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

National Health Commission of the People’s Republic of China [to 16 Jan 2021]
http://en.nhc.gov.cn/
News
WHO team for virus origin-tracing arrives in Wuhan
2021-01-15
An international expert team from the World Health Organization arrived in Wuhan, Hubei province, on Jan 14 to work with its Chinese counterparts on origin-tracing and scientific research of the novel coronavirus.
The team landed at Wuhan Tianhe International Airport on Thursday morning, where they received throat swab and serum antibody tests for the coronavirus before going into a 14-day quarantine, according to China Global Television Network.
Foreign Ministry spokesman Zhao Lijian said at a regular news briefing in Beijing on Thursday that, during their quarantine, the WHO experts will have exchanges via video link with Chinese scientists and medical experts.
All of the team members had multiple tests for COVID-19 in their home countries before traveling.
The WHO confirmed the arrival of the international team of 13 scientists in Wuhan in a post on social media, which also said that another two scientists are still in Singapore to be retested after they tested positive for antibodies associated with COVID-19…

China to expand COVID-19 vaccination to include people aged over 60
2021-01-14

COVID-19 vaccine safe, effective, official says
2021-01-11
[See COVID – CHINA above for detail]

China’s COVID-19 vaccine found capable of neutralizing UK strain
2021-01-11
[See COVID – CHINA above for detail]

National Medical Products Administration [to 16 Jan 2021]
http://english.nmpa.gov.cn/news.html
News
Chinese mainland reports 135 new locally transmitted COVID-19 cases
2021-01-15
The Chinese mainland on Jan 14 reported 144 newly confirmed COVID-19 cases, of whom 135 were locally transmitted and the rest arrived from outside the mainland, the National Health Commission said on Jan 15.

Public likely to receive vaccines in February
2021-01-14
Vaccinations for the general public against COVID-19 are expected to start around Spring Festival, which begins on Feb 12, China’s health authorities said.

WHO team working with Chinese vaccine producers ahead of potential emergency use: WHO director-general
2021-01-13
[See COVID – CHINA above for detail]

Organization Announcements

Paul G. Allen Frontiers Group [to 16 Jan 2021]
https://alleninstitute.org/what-we-do/frontiers-group/news-press/
News
No new digest content identified.

BARDA – U.S. Department of HHS [to 16 Jan 2021]
https://www.phe.gov/about/barda/Pages/default.aspx
BARDA News
January 12, 2021: HHS, DOD purchase additional doses of Regeneron’s antibody therapeutic to treat patients with mild to moderate COVID-19

January 11, 2021: HHS Launches Web-Based Locator for COVID-19 Outpatient Treatment Sites for Monoclonal Antibodies

BMGF – Gates Foundation [to 16 Jan 2021]
http://www.gatesfoundation.org/Media-Center/Press-Releases
Press Releases and Statements
No new digest content identified.

Bill & Melinda Gates Medical Research Institute [to 16 Jan 2021]
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 16 Jan 2021]
https://carb-x.org/
News
No new digest content identified.

Center for Vaccine Ethics and Policy – GE2P2 Global Foundation [to 16 Jan 2021]
https://centerforvaccineethicsandpolicy.net/
News/Analysis/Statements
No new digest content identified.

CEPI – Coalition for Epidemic Preparedness Innovations [to 16 Jan 2021]
http://cepi.net/
Latest News
The importance of blood markers in assessing vaccine efficacy
13 Jan 2021
By Mario Christodoulou

EDCTP [to 16 Jan 2021]
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
13 January 2021
Public consultation: Global Roadmap for research and development for TB vaccines
EDCTP has commissioned the Amsterdam Institute for Global Health and Development (AIGHD) to develop a Global Roadmap for research and development for tuberculosis (TB) vaccines. The Roadmap intents to provide global stakeholders such as researchers, funders, industry, regulatory and policy decision makers with key actionable priorities that could help guide their actions. It lists both the short-term objectives as well as the long-term strategic objectives for global TB vaccine development, and focuses on developing and delivering affordable and effective vaccines for use in low- and middle-income countries where the vast majority of people affected by TB are concentrated.

AIGHD and EDCTP invite researchers and stakeholders, as well as everyone who has been involved in the roadmap development process to respond to a public consultation and express their views on aspects of the draft Roadmap before a final version is published.

This is part of the process for developing this Roadmap, which consists of several steps:
:: Desk review and stakeholder inventory
:: In-depth interviews with selected stakeholders
:: A consensus workshop and various rounds of stakeholder consultation on the subsequent draft versions of the Roadmap.

These rounds of consultation included both targeted requests for feedback to selected stakeholders and the current public consultation. The contributions will be published on the AIGHD website (in cases consent was provided) and will be used to complete the final version of the Roadmap.

Draft Roadmap and online form
Draft global roadmap for research and development for tuberculosis vaccines (PDF)
Background document which summarizes the state-of-the-art in research and development for new vaccines for tuberculosis for a TB Vaccine Research & Development Roadmap (PDF).
Contribute to this consultation by filling in the on-line survey.

Emory Vaccine Center [to 16 Jan 2021]
http://www.vaccines.emory.edu/
Vaccine Center News
No new digest content identified.

European Medicines Agency [to 16 Jan 2021]
http://www.ema.europa.eu/ema/
News & Press Releases
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 January 2021
News 15/01/2021
First monthly summary safety report for COVID-19 vaccine Comirnaty
[See COVID – EMA above for detail]

News: EMA receives application for conditional marketing authorisation of COVID-19 Vaccine AstraZeneca
Last updated: 12/01/2021

European Vaccine Initiative [to 16 Jan 2021]
http://www.euvaccine.eu/
Latest News
McKinsey & Company awarded subcontract by EVI
13 Jan 2021
The European Vaccine Initiative (EVI) has selected McKinsey & Company to develop a business plan, including suitable governance structure and financing strategy, that can guide the establishment of a sustainable infrastructure for European vaccine research. Subcontracting McKinsey & Company adds valuable business experience and will be advantageous to the conceptual and technical design of a European vaccine infrastructure. The sub-contract is awarded as part of the project TRANSVAC-DS, Design study for a European vaccine infrastructure, which is funded by the European Commission and comprises a consortium of twenty-five partners from eleven European countries and includes leading academic and other organisations working in areas related to vaccine development…

FDA [to 16 Jan 2021]
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
Press Announcements /Selected Details
January 15, 2021 – Coronavirus (COVID-19) Update: January 15, 2021
:: Today, the FDA issued and immediately implemented a new guidance entitled, “Protecting Participants in Bioequivalence Studies for Abbreviated New Drug Applications During the COVID-19 Public Health Emergency.” This guidance assists prospective applicants of abbreviated new drug applications (ANDAs) on ensuring participants are protected when resuming or initiating bioequivalence studies conducted to support the approval of an ANDA that has been disrupted during the COVID-19 public health emergency.

January 12, 2021 – FDA Releases Artificial Intelligence/Machine Learning Action Plan
“This action plan outlines the FDA’s next steps towards furthering oversight for AI/ML-based SaMD,” said Bakul Patel, director of the Digital Health Center of Excellence in the Center for Devices and Radiological Health (CDRH). “The plan outlines a holistic approach based on total product lifecycle oversight to further the enormous potential that these technologies have to improve patient care while delivering safe and effective software functionality that improves the quality of care that patients receive. To stay current and address patient safety and improve access to these promising technologies, we anticipate that this action plan will continue to evolve over time.”

FDA – COVID-19 Vaccines [to 16 Jan 2021]
www.fda.gov/covid19vaccines
News and Updates; Upcoming Events
I’m a disabled woman of color. Here’s how I overcame my fear of receiving a COVID vaccineExternal Link Disclaimer
An FDA staff member discusses how her former hesitancy and fear grew into hope and a willingness to receive a COVID-19 vaccine.
01/14/2021

Fondation Merieux [to 16 Jan 2021]
http://www.fondation-merieux.org/
News, Events
Mérieux Foundation co-organized event
ADVA – Managing the severely ill dengue patients: adults & children
January 20, 2021 – 12:00pm – 3:30pm (CET) Webinar
Register
Context
Co-organized by Asia Dengue Voice & Action Group (ADVA), GDAC, Mérieux Foundation, ISNTD and SEAMEO in support of the 5th Asia Dengue Summit, this webinar is the first in a series titled “Decimate Dengue: The 5th ADS Pre-Summit Webinars”, aimed at bridging the dengue healthcare and research communities via an online platform that allows for closer interaction, learning and adoption of the latest dengue management strategies in the run-up to the 5th Asia Dengue Summit 2022.

Gavi [to 16 Jan 2021]
https://www.gavi.org/
News releases
500,000 doses of Ebola vaccine to be made available to countries for outbreak response
12 Jan 2021
:: A Gavi-funded global emergency stockpile of Ebola vaccines will be accessible to all countries following a procurement process concluded by UNICEF
:: Seth Berkley: “The accelerated development of the Ebola vaccine was possible thanks to a first-of-its-kind agreement between Gavi and the vaccine manufacturer, which set a precedent for fast-tracking development and production of vaccines against COVID-19”
:: The new Ebola vaccine played an important role in ending the Ebola outbreak in the eastern part of the Democratic Republic of the Congo (DRC), which was officially declared over in June last year. The stockpile is an example of how Gavi, the Vaccine Alliance and UNICEF are strengthening the world’s defenses against potentially devastating infectious disease outbreaks

GHIT Fund [to 16 Jan 2021]
https://www.ghitfund.org/newsroom/press
GHIT was set up in 212 with the aim of developing new tools to tackle infectious diseases that
Press Releases
No new digest content identified.

Global Fund [to 16 Jan 2021]
https://www.theglobalfund.org/en/news/
News
Global Fund signs a record-breaking $8.54 billion in grants to fight HIV, TB and malaria
12 January 2021
In 2020, the Global Fund signed 157 grants for a total of US$8.54 billion for lifesaving HIV, TB and malaria programs and to strengthen systems for health. This is the highest amount of grants ever signed in a single year by the Global Fund. The grants will begin implementation this month.

Global Research Collaboration for Infectious Disease Preparedness [GloPID-R] [to 16 Jan 2021]
https://www.glopid-r.org/news/
News
No new digest content identified.

Hilleman Laboratories [to 16 Jan 2021]
http://www.hillemanlabs.org/
No new digest content identified.

Human Vaccines Project [to 16 Jan 2021]
http://www.humanvaccinesproject.org/media/press-releases/
Press Releases
HVP COVID Report
Issue 24: Can Changing COVID Vaccine Regimens End the Pandemic Faster?
Jan 15, 2021
…Recently, there was also discussion among U.S. scientists and the company Moderna about cutting the two doses of their mRNA vaccine in half for people ages 18-55 in an effort to double the available doses. This suggestion was based on data from earlier stage clinical trials of this vaccine.
For now, the U.S. Food and Drug Administration (FDA) is opposed to any changes to the dosing regimens. In a statement issued on January 4th, the agency, which granted an Emergency Use Authorization to both the Pfizer/BioNtech and Moderna mRNA COVID-19 vaccines in December, said that altering the dose, reducing the number of doses, or extending the time between doses of these vaccines are reasonable questions to consider and evaluate in clinical trials. “However, at this time, suggesting changes to the FDA-authorized dosing or schedules of these vaccines is premature and not rooted solidly in available evidence.” The AstraZeneca vaccine has not been submitted to the FDA yet for authorization, however, it was authorized already in the U.K., India, and other countries.
But others argue that these strategies to free up more vaccine are warranted given the terrifying course of the pandemic. “As long as there is a shortage of vaccine, protection of the largest number of people against death and disability in the shortest time should take priority over formalism and insufficiency of conclusive data,” says Stanley Plotkin, veteran vaccine developer, Emeritus Professor of Pediatrics at the University of Pennsylvania, and founding board chair of the Human Vaccines Project. “This is an emergency, not a time to stick to routine rules.”
Furthermore, Plotkin argues that there is actually an immunological benefit to delaying vaccine doses. “The optional delay for non-live vaccines is four to six months,” he says…

IAVI [to 16 Jan 2021]
https://www.iavi.org/newsroom
PRESS RELEASES/FEATURES
No new digest content identified.

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

International Generic and Biosimilar Medicines Association [IGBA]
https://www.igbamedicines.org/
News
Sudarshan Jain takes over the position of IGBA Chair (January 2021)
Geneva, 11 January 2021 – IGBA, the International Generic and Biosimilar Medicines Association (IGBA), representing global manufacturers of generic and biosimilar medicines, announced today that Sudarshan Jain, Secretary General of the Indian Pharmaceutical Alliance (IPA), is taking over the position of IGBA Chair for 2021 from Hanan Sboul, Secretary General of the Jordanian Association of Pharmaceutical Manufacturers.

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

IFRC [to 16 Jan 2021]
http://media.ifrc.org/ifrc/news/press-releases/
Selected Press Releases, Announcements
Americas, Honduras
Red Cross: Providing services and protection to migrants in Central America is a humanitarian imperative
Panama/Geneva, 15 January 2021 – The Red Cross is preparing to provide humanitarian assistance to migrants ready to depart Honduras for Guatemala as part of a ‘migrant caravan’. More than 4,000 thousand people are expected to join the caravan that will …
15 January 2021

Armenia, Azerbaijan, Europe, Georgia
New study finds coronavirus has left older people poorer, sicker and more alone
Budapest/Geneva, 13 January 2021 – The COVID-19 pandemic is having catastrophic health, social and financial impacts on older people in Europe’s South Caucasus region, according to a new study led by the International Federation of Red Cross and Red Cr …
13 January 2021

Global
UNICEF, WHO, IFRC and MSF announce the establishment of a global Ebola vaccine stockpile
NEW YORK/ GENEVA, 12 JANUARY 2021: The four leading international health and humanitarian organizations announced today the establishment of a global Ebola vaccine stockpile to ensure outbreak response. The effort to establish the stockpile was led by …
12 January 2021

Global
COVID-19: Vaccines alone will not end pandemic, warns IFRC
Geneva, 11 January 2021 – With COVID-19 vaccines rolling out across many countries, the world’s largest humanitarian network is once again warning that vaccines alone will not end the pandemic. People need to remain vigilant and continue to adhere to b …
… Emanuele Capobianco, IFRC’s Director of Health, said: “We are very concerned about this convergence of a potential false sense of security due to the rollout of vaccines, the emergence of new variants, and the impact of holiday-season travel. Our first line of defence against the virus remains our individual behaviour. Beyond this, the ability of Governments to take swift actions based on scientific evidence is also key to slowing down the pandemic. “Vaccines will help, but unless we all remain vigilant, and unless their deployment is accelerated across the world in a fair and equitable manner, the entire world remains at risk.”

Institut Pasteur [to 16 Jan 2021]
https://www.pasteur.fr/en/press-area
Press documents
No new digest content identified.

IRC International Rescue Committee [to 16 Jan 2021]
http://www.rescue.org/press-release-index
Media highlights [Selected]
Press Release
Billions will not receive a COVID-19 vaccine in 2021
January 12, 2021
:: Shortages of COVID-19 vaccines, coupled with vaccine nationalism, means the majority of people in crisis and conflict-affected contexts will not receive a COVID-19 vaccine this year.
:: Investments must be made immediately to strengthen health systems, including shoring up supply chains, allocating sustainable and adequate financing, and empowering community and frontline health workers to ensure no one is left behind.
:: Efforts must also be focused on continuing routine immunizations – in addition to preparation for the COVID-19 vaccines – to protect hard-won gains and avoid the spread of other vaccine-preventable disease outbreaks.

Press Release
24 million Yemenis at catastrophic humanitarian risk following new U.S. terrorist designations of Ansar Allah, warns IRC
January 11, 2021

IVAC [to 16 Jan 2021]
https://www.jhsph.edu/research/centers-and-institutes/ivac/index.html
Updates; Events
No new digest content identified.

IVI [to 16 Jan 2021]
http://www.ivi.int/
Selected IVI News, Announcements, Events
No new digest content identified.

JEE Alliance [to 16 Jan 2021]
https://www.jeealliance.org/
Selected News and Events
No new digest content identified.

Johns Hopkins Center for Health Security [to 16 Jan 2021]
https://www.centerforhealthsecurity.org/news/center-news/
Center News
No new digest content identified.

MSF/Médecins Sans Frontières [to 16 Jan 2021]
http://www.msf.org/
Latest [Selected Announcements]
CENTRAL AFRICAN REPUBLIC
MSF teams ramp up support as violence escalates
PROJECT UPDATE14 JAN 2021

ETHIOPIA
Providing assistance to people in Ethiopia and Sudan in wake of Tigray violence
PROJECT UPDATE12 JAN 2021

SWITZERLAND
Responding to the second wave of COVID-19 in Switzerland
PROJECT UPDATE11 JAN 2021

National Vaccine Program Office – U.S. HHS [to 16 Jan 2021]
https://www.hhs.gov/vaccines/about/index.html
Upcoming Meetings/Latest Updates
No new digest content identified.

NIH [to 16 Jan 2021]
http://www.nih.gov/news-events/news-releases
News Releases
NIH scientists identify nutrient that helps prevent bacterial infection
January 15, 2021 — Taurine, which helps the body digest fats and oils, could offer treatment benefit.

PATH [to 16 Jan 2021]
https://www.path.org/media-center/
Press Release
No new digest content identified

Sabin Vaccine Institute [to 16 Jan 2021]
http://www.sabin.org/updates/pressreleases
Statements and Press Releases
Sabin Vaccine Institute Funds Researchers to Investigate COVID-19 Misinformation, Design Solutions to Increase Vaccine Acceptance
Wednesday, January 13, 2021
, D.C. – The Sabin Vaccine Institute (Sabin) announced today that it has awarded grants to research teams in four countries to explore the social drivers of COVID-19 misinformation, and its impact on routine immunization acceptance and the acceptance of a COVID-19 vaccine.
The grants are part of Sabin’s Social and Behavioral Interventions for Vaccination Acceptance Small Grants Program, which provides funding to researchers in low- and middle-income countries to better understand the social drivers of vaccination and design small-scale interventions to assess their impact on vaccination acceptance.
Five research teams in India, Kenya, Pakistan and Uganda will receive up to $30,000 to conduct this research and pilot a small-scale intervention in their respective communities over a period of 10 months…

UNAIDS [to 16 Jan 2021]
http://www.unaids.org/en
Selected Press Releases/Reports/Statements
12 January 2021
Vulnerability mapping to help sex workers in Bangladesh and Myanmar

11 January 2021
Attaining UNAIDS’ proposed societal and legal barrier targets could stop 440 000 AIDS-related deaths

UNICEF [to 16 Jan 2021]
https://www.unicef.org/media/press-releases
Selected Press releases, Statements
Statement  01/12/2021
Children cannot afford another year of school disruption
Statement by UNICEF Executive Director Henrietta Fore

Press release  01/11/2021
UNICEF, WHO, IFRC and MSF announce the establishment of a global Ebola vaccine stockpile
[See Milestones above for detail]

Unitaid [to 16 Jan 2021]
https://unitaid.org/
Featured News
12 JANUARY 2021
Unitaid funding sees launch of world’s first long-acting medicines centre at University of Liverpool
Geneva – Efforts to revolutionise treatments for debilitating infectious diseases have been amplified today with the launch of a new research centre at the University of Liverpool.
Established as part of a US$40 million international research consortium, primarily funded by Unitaid, the University of Liverpool’s Centre of Excellence for Long-acting Therapeutics (CELT) will be the first of its kind in the world.
By repurposing existing medicines into slow-release formulations, where drug effectiveness can be sustained over several months, ‘long-acting’ technology has already been successfully implemented in the fields of contraception and schizophrenia.
It now has the potential to improve the outcomes for treatment and prevention of deadly diseases such as HIV, malaria, Hepatitis C and tuberculosis, which particularly impact low- and middle-income countries.
Current treatment courses for these conditions have often resulted in poor outcomes in low-resource environments, as those living with diseases struggle with regimens that can involve taking dozens of tablets every day and rely on regular access to healthcare settings.
CELT’s mission is to broaden knowledge of long-acting medicines and disseminate key research, with the aim of revolutionising how these devastating diseases are treated, particularly in countries where access to healthcare is challenging…

Vaccination Acceptance Research Network (VARN) [to 16 Jan 2021]
https://vaccineacceptance.org/news.html#header1-2r
Announcements
No new digest content identified.

Vaccine Confidence Project [to 16 Jan 2021]
http://www.vaccineconfidence.org/
News, Research and Reports
15 Jan 2021
CONVINCE (COVID New Vaccine Information, Communication and Engagement)
Vaccine Literacy: Building Public Support for a COVID-19 vaccine
Call to Action from Wilton Park, City University of New York (CUNY) Graduate School of Public Health & Health Policy and the Vaccine Confidence Project at the London School of Hygiene and Tropical Medicine
Effective communication to prepare a ‘vaccine literate’ public and persuade policymakers to trust the science and embrace new vaccines for COVID-19 as they become available must begin now.
To ensure a COVID-19 vaccine is accepted, we must invest in:
:: a multi-sectoral commitment to develop trust in vaccines
:: preparation of accurate and convincing information sources about vaccines
:: innovative multi-media and interpersonal approaches to communicate and engage with all audiences..

Vaccine Education Center – Children’s Hospital of Philadelphia [to 16 Jan 2021]
http://www.chop.edu/centers-programs/vaccine-education-center
News
No new digest content identified.

Wellcome Trust [to 16 Jan 2021]
https://wellcome.ac.uk/news
News
Explainer | 13 January 2021
What drugs are working as treatments for Covid-19?
From existing antivirals to new antibody therapies – researchers are working at incredible speed to find the best drugs to treat Covid-19.

The Wistar Institute [to 16 Jan 2021]
https://www.wistar.org/news/press-releases
Press Releases
Jan. 13, 2021
New Insights Into the Control of Inflammation 
The EGR1 transcription factor has distinct roles in early and late macrophage maturation stages, blunting macrophage activation and inflammation.

Press Release 
Jan. 12, 2021
Wistar Researchers Develop New Humanized Mouse Model That Provides Insight Into Immunotherapy Resistance
Tumor-infiltrating mast cells are connected to immune checkpoint inhibitor resistance in melanoma.

Press Release 
Jan. 11, 2021
Wistar Scientists Discover Link Between a Genetic Driver of Ovarian Cancer and Metabolism, Opening the Way for New Therapeutic Strategies
Loss of ARID1A causes increased glutamine metabolism, which can be blocked pharmacologically to target ARID1A-mutant tumors.

WFPHA: World Federation of Public Health Associations [to 16 Jan 2021]
https://www.wfpha.org/
Latest News
Norwegian Perspectives on Immunization: A Positive Response to Public Health Advocacy during COVID-19
Jan 14, 2021
Throughout the COVID-19 pandemic, health inequity has become increasingly apparent. The public health workforce has rapidly mobilized to advocate…

Building Confidence in COVID-19 Vaccination
Jan 13, 2021
The COVID-19 vaccines bring the promise of a global rescue from the coronavirus pandemic; however, building people’s confidence in these new vaccines seems to be a herculean task. Myths and misinformation…

World Organisation for Animal Health (OIE) [to 16 Jan 2021]
https://www.oie.int/en/for-the-media/press-releases/2021/
No new digest content identified.

::::::

ARM [Alliance for Regenerative Medicine] [to 16 Jan 2021]
Press Releases – Alliance for Regenerative Medicine (alliancerm.org)
Press Releases
No new digest content identified.

BIO [to 16 Jan 2021]
https://www.bio.org/press-releases
Press Releases
BIO Releases Statement Concerning Future Political Giving
January 11, 2021
Dr. Michelle McMurry-Heath, president and CEO of the Biotechnology Innovation Organization (BIO), released the following statement on BIO’s political contributions:   “As of today BIO will be pausing our political giving so we can…

DCVMN – Developing Country Vaccine Manufacturers Network [to 16 Jan 2021]
http://www.dcvmn.org/
News; Upcoming events
No new digest content identified.

ICBA – International Council of Biotechnology Associations [to 16 Jan 2021]
https://internationalbiotech.org/news/
News
No new digest content identified.

IFPMA [to 16 Jan 2021]
http://www.ifpma.org/resources/news-releases/
Selected Press Releases, Statements, Publications
Innovative biopharmaceutical industry comment on COVID-19 vaccines dosing strategies and recommend following the science
13 January 2021
[See COVID above for full text]

Speak Up Africa and IFPMA start their search for winners of the Africa Young Innovators
12 January 2021

Pharma innovation delivers COVID-19 solutions beyond expectations, but calls for the dilution of intellectual property
08 December 2020
…despite a lack of any evidence, there have been claims that intellectual property (IP) rights are hindering the response to the pandemic. A waiver proposal currently being discussed by the World Trade Organization (WTO) is looking to suspend Member States’ obligations to protect innovator’s intellectual property assets that are critical to tackle the COVID-19 pandemic. In view of the progress made so far in providing COVID-19 solutions and the partnerships in place to boost research and scale-up manufacturing of vaccines and treatments, diluting national and international IP frameworks during this pandemic is counterproductive. It will not lead to faster research and development or access, but it will undermine confidence in what has proven to be a well-functioning IP system, allowing industry to partner with confidence with academia, research institutes, foundations and other private companies, significantly expediting the research and development of medicines to address the worlds’ many unmet medical needs…

PhRMA [to 16 Jan 2021]
http://www.phrma.org/
Selected Press Releases, Statements
Innovative Biopharmaceutical Industry Comment on COVID-19 Vaccines Dosing Strategies and Recommend Following the Science
January 13, 2021
This statement on COVID-19 vaccine dosing strategies was issued by the Pharmaceutical Research and Manufacturers of America (PhRMA), the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA),  the International Council of Biotech Associations (ICBA), the Biotechnology Innovation Organization (BIO), the European Federation of Pharmaceutical Industries and Associations (EFPIA) and Vaccines Europe.
PRESS RELEASE
[See COVID above for full text]

PhRMA Statement on Political Giving
January 12, 2021
Pharmaceutical Research and Manufacturers of America (PhRMA) president and CEO Stephen J. Ubl released the following statement regarding violent protests in Washington D.C. and the organization’s decision on political giving.
PRESS RELEASE

Paper finds gaps in health data are a barrier to health equity
January 11, 2021
COVID-19 has laid bare racial disparities in the United States health system. For example, COVID-19 cases among Native Hawaiian/Pacific Islanders are up to 2.5 times higher as compared to whites. Similarly, the rate of COVID-19 related deaths among Black Americans and American Indian/Alaskan Natives are twice as high as whites. A recent PhRMA paper finds that gaps in information on race, ethnicity and health are barriers to achieving health equity for many groups…
PhRMA has decided to address these issues head on and will support others willing to do the same. Read our first paper in the series, “Gaps in Available Data Exacerbate Health Disparities and Create Barriers to Change.”
Emily Donald
BLOG POST

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 Public Health
February 2021 111(2)
http://ajph.aphapublications.org/toc/ajph/current

PERSPECTIVES
The Need for Novel Approaches in Assessing the Value of COVID-19 Vaccines
Immunization/Vaccines, Social Science, Socioeconomic Factors, Statistics/Evaluation/Research, Health Policy, Other Statistics/Evaluation/Research
Aris Angelis, Rob Baltussen and Tommi Tervonen
111(2), pp. 205–208

Health Affairs
Vol. 40, No. 1 January 2021
https://www.healthaffairs.org/toc/hlthaff/current

COVID-19 Response, Medicaid & More
Analysis
An Overview Of Vaccine Development, Approval, And Regulation, With Implications For COVID-19
Aaron S. Kesselheim, Jonathan J. Darrow, Martin Kulldorff, Beatrice L. Brown, Mayookha Mitra-Majumdar, ChangWon C. Lee, Osman Moneer, and Jerry Avorn
Abstract
The Food and Drug Administration (FDA) approves vaccines when their benefits outweigh the risks for their intended use. In this article we review the standard FDA approach to vaccine evaluation, which underpins its current approaches to assessment of vaccines to prevent coronavirus disease 2019 (COVID-19). The FDA has established pathways to accelerate vaccine availability before approval, such as Emergency Use Authorization, and to channel resources to high-priority products and allow more flexibility in the evidence required for approval, including accelerated approval based on surrogate markers of effectiveness. Among the thirty-five new vaccines approved in the US from 2006 through October 2020, about two-thirds of their pivotal trials used the surrogate outcome of immune system response, and only one-third evaluated actual disease incidence. Postapproval safety surveillance of new vaccines, and particularly vaccines receiving expedited approval, is crucial. This has generally been accomplished through such mechanisms as the Centers for Disease Control and Prevention (CDC) and FDA Vaccine Adverse Event Reporting System, the CDC Vaccine Safety Datalink, and the CDC Clinical Immunization Safety Assessment Project. Adverse events detected in this way may lead to changes in a vaccine’s recommended use or withdrawal from the market. Regulatory oversight of new vaccines must balance speed with rigor to effectively address the pandemic.

Health Affairs
Vol. 40, No. 1 January 2021
https://www.healthaffairs.org/toc/hlthaff/current

Analysis COVID-19
COVID-19 Vaccine To Vaccination: Why Leaders Must Invest In Delivery Strategies Now
Rebecca L. Weintraub, Laura Subramanian, Ami Karlage, Iman Ahmad, and Julie Rosenberg
Free Access
Abstract
Worldwide, leaders are implementing nonpharmaceutical interventions to slow transmission of the novel coronavirus while pursuing vaccines that confer immunity to severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection. In this article we describe lessons learned from past pandemics and vaccine campaigns about the path to successful vaccine delivery. The historical record suggests that to have a widely immunized population, leaders must invest in evidence-based vaccine delivery strategies that generate demand, allocate and distribute vaccines, and verify coverage. To generate demand, there must be an understanding of the roots of vaccine hesitancy, involvement of trusted sources of authority in advocacy for vaccination, and commitment to longitudinal engagement with communities. To allocate vaccines, qualified organizations and expert coalitions must be allowed to determine evidence-based vaccination approaches and generate the political will to ensure the cooperation of local and national governments. To distribute vaccines, the people and organizations with expertise in manufacturing, supply chains, and last-mile distribution must be positioned to direct efforts. To verify vaccine coverage, vaccination tracking systems that are portable, interoperable, and secure must be identified. Lessons of past pandemics suggest that nations should invest in evidence-informed strategies to ensure that coronavirus disease 2019 (COVID-19) vaccines protect individuals, suppress transmission, and minimize disruption to health services and livelihoods.

Health Affairs
Vol. 40, No. 1 January 2021
https://www.healthaffairs.org/toc/hlthaff/current

Research Article COVID-19
Clinical Outcomes Of A COVID-19 Vaccine: Implementation Over Efficacy
A. David Paltiel, Jason L. Schwartz, Amy Zheng, and Rochelle P. Walensky
Free Access
Abstract
The global effort to develop a coronavirus disease 2019 (COVID-19) vaccine is on track to produce one or more authorized vaccines. We examine how different definitions and thresholds of vaccine efficacy, coupled with different levels of implementation effectiveness and background epidemic severity, translate into outcomes including cumulative infections, hospitalizations, and deaths. Using a mathematical simulation of vaccination, we find that factors related to implementation will contribute more to the success of vaccination programs than a vaccine’s efficacy as determined in clinical trials. The benefits of a vaccine will decline substantially in the event of manufacturing or deployment delays, significant vaccine hesitancy, or greater epidemic severity. Our findings demonstrate the urgent need for health officials to invest greater financial resources and attention to vaccine production and distribution programs, to redouble efforts to promote public confidence in COVID-19 vaccines, and to encourage continued adherence to other mitigation approaches, even after a vaccine becomes available.

Health Affairs
Vol. 40, No. 1 January 2021
https://www.healthaffairs.org/toc/hlthaff/current

Analysis COVID-19
Consideration Of Value-Based Pricing For Treatments And Vaccines Is Important, Even In The COVID-19 Pandemic
Peter J. Neumann, Joshua T. Cohen, David D. Kim, and Daniel A. Ollendorf
Free Access
Abstract
Prices send signals about consumer preferences and thus stimulate producers to make more of what people want. Pricing in a pandemic is complicated and fraught. The policy puzzle involves balancing lower prices to ensure access to essential medications, vaccines, and tests against the need for adequate revenue streams to provide manufacturers with incentives to make the substantial, risky investments needed to develop products in the first place. We review alternative pricing strategies (cost recovery models, monetary prizes, and advance market commitments) for coronavirus disease 2019 (COVID-19) drugs, vaccines, and diagnostics. Hybrid pricing strategies are undoubtedly needed in a pandemic, but even in a public health crisis, value-based pricing is important. Cost-effectiveness analyses can inform pricing. Ideally, analyses would be conducted from both a health system and a societal perspective. Incorporating the added value of social benefits into cost-effectiveness analyses does not mean that manufacturers should capture the entire societal benefit of a diagnostic, vaccine, or therapy. Such analyses can provide important information and help policy makers consider the full costs and benefits of products and the wide-ranging ramifications of their actions.

Health Affairs
Vol. 40, No. 1 January 2021
https://www.healthaffairs.org/toc/hlthaff/current

Analysis COVID-19
Ensuring Equitable Access To COVID-19 Vaccines In The US: Current System Challenges And Opportunities
Angela K. Shen, Richard Hughes IV, Erica DeWald, Sara Rosenbaum, Amy Pisani, and Walt Orenstein
Free Access
Abstract
There has been a worldwide effort to accelerate the development of safe and effective vaccines for severe acute respiratory syndrome coronavirus-2. When vaccines become licensed and available broadly to the public, the final hurdle is equitable distribution and access for all who are recommended for vaccination. Frameworks and existing systems for allocation, distribution, vaccination, and monitoring for safety and effectiveness are assets of the current immunization delivery system that should be leveraged to ensure the equitable distribution and broad uptake of licensed vaccines. The system should be strengthened to address gaps in access to immunization services and to modernize the public health infrastructure. We offer five recommendations as guideposts to ensure that policies and practices at the federal, state, local, and tribal levels support equity, transparency, accountability, availability, and access to coronavirus disease 2019 vaccines.

Humanitarian Exchange Magazine
Number 78, October 2020
https://odihpn.org/magazine/inclusion-of-persons-with-disabilities-in-humanitarian-action-what-now/

Disability inclusion in humanitarian action
by HPN October 2020
The theme of this edition of Humanitarian Exchange, co-edited with Sherin Alsheikh Ahmed from Islamic Relief Worldwide, is disability inclusion in humanitarian action. Persons with disabilities are not only disproportionately impacted by conflicts, disasters and other emergencies, but also face barriers to accessing humanitarian assistance. At the same time, global commitments and standards and the IASC Guidelines on the inclusion of persons with disabilities in humanitarian action all emphasise how persons with disabilities are also active agents of change. Disability and age-focused organisations have led on testing and demonstrating how inclusion can be done better. Yet despite this progress, challenges to effective inclusion remain.

As Kirstin Lange notes in the lead article, chief among these challenges is humanitarian agencies’ lack of engagement with organisations of persons with disabilities. Simione Bula, Elizabeth Morgan and Teresa Thomson look at disability inclusion in humanitarian response in the Pacific, and Kathy Al Jubeh and Alradi Abdalla argue for a ‘participation revolution’, building on learning from the gender movement. Tchaurea Fleury and Sulayman AbdulMumuni Ujah outline how the Bridge Article 11 training initiative is encouraging constructive exchange between humanitarian and disability actors. The lack of good, disaggregated data is highlighted by Sarah Collinson; Frances Hill, Jim Cranshaw and Carys Hughes emphasise the need for training resources in local languages and accessible formats; and Sophie Van Eetvelt and colleagues report on a review of the evidence on inclusion of people with disabilities and older people.

Rebecca Molyneux and co-authors analyse the findings of a review of a DFID programme in north-east Nigeria, while Carolin Funke highlights the importance of strategic partnerships between disability-focused organisations, drawing on her research in Cox’s Bazar. Sherin Alsheikh Ahmed describes Islamic Relief Worldwide’s approach to mainstreaming protection and inclusion, while Pauline Thivillier and Valentina Shafina outline IRC’s Client Responsive Programming. The edition ends with reflections by Mirela Turcanu and Yves Ngunzi Kahashi on CAFOD’s SADI approach.

JAMA
January 12, 2021, Vol 325, No. 2, Pages 105-195
https://jamanetwork.com/journals/jama/currentissue

Research Letter
Influenza, Varicella, and Mumps Outbreaks in US Migrant Detention Centers
Nathan C. Lo, MD, PhD; Sindiso Nyathi, BA; Lloyd A. C. Chapman, PhD; et al.
JAMA. 2021;325(2):180-182. doi:10.1001/jama.2020.20539
This study uses US Immigration and Customs Enforcement (ICE) Health Service Corps data to describe incident cases and outbreaks of influenza, varicella, and mumps in 22 US ICE detention centers between 2017 and March 2020.

JAMA
January 12, 2021, Vol 325, No. 2, Pages 105-195
https://jamanetwork.com/journals/jama/currentissue

Viewpoint
COVID-19 as the Leading Cause of Death in the United States
Steven H. Woolf, MD, MPH; Derek A. Chapman, PhD; Jong Hyung Lee, MS
free access has active quiz
JAMA. 2021;325(2):123-124. doi:10.1001/jama.2020.24865
This Viewpoint uses CDC data to compare the COVID-19 mortality rate in 2020 with prior leading causes of death (heart disease, cancer, lung disease, and injury) to put into context the cost of the infection in loss of life in the United States.

JAMA
January 12, 2021, Vol 325, No. 2, Pages 105-195
https://jamanetwork.com/journals/jama/currentissue

Behaviorally Informed Strategies for a National COVID-19 Vaccine Promotion Program
Kevin G. Volpp, MD, PhD; George Loewenstein, PhD; Alison M. Buttenheim, PhD, MBA
free access has active quiz has multimedia has audio
JAMA. 2021;325(2):125-126. doi:10.1001/jama.2020.24036
This Viewpoint proposes behavioral economic and social marketing strategies to motivate coronavirus disease 2019 (COVID-19) vaccination among the public, including making the vaccine free and accessible, requiring it for access to valued activities or settings, and securing public endorsements from leaders or celebrities to ease perceptions of safety and acceptability.

JAMA
January 12, 2021, Vol 325, No. 2, Pages 105-195
https://jamanetwork.com/journals/jama/currentissue

Editorial
Reassuring the Public and Clinical Community About the Scientific Review and Approval of a COVID-19 Vaccine
Howard Bauchner, MD; Preeti N. Malani, MD, MSJ; Joshua Sharfstein, MD

JAMA
January 12, 2021, Vol 325, No. 2, Pages 105-195
https://jamanetwork.com/journals/jama/currentissue

Digital Health—The Need to Assess Benefits, Risks, and Value
Eric Perakslis, PhD; Geoffrey S. Ginsburg, MD, PhD
free access has audio
JAMA. 2021;325(2):127-128. doi:10.1001/jama.2020.22919
This Viewpoint reviews the regulatory, ethical, and security issues attending the explosive growth in digital health technologies (apps, devices, and systems) and proposes a framework for evaluating the benefits, risks, and value of these new tools before recommending them for routine clinical care.

JAMA Network
COVID-19 Update January 16, 2021

These articles on COVID-19 were published across the JAMA Network in the last week.
Selected Articles
JAMA Health Forum
Opinion
While Waiting for Vaccination, Most US Adults Will Wear Masks, Follow Social Distancing Guidelines, Poll Finds: A Randomized Noninferiority Clinical Trial
Joan Stephenson, PhD

JAMA Network
COVID-19 Update January 16, 2021

Opinion
Wastewater Surveillance Can Have a Second Act in COVID-19 Vaccine Distribution: A Randomized Noninferiority Clinical Trial
Ted Smith, PhD; Gail Cassell, PhD; Aruni Bhatnagar, PhD

The Lancet
Jan 16, 2021 Volume 397 Number 10270 p171-252, e2
https://www.thelancet.com/journals/lancet/issue/current

Editorial
An opportunity for American renewal
The Lancet

Nature
Volume 589 Issue 7841, 14 January 2021
http://www.nature.com/nature/current_issue.html

Editorial | 12 January 2021
Science advisers: publish evidence behind COVID vaccine dosing strategy
Countries that change established coronavirus vaccine schedules must be transparent, both to maintain public trust and so others can benefit from their knowledge.

Nature
Volume 589 Issue 7841, 14 January 2021
http://www.nature.com/nature/current_issue.html

Editorial | 13 January 2021
Why a pioneering plan to distribute COVID vaccines equitably must succeed
COVAX is key to both immunizing the world’s poorest people and ending the pandemic.

Nature Biotechnology
Volume 39 Issue 1, January 2021
https://www.nature.com/nbt/volumes/39/issues/1

Editorial | 29 December 2020
Messengers of hope
Emergency Use Authorizations for two mRNA COVID-19 vaccines represent a turning point in the pandemic. They also herald a new era for vaccinology.

Nature Medicine
Volume 27 Issue 1, January 2021
https://www.nature.com/nm/volumes/27/issues/1

Editorial | 13 January 2021
2021: a new year for the WHO
The United Nations Assembly has named 2021 the International Year of Peace and Trust. In that spirit, the world can look forward with hope to the international collaborations spearheaded by the World Health Organization and consider the challenges the agency has yet to face.

Nature Medicine
Volume 27 Issue 1, January 2021
https://www.nature.com/nm/volumes/27/issues/1

World View | 13 January 2021
Women and children last? Shaking up exclusion criteria for vaccine trials
Is it time to shift to a model of ‘inclusion unless otherwise justified’ in trials of vaccines for pandemics?
Beate Kampmann

Nature Medicine
Volume 27 Issue 1, January 2021
https://www.nature.com/nm/volumes/27/issues/1

Comment | 18 December 2020
Difficult trade-offs in response to COVID-19: the case for open and inclusive decision making
We argue that deliberative decision making that is inclusive, transparent and accountable can contribute to more trustworthy and legitimate decisions on difficult ethical questions and political trade-offs during the pandemic and beyond.Ole F. Norheim, Joelle M. Abi-Rached[…] & Alex Voorhoeve

New England Journal of Medicine
January 14, 2021 Vol. 384 No. 2
http://www.nejm.org/toc/nejm/medical-journal

Perspective
Placebo-Controlled Trials of Covid-19 Vaccines — Why We Still Need Them
WHO Ad Hoc Expert Group on the Next Steps for Covid-19 Vaccine Evaluation
This article was published on December 2, 2020, at NEJM.org.

New England Journal of Medicine
January 14, 2021 Vol. 384 No. 2
http://www.nejm.org/toc/nejm/medical-journal

Points of View
Vaccinating Detained Migrants against SARS-CoV-2 — Preventing Another Tragedy C. Foppiano Palacios and M.A. Travassose5
… The provision of a SARS-CoV-2 vaccine is essential to provide protection against Covid-19 in one of the most vulnerable populations for which the federal government holds responsibility. Vaccinating detainees is both good medicine and a humane approach to a completely disenfranchised population. Although we urge each state to prioritize SARS-CoV-2 immunization of detained migrants, it is also the responsibility of the federal government to mandate the protection of members of this most vulnerable group by explicitly allocating vaccines for them.

New England Journal of Medicine
January 14, 2021 Vol. 384 No. 2
http://www.nejm.org/toc/nejm/medical-journal

Business Not as Usual — Covid-19 Vaccination in Persons with Substance Use Disorders J.A. Barocas

PLoS One
http://www.plosone.org/
[Accessed 16 Jan 2021]

Evaluation of a ‘serious game’ on nursing student knowledge and uptake of influenza vaccination
Gary Mitchell, Laurence Leonard, Gillian Carter, Olinda Santin, Christine Brown Wilson
Research Article | published 14 Jan 2021 PLOS ONE
https://doi.org/10.1371/journal.pone.0245389

PLoS One
http://www.plosone.org/
[Accessed 16 Jan 2021]

Costs of continuing RTS,S/ASO1E malaria vaccination in the three malaria vaccine pilot implementation countries
Ranju Baral, Ann Levin, Chris Odero, Clint Pecenka, Collins Tabu, Evans Mwendo, George Bonsu, John Bawa, John Frederick Dadzie, Joyce Charo, Kwadwo Odei Antwi-Agyei, Kwame Amponsa-Achianou, Rose Eddah Jalango, Rouden Mkisi, Scott Gordon, Temwa Mzengeza, Winthrop Morgan, Farzana Muhib
Research Article | published 11 Jan 2021 PLOS ONE
https://doi.org/10.1371/journal.pone.0244995

Research Ethics
Volume 17 Issue 1, January 2021
http://journals.sagepub.com/toc/reab/current

Original Article: Non-Empirical
Trust trumps comprehension, visceral factors trump all: A psychological cascade constraining informed consent to clinical trials: A qualitative study with stable patients
Michael Rost, Rebecca Nast, Bernice S Elger, David Shaw
First Published April 17, 2020; pp. 87–102

Research Ethics
Volume 17 Issue 1, January 2021
http://journals.sagepub.com/toc/reab/current

Patient perspectives on research use of residual biospecimens and health information: On the necessity of obtaining societal consent by creating a governance structure based on value-sharing
Mayumi Yamanaka, Mika Suzuki, Keiko Sato

First Published April 17, 2020; pp. 103–119

Science
15 January 2021 Vol 371, Issue 6526
http://www.sciencemag.org/current.dtl

Perspectives
Herd immunity by infection is not an option
By Devi Sridhar, Deepti Gurdasani
Science15 Jan 2021 : 230-231 Full Access
Difficult lessons are learned from a largely uncontrolled COVID-19 epidemic in Manaus, Brazil
Summary
Herd immunity is expected to arise when a virus cannot spread readily, because it encounters a population that has a level of immunity that reduces the number of individuals susceptible to infection. On page 288 of this issue, Buss et al. (1) describe the extent of the largely uncontrolled severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) epidemic in Manaus, the capital of Amazonas state in Brazil. Their data show the impact on mortality rates of a largely unmitigated outbreak where even with an estimated 76% of the population being infected, herd immunity was not achieved. Manaus provides a cautionary example of unmitigated spread across a population, showing that herd immunity is likely not achieved even at high levels of infection and that it comes with unacceptably high costs.

Science
15 January 2021 Vol 371, Issue 6526
http://www.sciencemag.org/current.dtl

Report
Three-quarters attack rate of SARS-CoV-2 in the Brazilian Amazon during a largely unmitigated epidemic
By Lewis F. Buss, Carlos A. Prete Jr., Claudia M. M. Abrahim, Alfredo Mendrone Jr., Tassila Salomon, Cesar de Almeida-Neto, Rafael F. O. França, Maria C. Belotti, Maria P. S. S. Carvalho, Allyson G. Costa, Myuki A. E. Crispim, Suzete C. Ferreira, Nelson A. Fraiji, Susie Gurzenda, Charles Whittaker, Leonardo T. Kamaura, Pedro L. Takecian, Pedro da Silva Peixoto, Marcio K. Oikawa, Anna S. Nishiya, Vanderson Rocha, Nanci A. Salles, Andreza Aruska de Souza Santos, Martirene A. da Silva, Brian Custer, Kris V. Parag, Manoel Barral-Netto, Moritz U. G. Kraemer, Rafael H. M. Pereira, Oliver G. Pybus, Michael P. Busch, Márcia C. Castro, Christopher Dye, Vítor H. Nascimento, Nuno R. Faria, Ester C. Sabino
Science15 Jan 2021 : 288-292 Open Access
Attack rate in Manaus
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) incidence peaked in Manaus, Brazil, in May 2020 with a devastating toll on the city’s inhabitants, leaving its health services shattered and cemeteries overwhelmed. Buss et al. collected data from blood donors from Manaus and São Paulo, noted when transmission began to fall, and estimated the final attack rates in October 2020 (see the Perspective by Sridhar and Gurdasani). Heterogeneities in immune protection, population structure, poverty, modes of public transport, and uneven adoption of nonpharmaceutical interventions mean that despite a high attack rate, herd immunity may not have been achieved. This unfortunate city has become a sentinel for how natural population immunity could influence future transmission. Events in Manaus reveal what tragedy and harm to society can unfold if this virus is left to run its course.
Abstract
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spread rapidly in Manaus, the capital of Amazonas state in northern Brazil. The attack rate there is an estimate of the final size of the largely unmitigated epidemic that occurred in Manaus. We use a convenience sample of blood donors to show that by June 2020, 1 month after the epidemic peak in Manaus, 44% of the population had detectable immunoglobulin G (IgG) antibodies. Correcting for cases without a detectable antibody response and for antibody waning, we estimate a 66% attack rate in June, rising to 76% in October. This is higher than in São Paulo, in southeastern Brazil, where the estimated attack rate in October was 29%. These results confirm that when poorly controlled, COVID-19 can infect a large proportion of the population, causing high mortality.

Vaccine
Volume 39, Issue 4 Pages 627-776 (22 January 2021)
https://www.sciencedirect.com/journal/vaccine/vol/39/issue/4

WHO Report
Discussion Open access
Key criteria for the ethical acceptability of COVID-19 human challenge studies: Report of a WHO Working Group
Euzebiusz Jamrozik, Katherine Littler, Susan Bull, Claudia Emerson, … Michael J Selgelid
Pages 633-640

Vaccine
Volume 39, Issue 4 Pages 627-776 (22 January 2021)
https://www.sciencedirect.com/journal/vaccine/vol/39/issue/4

Review article Abstract only
A review of hospital-based interventions to improve inpatient influenza vaccination uptake for high-risk adults
Kathleen McFadden, Holly Seale
Pages 658-666

Vaccine
Volume 39, Issue 4 Pages 627-776 (22 January 2021)
https://www.sciencedirect.com/journal/vaccine/vol/39/issue/4

Review article Full text access
Epidemiology of COVID-19 infection in young children under five years: A systematic review and meta-analysis
Mejbah Uddin Bhuiyan, Eunice Stiboy, Md. Zakiul Hassan, Mei Chan, … Nusrat Homaira
Pages 667-677

Vaccine
Volume 39, Issue 4 Pages 627-776 (22 January 2021)
https://www.sciencedirect.com/journal/vaccine/vol/39/issue/4

Research article Abstract only
Human papillomavirus vaccine guideline adherence among Arizona’s Medicaid beneficiaries
Alexis Koskan, Lynne Klasko-Foster, Chad Stecher, Sue Rodriguez, … Wonsuk Yoo
Pages 682-686

Vaccine
Volume 39, Issue 4 Pages 627-776 (22 January 2021)
https://www.sciencedirect.com/journal/vaccine/vol/39/issue/4

Research article Open access
Vaccination coverage and adherence to a dengue vaccination program in the state of Paraná, Brazil
Clara Preto, Angela Maron de Mello, Eliane Mara Cesário Pereira Maluf, Elias Teixeira Krainski, … Karin Regina Luhm
Pages 711-719

Vaccine
Volume 39, Issue 4 Pages 627-776 (22 January 2021)
https://www.sciencedirect.com/journal/vaccine/vol/39/issue/4

Research article Abstract only
Vaccination attitudes, beliefs and behaviours among primary health care workers in northern Croatia
Morana Tomljenovic, Goranka Petrovic, Nataša Antoljak, Lisa Hansen
Pages 738-745

Vaccine
Volume 39, Issue 4 Pages 627-776 (22 January 2021)
https://www.sciencedirect.com/journal/vaccine/vol/39/issue/4

Research article Abstract only
Vaccine sentiments and under-vaccination: Attitudes and behaviour around Measles, Mumps, and Rubella vaccine (MMR) in an Australian cohort
Mathew Toll, Ang Li
Pages 751-759

Vaccines — Open Access Journal
http://www.mdpi.com/journal/vaccines
(Accessed 16 Jan 2021)

Open Access Article
Willingness to Receive COVID-19 Vaccination in Japan
by Takeshi Yoda and Hironobu Katsuyama
Vaccines 2021, 9(1), 48; https://doi.org/10.3390/vaccines9010048 – 14 Jan 2021
Abstract
In the wake of the COVID-19 pandemic, vaccines are being developed by many countries for the safety of their population. However, people of various nations have revealed hesitancy towards being vaccinated, citing reasons such as side effects, safety, a lack of trust in […]

Vaccines — Open Access Journal
http://www.mdpi.com/journal/vaccines
(Accessed 16 Jan 2021)

Open Access Article
Flattening the Curve of COVID-19 Vaccine Rejection—An International Overview
by Wojciech Feleszko, Piotr Lewulis, Adam Czarnecki and Paweł Waszkiewicz
Vaccines 2021, 9(1), 44; https://doi.org/10.3390/vaccines9010044 – 13 Jan 2021
Abstract
Background: If globally implemented, a safe coronavirus disease 2019 (COVID-19) vaccination program will have broad clinical and socioeconomic benefits. However, individuals who anticipate that the coronavirus vaccine will bring life back to normality may be disappointed, due to the emerging antivaccination attitude within […]

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 16 Jan 2021
Ideas
We Need to Know Who Is Getting Vaccinated
The federal government must release demographic data about vaccine recipients.
January 13, 2021
Erin Kissane, Co-founder of the The COVID Tracking Project
Alice Goldfarb, Lead of the COVID Racial Data Tracker and a 2021 Nieman Visiting Fellow
A year into the coronavirus pandemic in the United States, we still lack a complete understanding of who is getting sick, and where, and when. Demographic data from many states are astonishingly incomplete, and even widely collected information, such as the age of patients at the time of diagnosis or death, is so inconsistently presented that it has been impossible to assemble into a clear national picture. The federal government is now making more demographic data available, but the information continues to emerge at a snail’s pace…

BBC
http://www.bbc.co.uk/
Accessed 16 Jan 2021
Covid: India to begin vaccine rollout on 16 January
PM Narendra Modi hails a “landmark step” and says the aim is to vaccinate 300 million people by July.
Published 16 Jan 2021

The Economist
http://www.economist.com/
Accessed 16 Jan 2021
Chaguan
Many in China are strikingly accepting of harsh virus controls
A year into the pandemic, ordinary Chinese are strikingly accepting of harsh virus controls
Jan 16th 2021 edition

Financial Times
https://www.ft.com/
Accessed 16 Jan 2021
Coronavirus treatment
India launches vaccine drive against backdrop of growing scepticism
Modi says domestic jab is just what the country has been waiting for but some states are already pushing back
January 16, 2021
India, a country of 1.4bn people, has the world’s second-highest number of coronavirus infections at 10.5m. Lockdowns have had limited effect in controlling the spread of the virus and contact tracing has faltered, making a successful inoculation programme essential. The first phase of the vaccination rollout targets 30m healthcare and frontline workers, with the goal of inoculating 300m people by July…
But New Delhi’s approval of Covaxin, a vaccine developed by Hyderabad-based Bharat Biotech, before phase 3 trial data was released has been criticised by healthcare experts and stoked vaccine scepticism. A survey this month by pollster Local Circles found that 69 per cent of respondents were hesitant about getting a jab…
As was the case with Russian and Chinese vaccines, Covaxin was fast-tracked without completing phase 3 trials. Experts argue that the growing doubt surrounding the vaccine, developed in partnership with India’s government, risks undermining the vaccination drive.
Some states are already pushing back: the health minister of Chhattisgarh, for example, has refused to accept Covaxin until the phase 3 trials are completed.
“What Indian regulators have done is pulled us down to Russia and China’s level,” said Dinesh Thakur, a former pharma executive in India who now works as a public health activist in the US…

Coronavirus pandemic
Rollout of China’s Sinovac vaccine in Hong Kong under threat
Beijing-backed jab faces greater scrutiny after Brazil trial confusion
January 16, 2021

Hong Kong is likely to delay the distribution of mainland Chinese producer Sinovac’s Covid-19 vaccine because of a lack of trial data, raising transparency concerns over a shot Beijing wants to sell throughout the developing world.
Any doubts over the Sinovac inoculation risks heightening political tension in Hong Kong over the government’s free vaccine strategy. Carrie Lam, the territory’s leader, is facing a struggle to convince some citizens to accept vaccines developed in mainland China.
Ms Lam said in December that she hoped Sinovac would deliver the vaccine in January and then start distribution to vulnerable members of the city’s population. But the head of the Hong Kong’s government vaccine panel said on Friday that the shot was unlikely to be approved this month.
“We haven’t received an application, we haven’t received documents from them so the advisory panel will not be vetting the Sinovac vaccine. It is not possible for that to go out anytime in Hong Kong yet,” Wallace Lau, convener of the government’s advisory panel on Covid-19 vaccines, told the Financial Times…

Coronavirus treatment
EU countries decry ‘very short notice’ of delay in delivery of Pfizer vaccine
Drugmaker blames temporary cutback on factory revamp designed to boost production this year
January 15, 2021
Top of Form
Bottom of Form

Medical science
Health and tech groups aim to create digital Covid ‘vaccination passport’
Coalition including Microsoft and Oracle says system can help people return to travel, work and education
Hannah Kuchler in New York
January 14 2021
Health and technology groups are working together to create a digital vaccination passport in the expectation that governments, airlines and other businesses will require proof people have been vaccinated against Covid-19.
The Vaccination Credential Initiative, a coalition of organisations including Microsoft, Oracle and the US healthcare non-profit Mayo Clinic, aims to establish standards to verify whether a person has had their shot and prevent people falsely claiming to be protected against the disease.
The coalition builds on work done by one of its members, The Commons Project, to develop an internationally accepted digital certificate to prove travellers have tested negative for Covid-19. The pass developed by the non-profit, established with support from the Rockefeller Foundation, is now being used by all three major airline alliances.
Paul Meyer, chief executive of The Commons Project, said people vaccinated so far were often handed just a piece of paper, reminiscent of the “old yellow cards”. By working with health IT companies, such as Epic and Cerner in the US, the new system will be able to draw from electronic medical records to create a digital card.
Mr Meyer said the coalition was in talks with several governments that expected their entry requirements to evolve over the next few months from mandating negative tests to a “hybrid”, accepting either tests or proof of vaccination…

Forbes
http://www.forbes.com/
Accessed 16 Jan 2021
16 Jan 2020
Rate Of Black Americans Getting Vaccinated Significantly Lower Than Rate Among Whites
Topline
Despite being hospitalized and killed by the coronavirus at a disproportionately higher rate, Black Americans are receiving Covid-19 vaccinations at a far lower rate than white Americans, according to an analysis by Kaiser Health News.
“If we don’t vaccinate the population that’s highest-risk, we’re going to see even more disproportional deaths in Black and brown communities.”
By Tommy Beer Forbes Staff

16 Jan 2020
Covid Vaccination Incentives: The Risks And Rewards For Employers
Offering incentives to workers to get their vaccine shots for Covid-19 — as Dollar General, Trader Joe’s, and Instacart plan to do — appears to be a generous and important gesture that can help address the worsening pandemic. But is the carrot and stick approach right for all companies?
By Edward Segal Contributor

Foreign Affairs
http://www.foreignaffairs.com/
Accessed 16 Jan 2021
[No new, unique, relevant content]

Foreign Policy
http://foreignpolicy.com/
Accessed 16 Jan 2021
Report
Trump Mounts Last-Minute Attempt to Starve Funding for Foreign Aid, Global Vaccine Efforts
But congressional sources say it’s highly unlikely lawmakers will cut billions of dollars of already appropriated funding.
By Robbie Gramer
January 15, 2021, 1:50 PM
…The rescission package targets $4 billion for Gavi, a public-private partnership that distributes vaccines worldwide, including COVID-19 vaccine doses, to low- and middle-income countries. It would also cut $1.5 billion in emergency food aid and around $2 billion for programs aimed at tackling AIDS…

The Guardian
http://www.guardiannews.com/
Accessed 16 Jan 2021
[No new, unique, relevant content]

New Yorker
http://www.newyorker.com/
Accessed 16 Jan 2021
[No new, unique, relevant content]

New York Times
http://www.nytimes.com/
Accessed 16 Jan 2021
Opinion
The Next President Actually Has a Covid Plan
America desperately needs a leader who takes the pandemic seriously.
By The Editorial Board
…Vaccinate quickly
The national vaccination effort is in a state of chaos. Only about one-third of the 30 million or so shots provided to states have been injected into arms. The rest have been held up by a roster of factors, including vaccine hesitancy, cumbersome federal prioritization guidelines, and poor coordination between major pharmacies and the thousands of nursing homes whose staff and residents they are supposed to inoculate.
This week, in an attempt to speed things up, the outgoing administration abandoned its own prioritization guidelines, and deemed some 152 million more people immediately eligible for vaccination. Officials also indicated that they would release an untold number of additional doses to the states quickly, rather than holding them in reserve as was originally planned. But those pronouncements have only made matters worse. Health departments have been overrun, web portals and phone lines have crashed, and consumers scrambling to secure appointments have been outraged to find that the vaccine is still not widely available. As The Washington Post has since reported, there are no reserve doses to be had…

Politics
Biden promises a ‘bold’ federal vaccination campaign.
By Sheryl Gay Stolberg and Katie Thomas Jan. 16

Business
Frustrations Boil at Pace of Vaccinations at Long-Term Care Facilities
The Trump administration raised hopes of a speedy process for nursing homes and assisted living facilities. Patience is wearing thin.
By Rebecca Robbins Jan. 16

Asia Pacific
A Mix of Pride and Doubts as Modi Launches India’s Covid-19 Vaccine Drive
One of the world’s largest inoculation programs is set to begin on Saturday, but experts have questioned the data behind one of the country’s two vaccines — and patients don’t get to pick their shot.
By Emily Schmall and Karan Deep Singh

World
Biden picks a former F.D.A. chief to lead federal vaccine efforts, which will drop the name Operation Warp Speed.
By Sheila Kaplan and Sheryl Gay Stolberg Jan. 15

Health
Biden Picks Former F.D.A. Chief to Lead Federal Vaccine Efforts
Dr. David Kessler, who helped speed the development and approval of AIDS drugs in the 1990s, will become the top science official for the initiative the Trump administration had called Operation Warp Speed.
By Sheila Kaplan and Sheryl Gay Stolberg Jan. 15

Washington Post
https://www.washingtonpost.com/
Accessed 16 Jan 2021
Asia & Pacific
A black market for illegal coronavirus vaccines is thriving in the Philippines
By Regine Cabato
…No coronavirus vaccine has been approved for general use in the Philippines, nor is one expected to arrive, officially, until at least February. It is illegal to import unauthorized pharmaceuticals. But soaring demand among Chinese workers, many of them employed in the Philippines’ lucrative online casinos catering to gamblers in China, is driving a black market where vaccine doses are sold for many times the standard $30 price in China.
The underground distribution exposes pandemic inequalities and problems with immunization drives in places plagued by corruption and patronage. In Southeast Asia, where there are millions of overseas Chinese workers, it also threatens to heighten long-standing resentment between local communities and the Chinese population.
The bootleg vaccines aren’t limited to Chinese workers. In late December, President Rodrigo Duterte said members of the Philippine military had already taken the coronavirus vaccine from Sinopharm, a Chinese state-owned pharmaceutical company. Members of the president’s security group admitted they had received the shots, angering ordinary Filipinos who are grappling with one of the region’s worst outbreaks yet lack access to vaccines…

Politics
Canada has secured more vaccine doses per capita than anyone else, but it’s been slow to administer
Amanda Coletta · Jan 15, 2021

Think Tanks et al

Brookings
http://www.brookings.edu/
Accessed 16 Jan 2021
[No new relevant content]

Center for Global Development [to 16 Jan 2021]
http://www.cgdev.org/page/press-center
[No new relevant content]

Chatham House [to 16 Jan 2021]
https://www.chathamhouse.org/
Accessed 16 Jan 2021
[No new relevant content]

CSIS
https://www.csis.org/
Accessed 16 Jan 2021
[No new relevant content]

Council on Foreign Relations
http://www.cfr.org/
Accessed 16 Jan 2021
[No new relevant content]

Kaiser Family Foundation
https://www.kff.org/search/?post_type=press-release
Accessed 16 Jan 2021
January 14, 2021 News Release
Most Hispanic Adults Lean Towards Getting a COVID-19 Vaccine, But Many Younger Adults are Hesitant
A new analysis of KFF COVID-19 Vaccine Monitor survey data finds that most Hispanic adults across the country want to get a COVID-19 vaccine at some point though younger adults are more hesitant, in part because of lower confidence that it is safe and effective. Overall a quarter (26%) of…

January 14, 2021 News Release
Despite Efforts to Slow the Spread of the Virus in Long-Term Care Facilities, KFF Analysis Finds Many States Experienced the Worst COVID-19 Outbreaks and Highest Number of Deaths in December
For some regions of the country, recent months have brought the worst COVID-19 outbreaks in long-term care facilities since the start of the pandemic, a new KFF analysis of state-reported cases and death shows, underscoring the importance of current efforts to vaccinate this high priority group. The novel coronavirus has…

January 11, 2021 News Release
New Analysis Takes In-Depth Look at How States are Prioritizing Who Gets a COVID-19 Vaccine
A new KFF analysis examines the different approaches states are taking to manage the limited initial supply of COVID-19 vaccines and balance the desire to vaccinate those at greatest risk first with the need to ensure a fast and effective statewide vaccination effort. Based on a review of state vaccination…

World Economic Forum [to 16 Jan 2021]
https://agenda.weforum.org/news/
Media
[No new relevant content]

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

Coronavirus [COVID-19]

Public Health Emergency of International Concern (PHEIC)

Weekly Epidemiological and Operational updates

Last update: 9 January 2021

Confirmed cases ::    87 589 206    [week ago: 82 356 727]    [two weeks ago: 78 604 532]

Confirmed deaths ::    1 906 606    [week ago:   1 815 433]   [two weeks ago:   1 744 235]

Countries, areas or territories with cases :: 222

Milestones :: Perspectives :: Research

UNICEF COVID-19 Vaccine Market Dashboard :: Agreements Table at 9 Jan 2021
An overview of information collected from publicly announced bilateral and multilateral supply agreement [Agreements view from 2020-12-30 to date]

Milestones :: Perspectives :: Research

WHO Director-General’s opening remarks at the media briefing on COVID-19 – 8 January 2021
:: COVAX – set up by GAVI, CEPI and WHO in April last year – has now secured contracts of 2 billion doses of safe and effective COVID-19 vaccines, which we are ready to rollout as soon as the vaccines are delivered.  
:: However, this is where the current challenge is. Rich countries have bought up the majority of the supply of multiple vaccines.  Going forward, I want to see manufacturers prioritise supply and rollout through COVAX.  
:: If I said one thing to people in areas where there are high numbers of cases, it would be to do all you can to avoid mixing with people from other households, especially inside.  
:: This year is the year of the health and care worker. Let’s show our respect and appreciation for health workers by protecting each other and vaccinating all health workers everywhere now. 

COVAX – set up by GAVI, CEPI and WHO in April last year – has now secured contracts of 2 billion doses of safe and effective COVID-19 vaccines, which we are ready to rollout as soon as the vaccines are delivered. And we also have the right of first refusal on an additional 1 billion doses.

However, this is where the current challenge is: At present, 42 countries are rolling out safe and effective COVID-19 vaccines. 36 of these are high-income countries and six are middle-income.

So there’s a clear problem that low- and most middle-income countries are not receiving the vaccine yet. This is a problem we can and we must solve together through COVAX and the ACT-Accelerator.

At the outset, rich countries have bought up the majority of the supply of multiple vaccines. Now we’re also seeing both high and middle-income countries, that are part of COVAX, making additional bilateral deals. This potentially bumps up the price for everyone and means high-risk people in the poorest and most marginalized countries don’t get the vaccine.

And some companies and countries have not submitted critical data, which we need to issue Emergency Use Listings, which blocks the whole system of procurement and delivery.   

Vaccine nationalism hurts us all and is self-defeating. But on the flipside, vaccinating equitably saves lives, stablises health systems and would lead to a truly global economic recovery that stimulates job creation…

…Going forward, I want to see manufacturers prioritise supply and rollout through COVAX.

I urge countries that have contracted more vaccines than they will need, and are controlling the global supply, to also donate and release them to COVAX immediately, which is ready TODAY to rollout quickly.

And I urge countries and manufacturers to stop making bilateral deals at the expense of COVAX. No country is exceptional and should cut the queue and vaccinate all their population while some remain with no supply of the vaccine.

Science has delivered, let’s not waste the opportunity to protect lives of those most at risk and ensure all economies have a fair shot at recovery…

Milestones :: Perspectives :: Research

Extraordinary meeting of the Strategic Advisory Group of Experts on Immunization (SAGE) – 5 January 2021 [Pfizer-BioNTech COVID-19 vaccine BNT162b2]
This extraordinary virtual meeting for the Strategic Advisory Group of Experts on Immunization (SAGE) was held on Tuesday 05 January 2021 to propose recommendations to WHO on the use of COVID-19 vaccine(s).

Interim recommendations for use of the Pfizer–BioNTech COVID-19 vaccine, BNT162b2, under Emergency Use Listing
WHO Team: WHO Headquarters (HQ)
Reference numbers: WHO Reference Number: WHO/2019-nCoV/vaccines/SAGE_recommendation/BNT162b2/2021.1
Copyright CC BY-NC-SA 3.0 IGO
Full text PDF: https://apps.who.int/iris/rest/bitstreams/1326072/retrieve [7 pages]

[Selected Excerpts; Full text at pdf link above]
… General goal and strategy for the use of the mRNA vaccine BNT162b2 against COVID-19 (Pfizer–BioNTech)
The COVID-19 pandemic has caused significant morbidity and mortality throughout the world, as well as major social, educational and economic disruptions. There is an urgent global need for effective and safe vaccines. On 31 December 2020, WHO listed the COVID-19 mRNA vaccine BNT162b2 for emergency use, making the Pfizer–BioNTech vaccine the first to receive emergency validation from WHO since the outbreak began a year earlier. The WHO Emergency Use Listing Procedure (EUL) is a risk-based procedure for assessing and listing unlicensed vaccines, therapeutics and in vitro diagnostics with the ultimate aim of expediting the availability of these products to people affected by a public health emergency.

BNT162b2, an mRNA vaccine against COVID-19 developed by BioNTech and Pfizer, has been shown to have an efficacy of approximately 95%, based on a median follow-up of two months. The data reviewed by WHO at this time support the conclusion that the known and potential benefits of BNT162b2 outweigh the known and potential risks. As sufficient vaccine supply will not be immediately available to immunize all who could benefit from it, countries are recommended to use the WHO Prioritization Roadmap [4] and the WHO Values Framework [5] as guidance for their prioritization of target groups. As long as vaccine supplies are very limited (stage I in the WHO Prioritization Roadmap), in settings with community transmission, the Roadmap recommends that priority be given initially to health workers at high risk and older people with and without comorbidities. Protecting high-risk health workers has a threefold purpose: (i) to protect the individual health workers; (ii) to protect critical essential services during the COVID-19 pandemic, and (iii) to prevent onward transmission to vulnerable people. Protecting older people will have the greatest public health impact in terms of reducing the number of deaths. As more vaccine becomes available, additional priority groups should be vaccinated as outlined in the WHO Prioritization Roadmap [4], taking into account national epidemiological data and other relevant considerations…

… Considerations for deferring the second dose
WHO acknowledges that a number of countries face exceptional circumstances of vaccine supply constraints combined with a high disease burden. Some countries have therefore considered delaying the administration of the second dose to allow for a higher initial coverage. This is based on the observation that efficacy has been shown to start from day 12 after the first dose and reached about 89% between days 14 and 21, at the time when the second dose was given. No data on longer term efficacy for a single dose of the mRNA vaccine BNT162b2 currently exist, as the trial participants received 2 doses with an interval between doses in the trial ranging from 19 to 42 days. Of note, neutralizing antibody responses are modest after the first dose and increase substantially after the second dose.

Countries experiencing exceptional epidemiological circumstances may consider delaying for a short period the administration of the second dose as a pragmatic approach to maximizing the number of individuals benefiting from a first dose while vaccine supply continues to increase. WHO’s recommendation at present is that the interval between doses may be extended up to 42 days (6 weeks), on the basis of currently available clinical trial data. Should additional data become available on longer intervals between doses, revision of this recommendation will be considered. Countries should ensure that any such programme adjustments to dose intervals do not affect the likelihood of receiving the second dose…

…Special settings
Persons in settings such as refugee and detention camps, prisons, slums, and other settings with high population densities, where physical distancing is not implementable, should be prioritized for vaccination as outlined in the WHO Prioritization Roadmap [4], taking into account national epidemiological data, vaccine supply and other relevant considerations.

As noted in the WHO Prioritization Roadmap, national programmes should give special consideration to groups that are disproportionately affected by COVID-19 or that face health inequities as a result of social or structural inequities. Such groups should be identified, barriers to vaccination should be addressed, and programmes should be developed to enable equitable access to vaccines.

In the current period of very limited vaccine supply, preferential vaccination of international travelers would counter the principle of equity. Because of this and the lack of evidence on whether vaccination reduces the risk of transmission, WHO currently does not recommend COVID-19 vaccination of travelers (unless they are also part of a high-risk group or in epidemiological settings identified in the WHO Prioritization Roadmap [4]). With increasing vaccine supply, these recommendations will be revisited…

…Community engagement, effective communication, and legitimacy
Community engagement and effective communication (including risk communication) are essential to the success of COVID-19 vaccination programmes. Prioritization decisions should be made through transparent processes that are based on shared values, the best available scientific evidence, and appropriate representation and input by affected parties. Furthermore, communication about the mechanism of action of mRNA vaccines, and efficacy and safety data derived from clinical trials and post-marketing studies, needs to be strengthened. Strategies should include: (1) culturally acceptable and linguistically accessible communications regarding COVID-19 vaccination made freely available; (2) active community engagement and involvement of community opinion leaders and trusted voices to improve awareness and understanding of such communications, and (3) inclusion of diverse and affected stakeholder opinions in decision-making. Such efforts are especially important in subpopulations who may be unfamiliar with or distrustful of health care systems and immunization…

…Recommendations on addressing current knowledge gaps through further research
In order to confirm the safety profile demonstrated in the clinical trials in the short term, active surveillance of large numbers of vaccinated individuals is necessary in the general population studied for a longer duration, as well as of specific at-risk subpopulations. It is essential for Pfizer–BioNTech and vaccination providers to report the following to adverse event reporting systems in countries: all vaccine administration errors, serious adverse events, cases of multisystem inflammatory syndrome (MIS) following vaccination, anaphylaxis and other serious allergic reactions, Bell`s palsy, and cases of COVID-19 following vaccination that result in hospitalization or death.

WHO recommends the following research and post-authorization monitoring activities:
vaccine effectiveness over time;
ongoing collection of safety data in vaccine recipients;
surveillance for COVID-19 among vaccinated individuals, looking for vaccine-induced enhanced disease (possibly as vaccine-induced antibody levels decline);
safety data from inadvertently vaccinated pregnant women during trials and post-authorization;
safety data from pregnant women who receive vaccine because they are members of prioritized groups, e.g. health workers;
prospective studies on the safety of BNT162b2 in pregnant women;
impact on infants of vaccination of breastfeeding mothers;
safety data on vaccination in immunocompromised persons, including persons living with HIV and persons with autoimmune disease;
impact of delayed second dose as currently implemented by certain countries;
clinical trials on the efficacy and safety of vaccination of children below the age of 16 years;
immunogenicity and safety studies of co-administration with other vaccines, including influenza and pneumococcal vaccines, to adults and older persons;
studies to determine how protection changes with time since vaccination and whether protection can be prolonged by booster doses;
studies to demonstrate whether this vaccine reduces SARS-CoV-2 transmission and viral shedding;
stability of vaccine under alternative cold-chain distribution and storage conditions;
effectiveness of the proposed strategies for the prevention and management of anaphylactic reactions;
interchangeability and “mix and match” studies within and across COVID-19 vaccine platforms;
global surveillance of virus evolution and the impact of virus mutants on vaccine effectiveness to support possible update of vaccines if needed;
head-to-head studies with other vaccines on extent and duration of immunity using standardized neutralization assays and mucosal immunity assays.

::::::

Meeting materials
Please find related materials for the meeting, including a final agenda, list of participants, declaration of interests, background materials and presentations made during the meeting, below.

Background Materials
:: Final Meeting Agenda
:: Background paper on Covid-19 disease and vaccines
:: mRNA vaccines against COVID-19: Pfizer-BioNTech COVID-19 vaccine BNT162b2

Presentations
:: Introduction, session objective setting, update on regulatory decisions and overview of Working Group deliverables H. NOHYNEK. pdf, 4.1Mb
:: Safety monitoring S. Pal. pdf, 1Mb
:: Assessment of Evidence (SAGE working group)

Milestones :: Perspectives :: Research

FDA

FDA Statement on Following the Authorized Dosing Schedules for COVID-19 Vaccines
January 04, 2021
Commissioner of Food and Drugs – Food and Drug Administration, Stephen M. Hahn M.D.
Director – Center for Biologics Evaluation and Research (CBER), Peter Marks M.D., PhD.

Two different mRNA vaccines have now shown remarkable effectiveness of about 95% in preventing COVID-19 infection in adults. As the first round of vaccine recipients become eligible to receive their second dose, we want to remind the public about the importance of receiving COVID-19 vaccines according to how they’ve been authorized by the FDA in order to safely receive the level of protection observed in the large randomized trials supporting their effectiveness.

We have been following the discussions and news reports about reducing the number of doses, extending the length of time between doses, changing the dose (half-dose), or mixing and matching vaccines in order to immunize more people against COVID-19. These are all reasonable questions to consider and evaluate in clinical trials. However, at this time, suggesting changes to the FDA-authorized dosing or schedules of these vaccines is premature and not rooted solidly in the available evidence. Without appropriate data supporting such changes in vaccine administration, we run a significant risk of placing public health at risk, undermining the historic vaccination efforts to protect the population from COVID-19.

The available data continue to support the use of two specified doses of each authorized vaccine at specified intervals. For the Pfizer-BioNTech COVID-19 vaccine, the interval is 21 days between the first and second dose. And for the Moderna COVID-19 vaccine, the interval is 28 days between the first and second dose. 

What we have seen is that the data in the firms’ submissions regarding the first dose is commonly being misinterpreted. In the phase 3 trials, 98% of participants in the Pfizer-BioNTech trial and 92% of participants in the Moderna trial received two doses of the vaccine at either a three- or four-week interval, respectively. Those participants who did not receive two vaccine doses at either a three-or four-week interval were generally only followed for a short period of time, such that we cannot conclude anything definitive about the depth or duration of protection after a single dose of vaccine from the single dose percentages reported by the companies.

Using a single dose regimen and/or administering less than the dose studied in the clinical trials without understanding the nature of the depth and duration of protection that it provides is concerning, as there is some indication that the depth of the immune response is associated with the duration of protection provided. If people do not truly know how protective a vaccine is, there is the potential for harm because they may assume that they are fully protected when they are not, and accordingly, alter their behavior to take unnecessary risks.

We know that some of these discussions about changing the dosing schedule or dose are based on a belief that changing the dose or dosing schedule can help get more vaccine to the public faster. However, making such changes that are not supported by adequate scientific evidence may ultimately be counterproductive to public health.

We have committed time and time again to make decisions based on data and science. Until vaccine manufacturers have data and science supporting a change, we continue to strongly recommend that health care providers follow the FDA-authorized dosing schedule for each COVID-19 vaccine. 

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.