Science
11 December 2020 Vol 370, Issue 6522
http://www.sciencemag.org/current.dtl

Policy Forum
COVID-19 vaccine trial ethics once we have efficacious vaccines
By David Wendler, Jorge Ochoa, Joseph Millum, Christine Grady, Holly A. Taylor
Science11 Dec 2020 : 1277-1279 Full Access
Some placebo-controlled trials can continue ethically after a candidate vaccine is found to be safe and efficacious
Summary
The unprecedented effort to identify one or more safe and effective vaccines for COVID-19 includes more than 180 candidates in development (1), with at least 12 in phase 3 trials (2). The testing of so many vaccine candidates, in a pandemic of a disease for which there are to date limited treatment options, raises a critical challenge: What should researchers do if a vaccine candidate is judged to be safe and efficacious? Guidance from the U.S. Food and Drug Administration (FDA) states that in the event that a COVID-19 vaccine candidate is judged to be “safe and effective,” discussion may be necessary “to address ethical arguments to break the blind and offer vaccine to placebo recipients” (3). We consider here two questions raised by this guidance: First, if a vaccine candidate is found to be safe and efficacious in a placebo-controlled trial, should the researchers continue that trial as designed? Second, should researchers continue to test other vaccine candidates using placebo-controlled trials? These two questions are especially timely given recent announcements by Pfizer and Moderna that their vaccine candidates have been found to be efficacious in preventing symptomatic COVID-19 (4, 5).

Science
11 December 2020 Vol 370, Issue 6522
http://www.sciencemag.org/current.dtl

Reports
Preexisting and de novo humoral immunity to SARS-CoV-2 in humans
By Kevin W. Ng, Nikhil Faulkner, Georgina H. Cornish, Annachiara Rosa, Ruth Harvey, Saira Hussain, Rachel Ulferts, Christopher Earl, Antoni G. Wrobel, Donald J. Benton, Chloe Roustan, William Bolland, Rachael Thompson, Ana Agua-Doce, Philip Hobson, Judith Heaney, Hannah Rickman, Stavroula Paraskevopoulou, Catherine F. Houlihan, Kirsty Thomson, Emilie Sanchez, Gee Yen Shin, Moira J. Spyer, Dhira Joshi, Nicola O’Reilly, Philip A. Walker, Svend Kjaer, Andrew Riddell, Catherine Moore, Bethany R. Jebson, Meredyth Wilkinson, Lucy R. Marshall, Elizabeth C. Rosser, Anna Radziszewska, Hannah Peckham, Coziana Ciurtin, Lucy R. Wedderburn, Rupert Beale, Charles Swanton, Sonia Gandhi, Brigitta Stockinger, John McCauley, Steve J. Gamblin, Laura E. McCoy, Peter Cherepanov, Eleni Nastouli, George Kassiotis
Science11 Dec 2020 : 1339-1343 Open Access
SARS-CoV-2 neutralizing antibodies can be found in some uninfected individuals—predominantly children and adolescents.
Antibodies predating infection
Immunological memory after infection with seasonal human coronaviruses (hCoVs) may potentially contribute to cross-protection against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Ng et al. report that in a cohort of 350 SARS-CoV-2–uninfected individuals, a small proportion had circulating immunoglobulin G (IgG) antibodies that could cross-react with the S2 subunit of the SARS-CoV-2 spike protein (see the Perspective by Guthmiller and Wilson). By contrast, COVID-19 patients generated IgA, IgG, and IgM antibodies that recognized both the S1 and S2 subunits. The anti-S2 antibodies from SARS-CoV-2–uninfected patients showed specific neutralizing activity against both SARS-CoV-2 and SARS-CoV-2 S pseudotypes. A much higher percentage of SARS-CoV-2–uninfected children and adolescents were positive for these antibodies compared with adults. This pattern may be due to the fact that children and adolescents generally have higher hCoV infection rates and a more diverse antibody repertoire, which may explain the age distribution of COVID-19 susceptibility.

Science Translational Medicine
09 December 2020 Vol 12, Issue 573
https://stm.sciencemag.org/

Research Articles
Genomic epidemiology of superspreading events in Austria reveals mutational dynamics and transmission properties of SARS-CoV-2
By Alexandra Popa, Jakob-Wendelin Genger, Michael D. Nicholson, Thomas Penz, Daniela Schmid, Stephan W. Aberle, Benedikt Agerer, Alexander Lercher, Lukas Endler, Henrique Colaço, Mark Smyth, Michael Schuster, Miguel L. Grau, Francisco Martínez-Jiménez, Oriol Pich, Wegene Borena, Erich Pawelka, Zsofia Keszei, Martin Senekowitsch, Jan Laine, Judith H. Aberle, Monika Redlberger-Fritz, Mario Karolyi, Alexander Zoufaly, Sabine Maritschnik, Martin Borkovec, Peter Hufnagl, Manfred Nairz, Günter Weiss, Michael T. Wolfinger, Dorothee von Laer, Giulio Superti-Furga, Nuria Lopez-Bigas, Elisabeth Puchhammer-Stöckl, Franz Allerberger, Franziska Michor, Christoph Bock, Andreas Bergthaler
Science Translational Medicine09 Dec 2020 Open Access
Epidemiological and genomic analyses uncover viral mutational dynamics and transmission bottleneck size during the early COVID-19 pandemic in Austria.

Science Translational Medicine
09 December 2020 Vol 12, Issue 573
https://stm.sciencemag.org/

Research Articles
Preexisting immunity shapes distinct antibody landscapes after influenza virus infection and vaccination in humans
By Haley L. Dugan, Jenna J. Guthmiller, Philip Arevalo, Min Huang, Yao-Qing Chen, Karlynn E. Neu, Carole Henry, Nai-Ying Zheng, Linda Yu-Ling Lan, Micah E. Tepora, Olivia Stovicek, Dalia Bitar, Anna-Karin E. Palm, Christopher T. Stamper, Siriruk Changrob, Henry A. Utset, Lynda Coughlan, Florian Krammer, Sarah Cobey, Patrick C. Wilson
Science Translational Medicine09 Dec 2020 Full Access
Antibody immunodominance to conserved influenza virus epitopes is affected by both preexisting B cell memory and route of exposure

Social Science & Medicine
Volume 265 November 2020
https://www.sciencedirect.com/journal/social-science-and-medicine/vol/264/suppl/C

Review article Abstract only
The Amish health culture and culturally sensitive health services: An exhaustive narrative review
Cory Anderson, Lindsey Potts
Article 113466

Vaccine
Volume 39, Issue 1 Pages 1-166 (3 January 2021)
https://www.sciencedirect.com/journal/vaccine/vol/39/issue/1

Research article Open access
A nationwide post-marketing survey of knowledge, attitude and practice toward human papillomavirus vaccine in general population: Implications for vaccine roll-out in mainland China
Shangying Hu, Xiaoqian Xu, Yanyang Zhang, Yawen Liu, … Fanghui Zhao
Pages 35-44

Vaccine
Volume 39, Issue 1 Pages 1-166 (3 January 2021)
https://www.sciencedirect.com/journal/vaccine/vol/39/issue/1

Research article Open access
Economic evaluation of the introduction of rotavirus vaccine in Hong Kong
Karene Hoi Ting Yeung, Shi Lin Lin, Andrew Clark, Sarah M. McGhee, … E. Anthony S. Nelson
Pages 45-58

Vaccine
Volume 39, Issue 1 Pages 1-166 (3 January 2021)
https://www.sciencedirect.com/journal/vaccine/vol/39/issue/1

Research article Open access
An immunization program for US-bound refugees: Development, challenges, and opportunities 2012–present
Tarissa Mitchell, Warren Dalal, Alexander Klosovsky, Catherine Yen, … Michelle Weinberg
Pages 68-77

Vaccine
Volume 39, Issue 1 Pages 1-166 (3 January 2021)
https://www.sciencedirect.com/journal/vaccine/vol/39/issue/1

Research article Open access
An immunization program for US-bound refugees: Development, challenges, and opportunities 2012–present
Tarissa Mitchell, Warren Dalal, Alexander Klosovsky, Catherine Yen, … Michelle Weinberg
Pages 68-77

Vaccine
Volume 39, Issue 1 Pages 1-166 (3 January 2021)
https://www.sciencedirect.com/journal/vaccine/vol/39/issue/1

Review article Open access
Pregnant women & vaccines against emerging epidemic threats: Ethics guidance for preparedness, research, and response
Carleigh B. Krubiner, Ruth R. Faden, Ruth A. Karron, Margaret O. Little, … Paulina O. Tindana
Pages 85-120

Vaccines — Open Access Journal
http://www.mdpi.com/journal/vaccines
(Accessed 12 Dec 2020)

Special Section on Maternal Pertussis Immunization: Cost-effectiveness in LMICs; Edited by Stanley Plotkin and Elizabeth Miller
Editorial Open access

Evaluating the cost-effectiveness of maternal pertussis immunization in low- and middle-income countries: A review of lessons learnt
Louise B. Russell, Ajoke Sobanjo-ter Meulen, Cristiana M. Toscano
Pages 121-124

Vaccines — Open Access Journal
http://www.mdpi.com/journal/vaccines
(Accessed 12 Dec 2020)

Special Section on Maternal Pertussis Immunization: Cost-effectiveness in LMICs; Edited by Stanley Plotkin and Elizabeth Miller
Editorial Open access

Research article Open access
Cost-effectiveness of maternal pertussis immunization: Implications of a dynamic transmission model for low- and middle-income countries
Sun-Young Kim, Kyung-Duk Min, Sung-mok Jung, Louise B. Russell, … Anushua Sinha
Pages 147-157

Vaccines — Open Access Journal
http://www.mdpi.com/journal/vaccines
(Accessed 12 Dec 2020)

Open Access Review
Parents’ Knowledge, Attitude and Perceptions on Childhood Vaccination in Saudi Arabia: A Systematic Literature Review
by Marwa Alabadi and Zakariya Aldawood
Vaccines 2020, 8(4), 750; https://doi.org/10.3390/vaccines8040750 – 10 Dec 2020
Viewed by 189
Background: The responsibility of vaccinating children lies with their parents. Therefore, parents’ attitudes, knowledge and perceptions towards vaccination are of great importance as it drives their actions for timely and complete immunisation. This systematic literature review was conducted to gain a bette…

Vaccines — Open Access Journal
http://www.mdpi.com/journal/vaccines
(Accessed 12 Dec 2020)

Open Access Article
Evaluating a Technology-Mediated HPV Vaccination Awareness Intervention: A Controlled, Quasi-Experimental, Mixed Methods Study
by Heather M. Brandt, Beth Sundstrom, Courtney M. Monroe, Gabrielle Turner-McGrievy
Chelsea Larsen, Melissa Stansbury, Karen Magradey, Andrea Gibson and Delia Smith West
Vaccines 2020, 8(4), 749; https://doi.org/10.3390/vaccines8040749 (registering DOI) – 10 Dec 2020
Viewed by 135
Abstract
College-aged women and men are an important catch-up population for human papillomavirus (HPV) vaccination interventions. Limited research has explored technology-mediated HPV vaccination awareness interventions aimed at college students. The purpose was to evaluate a novel, technology-mediated, social media-based intervention to promote HPV vaccination…

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 12 Dec 2020
Ideas
How to Build Trust in the Vaccines
To succeed in immunizing the population against COVID-19, the United States must draw on the resources it already has.
12 Dec 2020
Brendan Nyhan, Professor of government at Dartmouth College

The Next Six Months Will Be Vaccine Purgatory
The period after a vaccine is approved will be strange and confusing, as certain groups of people get vaccinated but others have to wait.
Sarah Zhang is a staff writer at The Atlantic.
December 11th, 2020 December 11th, 2020

Ideas
The Public-Health Value of Speaking Plainly
An interview with the infectious-disease expert and community health provider Lisa Fitzpatrick
December 10, 2020
Conor Friedersdorf, Staff writer at The Atlantic

BBC
http://www.bbc.co.uk/
Accessed 12 Dec 2020
[No new, unique, relevant content]

The Economist
http://www.economist.com/
Accessed 12 Dec 2020
Charlemagne
Why is Europe so riddled with vaccine scepticism?
Anti-vaxxers could hinder the struggle against covid-19
Dec 12th 2020 edition

Coming soon
Europe prepares for its first batches of covid-19 vaccines
But supplies and uptake are both uncertain
Dec 12th 2020 edition

Financial Times
https://www.ft.com/
Accessed 12 Dec 2020
US-China relations
Beijing racks up the points in its great game against Washington
December 13, 2020

News in-depth
Coronavirus treatment
US states wrestle with what makes workers ‘essential’ in Covid jab rush
December 11, 2020

Forbes
http://www.forbes.com/
Accessed 12 Dec 2020
Breaking  |  
Pfizer Covid Vaccine Expected To Arrive In All 50 States By Monday
The vaccines are already being packaged, an official said.
By Nicholas Reimann Forbes Staff

Breaking  |  
Pfizer Covid Vaccine Expected To Arrive In All 50 States By Monday
The vaccines are already being packaged, an official said.
By Nicholas Reimann Forbes Staff

Pfizer Covid Vaccine Expected To Arrive In All 50 States By Monday
The vaccines are already being packaged, an official said.
By Nicholas Reimann Forbes Staff

Editors’ Pick  |  
Dec 11, 2020
AstraZeneca, Oxford To Create Combination Covid-19 Vaccine With Russia’s Sputnik V
Many officials worried about how fast Russia developed and approved the vaccine, launching it without completing the large-scale clinical trials needed to prove safety and efficacy.
By Robert Hart Forbes Staff

Foreign Affairs
http://www.foreignaffairs.com/
Accessed 12 Dec 2020
Essay January/February 2021
Latin America’s Lost Decades
The region’s COVID-19 crisis is, above all, a crisis of inequality.
Luis Alberto Moreno
Audio available for this article

Comment January/February 2021
To Stop a Pandemic
The United States and other countries need to look beyond COVID-19 and focus on preparing for the next pandemic threat.
Jennifer Nuzzo

Foreign Policy
http://foreignpolicy.com/
Accessed 12 Dec 2020
[No new, unique, relevant content]

The Guardian
http://www.guardiannews.com/
Accessed 12 Dec 2020
[No new, unique, relevant content]

New Yorker
http://www.newyorker.com/
Accessed 12 Dec 2020
Daily Comment
What an F.D.A. Committee Weighed in Voting for the Pfizer COVID Vaccine
In the present circumstances, one could imagine a far more fraught F.D.A. hearing than the one that took place on Thursday.
By Amy Davidson Sorkin
December 11, 2020

Medical Dispatch
The Deadly Cost of America’s Pandemic Politics
Vaccines are on the way, but until they arrive tens of thousands of lives depend on the battle for public opinion.
By Dhruv Khullar
December 8, 2020

New York Times
http://www.nytimes.com/
Accessed 12 Dec 2020
Health
C.D.C. Panel Recommends Pfizer Vaccine for Patients as Young as 16
The advisory panel of experts endorsed the vaccine and will soon issue specific guidance for pregnant and lactating women and for people who have had severe allergic reactions to other shots.
By Jan Hoffman
PRINT EDITION December 13, 2020

Politics
First U.S. Coronavirus Vaccines Set to Be Delivered Monday
Gen. Gustave F. Perna, chief officer of Operation Warp Speed, said boxes of the Pfizer-BioNTech vaccine were being readied for shipment with an emphasis on quality control.
By Reuters

Deal Book
Should Companies Require Employees to Take the Vaccine?
It’s a debate that’s roiling boardrooms around the world.
By Andrew Ross Sorkin
Dec. 12

Americas
How the Vaccine Rollout Will Compare in Britain, Canada and the U.S.
Within days, all three countries could be giving the Pfizer-BioNTech vaccine, but they have varying strategies and challenges. The U.S. plan, working through the states, is the least centralized.
By Richard Pérez-Peña
PRINT EDITION December 13, 2020

World
Superspreading Boston biotech conference in February is linked to 1.9 percent of all U.S. cases.
By Amy Harmon
Dec. 11

Washington Post
https://www.washingtonpost.com/
Europe
As Germany awaits vaccine, mass vaccination centers are built in less than a week
Loveday Morris and Luisa Beck · Dec 12, 2020

Brazil govt releases pandemic vaccination plan with holes
·Dec 12, 2020

Morocco to use Chinese vaccine to kick off mass vaccinations
· Dec 8, 2020

Think Tanks et al
 
 
Brookings
http://www.brookings.edu/
Accessed 12 Dec 2020
[No new relevant content]
 
 
Center for Global Development [to 12 Dec 2020]
http://www.cgdev.org/page/press-center
December 10, 2020
Restricting Mobility Will Not Stop the Next Pandemic
Given that international travelers introduced COVID-19 to almost every country in the world, it’s natural to associate international mobility with the spread of disease. During the pandemic, 179 countries have implemented some form of travel restrictions. And beyond COVID-19, some countries may uphold such restrictions for fear of the next pandemic.
Michael Clemens, Thomas Ginn and Reva Resstack

The COVID-19 Vaccine: Do We Know Enough to End the Pandemic?
Publication
12/7/20
The SARS-COV-2/COVID-19 pandemic has created an unprecedented public health challenge, spurring a global race to develop and distribute viable vaccines. By mid-2021, there will likely be multiple licensed vaccines. Although there is an urgent need for these vaccines to be made available, several critical features of any COVID-19 vaccine must be considered to ensure optimal delivery and impact.
 
 
Chatham House [to 12 Dec 2020]
https://www.chathamhouse.org/
Accessed 12 Dec 2020
[No new relevant content]

 
 
CSIS
https://www.csis.org/
Accessed 12 Dec 2020
Upcoming Event
Online Event: Trusting a Covid-19 Vaccine: Where Do We Stand?
December 16, 2020
 
 
Upcoming Event
Online Event: Year-End Reflections on 2020 with Dr. Anthony Fauci
December 14, 2020

Council on Foreign Relations
http://www.cfr.org/
Accessed 12 Dec 2020
December 10, 2020
Pharmaceuticals and Vaccines
Russian Disinformation Popularizes Sputnik V Vaccine in Africa
In Africa, perceptions of Russia’s flagship vaccine, Sputnik V, are largely positive, despite it having not undergone the rigorous clinical trials that other vaccines have.
Blog Post by Guest Blogger for John Campbell

Kaiser Family Foundation
https://www.kff.org/search/?post_type=press-release
Accessed 12 Dec 2020
December 10, 2020 News Release
New National and State Estimates for Recommended COVID-19 Vaccination Priority Population
This month the Centers for Disease Control and Prevention (CDC) adopted a recommendation that health care workers and long-term care residents should be the first to receive the COVID-19 vaccine once it is authorized or approved by the FDA. A new KFF analysis estimates there are 15.5 million people working…

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: 

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

– Twitter:  Readers can also follow developments on twitter: @vaxethicspolicy.
.
– 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.

Support this knowledge-sharing service: Your financial support helps us cover our costs and to address a current shortfall in our annual operating budget. Click here to donate and thank you in advance for your contribution.

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

Milestones :: Perspectives :: Research

Ending the Covid-19 pandemic: The need for a global approach
Report – Eurasia Group COMMISSIONED BY THE BILL & MELINDA GATES FOUNDATION
25 NOVEMBER 2020 Publication date: 3 December 2020 :: 3 pages
PDF: https://www.who.int/docs/default-source/coronaviruse/act-accelerator/2020-summary-analysis-of-ten-donor-countries-11_26_2020-v2.pdf?sfvrsn=6d6f630c_5&download=true

executive summary
:: Eurasia Group’s analysis suggests that leaving low- and lower-middle-income countries (LLMICs) to fend for themselves amid the Covid-19 pandemic will cause significant economic damage that puts decades of economic progress at risk.
:: The Access to Covid-19 Tools Accelerator (Act-A) program is the only “end-to-end,” complete global solution – across tests, treatments, and vaccines – for tackling the pandemic. The world needs strong leadership and international cooperation to make this program a success. The Act-A program needs $38 billion in funding, of which $28.2 billion is still currently outstanding. Without contributions from advanced economies to fill that gap, Act-A will not be able to provide LLMICs with the life-saving tests, treatments, and vaccines they need.

:: Rapid, widespread, and equitable vaccination, tests, and treatments will save countless lives in LLMICs, allowing policymakers’ focus to return to the core development goals of raising living standards, empowering women, and marginalized communities, and strengthening institutions.
:: There is also a clear self-interested case for advanced economies to contribute to Act-A, and in particular, to the Gavi Covax-Advance Market Commitment (AMC), which aims to secure doses of Covid-19 vaccines for 92 LLMICs through the Covax Facility.

:: On the basis of the IMF’s October 2020 World Economic Outlook forecasts, Eurasia Group has estimated selected industry-level impacts for ten donor economies to quantify the economic impact of equitable vaccine distribution to Covax-AMC-eligible LLMICs. The US, the UK, Germany, Japan, and France were chosen based on their track record as the five largest donors in the world; Canada, Qatar, South Korea, Sweden, and the UAE were chosen to provide broader coverage across geographies and donor profiles.

:: This analysis suggests that the economic benefits of an equitable vaccine solution accrued by these ten donor countries alone would be at least $153 billion in 2020-21 (at constant exchange rates). Over the next five years, this sum rises to a cumulative $466 billion, more than 12 times the $38 billion total estimated cost of the Act-A program.

:: Apart from the clear economic benefits, each country involved stands to gain geopolitically—not only by taking a leading role in a coordinated multilateral response to Covid-19, but also by promoting prosperity and stability in the potential growth economies of the future.

3 December 2020 Joint News Release
Global equitable access to COVID-19 vaccines estimated to generate economic benefits of at least US$ 153 billion in 2020–21, and US$ 466 billion by 2025, in 10 major economies, according to new report by the Eurasia Group

Milestones :: Perspectives :: Research

COVID-19 Vaccines Regulatory Processes :: Announcements/Meeting Dates/Milestones

::::::

Week of 30 November 2020

European Medicines Agency
News & Press Releases
News: EMA starts rolling review of Janssen’s COVID-19 vaccine Ad26.COV2.S
Last updated: 01/12/2020

News: EMA receives application for conditional marketing authorisation of COVID-19 mRNA vaccine BNT162b2
Last updated: 01/12/2020

News: EMA receives application for conditional marketing authorisation of Moderna COVID-19 vaccine
Last updated: 01/12/2020

::::::

UK medicines regulator gives approval for first UK COVID-19 vaccine – MHRA
2 December 2020 — Press release
The first COVID-19 vaccine for the UK, developed by Pfizer/BioNTech, has today been given approval for use following a thorough review carried out by the Medicines and Healthcare products Regulatory Agency (MHRA).
The decision by the UK regulatory authority was made with advice from the Commission on Human Medicines (CHM), the government’s independent expert scientific advisory body. A dedicated team of MHRA scientists and clinicians carried out a rigorous, scientific and detailed review of all the available data, starting in October 2020.

This was done using a regulatory process known as a ‘rolling review’. A ‘rolling review’ can be used to complete the assessment of a promising medicine or vaccine during a public health emergency in the shortest time possible. This is done as the packages of data become available from ongoing studies on a staggered basis.

The MHRA expert scientists and clinicians reviewed data from the laboratory pre-clinical studies, clinical trials, manufacturing and quality controls, product sampling and testing of the final vaccine and also considered the conditions for its safe supply and distribution.

The National Institute for Biological Standards and Control, part of the agency, has been and will continue doing, independent laboratory testing so that every batch of the vaccine meets the expected standards of safety and quality.

MHRA Chief Executive, Dr June Raine said:
“We have carried out a rigorous scientific assessment of all the available evidence of quality, safety and effectiveness. The public’s safety has always been at the forefront of our minds – safety is our watchword.
“I’m really pleased to say that the UK is now one step closer to providing a safe and effective vaccine to help in the fight against COVID-19 – a virus that has affected each and every one of us in some way – and in helping to save lives.
“We are globally recognised for requiring high standards of safety, quality and effectiveness for any vaccine. Our expert scientists and clinicians worked tirelessly, around the clock, carefully, scientifically, robustly and rigorously poring over hundreds of pages and tables of data, methodically reviewing the data.
“Vaccines are the most effective way to prevent infectious diseases. They save millions of lives worldwide.”

::::::

Advisory Committee on Immunization Practices (ACIP) – CDC
December 1, 2020 Meeting Recommendation
ACIP approved the following recommendation by majority (13-1) vote at its December 1, 2020 emergency meeting:

When a COVID-19 vaccine is authorized by FDA and recommended by ACIP, vaccination in the initial phase of the COVID-19 vaccination program (Phase 1a) should be offered to both 1) health care personnel§ and 2) residents of long-term care facilities¶

This recommendation has been adopted by the CDC Director.
§Health care personnel are defined as paid and unpaid persons serving in health care settings who have the potential for direct or indirect exposure to patients or infectious materials
¶ Long-term care facility residents are defined as adults who reside in facilities that provide a variety of services, including medical and personal care, to persons who are unable to live independently

::::::

Covid: Russia begins vaccinations in Moscow – BBC
5 December 2020
Russia is starting its Covid-19 vaccination programme, with clinics in the capital Moscow inoculating those most at risk from the virus.
Its own vaccine Sputnik V, which was registered in August, is being used. Developers say it is 95% effective and causes no major side effects, but it is still undergoing mass testing.
Thousands of people have already registered to get the first of two jabs over the weekend, but it is unclear how much Russia can manufacture.
Producers are only expected to make two million doses of the vaccine by the end of the year.
Moscow Mayor Sergei Sobyanin, who announced the programme earlier in the week, said it was being offered to people in the city of 13 million who work in schools and the health service, and social workers.
He said the list would grow as more of the vaccine became available…

Milestones :: Perspectives :: Research

Week of 7 December 2020

10 December 2020 – Thursday – 0900-1800/New York
FDA – Vaccines and Related Biological Products Advisory Committee
The FDA’s Center for Biologics Evaluation and Research’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet in open session to discuss Emergency Use Authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 in individuals 16 years of age and older.
Webcast Information
CBER plans to provide a free of charge, live webcast of the Vaccines and Related Biological Products Advisory Committee meeting. If there are instances where the webcast transmission is not successful; staff will work to re-establish the transmission as soon as possible. The online web conference meeting will be available at the following:
https://youtu.be/owveMJBTc2IExternal Link Disclaimer
https://twitter.com/US_FDAExternal Link Disclaimer (Supported in Chrome browser)
https://fda.yorkcast.com/webcast/Play/d75d80a3eb6e419986181c1a881fe2671d.

::::::

11 December 2020 – Thursday – 1300-1630/CET
EMA Public stakeholder meeting: development and authorisation of safe and effective COVID-19 vaccines in the EU
:: Agenda – EMA public stakeholder meeting on COVID-19 (PDF/310.91 KB) (new)
:: Documents
:: Live broadcast
EMA is organising this virtual meeting to explain the processes for the development, evaluation, approval and safety monitoring of COVID-19 vaccines in the EU, including EMA’s specific role, to all interested parties.
It will also give the opportunity to the public and stakeholder groups to speak and share their needs, expectations and any concerns, that will be considered by EMA and the European medicines regulatory network in the decision-making process.
Please note that some issues of high public interest, such as patient access to COVID-19 vaccines and national vaccination campaigns, lie outside EMA’s remit and will not be covered at this event.

EMA starts rolling review of mRNA COVID-19 vaccine by Moderna Biotech Spain, S.L.
Last updated: 16/11/2020
MA’s human medicines committee (CHMP) has started a ‘rolling review’ of data on a vaccine for COVID-19 known as mRNA-1273, which is being developed by Moderna Biotech Spain, S.L. (a subsidiary of Moderna, Inc.)…The rolling review will continue until enough evidence is available to support a formal marketing authorisation application…

Milestones :: Perspectives :: Research

Week of 14 December 2020

17 December 2020 – Thursday – 0900-1800/New York
Vaccines and Related Biological Products Advisory Committee Meeting
Meeting Agenda
The Center for Biologics Evaluation and Research’s (CBER), Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet in open session to discuss Emergency Use Authorization (EUA) of the Moderna, Inc., COVID-19 Vaccine for the prevention of COVID-19 in individuals 18 years and older.
The online web conference meeting will be available at the following: 
https://fda.yorkcast.com/webcast/Play/5cf9198bcc0745769b39c699850945911d

Milestones :: Perspectives :: Research

COVID-19 Vaccines :: Development/Procurement/Distribution/Logistics

Washington Post
Business
Trump’s Operation Warp Speed promised a flood of covid vaccines. Instead, states are expecting a trickle.
The administration pledged several hundred million doses in 2020. Companies will actually ship about 10 percent of that.
Christopher Rowland, Lena H. Sun, Isaac Stanley-Becker and Carolyn Y. Johnson
Dec 5, 2020
Federal officials have slashed the amount of coronavirus vaccine they plan to ship to states in December because of constraints on supply, sending local officials into a scramble to adjust vaccination plans and highlighting how early promises of a vast stockpile before the end of 2020 have fallen short.

Instead of the delivery of 300 million or so doses of vaccine immediately after emergency-use approval and before the end of 2020 as the Trump administration had originally promised, current plans call for availability of around a tenth of that, or 35 to 40 million doses…

As planning accelerated for distributing supplies, the government began to further lower expectations. To make sure supplies don’t run out and leave some people only partially immunized, the government said it would stagger deliveries to ensure that states have enough supply for the second shot, required 21 days later for the Pfizer vaccine, which is expected to be first to gain approval.

Lower-than-anticipated allocations have caused widespread confusion and concern in states, which are beginning to grasp the level of vaccine scarcity they will confront in the early going of the massive vaccination campaign.

The gap reflects the disconnect between Trump’s campaign promises, as well as the optimistic estimates from some drug companies, and scientific and manufacturing realities.

The drop-off is a product of manufacturing problems, bottlenecks in the supply of raw materials and other hurdles in ramping up clinical-trial production of 5 liters of protein-based vaccine at a time to commercial-scale fermentation of 2,000-liter batches, the companies and the Trump administration said.

“There were a couple of our vaccine candidates that took significantly longer, in terms of failed batches, in terms of not having the purity we sought,” Paul Mango, deputy chief of staff for policy at the Department of Health and Human Services, said in an interview. He declined to say which company experienced batch failures…

::::::

Moderna Announces Amendment to Supply Agreement with the Ministry of Health of Israel to Supply Additional Doses of mRNA Vaccine Against COVID-19 (mRNA-1273)
December 04, 2020
CAMBRIDGE, Mass.–(BUSINESS WIRE)–Moderna, Inc., (Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced an expanded supply agreement with the Ministry of Health of Israel for an additional 4 million doses of mRNA-1273..

Moderna Provides Updates on the Clinical Development and Production of Its COVID-19 Vaccine Candidate
December 03, 2020

Moderna Announces Primary Efficacy Analysis in Phase 3 COVE Study for Its COVID-19 Vaccine Candidate and Filing Today with U.S. FDA for Emergency Use Authorization
November 30, 2020

Moderna Announces Amendment to Current Supply Agreement with United Kingdom Government for an Additional 2 Million Doses of mRNA Vaccine Against COVID-19 (mRNA-1273)
November 29, 2020
CAMBRIDGE, Mass.–(BUSINESS WIRE)–Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced a supply agreement with the UK government for an additional 2 million doses of mRNA-1273,

::::::

Pfizer and BioNTech Achieve First Authorization in the World for a Vaccine to Combat COVID-19
December 01, 2020
:: U.K. regulator, MHRA, authorizes supply of COVID-19 mRNA vaccine for emergency supply under Regulation 174; Companies are ready to deliver the first doses to the U.K. immediately
:: First authorization for a COVID-19 vaccine represents a breakthrough scientific achievement to help combat this devastating pandemic
:: The companies previously signed an agreement to supply a total of 40 million doses to the U.K. with delivery in 2020 and 2021
:: U.S. FDA and EU EMA decisions on authorization are expected in December

::::::

Dr. Reddy’s and RDIF commence clinical trials for Sputnik V vaccine in India
December 01, 2020
HYDERABAD, India–(BUSINESS WIRE)–Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY), and Russian Direct Investment Fund (RDIF) announced today that they have commenced adaptive phase 2/3 clinical trials for Sputnik V vaccine in India after receiving the necessary clearance from the Central Drugs Laboratory, Kasauli, India. This will be a multicenter and randomized controlled study, which will include safety and immunogenicity study.
The clinical trials are being conducted by JSS Medical Research as the clinical research partner. Further, Dr. Reddy’s has partnered with the Biotechnology Industry Research Assistance Council (BIRAC), Department of Biotechnology (DBT) for advisory support and to use BIRAC’s clinical trial centres for the vaccine…

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Editor’s Note:
To better present a global view of COVID-19 vaccine development, regulatory review, procurement and deployment, we will present headlines from this site – which provides as its contact point the Russian Direct Investment Fund [RDIF].

Sputnik V – “the first registered COVID-19 vaccine” [to 05 Dec 2020]
https://sputnikvaccine.com/newsroom/pressreleases/
Press Releases
RDIF and Ministry of Health of Kazakhstan announce cooperation on the registration, production and distribution of the Sputnik V vaccine
04.12.2020
…Upon obtaining the regulatory approval, the production technology and the materials required for the production of 2 million doses of the vaccine will be transferred to Kazakhstan.
Currently, Phase III clinical trials have approval and are ongoing in Belarus, the UAE, Venezuela and a number of other countries, as well as Phase II-III being underway in India. Requests for more than 1.2 billion doses of the Sputnik V vaccine have come from more than 50 countries. Vaccine production for the global market will be undertaken by RDIF’s international partners in India, Brazil, China, South Korea and four other countries…

EMERGENCIES

Coronavirus [COVID-19]
Public Health Emergency of International Concern (PHEIC)

Weekly Epidemiological and Operational updates
Last update: 5 December 2020, 9:02 am GMT-5
Confirmed cases :: 65 257 767 [week ago: 61 299 371] [two weeks ago: 57 274 018]
Confirmed deaths :: 1 513 179 [week ago: 1 439 784] [two weeks ago: 1 368 000]
Countries, areas or territories with cases :: 220

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WHO Director-General’s opening remarks at the media briefing on COVID-19 – 30 November 2020
:: Last week saw the first decline in newly-reported cases globally since September. This is no time for complacency, especially with the holiday season approaching in many cultures and countries.
:: The COVID-19 pandemic will change the way we celebrate, but it doesn’t mean we can’t celebrate. The changes you make will depend on where you live. Always follow your local or national guidelines.
:: Tomorrow is World AIDS Day. New HIV infections have declined by 23% since 2010, and AIDS-related deaths have fallen by 39%.
:: A record 26 million people are on antiretroviral treatment – but the pace of increase has slowed, and that leaves 12 million people who are living with HIV but are not on treatment. That gap is jeopardising our goal of ending AIDS as a public health threat by 2030.

::::::

Weekly epidemiological update – 1 December 2020
Overview
Globally in the past week, cases of COVID-19 have remained at approximately 4 million new cases, while new deaths have continued to increase to over 69 000. This brings the cumulative numbers to over 61.8 million reported cases and 1.4 million deaths globally since the start of the pandemic.

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

EmergencieS

POLIO
Public Health Emergency of International Concern (PHEIC)

Polio this week as of 02 December 2020
:: One of the largest polio immunization campaigns in the African Region this year has just concluded in Chad, where over 3.3 million children in 91 districts were vaccinated. This pushes the total number of children vaccinated against polio to over forty million across 16 countries in the Region, since campaigns resumed following a necessary pause in immunizations due to the COVID-19 pandemic.

Summary of new WPV and cVDPV viruses this week (AFP cases and ES postitives):
:: Pakistan: one WPV1 case, 13 WPV1 positive environmental samples and five cVDPV2 positive environmental samples
:: Democratic Republic of the Congo (DR Congo): five cVDPV2 cases
:: Mali: two cVDPV2 cases

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::::::

Editor’s Note:
A number of country pages below did not load at inquiry.

WHO Grade 3 Emergencies [to 05 Dec 2020]

Democratic Republic of the Congo – No new digest announcements identified
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

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WHO Grade 2 Emergencies [to 05 Dec 2020]
Iraq
:: Baghdad, 30 November 2020 – On Sunday, Iraqi health authorities, in partnership with the World Health Organization (WHO) and UNICEF began a mass polio vaccination campaign targeting more than 1.9 million children under the age of 5…

Angola
:: Battling COVID-19 rumours and hoaxes in Angola 03 December 2020

Afghanistan – No new digest announcements identified
Burkina Faso – 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
Iran floods 2019 – 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
Mozambique – 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
HIV in Pakistan – No new digest announcements identified
Sao Tome and Principe Necrotizing Cellulitis (2017) – No new digest announcements identified
Sudan – No new digest announcements identified
Ukraine – No new digest announcements identified
Zimbabwe – No new digest announcements identified

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WHO Grade 1 Emergencies [to 05 Dec 2020]

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
:: Syrian Arab Republic: COVID-19 Humanitarian Update No. 21 As of 30 November 2020

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.
COVID-19
:: Coronavirus Disease (COVID-19): Weekly Epidemiological Update (1 December 2020)

East Africa Locust Infestation – No new digest announcements identified

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

WHO & Regional Offices [to 05 Dec 2020]
3 December 2020 Joint News Release
Global equitable access to COVID-19 vaccines estimated to generate economic benefits of at least US$ 153 billion in 2020–21, and US$ 466 billion by 2025, in 10 major economies, according to new report by the Eurasia Group

30 November 2020 News release
WHO calls for reinvigorated action to fight malaria

25 November 2020 News release
Every move counts towards better health – says WHO

::::::

Weekly Epidemiological Record, 4 December 2020, vol. 95, 49 (pp. 609–628)
:: Immunization and Vaccine-related Implementation Research Advisory Committee (IVIR-AC)
:: WHO calls for reinvigorated action to fight malaria

::::::

WHO Regional Offices
Selected Press Releases, Announcements
WHO African Region AFRO
:: Working with the media in Nigeria’s COVID-19 fight 03 December 2020
When Regina Otokpa, an Abuja-based journalist, co-authored a newspaper article on poor observance of mask-wearing and physical distancing directives in Nigeria, it caused some buzz.
:: Battling COVID-19 rumours and hoaxes in Angola 03 December 2020
“COVID-19 doesn’t kill anybody in Angola as we are immune due to malaria,” so goes one of the myriad falsehoods about the pandemic in the southern African country.
:: Over 3.3 million children vaccinated in Chad in large-scale polio campaign 02 December 2020
More than 3.3 million children have been vaccinated against polio in Chad in a just-concluded immunization drive – one of the largest of its kind in the African region this year as campaigns that were halted due to the COVID-19 pandemic resume.
:: How the world’s highest HIV-prevalence country turned around, and in record time 01 December 2020
Because her government aggressively pursued treatment as prevention for people living with HIV, Thembi Dlamini and several women in her support group have been able to counsel each other, give family advice and run an artisanal business. In other words, their government gave them a life together.
:: A double challenge: Tackling COVID-19 and malaria in Uganda 30 November 2020
A month after Uganda instituted stringent measures to curb the spread of COVID-19, the threat of another disease outbreak prompted a new nationwide campaign: “Why survive COVID-19 and die of malaria?” rang a slogan on the airwaves.
:: Tanzania intensifies malaria fight in hotspots 30 November 2020

WHO Region of the Americas PAHO
No new digest content identified

WHO South-East Asia Region SEARO
:: 1 December 2020 News release
Reinvigorate response to HIV among challenges posed by pandemic: WHO
Between 2010 and 2019, the Region has taken large strides in its response to HIV. Epidemiological trends show that both new infections and HIV-related deaths are continuing to decl …

WHO European Region EURO
:: WHO works with Kyrgyz authorities to reduce risk of COVID-19 infection at border crossings 04-12-2020
:: WHO/Europe and the Turkic Council begin putting memorandum of understanding into action 03-12-2020
:: Latest update on the pandemic and preparations for COVID-19 vaccine deployment 03-12-2020
:: Building back better: people with disabilities in the workforce 03-12-2020
:: New WHO report reveals that while smoking continues to decline among European adolescents, the use of electronic cigarettes by young people is on the rise 02-12-2020

WHO Eastern Mediterranean Region EMRO
No new digest content identified

WHO Western Pacific Region
:: 2 December 2020 | Feature story
Evacuating to safer shelter in the time of COVID-19
In recent weeks, floods or typhoons have forced thousands of people from their homes in Cambodia, the Lao People’s Democratic Republic, the Philippines and Viet Nam, and Pacific island countries and areas have braced for the cyclone season, which has just started.
:: 2 December 2020 | Feature story
Sharing COVID-19 experiences: The Republic of Korea response
When the first case of coronavirus disease 2019 (COVID-19) was confirmed in the Republic of Korea on 20 January 2020, the country immediately implemented a strategy to test, trace and treat and to build the trust needed to successfully manage the virus while preserving social and economic life as much as possible.

CDC/ACIP [to 05 Dec 2020]
http://www.cdc.gov/media/index.html
https://www.cdc.gov/vaccines/acip/index.html
Latest News Releases, Announcements
CDC Statement Regarding ACIP Recommendations Thursday, December 3, 2020
… Dr. Redfield supports their recommendations and has signed the memo and accepted these interim recommendations…

Transcript for CDC Telebriefing on the COVID-19 Outbreak Wednesday, December 2, 2020
BRIEFING TO DISCUSS CHANGES TO CDC’S QUARANTINE GUIDANCE AND CONSIDERATIONS TO DOMESTIC TRAVEL.

Media Statement from CDC Director Robert R. Redfield, M.D., in Observance of World AIDS Day 2020 Tuesday, December 1, 2020.

Coronavirus Disease 2019 (COVID-19)
Selected Resources
:: EARLY RELEASE: Summary of Guidance for Public Health Strategies to Address High Levels of Community Transmission of SARS-CoV-2 and Related Deaths, December 2020 Friday, December 04, 2020
:: COVID-19 Case Investigation and Contact Tracing among Refugee, Immigrant, and Migrant (RIM) Populations: Important Considerations for Health Departments Friday, December 04, 2020
:: Interim Guidance for Businesses and Employers Responding to Coronavirus Disease 2019 (COVID-19), May 2020 Friday, December 04, 2020
:: Information for School Nurses and Other Healthcare Personnel (HCP) Working in Schools and Child Care Settings Thursday, December 03, 2020
:: Frequently Asked Questions about COVID-19 Vaccination Thursday, December 03, 2020

MMWR News Synopsis Friday, December 4, 2020
:: Sex Differences in HIV Testing — 20 PEPFAR-Supported Sub-Saharan African Countries, 2019
:: Multidisciplinary Community-Based Investigation of a COVID-19 Outbreak Among Marshallese and Hispanic/Latino Communities — Benton and Washington Counties, Arkansas, March–June 2020

Africa CDC [to 05 Dec 2020]
http://www.africacdc.org/
News
Press Releases
Landmark alliance launches in Africa to fight COVID-19 misinformation
Brazzaville, 3 December 2020 – The World Health Organization (WHO) today launched a new alliance, the Africa Infodemic Response Alliance (AIRA), to coordinate actions and pool resources in combating misinformation around COVID-19 pandemic and other health emergencies in Africa.

Digital platforms have been inundated with COVID-19-related information since the pandemic began in late 2019. Information about the virus has been shared and viewed over 270 billion times online and mentioned almost 40 million times on Twitter and web-based news sites in the 47 countries of the WHO African Region between February and November 2020, according to UN Global Pulse, the United Nations’ Secretary-General’s initiative on big data and artificial intelligence…

Brazzaville, 3 December 2020 – The World Health Organization (WHO) today launched a new alliance, the Africa Infodemic Response Alliance (AIRA), to coordinate actions and pool resources in combating misinformation around COVID-19 pandemic and other health emergencies in Africa.

Digital platforms have been inundated with COVID-19-related information since the pandemic began in late 2019. Information about the virus has been shared and viewed over 270 billion times online and mentioned almost 40 million times on Twitter and web-based news sites in the 47 countries of the WHO African Region between February and November 2020, according to UN Global Pulse, the United Nations’ Secretary-General’s initiative on big data and artificial intelligence…

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

National Health Commission of the People’s Republic of China [to 05 Dec 2020]
http://en.nhc.gov.cn/
News
Dec 5: Daily briefing on novel coronavirus cases in China
On Dec 4, 31 provincial-level regions and the Xinjiang Production and Construction Corps on the Chinese mainland reported 17 new cases of confirmed infections.

National Medical Products Administration [to 05 Dec 2020]
http://english.nmpa.gov.cn/news.html
News
Vice-premier underlines progress in COVID-19 vaccine development
2020-12-03
BEIJING — Vice-Premier Sun Chunlan on Dec 2 said China has achieved major progress in the research and development of COVID-19 vaccines, with five vaccines having entered phase-III clinical trials.
Sun made the remarks as she and State Councilor Wang Yong inspected the work on COVID-19 vaccine development and production in Beijing.
Sun said 14 vaccines developed from five technological routes have entered clinical trials, five of which have entered phase-III clinical trials.
Emergency use and preparation for the production of the vaccines are progressing smoothly, she said.
Sun called for consistent efforts to carry out phase-III clinical trials of the vaccines with a scientific and rigorous approach, and ensure they meet relevant laws and regulations and international standards.
The vaccines should be developed safely and effectively and be able to withstand tests in various aspects, she noted.
Efforts should go into the preparation for mass production and the drafting of distribution plans when the vaccines are available for the public, Sun said…

Announcements

Paul G. Allen Frontiers Group [to 05 Dec 2020]
https://alleninstitute.org/what-we-do/frontiers-group/news-press/
News
News from The Paul G. Allen Frontiers Group: November 2020
November 5, 2020
Highlights include: new Allen Distinguished Investigators announced, a new podcast on SCANning for coronavirus, recent research on astrocytes, upcoming events, and more.

BARDA – U.S. Department of HHS [to 05 Dec 2020]
https://www.phe.gov/about/barda/Pages/default.aspx
BARDA News
No new digest content identified.

BMGF – Gates Foundation [to 05 Dec 2020]
http://www.gatesfoundation.org/Media-Center/Press-Releases
Press Releases and Statements
No new digest content identified.

Bill & Melinda Gates Medical Research Institute [to 05 Dec 2020]
https://www.gatesmri.org/
The Bill & Melinda Gates Medical Research Institute is a non-profit biotech organization. Our mission is to develop products to fight malaria, tuberculosis, and diarrheal diseases—three major causes of mortality, poverty, and inequality in developing countries. The world has unprecedented scientific tools at its disposal; now is the time to use them to save the lives of the world’s poorest people
No new digest content identified.

CARB-X [to 05 Dec 2020]
https://carb-x.org/
News
12.01.2020  |
CARB-X is funding a German team of scientists to develop a new treatment for difficult-to-treat Pseudomonas aeruginosa infections in cystic fibrosis patients
CARB-X is awarding up to US$1.75 million to the Helmholtz Institute for Pharmaceutical Research Saarland (HIPS) in Saarbrücken, Germany, to develop an innovative treatment for Pseudomonas aeruginosa infections in cystic fibrosis patients.

CEPI – Coalition for Epidemic Preparedness Innovations [to 05 Dec 2020]
http://cepi.net/
Latest News
CEPI welcomes UK approval of Pfizer/BioNtech vaccine
UK’s temporary authorization of the Pfizer/BioNtech vaccine is a significant milestone in the global fight to control COVID-19
COVID-19 02 Dec 2020

Malaysia joins CEPI, donating US$3 million to advance vaccine R&D
The funding will allow the world to better prepare and respond to future outbreaks.
COVID-19 30 Nov 2020

EDCTP [to 05 Dec 2020]
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
01 December 2020
World AIDS Day 2020

Emory Vaccine Center [to 05 Dec 2020]
http://www.vaccines.emory.edu/
Vaccine Center News
No new digest content identified.

European Medicines Agency [to 05 Dec 2020]
http://www.ema.europa.eu/ema/
News & Press Releases
News: EMA starts rolling review of Janssen’s COVID-19 vaccine Ad26.COV2.S
Last updated: 01/12/2020

News: EMA receives application for conditional marketing authorisation of COVID-19 mRNA vaccine BNT162b2
Last updated: 01/12/2020

News: EMA receives application for conditional marketing authorisation of Moderna COVID-19 vaccine
Last updated: 01/12/2020

European Vaccine Initiative [to 05 Dec 2020]
http://www.euvaccine.eu/
Latest News
Dec 1 2020
World AIDS Day 2020

FDA [to 05 Dec 2020]
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
Press Announcements /Selected Details
December 4, 2020 – Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 and Flu Combination Test for use with home-collected samples
… “Today’s authorization for a COVID-19 plus flu test using samples collected at home is a significant step toward FDA’s nationwide response to COVID-19. With the authorization of this test, the FDA is helping to address the ongoing fight against COVID-19 while in the middle of the flu season, which is important for many, including the most vulnerable of Americans. This is another example of the FDA working with test developers to bring important diagnostics to Americans,” said FDA Commissioner Stephen M. Hahn, M.D. “With just one swab or sample, combination tests that are authorized for use with home-collected samples can be used to get answers to Americans faster, in the comfort and relative safety of their home, which allows patients to continue to quarantine while awaiting results. This efficiency can go a long way to providing timely information for those sick with an unknown respiratory ailment.”…

December 4, 2020 – Coronavirus (COVID-19) Update: December 4, 2020
:: The FDA has added content to the question-and-answer appendix in its guidance titled, “Conduct of Clinical Trials of Medical Products During COVID-19 Public Health Emergency.” The updated guidance includes a new question and answer regarding considerations for disposing unused investigational drug product when a study participant cannot return it to the study site.
:: PrecisionFDA has launched the COVID-19 Precision Immunology App-a-thon. The agency encourages the scientific and analytics community to develop innovative applications to explore the relationship between personalized immune repertoires and COVID-19 disease variables and associated factors.

December 3, 2020 – Coronavirus (COVID-19) Update: December 3, 2020
:: On Dec. 2, the FDA updated the SARS CoV-2 reference panel comparative data on our website to reflect the latest information. The FDA SARS-CoV-2 reference panel is an independent performance validation step for diagnostic tests of SARS-CoV-2 infection that are being used for clinical purposes.

December 1, 2020 – Coronavirus (COVID-19) Update: December 1, 2020

November 30, 2020 – Coronavirus (COVID-19) Update: FDA Announces Advisory Committee Meeting to Discuss Second COVID-19 Vaccine Candidate

FDA – COVID-19 Vaccines [to 05 Dec 2020]
www.fda.gov/covid19vaccines
Upcoming Events
12/17/2020: Vaccines and Related Biological Products Advisory Committee Meeting
12/10/2020: Vaccines and Related Biological Products Advisory Committee Meeting
[See Regulatory Calendar above for details]

Fondation Merieux [to 05 Dec 2020]
http://www.fondation-merieux.org/
News, Events
Mérieux Foundation co-organized event
7th Meeting of the GTFCC Working Group on Oral Cholera Vaccine Webinars
November 19 – December 10, 2020 – Webinars

Vaccine Acceptance Virtual Event Series – How to maintain and build trust in immunization
December 16, 2020 – 2:00pm – 4:30pm (CET) Virtual
An event to continue the dialogue and increase multi-sectoral efforts to promote vaccination acceptance and immunization programs resilience, now particularly challenged by the ongoing COVID-19 pandemic.
The erosion in vaccination trust and additional disruptions in routine immunization programs caused by the current pandemic is becoming an increasing threat to public health. How to tackle it?
To keep the momentum in this critical topic, we would like to bring together the vaccine acceptance public in this 2.5-hour webinar.

Gavi [to 05 Dec 2020]
https://www.gavi.org/
News releases
The COVID-19 vaccine race
Updated: 2 December 2020
Scientists around the world are working faster than ever to find vaccines that could stop the spread of COVID-19. Now, nearly a year on from the start of the pandemic, we have several promising vaccines on the brink of going through regulatory approval to be rolled out.
Here is a slightly more in-depth look at the candidate vaccines that are in phase 1 trials or beyond:

GHIT Fund [to 05 Dec 2020]
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 05 Dec 2020]
https://www.theglobalfund.org/en/news/
News
Global Fund Board Appoints Tracy Staines as Inspector General
03 December 2020
The Board of the Global Fund to Fight AIDS, Tuberculosis and Malaria has appointed Tracy Staines, a distinguished auditor and seasoned executive, as Inspector General. Staines brings over 20 years of multi-sectoral experience in audit and risk management, including eight years at the Global Fund.

Without Equity, We Cannot End COVID-19, HIV Or Any Other Pandemic
01 December 2020 by Peter Sands and Mark Vermeulen
While COVID-19 continues to accelerate around the world, the last few weeks have seen new optimism in the fight against the pandemic. Pfizer and Moderna have shared data showing their vaccines are more than 90% effective. People now dare to dream that 2021 will bring a semblance of normality to their lives. The vaccine news is proof of the power of science. Yet our optimism must be tempered with caution. Will the world deliver vaccines to all? Will we see the commitment to finish the fight against COVID-19 sustained once people in rich countries have been vaccinated and are safe from the virus?
The fight against HIV offers a sobering reality-check…

Sue Ackerly Appointed as Global Fund Ombudsperson
30 November 2020
The Global Fund to Fight AIDS, tuberculosis and Malaria today announced the appointment of Sue Ackerly as Ombudsperson, reinforcing its commitment to a strong and independent informal mechanism for staff and strengthening the Global Fund’s culture of diversity, inclusion and dignity.

Global Research Collaboration for Infectious Disease Preparedness [GloPID-R] [to 05 Dec 2020]
https://www.glopid-r.org/news/
News
No new digest content identified.

Hilleman Laboratories [to 05 Dec 2020]
http://www.hillemanlabs.org/
No new digest content identified.

Human Vaccines Project [to 05 Dec 2020]
http://www.humanvaccinesproject.org/media/press-releases/
Press Releases
No new digest content identified.

IAVI [to 05 Dec 2020]
https://www.iavi.org/newsroom
PRESS RELEASES/FEATURES
December 3, 2020
IAVI Announces Launch of EDCTP-funded Socio-behavioral Project on Accessible HIV Prevention Tools for African Women
Universally accessible HIV Prevention Technologies for African girls and young women through Knowledge applied from behavioral Economics (UPTAKE) presents a unique multidisciplinary collaboration of five leading research institutions in both Africa and Europe

AMSTERDAM – DECEMBER 03, 2020 – IAVI today announced the initiation of UPTAKE, an innovative behavioral science research project with support from the European and Developing Countries Clinical Trials Partnership (EDCTP). UPTAKE seeks to determine factors that facilitate future uptake of long-acting (LA) technologies to prevent HIV and unintended pregnancy in adolescent girls and young women (AGYW) in Kenya and Uganda. AGYW in sub-Saharan Africa aged 15-24 years are twice as likely to be living with HIV as men in the same age group.

Due to access and adherence issues, existing prevention products, such as condoms, voluntary medical male circumcision, Pre-exposure prophylaxis (PrEP), and treatment as prevention (TasP), continue to fall short in curbing HIV infections among AGYW. LA antiretroviral-based technologies represent a promising avenue for HIV prevention, with recent results from the HIV Prevention Trials Network (HPTN) HPTN 083 study demonstrating LA injectable cabotegravir used as PrEP to be highly effective in preventing HIV acquisition in women in sub-Saharan Africa. Future LA antibody-based technologies are also being explored. This study will determine and test behavioral factors that facilitate adoption and use of future LA HIV pre-exposure prophylaxis (LA-PrEP) alone or in combination with marketed LA contraceptives in Kenya and Uganda.

Funded by a three-year €2.24 million grant from EDCTP and led by IAVI’s offices in Amsterdam and Nairobi, UPTAKE features a unique international consortium of five leading academic, public health, and product development organizations in Africa and Europe…

FEATURES
December 1, 2020
HIV Activist Winifred Ikilai: 5 Things to Know on World AIDS Day 2020

International Coalition of Medicines Regulatory Authorities [ICMRA]
http://www.icmra.info/drupal/en/news
Selected Statements, Press Releases, Research
Supply Chain Integrity
Recommendations on common technical denominators for track and trace systems to allow for interoperability: open for public consultation
November 27, 2020
The International Coalition of Medicines Regulatory Authorities (ICMRA) has developed a draft paper with recommendations on common technical denominators for track and trace (T&T) systems. It aims to facilitate the implementation of interoperable systems for medicines around the world.
In this paper, regulators emphasise that interoperability of T&T systems would help to protect public health by improving information sharing in case of quality defects, reducing shortages, contributing to the fight against falsified medicines and supporting pharmacovigilance activities.
The draft recommendations are available for public consultation until 28 February 2021:
Recommendations on common technical denominators for track and trace systems to allow for interoperability
Stakeholders can send their comments on the document via an online form to icmratrackandtrace@ema.europa.eu.
The draft recommendations were developed in consultation with the World Health Organisation (WHO), representatives from international medicines regulatory authorities and experts from the private sector.
ICMRA intends to publish the final document in 2021 after considering the responses to the public consultation…

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

IFFIm
http://www.iffim.org/
Press Releases/Announcements
No new digest content identified.

IFRC [to 05 Dec 2020]
http://media.ifrc.org/ifrc/news/press-releases/
Selected Press Releases, Announcements
Global
Red Cross and Red Crescent societies report massive surge in volunteer numbers in response to COVID-19
Geneva, 2 December 2020 – Hundreds of thousands of new volunteers worldwide have joined their National Red Cross and Red Crescent Society this year, providing vital support to their local communities during the COVID-19 pandemic.
2 December 2020

Global
IFRC: Success of COVID-19 vaccine relies on our ability to address “mistrust pandemic”
New York/Geneva, 30 November 2020 – The President of the world’s largest humanitarian organization has warned that efforts to roll out a potential COVID-19 vaccine could fail unless equally ambitious efforts to counteract rapidly rising levels of mistrust and misinformation are put in place.
Speaking ahead of a United Nations High-Level Special Session on the COVID-19 Pandemic taking place this week in New York, Mr Francesco Rocca, President of the International Federation of Red Cross and Red Crescent Societies (IFRC), said:
“We welcome the news that a viable COVID-19 vaccine may be imminent. However, we caution that a vaccine in-and-of-itself will not be enough to end this pandemic.
“To beat COVID-19, we also need to defeat the parallel pandemic of mistrust that has consistently hindered our collective response to this disease, and that could undermine our shared ability to vaccinate against it.”…

Institut Pasteur [to 05 Dec 2020]
https://www.pasteur.fr/en/press-area
Press documents
No new digest content identified.

IRC International Rescue Committee [to 05 Dec 2020]
http://www.rescue.org/press-release-index
Media highlights [Selected]
Press Release
IRC calls for truly global COVID-19 action and global ceasefire ahead of UN General Assembly Session on Covid-19
December 3, 2020

Press Release
New UN data shows 40% increase in people in need; IRC calls on world leaders to step up and fund frontline response
December 1, 2020

IVAC [to 05 Dec 2020]
https://www.jhsph.edu/research/centers-and-institutes/ivac/index.html
Updates; Events
No new digest content identified.

IVI [to 05 Dec 2020]
http://www.ivi.int/
Selected IVI News, Announcements, Events
EuBiologics partners up with IVI in COVID-19 vaccine development
December 3, 2020, SEOUL, South Korea – The International Vaccine Institute (IVI) and EuBiologics exchanged an MOU to cooperate in clinical development of the COVID-19 vaccine the company is currently developing. The signing ceremony at IVI headquarters on December 2 was attended by Dr. Jerome Kim, Director General, and Dr. Manki Song, Deputy Director General of Science from IVI, co-CEO Dr. Yeong Ok Baik co-CEO Seuk-Keun Choi from EuBiologics…

How to take action on AMR during the COVID-19 pandemic, a webinar co-hosted by IVI, ICARS, and the Embassy of Denmark in Korea
December 1, 2020
Free webinar, Evidence to Action: Advancing the Antimicrobial Resistance Agenda during a Pandemic, will be held on Thursday, December 3, 2020 at 9:00 Central European Time (17:00 Korean Standard Time). Registration available at ivi.int/evidence-to-action/ 

JEE Alliance [to 05 Dec 2020]
https://www.jeealliance.org/
Selected News and Events
No new digest content identified.

MSF/Médecins Sans Frontières [to 05 Dec 2020]
http://www.msf.org/
Latest [Selected Announcements]
Coronavirus COVID-19 pandemic
Responding to COVID-19: Global Accountability Report 2 – June to August 2020
Report 2 Dec 2020
…From June to August, Médecins Sans Frontières (MSF) continued to respond to the pandemic through its existing programmes, as well as dedicated COVID-19 interventions in more than 250 projects in 63 countries….

HIV/AIDS
HIV is in a state of silent crisis in Central African Republic
Project Update 30 Nov 2020

HIV/AIDS
Bending the HIV curve in Kenya’s Ndhiwa sub-county
Project Update 30 Nov 2020

National Vaccine Program Office – U.S. HHS [to 05 Dec 2020]
https://www.hhs.gov/vaccines/about/index.html
Upcoming Meetings/Latest Updates
No new digest content identified.

NIH [to 05 Dec 2020]
http://www.nih.gov/news-events/news-releases
News Releases
High-dose influenza vaccine shows no additional benefit for heart disease patients
December 4, 2020 — NIH-funded study finds higher dose is not more effective at reducing serious flu complications in this high-risk group.

NIH Statement on World AIDS Day 2020
December 1, 2020 — We reflect both on the remarkable progress that has been made against HIV as well as the considerable challenges that remain.

NIH announces restructured HIV clinical trials networks
November 30, 2020 —
Grant awards set stage for next seven years of science-driven HIV clinical research.
The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, today announced the clinical investigators and institutions that will lead four NIH HIV clinical trials networks over the next seven years to conduct the innovative, efficient clinical research needed to accelerate progress against the HIV pandemic. NIAID also awarded grants to 35 U.S. and international institutions selected as HIV clinical trials units (CTUs). NIAID and co-funding NIH Institutes intend to provide approximately $375.3 million in the first year to support the networks…

Experimental Vaccine for Deadly Tickborne Virus Effective in Cynomolgus Macaques
November 30, 2020 — Monkeys protected against CCHFV, which infects thousands of people annually.

PATH [to 05 Dec 2020]
https://www.path.org/media-center/
Press Release
PATH’s statement on the World Health Organization’s World Malaria Report, 2020
November 30, 2020 by PATH
Country-led, data-centered approaches are saving millions of lives in the fight against malaria. However, we have more work to do.
A statement from PATH’s Director of Malaria and Neglected Tropical Diseases, Center for Malaria Control and Elimination, Kammerle Schneider:
“This week, the World Health Organization (WHO) released the 2020 World Malaria Report, its annual update on global malaria control and elimination. This year’s report reflects on 20 years of collaboration and progress against malaria and calls on the global community to maintain essential malaria services to mitigate the impact of COVID-19.
“PATH is proud of the progress the global community has made in reducing the burden of malaria over the past two decades—1.5 billion cases and 7.6 million deaths have been averted because of sustained political commitment and increased investment in the development and scale-up of effective tools and approaches. Further, we are on track to achieve two milestones laid out in the Global Technical Strategy for Malaria 2016-2030: Ten countries where malaria was endemic in 2015 are now on track for elimination and WHO-certified malaria-free countries continue to maintain no local transmission.
“However, progress against malaria has plateaued over the past four years—global malaria case incidence declined by 27% between 2000 and 2015, as compared to less than 2% from 2015 to 2019…

Sabin Vaccine Institute [to 05 Dec 2020]
http://www.sabin.org/updates/pressreleases
Statements and Press Releases
No new digest content identified.

UNAIDS [to 05 Dec 2020]
http://www.unaids.org/en
Selected Press Releases/Reports/Statements
4 December 2020
Dakar addiction centre reaches out to women

3 December 2020
Snapshots on how UNAIDS is supporting the HIV response during COVID-19

2 December 2020
HIV community activists tackle COVID-19 in Lesotho

1 December 2020
In South Africa, young women leading HIV and violence prevention say men’s involvement is key

UNICEF [to 05 Dec 2020]
https://www.unicef.org/media/press-releases
Selected Press releases, Statements
Press release
12/03/2020
UNICEF issues record US$6.4 billion emergency funding appeal to reach more than 190 million children impacted by humanitarian crises and the COVID-19 pandemic
Funds will support essential programs for children and families in need across 149 countries and territories through 2021

Press release
12/01/2020
Norway commits more than $163 million to UNICEF education, health and inclusivity programmes for children

Unitaid [to 05 Dec 2020]
https://unitaid.org/
Featured News
03 December 2020
Republic of Korea contributes US$1 million to increase access to COVID-19 diagnostics
Geneva – Unitaid is pleased to announce that the Republic of Korea has contributed a US$1 million to support the Diagnostic Partnership of the Access to COVID-19 Tools Accelerator (ACT-A). This extra funding comes in addition to the core financial support provided by the Republic of Korea to Unitaid.
Effective and rapid testing strategies are crucial to ensure the COVID-19 pandemic is brought to an end. The ACT-A has identified that an estimated 500 million COVID-19 diagnostic tests will be needed in low and middle-income countries (LMICs) by mid-2021…

01 December 2020
Unitaid reaffirms its commitment to the fight against HIV in the context of the COVID-19 pandemic
This World AIDS Day 2020, Unitaid reaffirms its commitment to the fight against HIV, while calling for innovative solutions to overcome stagnating progress towards global targets and challenges presented by the COVID-19 pandemic.
Despite significant gains achieved in the fight against HIV, global targets for 2020 have been missed.
:: In 2019, there were 1.7 million new infections, with key populations accounting for 62% of new infections globally, and young women and girls accounting for 48% in sub-Saharan Africa.
:: Of the 38 million people living with HIV in 2019, 12 million individuals did not have access to treatment.
Global efforts to meet international targets were already off-track in 2019, and progress has been further derailed by the COVID-19 pandemic…

01 December 2020
Groundbreaking Agreement Reduces by 75% the Cost of HIV Treatment for Children in Low-and Middle-Income Countries
New formulation is dispersible and strawberry-flavoured, enabling the youngest children living with HIV to be treated with the best available medication
New price agreement with Viatris and Macleods will significantly lower cost for yearly paediatric HIV treatment from over $480 per child to under $120 per child[1]
Innovative partnership has accelerated development of first generic paediatric dispersible formulation of dolutegravir (DTG), the recommended first-line HIV treatment
A long-awaited HIV treatment designed specifically for children will now be available in low-and middle-income countries, thanks to a landmark agreement from Unitaid and the Clinton Health Access Initiative (CHAI)…

Vaccination Acceptance Research Network (VARN) [to 05 Dec 2020]
https://vaccineacceptance.org/news.html#header1-2r
Announcements
No new digest content identified.

Vaccine Confidence Project [to 05 Dec 2020]
http://www.vaccineconfidence.org/
Research and Reports
No new digest content identified.

Vaccine Education Center – Children’s Hospital of Philadelphia [to 05 Dec 2020]
http://www.chop.edu/centers-programs/vaccine-education-center
News
No new digest content identified.

Wellcome Trust [to 05 Dec 2020]
https://wellcome.ac.uk/news
Explainer | 2 December 2020
Seven vital questions about RNA Covid-19 vaccines
The Pfizer-BioNTech and Moderna Covid-19 vaccines are more than 90% effective, as reported in phase III clinical trials – and the Pfizer-BioNTech vaccine is the first Covid-19 vaccine to be licensed. This is a historic moment and the result of a global, collaborative research effort.

Opinion | 3 December 2020
Why we’re launching a new round of PhD funding for health professionals
Sara Marshall, Head of Clinical and Physiological Sciences, Wellcome
When research and healthcare come together, everyone benefits. That’s why we’re announcing a new call for PhD programmes to support health professionals in their research careers.

The Wistar Institute [to 05 Dec 2020]
https://www.wistar.org/news/press-releases
Press Releases
No new digest content identified.

WFPHA: World Federation of Public Health Associations [to 05 Dec 2020]
https://www.wfpha.org/
Latest News
WFPHA Supports the Proposal for the Temporary Suspension of Intellectual Property Rights for Necessary Products to Address the COVID-19 Pandemic!
The World Federation of Public Health Associations (WFPHA) has sent an open letter to the World Trade Organization (WTO), the World Health Organization (WHO), the World Intellectual Property Organization (WIPO) and the Secretary-General of the United Nations (SG-UN) to support the proposal for the temporary suspension of Intellectual Property Rights for necessary products to address the COVID-19 pandemic.

On December 9, a session of the TRIPS Council of the WTO will be held. The main discussion issue will be the proposal submitted by South Africa and India and co-sponsored by Kenya and Eswatini (formerly Swaziland) to adopt a “waiver”, a temporary suspension of intellectual property rights of applicable knowledge to combat the COVID-19 pandemic. Such a waiver would be subject to the protections available through patents, copyrights, undisclosed information projection, integrated circuits and enforcement, as provided in WTO agreements for exceptional situations such as the COVID-19 public health pandemic.

The proposal seeks to resolve the restrictions by low, lower-middle, and higher-middle income countries (as defined by The World Bank) to have timely affordable access under competitive market conditions to COVID-19 diagnostic kits, medical devices such as respirators and particularly vaccines and medicines to combat the virus. A pandemic cannot be resolved in a small number of countries.

The widest possible access internationally is required to bring the COVID-19 pandemic to an end.

World Organisation for Animal Health (OIE) [to 05 Dec 2020]
https://www.oie.int/en/for-the-media/press-releases/2020/
No new digest content identified.

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ARM [Alliance for Regenerative Medicine] [to 05 Dec 2020]
https://alliancerm.org/
Press Releases
No new digest content identified.

BIO [to 05 Dec 2020]
https://www.bio.org/press-releases
Press Releases
New Website Will Combat Vaccine Myths, Boost Public Confidence, Increase Acceptance
December 4, 2020
Public opinion polls show there is significant mistrust among the American public in the safety and efficacy of vaccines. So today, the Biotechnology Innovation Organization (BIO) announced the launch of COVIDVaccineFacts.org. As a subsidiary website of BIO, COVIDVaccineFacts.org is an educational tool that links healthcare providers and the public to scientific and evidenced-based information related to the vaccine development process. Vaccine safety, efficacy, availability, and affordability are among the topics covered on the website.
On the website, which is translated in English and Spanish, users will find answers to a number of “frequently asked questions” related to vaccine development, including:
:: What is a vaccine?
:: How are vaccines developed?
:: How is everyone moving so quickly to develop a vaccine for Covid-19?
: How will we know a Covid-19 vaccine is safe and effective?
:: When will my family and I receive a vaccine for Covid-19?
BIO will continue to update the website and add new questions in the coming months.
The text on this website has been independently reviewed by health experts. It also incorporates several visual elements to help explain concepts like herd immunity, emergency use authorization, and more…
… Click here to visit the site.

Editor’s Note:
We took a moment to use the search function on this new site and explored the following keywords: consent, mandate, refusal, hesitancy, ethics, equity, access, and allocation. There were no results.

DCVMN – Developing Country Vaccine Manufacturers Network [to 05 Dec 2020]
http://www.dcvmn.org/
News; Upcoming events
No new digest content identified.

ICBA – International Council of Biotechnology Associations [to 05 Dec 2020]
https://internationalbiotech.org/news/
News
No new digest content identified.

IFPMA [to 05 Dec 2020]
http://www.ifpma.org/resources/news-releases/
Selected Press Releases, Statements, Publications
No new digest content identified.

PhRMA [to 05 Dec 2020]
http://www.phrma.org/
Selected Press Releases, Statements
PhRMA Statement on ACIP Recommendations for COVID-19 Allocation
December 3, 2020
Pharmaceutical Research and Manufacturers of America president and CEO, Stephen J. Ubl issued the following statement on ACIP Recommendations for COVID-19 Allocation:
…“As states and territories prepare for the arrival of critically needed COVID-19 vaccines and seek to address key issues regarding priority of vaccine distribution, PhRMA supports ACIP’s prioritization of essential health care, public health industry workers and those most at risk as part of their allocation decisions.
“As we continue to fight COVID-19, we are committed to ensuring that the highest of standards of research, clinical testing and manufacturing are upheld throughout the vaccine research and development process. Our companies have further pledged ‘to make the safety and well-being of vaccinated individuals the top priority in development of the first Covid-19 vaccines.’ This commitment to safety isn’t new — it’s what the industry does day in and day out.

Guest Post: Bringing our best to the fight against COVID-19
Guest Contributor   |     December 3, 2020
…A guest post by Michel Pairet, a member of the Board of Managing Directors in charge of Innovation at Boehringer Ingelheim and Clive R. Wood, Global Head of Discovery Research:
As the world grapples with the challenge of another potentially more deadly upsurge in COVID-19 infections, we at Boehringer Ingelheim, along with the rest of the global scientific community, are digging deep into our knowledge and pipeline to find new options to combat this disease. Every statistic has a human story associated with it and it is this, together with our scientists’ deep commitment to rapidly find effective treatments to fight this devastating disease, that compels us to do everything we can to help patients who are suffering and relieve pressure on health care systems around the world…

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

American Journal of Infection Control
December 2020 Volume 48Issue 12p1415-1570
http://www.ajicjournal.org/current

Major Articles
Impact of repeated yearly vaccination on immune responses to influenza vaccine in an elderly population
Satoko Kitamura, MD et al
Highlights
:: One hundred and 11 volunteers aged >61 years were vaccinated with inactivated influenza vaccine over 5 consecutive years.
:: Hemagglutination inhibition antibody titers were determined in each of 5 consecutive years.
:: Annual vaccination is necessary to maintain humoral immunity.
:: Annual seasonal vaccination was not associated with reduced vaccine effectiveness.
:: Vaccine strain changes were associated with specific immune responses among those undergoing yearly vaccination.

American Journal of Preventive Medicine
December 2020 Volume 59Issue 6p773-914
http://www.ajpmonline.org/current

Research Articles
Human Papillomavirus Vaccination Prevalence Among Adults Aged 19–45 Years: An Analysis of the 2017 National Health Interview Survey
Monica L. Kasting, Anna R. Giuliano, Shannon M. Christy, Caroline E. Rouse, Sharon E. Robertson,
Erika L. Thompson
Published online: November 05, 2020
p837-849
This study estimates the pre-recommendation prevalence of human papillomavirus vaccination and factors associated with vaccination in 2 age groups (19–26 years [young adults] and 27–45 years [mid-adults]), forming a baseline to monitor future coverage among U.S. adults.

American Journal of Public Health
December 2020 110(12)
http://ajph.aphapublications.org/toc/ajph/current

AJPH EDITOR’S CHOICE
Climate Change and Health Justice: New Perspectives on Pressing Challenges
Environment, Climate Change, Other Environment, Writing/Reviewing/Publishing, Health Policy
Jonathan I. Levy
110(12), pp. 1718–1718

American Journal of Public Health
December 2020 110(12)
http://ajph.aphapublications.org/toc/ajph/current

COVID-19
Populist Nationalism Threatens Health and Human Rights in the COVID-19 Response
Global Health, Government, Human Rights, Social Science
Caitlin R. Williams, Jocelyn Getgen Kestenbaum and Benjamin Mason Meier
110(12), pp. 1766–1768
COVID-19 demands international cooperation, yet populist nationalism is resurgent, threatening public health, human rights, and global governance. In responding to the pandemic, populist nationalism and global solidarity represent distinct paths, with enduring consequences for health and human rights.

American Journal of Public Health
December 2020 110(12)
http://ajph.aphapublications.org/toc/ajph/current

SURVEILLANCE
COVID-19 and the Rise of Participatory SIGINT: An Examination of the Rise in Government Surveillance Through Mobile Applications
Global Health, Government, Human Rights, Social Science, Ethics
Rose Bernard, Gemma Bowsher and Richard Sullivan
110(12), pp. 1780–1785
The COVID-19 pandemic has triggered a significant growth in government surveillance techniques globally, primarily through the use of cell phone applications. However, although these applications can have actionable effects on public health efforts to control pandemics, the participatory or voluntary nature of these measures is obscuring the relationship between health information and traditional government surveillance techniques, potentially preventing effective oversight. Public health measures have traditionally been resistant to the integration of government-led intelligence techniques, such as signals intelligence (SIGINT), because of ethical and legal issues arising from the nature of surveillance techniques.
We explore this rise of participatory SIGINT and its nature as an extension of biosurveillance through 3 drivers: the rise of surveillance capitalism, the exploitation of a public health crisis to obscure state of exception politics with a moral imperative, and the historically enduring nature of emergency-implemented surveillance measures.
We conclude that although mobile applications may indeed be useful in containing pandemics, they should be subject to similar oversight and regulation as other government intelligence collection techniques.

American Journal of Public Health
December 2020 110(12)
http://ajph.aphapublications.org/toc/ajph/current

REGISTRY
Global Policy Surveillance: Creating and Using Comparative National Data on Health Law and Policy
Global Health, Health Law, Statistics/Evaluation/Research, Health Policy, Other Statistics/Evaluation/Research
Matthew M. Kavanagh, Benjamin Mason Meier, Mara Pillinger, Hanna Huffstetler and Scott Burris
Throughout the world, laws play an important role in shaping population health. Law making is an intervention with measurable effects yet often unfolds without evaluation or monitoring. Policy surveillance—the systematic, scientific collection and analysis of laws of public health significance—can help bridge this gap by capturing important features of law in numeric form in structured longitudinal data sets.
Currently deployed primarily in high-income countries, methods for cross-national policy surveillance hold significant promise, particularly given the growing quality and accessibility of global health data. Global policy surveillance can enable comparative research on the implementation and health impact of laws, their spread, and their political determinants. Greater transparency of status and trends in law supports health policy advocacy and promotes public accountability. Collecting, coding, and analyzing laws across countries presents numerous challenges—especially in low-resource settings.
With insights from comparative politics and law, we suggest methods to address those challenges. We describe how longitudinal legal data have been used in limited, but important, ways for cross-national analysis and propose incorporating global policy surveillance into core global public health practice.

American Journal of Tropical Medicine and Hygiene
Volume 103, Issue 6, December 2020
http://www.ajtmh.org/content/journals/14761645/103/6

Editorial
Opportunities for Subnational Malaria Elimination in High-Burden Countries
Kim A. Lindblade and S. Patrick Kachur
Pages: 2153–2154
https://doi.org/10.4269/ajtmh.20-1342

Annals of Internal Medicine
1 December 2020 Volume 173, Issue 11
http://annals.org/aim/issue

Original Research
Prevalence of Human Papillomavirus and Estimation of Human Papillomavirus Vaccine Effectiveness in Thimphu, Bhutan, in 2011–2012 and 2018 A Cross-sectional Study
Iacopo Baussano, MD, Ugyen Tshomo, MD, Vanessa Tenet, MSc, Daniëlle A.M. Heideman, PhD, … et al.
In 2010, Bhutan implemented a nationwide human papillomavirus (HPV) vaccination program targeting girls aged 12 to 18 years. This analysis examined the prevalence of HPV in 2011–2012 and 2018 and estimated vaccine effectiveness by using data from a single city.

Annals of Internal Medicine
1 December 2020 Volume 173, Issue 11
http://annals.org/aim/issue

Editorials
Human Papillomavirus Immunization and the Elimination of Cervical Carcinoma
Timothy Palmer, MBBS and Kate Cuschieri, BSc, PhD
Baussano and colleagues described how an HPV immunization program in Bhutan is helping to achieve the World Health Organization’s goal of eliminating cervical cancer. The editorialists discuss what other countries must do to achieve the level of HPV vaccine uptake needed to eliminate cervical cancer.

BMC Health Services Research
http://www.biomedcentral.com/bmchealthservres/content
(Accessed 05 Dec 2020)

Barriers and facilitators of clinician and researcher collaborations: a qualitative study
The poor translation of research findings into routine clinical practice is common in all areas of healthcare. Having a better understanding of how researchers and clinicians experience engagement in and with research, their working relationships and expectations of each other, may be one way to help to facilitate collaborative partnerships and therefore increase successful translation of research into clinical practice.
Authors: Julie Williams, Tom J. Craig and Debbie Robson
Citation: BMC Health Services Research 2020 20:1126
Content type: Research article
Published on: 5 December 2020

BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles
(Accessed 05 Dec 2020)

Comparative analysis of COVID-19 guidelines from six countries: a qualitative study on the US, China, South Korea, the UK, Brazil, and Haiti
In late January, a worldwide crisis known as COVID-19 was declared a Public Health Emergency of International Concern by the WHO. Within only a few weeks, the outbreak took on pandemic proportions, affecting o…
Authors: Ji Youn Yoo, Samia Valeria Ozorio Dutra, Dany Fanfan, Sarah Sniffen, Hao Wang, Jamile Siddiqui, Hyo-Suk Song, Sung Hwan Bang, Dong Eun Kim, Shihoon Kim and Maureen Groer
Citation: BMC Public Health 2020 20:1853
Content type: Research article
Published on: 3 December 2020

BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles
(Accessed 05 Dec 2020)

Complete basic childhood vaccination and associated factors among children aged 12–23 months in East Africa: a multilevel analysis of recent demographic and health surveys
Complete childhood vaccination remains poor in Sub-Saharan Africa, despite major improvement in childhood vaccination coverage worldwide. Globally, an estimated 2.5 million children die annually from vaccine-p…
Authors: Getayeneh Antehunegn Tesema, Zemenu Tadesse Tessema, Koku Sisay Tamirat and Achamyeleh Birhanu Teshale
Citation: BMC Public Health 2020 20:1837
Content type: Research article
Published on: 1 December 2020

BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles
(Accessed 05 Dec 2020)

Improvement of Parent’s awareness, knowledge, perception, and acceptability of human papillomavirus vaccination after a structured-educational intervention
Regardless of the disease burden of human papillomavirus (HPV), the vaccine has not been included in the Indonesia National Immunization Program. Since 2017 there was a demonstration program of the HPV vaccina…
Authors: Mei Neni Sitaresmi, Nisrina Maulida Rozanti, Lamria Besty Simangunsong and Abdul Wahab
Citation: BMC Public Health 2020 20:1836
Content type: Research article
Published on: 1 December 2020

Bulletin of the World Health Organization
Volume 98, Number 12, December 2020, 821-908
https://www.who.int/bulletin/volumes/98/12/en/

EDITORIALS
A research and development fund for new treatments for bacterial infections
— Peter Beyer, Thomas B Cueni, Jeremy Knox & Felicitas Riedl
http://dx.doi.org/10.2471/BLT.20.282004

Bulletin of the World Health Organization
Volume 98, Number 12, December 2020, 821-908
https://www.who.int/bulletin/volumes/98/12/en/

Social, cultural and economic aspects of antimicrobial resistance
— Timo Minssen, Kevin Outterson, Susan Rogers Van Katwyk, Pedro Henrique D Batista, Clare I R Chandler, Francesco Ciabuschi, Stephan Harbarth, Aaron S Kesselheim, Ramanan Laxminarayan, Kathleen Liddell, Michael T Osterholm, Lance Price & Steven J Hoffman
http://dx.doi.org/10.2471/BLT.20.275875

Contemporary Clinical Trials
Volume 98 November 2020
https://www.sciencedirect.com/journal/contemporary-clinical-trials/vol/98/suppl/C

Research article Full text access
Data monitoring committees for clinical trials evaluating treatments of COVID-19
Tobias Mütze, Tim Friede
Article 106154

Expert Review of Vaccines
Vol 19 (109) 2020
https://www.tandfonline.com/toc/ierv20/current

Editorial
How can a global pandemic affect vaccine hesitancy?
Eve Dubé & Noni E MacDonald
Pages: 899-901
Published online: 05 Oct 2020

Expert Review of Vaccines
Vol 19 (109) 2020
https://www.tandfonline.com/toc/ierv20/current

Review
Potential effects of vaccinations on the prevention of COVID-19: rationale, clinical evidence, risks, and public health considerations
Janet Sultana , Giampiero Mazzaglia , Nicoletta Luxi , Antonino Cancellieri , Annalisa Capuano , Carmen Ferrajolo , Chiara de Waure , Guido Ferlazzo & Gianluca Trifirò
Pages: 919-936
Published online: 06 Oct 2020