December. Today, two thirds of all people with HIV live in the African Region.

The new “WHO consolidated guidelines on HIV testing services” recommend a range of innovative approaches to respond to contemporary needs…

::::::

Weekly Epidemiological Record, 29 November 2019, vol. 94, 48 (pp. 561–580)
:: Cholera, 2018
:: Global update on Middle East respiratory syndrome, 2019
:: Fact sheet on echinococcosis (updated May 2019)

::::::

WHO Regional Offices
Selected Press Releases, Announcements
WHO African Region AFRO
:: WHO, UNICEF help boost West Africa’s capacity to respond to polio outbreaks 27 November 2019

WHO Region of the Americas PAHO
:: Campaign encourages health workers and youth to have open conversations about HIV (11/27/2019)

WHO South-East Asia Region SEARO
:: Statement: Intensify action to eliminate violence against women 25 November 2019

WHO European Region EURO
:: WHO working with health authorities in European Region after outbreak of Lassa fever in Sierra Leone 29-11-2019
:: Gaps in access undermine universal health coverage across the EU 29-11-2019
:: Half of all women with HIV are diagnosed late in Europe 28-11-2019
:: Medical facilities coping well in Albania following earthquake 27-11-2019

WHO Eastern Mediterranean Region EMRO
:: Polio vaccination campaign targets more than 3.1 million Iraqi children 26 November 2019

WHO Western Pacific Region
No new digest content identified.

CDC/ACIP [to 30 Nov 2019]
http://www.cdc.gov/media/index.html
https://www.cdc.gov/vaccines/acip/index.html

MMWR News Synopsis for Friday, November 29, 2019
Status of HIV Case-Based Surveillance Implementation — 39 U.S. PEPFAR-Supported Countries, May–July 2019
A new CDC study is one of the first global assessments of the pace and scale of human immunodeficiency virus (HIV) case-based surveillance (CBS) in 39 countries supported by the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR). Twenty of the countries reported implementing CBS, and 15 others reported current planning for implementation. Closing gaps in policies and improving technical infrastructure are necessary steps towards implementing a comprehensive CBS system able to inform responses to end the HIV epidemic. HIV case-based surveillance is the systematic and continuous reporting of individual HIV cases to monitor HIV-positive patients throughout their clinical care and to facilitate rapid public health action. To date, few assessments have reported on the status of CBS implementation in countries on a global scale. Among 39 -PEPFAR-supported countries around the globe surveyed from May to July 2019, about half (20) reported implementing case-based surveillance. Among the remaining countries, 15 were planning for implementation. Despite this effort, gaps exist including patient-level unique identifiers to link data across systems, supportive national policy environments, and data security standards. The assessment identified critical barriers that must be addressed to implement CBS effectively and to better inform responses to end the HIV epidemic.

Africa CDC [to 30 Nov 2019]
http://www.africacdc.org/
News
No new digest content identified.

China CDC
http://www.chinacdc.cn/en/
No new digest content identified.

National Health Commission of the People’s Republic of China
http://en.nhc.gov.cn/
No new digest content identified.

Announcements
November 29, 2019
FDA issues guidance for industry on adaptive designs for clinical trials of drugs and biologics – Drug Information Update
Today, the Food and Drug Administration (FDA) issued a final guidance for industry entitled, “Adaptive Designs for Clinical Trials of Drugs and Biologics.” Adaptive design clinical trials allow for prospectively planned modifications to one or more aspects of the design based on accumulating data from subjects in the trial. The guidance provides information to sponsors submitting investigational new drug applications (INDs), new drug applications (NDAs), biologics licensing applications (BLAs), or supplemental applications on the appropriate use of adaptive designs for clinical trials to provide evidence of the effectiveness and safety of a drug or biologic. The guidance also advises sponsors on the types of information to submit to facilitate FDA evaluation of clinical trials with adaptive designs, including Bayesian adaptive and complex trials that rely on computer simulations for their design.

The Adaptive Design guidance is a revision of the 2018 draft guidance entitled “Adaptive Design Clinical Trials for Drugs and Biologics.” The final guidance contains revisions to the Bayesian subsection of the guidance, provides clarifications on the prespecification principle for adaptive design, and cross-references advice from the newly published draft guidance on Interacting with the FDA on Complex Innovative Trial Designs.

Fondation Merieux [to 30 Nov 2019]
http://www.fondation-merieux.org/
News, Events
December 3 – 4, 2019 – Geneva (Switzerland)
Mérieux Foundation co-organized event
6th GTFCC Working Group on Oral Cholera Vaccine

20 – 22 Jan 2020
Mérieux Foundation co-organized event
Dengue pre-vaccination screening strategies workshop
Les Pensières Center for Global Health, Veyrier-du-Lac (France)

Gavi [to 30 Nov 2019]
https://www.gavi.org/
No new digest content identified.

GHIT Fund [to 30 Nov 2019]
https://www.ghitfund.org/newsroom/press
GHIT was set up in 2012 with the aim of developing new tools to tackle infectious diseases that No new digest content identified.

Global Fund [to 30 Nov 2019]
https://www.theglobalfund.org/en/news/
News & Stories
Feature Story
Communities Uniting Against HIV
29 November 2019

Voices
On World AIDS Day: Step Up the Fight Against HIV
29 November 2019

News
Global Fund Praises PEPFAR’s Leadership and Results
26 November 2019

Updates
Data Service: Grant Detailed Budgets
26 November 2019

Hilleman Laboratories [to 30 Nov 2019]
http://www.hillemanlabs.org/
No new digest content identified.

Human Vaccines Project [to 30 Nov 2019]
http://www.humanvaccinesproject.org/media/press-releases/
Press Releases
No new digest content identified.
IAVI [to 30 Nov 2019]
https://www.iavi.org/newsroom
No new digest content identified.

International Coalition of Medicines Regulatory Authorities [ICMRA]
http://www.icmra.info/drupal/en/news
Selected Statements, Press Releases, Research
No new digest content identified.

International Generic and Biosimilar Medicines Association [IGBA]
https://www.igbamedicines.org/
No new digest content identified.

IFFIm
http://www.iffim.org/library/news/press-releases/
No new digest content identified.

IFRC [to 30 Nov 2019]
http://media.ifrc.org/ifrc/news/press-releases/
Selected Press Releases, Announcements
Global
Media Advisory: World’s largest humanitarian network gathers in Geneva to shape its response to global challenges
Geneva, 29 November 2019 – The leaders of the International Red Cross and Red Crescent Movement will gather next week at the Centre International de Conferences (CICG) in Geneva, Switzerland, for a series of meetings that will shape the future of the w …

Democratic Republic of the Congo
Tragic attacks on responders and increased violence threaten to reverse positive gains in Ebola response, warns Red Cross
Goma/Kinshasa/Nairobi/Geneva, 28 November 2019 – Several violent attacks in the Democratic Republic of Congo (DR Congo) have killed, wounded and displaced many. Those killed included four Ebola responders. The President of DR Congo Red Cross, Grégoire …

IVAC [to 30 Nov 2019]
https://www.jhsph.edu/research/centers-and-institutes/ivac/index.html
Updates
No new digest content identified.

IVI [to 30 Nov 2019]
http://www.ivi.int/
Selected IVI News & Announcements
No new digest content identified.

JEE Alliance [to 30 Nov 2019]
https://www.jeealliance.org/
Selected News and Events
No new digest content identified.

MSF/Médecins Sans Frontières [to 30 Nov 2019]
http://www.msf.org/
Latest [Selected Announcements]
Niger
Fifteen years treating malnutrition and malaria around the cl…
Project Update 25 Nov 2019

DRC Ebola outbreaks
Crisis update – November 2019
Crisis Update 25 Nov 2019

National Vaccine Program Office – U.S. HHS [to 30 Nov 2019]
https://www.hhs.gov/vaccines/about/index.html
NVAC 2020 Meetings
February 13-14, 2020 NVAC Meeting
June 9-10, 2020 NVAC Meeting
September 23-24, 2020 Meeting (Virtual)

NIH [to 30 Nov 2019]
http://www.nih.gov/news-events/news-releases
Selected News Releases
Investigational Drugs Reduce Risk of Death from Ebola Virus Disease
November 27, 2019 — Study Leaders Publish Results from NIH-DRC-WHO Clinical Trial of Four Experimental Therapies.
[See Milestones above for detail]

NIH Statement on World AIDS Day 2019
November 25, 2019 — NIH is playing a pivotal role in supporting the innovative science underpinning the effort to reduce the incidence of HIV domestically by 75% in 5 years, and by 90% by 2030.

PATH [to 30 Nov 2019]
https://www.path.org/media-center/
Selected Announcements
Review of one year of PrEP implementation in 11 provinces and rollout of PrEP in 15 new provinces in Vietnam
Ho Chi Minh City, November 27, 2019—Since the one year anniversary of the nationwide launch of the pre-exposure prophylaxis (PrEP) program in 11 provinces in Vietnam, the country is ready to roll out the program more widely due to global PrEP successes in reaching epidemic control for HIV. At the One-year PrEP Implementation Review Forum today, the Vietnam Administration for HIV/AIDS Control (VAAC) presented a review of the PrEP program’s progress to date and announced its expansion to an additional 15 provinces across Vietnam, as part of the country’s commitment to ending HIV by 2030…

Sabin Vaccine Institute [to 30 Nov 2019]
http://www.sabin.org/updates/pressreleases
Statements and Press Releases
No new digest content identified.

UNAIDS [to 30 Nov 2019]
http://www.unaids.org/en
Selected Press Releases/Reports/Statements
29 November 2019
United Republic of Tanzania lowers age of consent for HIV testing
The United Republic of Tanzania has approved a change to the law that lowers the age of consent for HIV testing from 18 years to 15 years. The amendment to legislation also makes self-testing for HIV legal, also from the age of 15 years.
“These amendments will significantly accelerate our intention to meet the 90–90–90 goals, which aim at ending the AIDS epidemic by 2030,” said Ummy Mwalimu, Minister of Health, Community Development, Gender, Elderly and Children. The ministry was instrumental in tabling the amendments to the legislation…

29 November 2019
HIV positive refugees support one another in Uganda

26 November 2019
Speech by UNAIDS Executive Director Winnie Byanyima at the World AIDS Day 2019 report launch

25 November 2019
Women are leading the response to HIV in their communities

UNICEF [to 30 Nov 2019]
https://www.unicef.org/media/press-releases
Selected Statements, Press Releases, Reports
News note
UNICEF delivers over 260,000 vaccines and medical supplies to fight measles outbreaks in Samoa, Fiji and Tonga
Delivers 115,500 doses of measles vaccines to worst-affected Samoa
28/11/2019

Statement
4,500 children under the age of five died from measles in the Democratic Republic of the Congo so far this year
Statement by UNICEF Representative in the DRC Edouard Beigbeder
27/11/2019

Press release
Over 300 children and adolescents die every day from AIDS-related causes
Only half of children living with HIV have access to life-saving treatment – UNICEF
26/11/2019

Vaccination Acceptance Research Network (VARN) [to 30 Nov 2019]
https://vaccineacceptance.org/news.html#header1-2r
No new digest content identified.

Vaccine Confidence Project [to 30 Nov 2019]
http://www.vaccineconfidence.org/
No new digest content identified.

Vaccine Education Center – Children’s Hospital of Philadelphia [to 30 Nov 2019]
http://www.chop.edu/centers-programs/vaccine-education-center
No new digest content identified.

Wellcome Trust [to 30 Nov 2019]
https://wellcome.ac.uk/news
No new digest content identified.

The Wistar Institute [to 30 Nov 2019]
https://www.wistar.org/news/press-releases
No new digest content identified.

World Organisation for Animal Health (OIE) [to 30 Nov 2019]
https://www.oie.int/en/for-the-media/press-releases/2019/
No new digest content identified.

::::::

ARM [Alliance for Regenerative Medicine] [to 30 Nov 2019]
https://alliancerm.org/press-releases/
No new digest content identified.

BIO [to 30 Nov 2019]
https://www.bio.org/press-releases
No new digest content identified.

DCVMN – Developing Country Vaccine Manufacturers Network [to 30 Nov 2019]
http://www.dcvmn.org/
News
Research and Development as the answer to vaccine shortages and low coverage
[Posted as 25 Nov 2019]
Rio de Janeiro, 22nd October 2019 – The Brazilian Minister of Health, Luiz Henrique Mandetta, addressed the delegates of the 20th DCVMN Annual General Meeting, affirming that vaccines represent a global public good, considering that their benefits are universal across countries, people and generations. He mentioned the challenges imposed by the reemergence of vaccine preventable diseases, due to low vaccination coverage, shortages of vaccines, vaccine hesitancy, anti-vaccination lobbying and the spreading of disinformation…

IFPMA [to 30 Nov 2019]
http://www.ifpma.org/resources/news-releases/
Selected Press Releases, Statements, Publications
No new digest content identified.

PhRMA [to 30 Nov 2019]
http://www.phrma.org/
Selected Press Releases, Statements
No new digest content identified.

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 focu-s 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

BMC Health Services Research
http://www.biomedcentral.com/bmchealthservres/content
(Accessed 30 Nov 2019)

Exploring strategies to promote influenza vaccination of children with medical comorbidities: the perceptions and practices of hospital healthcare workers
To explore how the influenza vaccine is promoted and delivered to children with medical comorbidities in the hospital setting, as well as the facilitators of and barriers to vaccination from the healthcare wor…
Authors: Vanessa Ma, Pamela Palasanthiran and Holly Seale
Citation: BMC Health Services Research 2019 19:911
Content type: Research article
Published on: 29 November 2019

BMC Infectious Diseases
http://www.biomedcentral.com/bmcinfectdis/content
(Accessed 30 Nov 2019)

Research article
Rotavirus symptomatic infection among unvaccinated and vaccinated children in Valencia, Spain
Human group A rotavirus is the leading cause of severe acute gastroenteritis in young children worldwide. Immunization programs have reduced the disease burden in many countries. Vaccination coverage in the Au…
Authors: Raúl Pérez-Ortín, Cristina Santiso-Bellón, Susana Vila-Vicent, Noelia Carmona-Vicente, Jesús Rodríguez-Díaz and Javier Buesa
Citation: BMC Infectious Diseases 2019 19:998
Content type: Research article
Published on: 27 November 2019

BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles
(Accessed 30 Nov 2019)

Research article
Vaccine confidence in China after the Changsheng vaccine incident: a cross-sectional study
Authors: Baohua Liu, Ruohui Chen, Miaomiao Zhao, Xin Zhang, Jiahui Wang, Lijun Gao, Jiao Xu, Qunhong Wu and Ning Ning
Citation: BMC Public Health 2019 19:1564
Published on: 27 November 2019
Abstract
Background
China’s achievements in immunization are being threatened by a vaccine crisis. This paper aims to investigate vaccine confidence in China after the Changsheng vaccine incident and attempts to identify the factors contributing to it.
Methods
An online cross-sectional investigation was conducted from 1 to 25 September 2018. Descriptive analysis and logistic regression were performed to examine the associations between socio-demographic factors, cognition and attitudes towards the Changsheng vaccine incident and vaccine confidence.
Results
We included 1115 respondents in the final analysis, and found that approximately 70% (783) of the respondents did not have vaccine confidence. More than half of the respondents (54.53%) were dissatisfied with the government’s response measures to the Changsheng vaccine incident. The logistic regression model indicated that vaccine confidence was positively associated with the degree of satisfaction with the government’s response measures (OR=1.621, 95% CI=1.215–2.163), attitudes towards the risks and benefits of vaccination (OR=1.501, 95% CI=1.119–2.013), concerns about vaccine safety (OR=0.480, 95% CI=0.317–0.726), and vaccine efficacy (OR=0.594, 95% CI=0.394–0.895).
Conclusions
A majority of the respondents held negative attitudes towards vaccines after the Changsheng vaccine incident. A coordinated effort is required to restore public confidence in vaccines, especially in China, where a nationwide mandatory immunization policy is implemented. To end dissent towards inoculation, a series of actions is crucial and multiple parties should work together to advance efforts and explore the possibility of establishing an open and transparent regulatory system.

Epidemics
Volume 29 December 2019
https://www.sciencedirect.com/journal/epidemics/vol/29/suppl/C

Research article Open access
A systematic review of MERS-CoV seroprevalence and RNA prevalence in dromedary camels: Implications for animal vaccination
Amy Dighe, Thibaut Jombart, Maria D. Van Kerkhove, Neil Ferguson
Article 100350

Epidemics
Volume 29 December 2019
https://www.sciencedirect.com/journal/epidemics/vol/29/suppl/C

Research article Open access
Accurate forecasts of the effectiveness of interventions against Ebola may require models that account for variations in symptoms during infection
W.S. Hart, L.F.R. Hochfilzer, N.J. Cunniffe, H. Lee, … R.N. Thompson
Article 100371

Globalization and Health
http://www.globalizationandhealth.com/
[Accessed 30 Nov 2019]

Building the capacity of users and producers of evidence in health policy and systems research for better control of endemic diseases in Nigeria: a situational analysis
There is a current need to build the capacity of Health Policy and Systems Research + Analysis (HPSR+A) in low and middle-income countries (LMICs) as this enhances the processes of decision-making at all levels…

Authors: Obinna Onwujekwe, Enyi Etiaba, Chinyere Mbachu, Uchenna Ezenwaka, Ifeanyi Chikezie, Ifeyinwa Arize, Chikezie Nwankwor and Benjamin Uzochukwu
Content type: Research
21 November 2019

JAMA
November 26, 2019, Vol 322, No. 20, Pages 1935-2032
http://jama.jamanetwork.com/issue.aspx

November 26, 2019
US Narrowly Preserves Measles Elimination Status
Bridget Kuehn, MSJ
JAMA. 2019;322(20):1949. doi:10.1001/jama.2019.18901
The official end of New York State’s measles outbreak allowed the United States to narrowly retain its measles elimination status, according to the US Department of Health and Human Services (HHS). Four other countries have already lost their measles elimination status in the past year, including the United Kingdom and Brazil…

Journal of Empirical Research on Human Research Ethics
Volume 14 Issue 5, December 2019
http://journals.sagepub.com/toc/jre/current

Special Issue: Empirical Studies in Empirical Ethics

Journal of Health Care for the Poor and Underserved (JHCPU)
Volume 30, Number 4, November 2019
https://muse.jhu.edu/issue/41160

Contents
Text and Email Messaging for Increasing Human Papillomavirus Vaccine Completion among Uninsured or Medicaid-insured Adolescents in Rural Eastern North Carolina
Alice R. Richman, Essie Torres, Qiang Wu, Lauren Carlston, Shawna O’Rorke, Carmen Moreno, John Olsson
pp. 1499-1517
DOI: 10.1353/hpu.2019.0090

The Lancet
Nov 30, 2019 Volume 394 Number 10213 p1965-2038, e38
https://www.thelancet.com/journals/lancet/issue/current

Editorial
Research integrity: time for global action
The Lancet
China has become a formidable global leader in scientific—including medical—research, with the world’s largest publication output, a rapid surge in the number of highly cited researchers, and an increasingly unparalleled quality of scientific publications. However, there is often a shadow hanging over any country’s progress, especially a nation that has advanced with spectacular velocity. China is no exception. And the current concern, escalated to the highest levels of the Chinese Government, is research integrity….

Nature
Volume 575 Issue 7784, 28 November 2019
http://www.nature.com/nature/current_issue.html

World View | 26 November 2019
Africa should set its own health-research agenda
Local experts — not rich donors — must design and control studies, says Francisca Mutapi.

Nature
Volume 575 Issue 7784, 28 November 2019
http://www.nature.com/nature/current_issue.html

Comment | 26 November 2019
Five ways China must cultivate research integrity
A swift increase in scientific productivity has outstripped the country’s ability to promote rigour and curb academic misconduct; it is time to seize solutions.
Li Tang

Pharmaceutics
Volume 11, Issue 11 (November 2019)
https://www.mdpi.com/1999-4923/11/11

Open Access Article
Classification of WHO Essential Oral Medicines for Children Applying a Provisional Pediatric Biopharmaceutics Classification System
by Jose-Manuel delMoral-Sanchez , Isabel Gonzalez-Alvarez , Marta Gonzalez-Alvarez , Andres Navarro and Marival Bermejo
Pharmaceutics 2019, 11(11), 567; https://doi.org/10.3390/pharmaceutics11110567 – 31 Oct 2019
Abstract
The objective was using the Essential Medicines List for children by the World Health Organization (WHO) to create a pediatric biopharmaceutics classification system (pBCS) of the oral drugs included in the Essential Medicines List by the World Health Organization and to compare our results with the BCS for adults (aBCS). Several methods to estimate the oral drug dose in different pediatric groups were used to calculate dose number (Do) and solubility (high/low). The estimation of the gastrointestinal water volume was adapted to each pediatric group. Provisional permeability classification was done by comparison of each drug lipophilicity versus metoprolol as the model drug of high permeability. As a result, 24.5% of the included drugs moved from the favorable to unfavorable class (i.e., from high to low solubility). Observed changes point out potential differences in product performance in pediatrics compared to adults, due to changes in the limiting factors for absorption. BCS Class Changes 1 to 2 or 3 to 4 are indicative of drugs that could be more sensitive to the choice of appropriate excipient in the development process. Validating a pBCS for each age group would provide a valuable tool to apply in specific pediatric formulation design by reducing time and costs and avoiding unnecessary pediatric experiments restricted due to ethical reasons. Additionally, pBCS could minimize the associated risks to the use of adult medicines or pharmaceutical compound formulations.

PLoS One
http://www.plosone.org/
[Accessed 30 Nov 2019]

Research Article
Factors associated with full immunization of children 12–23 months of age in Ethiopia: A multilevel analysis using 2016 Ethiopia Demographic and Health Survey
Yohannes Kinfe, Hagazi Gebre, Abate Bekele
Research Article | published 27 Nov 2019 PLOS ONE
https://doi.org/10.1371/journal.pone.0225639

PLoS One
http://www.plosone.org/
[Accessed 30 Nov 2019]

Research Article
Factors associated with full immunization of children 12–23 months of age in Ethiopia: A multilevel analysis using 2016 Ethiopia Demographic and Health Survey
Yohannes Kinfe, Hagazi Gebre, Abate Bekele
Research Article | published 27 Nov 2019 PLOS ONE
https://doi.org/10.1371/journal.pone.0225639

PLoS One
http://www.plosone.org/
[Accessed 30 Nov 2019]

Research Article
Enterovirus 71 vaccine acceptance among parents of children < 5 years old and their knowledge of hand, foot and mouth disease, Chongqing, China, 2017
Li Qi, Kun Su, Yu Xia, Wenge Tang, Tao Shen, Qin Li
Research Article | published 27 Nov 2019 PLOS ONE
https://doi.org/10.1371/journal.pone.0225569

Prehospital & Disaster Medicine
Volume 34 – Issue 6 – December 2019
https://www.cambridge.org/core/journals/prehospital-and-disaster-medicine/latest-issue

Special Report
Global Consensus Frameworks, Standards, Guidelines, and Tools: Their Implications in International Development Policy and Practice
Suresh Pokharel, Caroline Spencer, Dudley McArdle, Francis Archer
Published online by Cambridge University Press: 10 October 2019, pp. 644-652

In the present world, International Consensus Frameworks, commonly called global frameworks or global agendas, guide international development policies and practices. They guide the development of all countries and influence the development initiatives by their respective governments. Recent global frameworks, adopted mostly post-2015, include both a group of over-arching frameworks (eg, the Sendai Framework for Disaster Risk Reduction [SFDRR]) and a group of frameworks addressing specific issues (eg, the Dhaka Declaration on Disability and Disaster Risk Management). These global frameworks serve twin purposes: first, to set a global development standard, and second, to set policies and approaches to achieve these standards. A companion group of professional standards, guidelines, and tools (ie, Sphere’s Humanitarian Charter and Minimum Standards) guide the implementation and operationalization of these frameworks on the ground.

This paper gathers these global frameworks and core professional guidelines in one place, presents an analytical review of their essential features, and highlights the commonalities and differences between and among these frameworks. The aim of this paper is to facilitate understanding of these frameworks and to help in designing development and resilience policy, planning, and implementation, at international and national levels, where these frameworks complement and contribute to each other.

This Special Report describes an important and evolving aspect of the discipline and provides core information necessary to progress the science. Additionally, the report will help governments and policy makers to define their priorities and to design policies/strategies/ programs to reflect the global commitments. Development practitioners can pre-empt the focus of the international community and the assistance coming from donors to the priority sectors, as identified in the global agenda. This would then help governments and stakeholders to develop and design a realistic plan and program and prepare the instruments and mechanisms to deliver the goals.

Preventive Medicine
Volume 128, November 2019
https://www.sciencedirect.com/journal/preventive-medicine/vol/128/suppl/C

Behavior Change, Health, and Health Disparities 2019: Opioids, Tobacco, and Treatment Adherence
Edited by Stephen T. Higgins

Public Health
Volume 176, Pages 1-182 (November 2019)
https://www.sciencedirect.com/journal/public-health/vol/176/suppl/C

The Health of Indigenous Peoples
Edited by Denise Wilson, Heather Gifford, Heather Came

Science
29 November 2019 Vol 366, Issue 6469
http://www.sciencemag.org/current.dtl

Letters
Misguided approach to dengue vaccine risk
By Annelies Wilder-Smith, Joachim Hombach, Alejandro Cravioto
Science29 Nov 2019 : 1082-1083

Science Translational Medicine
27 November 2019 Vol 11, Issue 520
https://stm.sciencemag.org/

Research Articles
Early antiretroviral therapy in neonates with HIV-1 infection restricts viral reservoir size and induces a distinct innate immune profile
By Pilar Garcia-Broncano, Shivaali Maddali, Kevin B. Einkauf, Chenyang Jiang, Ce Gao, Joshua Chevalier, Fatema Z. Chowdhury, Kenneth Maswabi, Gbolahan Ajibola, Sikhulile Moyo, Terence Mohammed, Thabani Ncube, Joseph Makhema, Patrick Jean-Philippe, Xu G. Yu, Kathleen M. Powis, Shahin Lockman, Daniel R. Kuritzkes, Roger Shapiro, Mathias Lichterfeld
Science Translational Medicine27 Nov 2019 Full Access
Antiretroviral treatment initiation immediately after birth reduces HIV-1 viral reservoir size and alters innate immune responses in neonates.

Science Translational Medicine
27 November 2019 Vol 11, Issue 520
https://stm.sciencemag.org/

Report
A meta-analysis of clinical studies conducted during the West Africa Ebola virus disease outbreak confirms the need for randomized control groups
By Lori E. Dodd, Dean Follmann, Michael Proschan, Jing Wang, Denis Malvy, Johan van Griensven, Iza Ciglenecki, Peter W. Horby, Rashid Ansumana, Jia-Fu Jiang, Richard T. Davey, H. Clifford Lane, Aurelie Gouel-Cheron
Science Translational Medicine27 Nov 2019 Restricted Access
Randomized controlled clinical trials are critical for evaluating new experimental therapeutics to treat Ebola virus disease.

Vaccine
Volume 37, Issue 52 Pages 7519-7642 (10 December 2019)
https://www.sciencedirect.com/journal/vaccine/vol/37/issue/52

Selected Content
Conference info Open access
Meeting report: Global vaccine and immunization research forum, 2018
Peter Dull, Martin Friede, Angela Hwang, B. Fenton Hall
Pages 7519-7526

Vaccine
Volume 37, Issue 52 Pages 7519-7642 (10 December 2019)
https://www.sciencedirect.com/journal/vaccine/vol/37/issue/52

Discussion No access
National immunization programme development and vaccine legislation
Shawn H.E. Harmon, Noni E. MacDonald
Pages 7527-7529

Vaccine
Volume 37, Issue 52 Pages 7519-7642 (10 December 2019)
https://www.sciencedirect.com/journal/vaccine/vol/37/issue/52

Research article Abstract only
Policy and socio-cultural differences between cantons in Switzerland with high and low adolescent vaccination coverage for hepatitis B and HPV
Virginie Masserey Spicher, Mitchell G Weiss
Pages 7539-7546