Coronavirus Disease 2019 (COVID-19)
Selected Resources
:: Requirement for Proof of Negative COVID-19 Test for All Air Passengers Arriving from the UK to the US Friday, December 25, 2020

:: When Vaccine is Limited, Who Gets Vaccinated First? Wednesday, December 23, 2020

:: EARLY RELEASE: The Advisory Committee on Immunization Practices’ Updated Interim Recommendation for Allocation of COVID-19 Vaccine – United States, December 2020 Tuesday, December 22, 2020

:: Importance of COVID-19 Vaccination for Residents of Long-term Care Facilities Monday, December 21, 2020

Africa CDC [to 26 Dec 2020]
http://www.africacdc.org/
News
Statement on new SARS-CoV-2 variant with multiple spike protein mutations
ADDIS ABABA, ETHIOPIA, 22 DECEMBER 2020. The Africa Centres for Disease Control and Prevention (Africa CDC) wishes to raise awareness of Member States regarding the new variant of SARS-CoV-2, the virus that causes COVID-19, which was reported in South Africa and the United Kingdom over the past week. Africa CDC is closely following up with authorities in South Africa, where the variant was first identified in Nelson Mandela Bay and has rapidly spread through the Eastern and Western Capes, as well as KwaZulu-Natal…

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

National Health Commission of the People’s Republic of China [to 26 Dec 2020]
http://en.nhc.gov.cn/
News
Dec 26: Daily briefing on novel coronavirus cases in China
On Dec 25, 31 provincial-level regions and the Xinjiang Production and Construction Corps on the Chinese mainland reported 20 new cases of confirmed infections.

National Medical Products Administration [to 26 Dec 2020]
http://english.nmpa.gov.cn/news.html
News
Official: Vaccines good for at least 6 months
2020-12-24
The COVID-19 vaccine’s protection can last for more than half a year at least, said Zeng Yixin, deputy head of the National Health Commission, at news conference in Beijing on Dec 19.

Official affirms safety of Chinese vaccines
2020-12-22
Experimental COVID-19 vaccines developed by Chinese researchers are safe, and ongoing efforts to push for their market approval will strictly follow the rules of science, a health official said on Dec 21.

China starts building COVID-19 vaccine production facility
2020-12-22
China started the construction of a plant for manufacturing an mRNA-based COVID-19 vaccine on Dec 21, with production operations due to begin in eight months, according to local authorities.

China at forefront of global COVID-19 vaccine development: official
2020-12-22
China is at the forefront of global COVID-19 vaccine development, with most jabs undergoing phase-3 clinical trials, a health official said at a press conference on Dec 21.

Announcements

Paul G. Allen Frontiers Group [to 26 Dec 2020]
https://alleninstitute.org/what-we-do/frontiers-group/news-press/
News
No new digest content identified.

BARDA – U.S. Department of HHS [to 26 Dec 2020]
https://www.phe.gov/about/barda/Pages/default.aspx
BARDA News
December 23, 2020: HHS, DOD collaborate with Merck to continue the development and large-scale manufacturing of investigational COVID-19 treatment
The U.S. Department of the Health and Human Services (HHS) and the Department of Defense (DOD) jointly announced an agreement with Merck to support advanced development and large-scale manufacturing of the their investigational therapeutic MK-7110 to treat hospitalized patients with severe or critical COVID-19.
The investigational therapeutic is a promising first-in-class fusion protein and immune modulator. Immune modulators have the potential to minimize the damaging effects of an overactive immune response to COVID-19. This overactive response can contribute to the severity of the illness…

December 23, 2020: Trump Administration purchases additional 100 million doses of COVID-19 investigational vaccine from Pfizer
… Under the agreement, Pfizer will manufacture and deliver up to 100 million doses of its SARS-CoV-2 vaccine, BNT162b2, to Government designated locations. Under the terms of the agreement, Pfizer will deliver at least 70 million doses by June 30, 2021, with the balance of the 100 million doses to be delivered no later than July 31, 2021…

BMGF – Gates Foundation [to 26 Dec 2020]
http://www.gatesfoundation.org/Media-Center/Press-Releases
Press Releases and Statements
No new digest content identified.

Bill & Melinda Gates Medical Research Institute [to 26 Dec 2020]
https://www.gatesmri.org/
The Bill & Melinda Gates Medical Research Institute is a non-profit biotech organization. Our mission is to develop products to fight malaria, tuberculosis, and diarrheal diseases—three major causes of mortality, poverty, and inequality in developing countries. The world has unprecedented scientific tools at its disposal; now is the time to use them to save the lives of the world’s poorest people
No new digest content identified.

CARB-X [to 26 Dec 2020]
https://carb-x.org/
News
No new digest content identified.

CEPI – Coalition for Epidemic Preparedness Innovations [to 26 Dec 2020]
http://cepi.net/
Latest News
Coming soon: Call to join CEPI’s Scientific Advisory Committee
24 Dec 2020
To ensure world class rigour in our work advancing the development of vaccines against COVID-19 and other emerging health threats, CEPI is looking for senior scientific researchers and global health professionals to join its Scientific Advisory Committee, or SAC. We will be seeking applicants with extensive experience in disciplines relating to vaccine development, innovation, licensure, and deployment. The formal period for application will open in January.
Working as an independent body, the SAC advises CEPI staff and the Board on funding and R&D decisions relating to our vaccine programmes and enabling sciences activities, as well as the overall vaccine portfolio and scientific aspects of the CEPI strategy.
Up to twenty-five positions will be available – including the role of CEPI SAC Chair and Vice-Chair. Existing members are invited to re-apply to serve an additional 2-year period…

EDCTP [to 26 Dec 2020]
http://www.edctp.org/
The European & Developing Countries Clinical Trials Partnership (EDCTP) aims to accelerate the development of new or improved drugs, vaccines, microbicides and diagnostics against HIV/AIDS, tuberculosis and malaria as well as other poverty-related and neglected infectious diseases in sub-Saharan Africa, with a focus on phase II and III clinical trials
No new digest content identified.

Emory Vaccine Center [to 26 Dec 2020]
http://www.vaccines.emory.edu/
Vaccine Center News
No new digest content identified.

European Medicines Agency [to 26 Dec 2020]
http://www.ema.europa.eu/ema/
News & Press Releases
News: EMA organises a second public meeting about the new COVID-19 vaccines
Last updated: 22/12/2020
EMA will organise a second public meeting on 8 January 2021 to inform European citizens about the assessment, approval and roll-out of new COVID-19 vaccines.
Together with the EU medicines regulatory network, EMA has been working around the clock to bring much needed COVID-19 vaccines to EU citizens as quickly as possible, while keeping the same rigorous standards of approval as for all vaccines.
The first COVID-19 vaccine, Comirnaty, developed by BioNTech and Pfizer has been authorised in the EU on 21 December 2020. An application for a marketing authorisation for another COVID-19 vaccine, developed by Moderna, is currently ongoing and could be concluded at an extraordinary meeting of EMA’s human medicines committee (CHMP) on 6 January 2021…

News: EMA recommends first COVID-19 vaccine for authorisation in the EU (updated)
CHMP, Last updated: 22/12/2020
[See Regulatory Milestones above for detail]

European Vaccine Initiative [to 26 Dec 2020]
http://www.euvaccine.eu/
Latest News
No new digest content identified.

FDA [to 26 Dec 2020]
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
Press Announcements /Selected Details
December 22, 2020 – Coronavirus (COVID-19) Update: December 22, 2020
:: The FDA has posted translations of the Moderna COVID-19 Vaccine fact sheet for recipients and caregivers, and the fact sheet for healthcare providers in languages including: Arabic, Chinese, French, Spanish, Tagalog, and Vietnamese. We will post additional language translations of the fact sheet for recipients and caregivers to this page as we receive the translations.

December 21, 2020 – Coronavirus (COVID-19) Update: December 21, 2020
:: The FDA has posted translations of the Pfizer-BioNTech COVID-19 Vaccine fact sheet for recipients and caregivers in languages including: Arabic, Burmese, Cherokee, Chinese (Simplified and Traditional), Chuukese, German, Haitian Creole, Hindi, Hmong, Korean, Mam, Polish, Portuguese, Russian, Spanish, Somali, Tagalog, Vietnamese, and Yiddish. We will post additional language translations of the fact sheet for recipients and caregivers to this page as we receive the translations.
:: Today, the agency updated its FDA COVID-19 Response At-A-Glance Summary, which provides a quick look at facts, figures, and highlights on the FDA’s response efforts.

FDA – COVID-19 Vaccines [to 26 Dec 2020]
www.fda.gov/covid19vaccines
News and Updates; Upcoming Events
No new digest content identified.

Fondation Merieux [to 26 Dec 2020]
http://www.fondation-merieux.org/
News, Events
Press Releases
No new digest content identified.

Gavi [to 26 Dec 2020]
https://www.gavi.org/
News releases
No new digest content identified.

GHIT Fund [to 26 Dec 2020]
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 26 Dec 2020]
https://www.theglobalfund.org/en/news/
News
Global Fund has awarded $1 billion to support countries’ COVID-19 responses, but funding for this purpose is now fully deployed
22 December 2020
The Global Fund has awarded nearly US$1 billion to 106 countries to support their responses to COVID-19, but has now fully deployed all its funding for this purpose. There are significant further needs for immediate funding, including for personal protective equipment (PPE), testing and treatment, and to mitigate the impact on lifesaving HIV, TB and malaria programs…

News
Denmark, Norway and Sweden Support Global Fund’s COVID-19 Response By Contributing a Total US$45 million
21 December 2020
The Global Fund praises Denmark, Norway and Sweden for allocating a total US$45 million to the Global Fund’s efforts to support low- and middle-income countries to fight COVID-19. Denmark, Norway and Sweden respectively pledged DKK 25 million, NOK 285.2 million and SEK 100 million…

Global Research Collaboration for Infectious Disease Preparedness [GloPID-R] [to 26 Dec 2020]
https://www.glopid-r.org/news/
News
GloPID-R COVID-19 highlights of 2020
22/12/2020
As we approach the end of 2020, GloPID-R would like to thank its members, observers and partners for their collaboration,…

Hilleman Laboratories [to 26 Dec 2020]
http://www.hillemanlabs.org/
No new digest content identified.

Human Vaccines Project [to 26 Dec 2020]
http://www.humanvaccinesproject.org/media/press-releases/
Press Release
Reflections on 2020
Dec 21, 2020

IAVI [to 26 Dec 2020]
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
No new digest content identified.

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

IFRC [to 26 Dec 2020]
http://media.ifrc.org/ifrc/news/press-releases/
Selected Press Releases, Announcements
No new digest content identified.

Institut Pasteur [to 26 Dec 2020]
https://www.pasteur.fr/en/press-area
Press documents
Press Info
19.11.2020
COVID-19: neutralizing immune response lasts longer in women than in men
As part of the SEROCoV-HUS study, teams from Strasbourg University Hospital and the Institut Pasteur monitored 308…

IRC International Rescue Committee [to 26 Dec 2020]
http://www.rescue.org/press-release-index
Media highlights [Selected]
Press Release
Iraq: Amid a recent rise in reported domestic violence cases, IRC warns of a shadow pandemic spreading across the country​
December 22, 2020

IVAC [to 26 Dec 2020]
https://www.jhsph.edu/research/centers-and-institutes/ivac/index.html
Updates; Events
No new digest content identified.

IVI [to 26 Dec 2020]
http://www.ivi.int/
Selected IVI News, Announcements, Events
No new digest content identified.

JEE Alliance [to 26 Dec 2020]
https://www.jeealliance.org/
Selected News and Events
No new digest content identified.

Johns Hopkins Center for Health Security [to 26 Dec 2020]
https://www.centerforhealthsecurity.org/news/center-news/
Center News
Johns Hopkins Center for Health Security and National Organizations Call for Action to Implement Crisis Standards of Care During COVID-19 Surge
December 18, 2020
… The Johns Hopkins Center for Health Security and 8 other national organizations have issued a statement calling for immediate action to implement crisis standards of care (CSC) during the current COVID-19 surge. CSC occur when health care resource shortages – such as staff, hospital beds, and medications – are severe enough to require a change in conventional standards and processes care. Many hospitals and localities are experiencing such shortages now. When limited resources require tough decisions, CSC plans ensure that the most good is done for the largest number of people.
Our joint statement recommends key actions for governors, state health departments, and hospitals and health systems to support, plan for, and equitably implement crisis standards of care. A list of CSC tools and resources is also available. Please take a moment to read our statement today. Urgent action is essential to prevent further loss of life…

MSF/Médecins Sans Frontières [to 26 Dec 2020]
http://www.msf.org/
Latest [Selected Announcements]
Central African Republic
Medical care at arm’s length: the continuous struggle of the people of…
Project Update 24 Dec 2020

Sudan
“Services for the refugees need to increase, otherwise it will be a dis…
Project Update 23 Dec 2020

Mali
Central Mali: no choice but to flee
Project Update 22 Dec 2020

National Vaccine Program Office – U.S. HHS [to 26 Dec 2020]
https://www.hhs.gov/vaccines/about/index.html
Upcoming Meetings/Latest Updates
No new digest content identified.

NIH [to 26 Dec 2020]
http://www.nih.gov/news-events/news-releases
News Releases
Results of NIH-sponsored ACTIV-3 trial published
December 22, 2020 — Experimental monoclonal antibody not efficacious in Phase 3 trial.
Preliminary results of a Phase 3, randomized, placebo-controlled clinical trial testing the investigative monoclonal antibody LY-CoV555 in hospitalized COVID-19 patients were published today in The New England Journal of Medicine. The antibody did not provide clinical benefit compared to placebo. The trial, which had been halted to new enrollment in late October following a recommendation by the independent Data and Safety Monitoring Board (DSMB), is part of the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) program. The trial is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health…

Pregnant women in third trimester unlikely to pass SARS-CoV-2 infection to newborns
December 22, 2020 — NIH-funded findings also suggest less-than-expected transfer of maternal SARS-CoV-2 antibodies through placenta.

NIH holds COVID-19 vaccine kick-off event
December 21, 2020 — NIH Clinical Center front-line workers, Azar, Collins, Fauci to receive doses from agency’s initial stock.

NIH funds eight studies to uncover risk factors for COVID-19-related inflammatory syndrome in children
December 21, 2020 — Awards part of a larger effort to study pediatric COVID-19 and related conditions.

NIH to support radical approaches to nationwide COVID-19 testing and surveillance
December 21, 2020 — RADx-rad program will fund non-traditional and repurposed technologies to combat the current pandemic and address future viral disease outbreaks.
The National Institutes of Health has awarded over $107 million to support new, non-traditional approaches and reimagined uses of existing tools to address gaps in COVID-19 testing and surveillance. The program also will develop platforms that can be deployed in future outbreaks of COVID-19 and other infectious diseases. A part of the Rapid Acceleration of Diagnostics (RADx) initiative, the awards from the RADx Radical (RADx-rad) program will support 49 research projects and grant supplements at 43 institutions across the United States. It will focus on non-traditional viral screening approaches, such as biological or physiological markers, new analytical platforms with novel chemistries or engineering, rapid detection strategies, point-of-care devices, and home-based testing technologies.
“To solve a problem as complicated as COVID-19, we need ideas, tools, and technologies that challenge the way we think about pandemic control,” said NIH Director Francis S. Collins, M.D., Ph.D. “These awards from the RADx-rad program provide superb examples of outside-the-box concepts that will help us overcome this pandemic and give us a cadre of devices and tactics to confront future outbreaks.”…

PATH [to 26 Dec 2020]
https://www.path.org/media-center/
Press Release
No new digest content identified.

Rand [to 26 Dec 2020]
https://www.rand.org/pubs.html
Selected Research Reports/Journal Articles
Research Brief
The economic benefits of equitable global access to COVID-19 vaccines
Researchers used a global macroeconomic model to examine the economic effects of vaccine nationalism. This brief highlights the cost to 30 high-income countries if low and middle-income countries miss out on initial access to COVID-19 vaccines.
Dec 17, 2020
Marco Hafner, Erez Yerushalmi, Clement Fays, Eliane Dufresne, Christian Van Stolk

Sabin Vaccine Institute [to 26 Dec 2020]
http://www.sabin.org/updates/pressreleases
Statements and Press Releases
No new digest content identified.

UNAIDS [to 26 Dec 2020]
http://www.unaids.org/en
Selected Press Releases/Reports/Statements
Joint statement calling for urgent country scale-up of access to optimal HIV treatment for infants and children living with HIV
22 December 2020
Global partners that are committed to ending paediatric AIDS have come together to call on countries to rapidly scale up access to optimal, child-friendly HIV treatment for infants and children. The partners include the United Nations Children’s Fund, the World Health Organization (WHO), UNAIDS, the United States President’s Emergency Plan for AIDS Relief, the Global Fund to Fight AIDS, Tuberculosis and Malaria, Unitaid, the Elizabeth Glaser Pediatric AIDS Foundation, and the Clinton Health Access Initiative (CHAI).
Children living with HIV continue to be left behind by the global AIDS response. In 2019, only 53% (950 000) of the 1.8 million children living with HIV (aged 0–14 years) globally were diagnosed and on treatment, compared to 68% of adults. [1] The remaining 850 000 children living with HIV have not been diagnosed and are not receiving life-saving HIV treatment. Two thirds of the missing children are aged 5–14 years and do not routinely attend traditional health facilities. Engaging communities and the families of people living with HIV, tuberculosis and other related diseases and offering family services are needed in order to find and start on treatment those missing children.
An estimated 95 000 children died of AIDS-related illnesses in 2019, in part due to lack of early diagnosis of HIV among infants and children and immediate linkage to optimal HIV treatment regimens. Untreated, 50% of infants infected with HIV during or around the time of birth will die before the age of two years. [1]…

UNICEF [to 26 Dec 2020]
https://www.unicef.org/media/press-releases
Selected Press releases, Statements
Press release
12/22/2020
Mozambique: Malnutrition and deadly diseases threaten 250,000 displaced children in Cabo Delgado province as the rainy season starts

News note
UNICEF and the World Economic Forum sign charter with 18 shipping, airlines and logistics companies to deliver COVID-19 vaccines
NEW YORK/ WASHINGTON DC,  21 December 2020 —The unprecedented magnitude of the pandemic requires innovative and bold collective action from multinational organizations, governments and industries for inclusive and efficient distribution of safe vaccines. With lives and livelihoods of millions across the globe depending on multiple stakeholders harnessing the power of collective action – whether in the field of health delivery, goods delivery or humanitarian service delivery, the logistics sector and UNICEF will play a central role in vaccine distribution.
Recognizing this need, 18 shipping, airlines and logistics industry CEOs, the Executive Director of UNICEF, and the President of the World Economic Forum, have signed a charter supporting UNICEF and COVAX countries in four main ways:
[1] Engage with governments, customs authorities, UNICEF and other UN Agencies, and NGOs;
[2] Participate in operational asset and competency sharing
[3] Assign expertise to support governments, where requested by UNICEF
[4] Support UNICEF’s Global Vaccine Logistics Distribution, for COVID-19, with prioritization and solutions for international and in country distribution of vaccines and related supplies on behalf of the COVAX facility

News note
12/21/2020
UNICEF launches the COVID-19 vaccine market dashboard
As the designated COVAX procurement coordinator and procurement agent, UNICEF has launched the COVID-19 Vaccine Market Dashboard – an interactive tool for countries, partners and industry to follow the developments of the rapidly evolving COVID-19 vaccine market and the efforts of the COVAX Facility to ensure fair and equitable access for every country in the world.
In this first release, the dashboard provides a regularly updated overview of the global research and development pipeline, the projected production capacity, publicly announced bilateral and multilateral supply agreements, as well as reported price points…

Unitaid [to 26 Dec 2020]
https://unitaid.org/
Featured News
22 December 2020
Unitaid welcomes US$40 million from Norway to fight COVID-19
Geneva – Unitaid is pleased to welcome a contribution of NOK 350 million (US$40 million) from Norway towards its vital work on COVID-19 treatments and tests.
As a founding member of Unitaid, Norway has been a longstanding supporter of its efforts to bring forward life-saving global health innovations.
This funding will enable Unitaid to advance the development and equitable access to therapeutics and diagnostics for COVID-19 in low- and middle-income countries, under the umbrella of the global Access to COVID Tools Accelerator (ACT-A).
The focus will be twofold: firstly, collaborating with FIND and industry partners to push forward the development of high-quality, affordable self-tests for COVID-19 that are suitable for use in low-resource settings.
Secondly, Unitaid will work with ACT-A partners to adapt COVID-19 treatments and initiate country preparedness for promising treatments such as monoclonal antibodies…

Vaccination Acceptance Research Network (VARN) [to 26 Dec 2020]
https://vaccineacceptance.org/news.html#header1-2r
Announcements
No new digest content identified.

Vaccine Confidence Project [to 26 Dec 2020]
http://www.vaccineconfidence.org/
News, Research and Reports
No new digest content identified.

Vaccine Education Center – Children’s Hospital of Philadelphia [to 26 Dec 2020]
http://www.chop.edu/centers-programs/vaccine-education-center
News
COVID RESOURCES
:: A Look at Each Vaccine: COVID-19 Vaccine
https://www.chop.edu/centers-programs/vaccine-education-center/vaccine-details/covid-19-vaccine

:: COVID-19 MRNA VACCINES: WHAT YOU SHOULD KNOW
https://media.chop.edu/data/files/pdfs/vaccine-education-center-covid-qa.pdf

:: Questions and Answers about COVID-19 Vaccines
https://www.chop.edu/centers-programs/vaccine-education-center/making-vaccines/prevent-covid

Wellcome Trust [to 26 Dec 2020]
https://wellcome.ac.uk/news
News
No new digest content identified.

The Wistar Institute [to 26 Dec 2020]
https://www.wistar.org/news/press-releases
Press Releases
Dec. 23, 2020
Wistar Reports New Class of Antibiotics Active Against a Wide Range of Bacteria
Dual-acting immuno-antibiotics block an essential pathway in bacteria and activate the adaptive immune response.

WFPHA: World Federation of Public Health Associations [to 26 Dec 2020]
https://www.wfpha.org/
Latest News
Rejecting All Collaborations of Public Health Organizations with the Tobacco Industry
Dec 22, 2020
The tobacco epidemic is an urgent public health concern, with tobacco use responsible for more than 8 million deaths annually. In 2003, the World Health Assembly…

World Organisation for Animal Health (OIE) [to 26 Dec 2020]
https://www.oie.int/en/for-the-media/press-releases/2020/
No new digest content identified.

::::::

ARM [Alliance for Regenerative Medicine] [to 26 Dec 2020]
https://alliancerm.org/
Press Releases
No new digest content identified.

BIO [to 26 Dec 2020]
https://www.bio.org/press-releases
Press Releases
Modernizing Oversight of Animal Biotechnology Will Help Tackle Climate Change and Nutrition Challenges
December 21, 2020
The Biotechnology Innovation Organization (BIO) appreciates the U.S. Department of Agriculture’s (USDA) longstanding commitment to food and agricultural innovation and looks forward to reviewing the Advanced Notice of Proposed Rulemaking (ANPR) aimed at restructuring the U.S. regulatory system for animal biotechnology…

DCVMN – Developing Country Vaccine Manufacturers Network [to 26 Dec 2020]
http://www.dcvmn.org/
News; Upcoming events
No new digest content identified.

ICBA – International Council of Biotechnology Associations [to 26 Dec 2020]
https://internationalbiotech.org/news/
News
No new digest content identified.

IFPMA [to 26 Dec 2020]
http://www.ifpma.org/resources/news-releases/
Selected Press Releases, Statements, Publications
No new digest content identified.

PhRMA [to 26 Dec 2020]
http://www.phrma.org/
Selected Press Releases, Statements
American biopharmaceutical manufacturing: Fueling economic growth now and for years to come
December 21, 2020
As the world has grappled with the current pandemic, there has been increased focus on biopharmaceutical manufacturing and its global supply chain. Many wondered whether the biopharmaceutical industry could ensure continued and uninterrupted supply of innovative medicines relied on by so many Americans, as well as develop and supply new treatments and vaccines to address the pandemic. We are nearly a year into this public health crisis, and the biopharmaceutical manufacturing industry has stepped up to help beat COVID-19 in more ways than one. A new report from TEConomy Partners takes a closer look at what makes the U.S. biopharmaceutical manufacturing industry so globally competitive…

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

AMA Journal of Ethics
Volume 22, Number 12: E981-1070
https://journalofethics.ama-assn.org/issue/socially-situated-brain-death

Socially Situated Brain Death
In 1980, the Uniform Determination of Death Act (UDDA) defined death as “(1) irreversible cessation of circulatory and respiratory functions, or (2) irreversible cessation of all functions of the entire brain, including the brain stem … in accordance with accepted medical standards.” Interpreting the UDDA definition and applying neurological criteria for diagnosing brain death sound straightforward. Brain death is, however, socially situated, not observer independent, and fraught with uncertainty and ambiguity. This issue investigates some of the ethical, cultural, and legal complexities of one of medicine’s most critical tasks: being sharp and sure about who is alive and who is dead.
Full Issue PDF

Annals of Internal Medicine
15 December 2020 Volume 173, Issue 12
http://annals.org/aim/issue

Original Research
Attitudes Toward a Potential SARS-CoV-2 Vaccine – A Survey of U.S. Adults
FREE
Kimberly A. Fisher, MD, MSc, Sarah J. Bloomstone, BA, Jeremy Walder, DO, … et al.
Pages:964–973
Once a COVID-19 vaccine becomes available, maximizing uptake and coverage will be important. This national survey explored factors associated with vaccine hesitancy. The results suggest that multipronged efforts will be needed to increase acceptance of the vaccine

Annals of Internal Medicine
15 December 2020 Volume 173, Issue 12
http://annals.org/aim/issue

Editorials
SARS-CoV-2 Vaccine Acceptance: We May Need to Choose Our Battles
Alison M. Buttenheim, PhD, MBA
Pages:1018–1019
Fisher and colleagues reported a U.S. survey in which about 6 in 10 respondents intend to receive a COVID-19 vaccine when it becomes available. The editorialist discusses why closing the intention-to-behavior gap is likely to have population health benefit.

The CRISPR Journal
Volume 3, Issue 6 / December 2020
https://www.liebertpub.com/toc/crispr/3/6

Perspective Free
Heritable Human Genome Editing: The Public Engagement Imperative
Eli Y. Adashi, et al
Pages:434–439
Published Online:17 December 2020
https://doi.org/10.1089/crispr.2020.0049
Abstract
In the view of many, heritable human genome editing (HHGE) harbors the remedial potential of ridding the world of deadly genetic diseases. A Hippocratic obligation, if there ever was one, HHGE is widely viewed as a life-sustaining proposition. The national go/no-go decision regarding the implementation of HHGE, however, must not, in the collective view of the authors, proceed absent thorough public engagement. A comparable call for an “extensive societal dialogue” was recently issued by the International Commission on the Clinical Use of Human Germline Genome Editing. In this communication, the authors lay out the foundational principles undergirding the formation, modification, and evaluation of public opinion. It is against this backdrop that the societal decision to warrant or enjoin the clinical conduct of HHGE will doubtlessly transpire.

Disaster Medicine and Public Health Preparedness
Volume 14 – Issue 5 – October 2020
https://www.cambridge.org/core/journals/disaster-medicine-and-public-health-preparedness/latest-issue

Systematic Review
Data Collection Tools for Maternal and Child Health in Humanitarian Emergencies: An Updated Systematic Review
Juliana Lima Constantino, Fernanda Dias Romeiro, Theresa Diaz, Allisyn C Moran, Cynthia Boschi-Pinto
Published online by Cambridge University Press: 10 December 2019, pp. 601-619
Abstract
The worst rates of preventable mortality and morbidity among women and children occur in humanitarian settings. Reliable, easy-to-use, standardized, and efficient tools for data collection are needed to enable different organizations to plan and act in the most effective way. In 2015, the World Health Organization (WHO) commissioned a review of tools for data collection on the health of women and children in humanitarian emergencies. An update of this review was conducted to investigate whether the recommendations made were taken forward and to identify newly developed tools. Fifty-three studies and 5 new tools were identified. Only 1 study used 1 of the tools identified in our search. Little has been done in terms of the previous recommendations. Authors may not be aware of the availability of such tools and of the importance of documenting their data using the same methods as other researchers. Currently used tools may not be suitable for use in humanitarian settings or may not include the domains of the authors’ interests. The development of standardized instruments should be done with all key workers in the area and could be coordinated by the WHO.

Disaster Medicine and Public Health Preparedness
Volume 14 – Issue 5 – October 2020
https://www.cambridge.org/core/journals/disaster-medicine-and-public-health-preparedness/latest-issue

Report from the Field
Developing a Public Health Monitoring System in a War-torn Region: A Field Report From Iraqi Kurdistan
Stefania Moramarco, Faiq B. Basa, Haveen H. Alsilefanee, Sivar A. Qadir, Leonardo Emberti Gialloreti
Published online by Cambridge University Press: 05 November 2019, pp. 620-622

Epidemics
Volume 33 December 2020
https://www.sciencedirect.com/journal/epidemics/vol/33/suppl/C

Review article Open access
Deriving risk maps from epidemiological models of vector borne diseases: State-of-the-art and suggestions for best practice
Yanchao Cheng, Nils Benjamin Tjaden, Anja Jaeschke, Stephanie Margarete Thomas, Carl Beierkuhnlein
Article 100411

Epidemics
Volume 33 December 2020
https://www.sciencedirect.com/journal/epidemics/vol/33/suppl/C

Review article Open access
Responsible modelling: Unit testing for infectious disease epidemiology
Tim C.D. Lucas, Timothy M Pollington, Emma L Davis, T Déirdre Hollingsworth
Article 100425

Global Health: Science and Practice (GHSP)
Vol. 8, No. 4 December 23, 2020
http://www.ghspjournal.org/content/current

ORIGINAL ARTICLES
Health Care Worker Preferences and Perspectives on Doses per Container for 2 Lyophilized Vaccines in Senegal, Vietnam, and Zambia
Natasha Kanagat, Kirstin Krudwig, Karen A. Wilkins, Sydney Kaweme, Guissimon Phiri, Frances D. Mwansa, Mercy Mvundura, Joanie Robertson, Debra Kristensen, Abdoulaye Gueye, Sang D. Dao, Pham Q. Thai, Huyen T. Nguyen and Thang C. Tran
Global Health: Science and Practice December 2020, 8(4):680-688; https://doi.org/10.9745/GHSP-D-20-00112
When providing immunization services, health care workers balance the mandate of achieving high coverage with limiting vaccine wastage. Workers in 3 countries said that containers with fewer vaccine doses for measles and BCG would enable them to immunize all children who present, while reducing concerns about wasting vaccine.

Health Policy and Planning
Volume 35, Issue Supplement_2, November 2020
https://academic.oup.com/heapol/issue/35/Supplement_2

SUPPLEMENT
Innovations in Implementation Research in Low- and Middle-Income Countries
Editorial
Implementation research in LMICs—evolution through innovation
Kabir Sheikh, James Hargreaves, Mishal Khan, Sandra Mounier-Jack
Extract
Major global health gains can be achieved by strengthening the delivery of public health policies and programmes in low- and middle-income countries (LMICs). The population impact of evidence-based technologies and interventions such as drugs, vaccines and health know-how can only be maximized where programmes optimally identify and reach target populations and support them to take up and sustain their effective use. Examples include significant gaps in the coverage and quality of maternal health, newborn, immunization, non-communicable disease, primary care and adolescent sexual and reproductive health services—all issues tackled in this supplement. While structural change…

Health Policy and Planning
Volume 35, Issue Supplement_2, November 2020
https://academic.oup.com/heapol/issue/35/Supplement_2

Supplement Articles
How to evaluate the implementation of complex health programmes in low-income settings: the approach of the Gavi Full Country Evaluations
Caroline Soi, Jessica C Shearer, Ashwin Budden, Emily Carnahan, Nicole Salisbury …
Health Policy and Planning, Volume 35, Issue Supplement_2, November 2020, Pages ii35–ii46, https://doi.org/10.1093/heapol/czaa127
Abstract
Vaccination, like most other public health services, relies on a complex package of intervention components, functioning systems and committed actors to achieve universal coverage. Despite significant investment in immunization programmes, national coverage trends have slowed and equity gaps have grown. This paper describes the design and implementation of the Gavi Full Country Evaluations, a multi-country, prospective, mixed-methods approach whose goal was to monitor and evaluate processes, inputs, outputs and outcomes of immunization programmes in Bangladesh, Mozambique, Uganda and Zambia. We implemented the Full Country Evaluations from 2013 to 2018 with the goal of identifying the drivers of immunization programme improvement to support programme implementation and increase equitable immunization coverage. The framework supported methodological and paradigmatic flexibility to respond to a broad range of evaluation and implementation research questions at global, national and cross-country levels, but was primarily underpinned by a focus on evaluating processes and identifying the root causes of implementation breakdowns. Process evaluation was driven by theories of change for each Gavi funding stream (e.g. Health Systems Strengthening) or activity, ranging from global policy development to district-level programme implementation. Mixing of methods increased in relevance and rigour over time as we learned to build multiple methods into increasingly tailored evaluation questions. Evaluation teams in country-based research institutes increasingly strengthened their level of embeddedness with immunization programmes as the emphasis shifted over time to focus more heavily on the use of findings for programme learning and adaptation. Based on our experiences implementing this approach, we recommend it for the evaluation of other complex interventions, health programmes or development assistance.

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
December 22/29, 2020, Vol 324, No. 24, Pages 2467-2566
https://jamanetwork.com/journals/jama/currentissue

Viewpoint
Accelerating Global Improvements in Health Care Quality
Sheila Leatherman, MSW; Donald M. Berwick, MD, MPP
free access has multimedia
JAMA. 2020;324(24):2479-2480. doi:10.1001/jama.2020.17628
This Viewpoint proposes a policy framework for thinking about health care quality in low- and middle-income countries, emphasizing the importance of infrastructure, enforceable quality standards, safety practices, guideline-directed clinical care, and patient and family involvement.

JAMA
December 22/29, 2020, Vol 324, No. 24, Pages 2467-2566
https://jamanetwork.com/journals/jama/currentissue

Health Agencies Update
December 22/29, 2020
More Transparency Needed for COVID-19 Emergency Authorizations
Rita Rubin, MA
JAMA. 2020;324(24):2475. doi:10.1001/jama.2020.24201
To improve public trust, the US Food and Drug Administration (FDA) should be more transparent in publicly disclosing its reviews of safety and effectiveness data leading to Emergency Use Authorization (EUA) of coronavirus disease 2019 (COVID-19) vaccines and treatments, according to a recent report from the US Government Accountability Office (GAO)…

JAMA Network
COVID-19 Update December 26, 2020

These articles on COVID-19 were published across the JAMA Network in the last week.
Selected Articles
[No digest content identified]

Journal of Travel Medicine
Volume 27, Issue 8, December 2020

Perspectives
The International Health Regulations (2005) and the re-establishment of international travel amidst the COVID-19 pandemic
Barbara J von Tigerstrom, PhD, Sam F Halabi, JD, Kumanan R Wilson, MD
Journal of Travel Medicine, Volume 27, Issue 8, December 2020, taaa127, https://doi.org/10.1093/jtm/taaa127
As countries modify or lift travel restrictions implemented in response to the COVID-19 pandemic, some variation in approaches is to be expected, but harmonization is important to re-establishing international travel. Despite challenges, the International Health Regulations (2005) and WHO recommendations can provide a balance of consistency and flexibility.

Journal of Travel Medicine
Volume 27, Issue 8, December 2020

Call to avert acceleration of COVID-19 from India’s Sabarimala pilgrimage of 25 million devotees
K Rajasekharan Nayar, Shaffi Fazaludeen Koya, Venkitesh Ramakrishnan, Arathi P Rao, Gnanaseelan Kanakamma Libu …
Journal of Travel Medicine, Volume 27, Issue 8, December 2020, taaa153, https://doi.org/10.1093/jtm/taaa153
India has the third-highest COVID-19 burden. Hosting the Sabarimala pilgrimage of an estimated 25 million can compromise the near-mitigated but fragile COVID-19 status of the host State of Kerala, accelerate the ongoing outbreaks in other states of India, and potentially in multiple countries with emigrants from Kerala.

Journal of Travel Medicine
Volume 27, Issue 8, December 2020

Public health emergencies of international concern: a historic overview
Annelies Wilder-Smith, MD, Sarah Osman, MPH
Journal of Travel Medicine, Volume 27, Issue 8, December 2020, taaa227, https://doi.org/10.1093/jtm/taaa227
Abstract
Rationale
The International Health Regulations (IHR) have been the governing framework for global health security since 2007. Declaring public health emergencies of international concern (PHEIC) is a cornerstone of the IHR. Here we review how PHEIC are formally declared, the diseases for which such declarations have been made from 2007 to 2020 and justifications for such declarations.
Key findings
Six events were declared PHEIC between 2007 and 2020: the 2009 H1N1 influenza pandemic, Ebola (West African outbreak 2013–2015, outbreak in Democratic Republic of Congo 2018–2020), poliomyelitis (2014 to present), Zika (2016) and COVID-19 (2020 to present). Poliomyelitis is the longest PHEIC. Zika was the first PHEIC for an arboviral disease. For several other emerging diseases a PHEIC was not declared despite the fact that the public health impact of the event was considered serious and associated with potential for international spread.
Recommendations
The binary nature of a PHEIC declaration is often not helpful for events where a tiered or graded approach is needed. The strength of PHEIC declarations is the ability to rapidly mobilize international coordination, streamline funding and accelerate the advancement of the development of vaccines, therapeutics and diagnostics under emergency use authorization. The ultimate purpose of such declaration is to catalyse timely evidence-based action, to limit the public health and societal impacts of emerging and re-emerging disease risks while preventing unwarranted travel and trade restrictions.

Journal of Travel Medicine
Volume 27, Issue 8, December 2020

Use of face masks and other personal preventive measures by Hajj pilgrims and their impact on health problems during the Hajj
Abrar K Alasmari, PhD, Phil J Edwards, PhD, Abdullah M Assiri, MD, Ronald H Behrens, MD, Amaya L Bustinduy, PhD
Journal of Travel Medicine, Volume 27, Issue 8, December 2020, taaa155, https://doi.org/10.1093/jtm/taaa155

Journal of Travel Medicine
Volume 27, Issue 8, December 2020

Estimating the COVID-19 risk during the Hajj pilgrimage
Anas Khan, MD, Kingsley Lezor Bieh, MSc, Ahmed El-Ganainy, MD, Sujoud Ghallab, MBBS, Abdullah Assiri, MD …
Journal of Travel Medicine, Volume 27, Issue 8, December 2020, taaa157, https://doi.org/10.1093/jtm/taaa157

Nature
Volume 588 Issue 7839, 24 December 2020
http://www.nature.com/nature/current_issue.html

2020: the year in review
Editorial | 22 December 2020
A review of 2020 through Nature’s editorials
From the COVID pandemic to a momentous US election, Nature’s editorials provide a lens through which to view an extraordinary year.

Nature
Volume 588 Issue 7839, 24 December 2020
http://www.nature.com/nature/current_issue.html

News Feature | 15 December 2020
Nature’s 10: ten people who helped shape science in 2020
A COVID vaccine developer, an Arctic voyager and a prime minister are some of the people behind the year’s big research stories.
David Cyranoski, Elie Dolgin[…] & Nidhi Subbaraman

Nature
Volume 588 Issue 7839, 24 December 2020
http://www.nature.com/nature/current_issue.html

Editorial | 15 December 2020
Nature’s 10: the human stories behind an extraordinary year in science
Ten profiles illustrate an unforgettable year that propelled research teams to the front of the world’s stage.

Nature
Volume 588 Issue 7839, 24 December 2020
http://www.nature.com/nature/current_issue.html

News | 14 December 2020
Arab nations first to approve Chinese COVID vaccine — despite lack of public data
The United Arab Emirates and Bahrain say the vaccine is 86% effective, but scientists would like to see data to support the claim.
David Cyranoski
Two Arab nations have become the first countries to approve a Chinese COVID-19 vaccine, a significant boost for China’s plans to roll out its vaccines worldwide. The United Arab Emirates (UAE) approved a vaccine developed by Chinese state-owned Sinopharm on 9 December, and Bahrain followed days later. But researchers say a lack of public data on the safety and efficacy of the vaccine could hinder the company’s plans to distribute the vaccine in a range of other countries…

Nature
Volume 588 Issue 7839, 24 December 2020
http://www.nature.com/nature/current_issue.html

Comment | 17 December 2020
The WHO’s chief scientist on a year of loss and learning
The head of scientific work at the World Health Organization reflects on the agency’s challenges and achievements as it navigates the COVID pandemic.
Soumya Swaminathan

Nature
Volume 588 Issue 7839, 24 December 2020
http://www.nature.com/nature/current_issue.html

Correspondence | 18 December 2020
Science advisers around the world on 2020
Seven government researchers who helped to guide their governments’ responses to the COVID-19 pandemic speak out.
Gordon Awandare, Emmanuel André[…] & Mona Nemer

PharmacoEconomics
Volume 38, issue 12, December 2020
https://link.springer.com/journal/40273/volumes-and-issues/38-12

Articles
Recalibrating Health Technology Assessment Methods for Cell and Gene Therapies
Authors
Aris Angelis, Huseyin Naci, Allan Hackshaw, Content type: Practical Application
Published: 22 September 2020
Pages: 1297 – 1308
Abstract
Recently licensed cell and gene therapies have promising but highly uncertain clinical benefits. They are entering the market at very high prices, with the latest entrants costing hundreds of thousands of dollars. The significant long-term uncertainty posed by these therapies has already complicated the use of conventional economic evaluation approaches such as cost-effectiveness and cost-utility analyses, which are widely used for assessing the value of new health interventions. Cell and gene therapies also risk jeopardising healthcare systems’ financial sustainability. As a result, there is a need to recalibrate the current health technology assessment methods used to measure and compensate their value. In this paper, we outline a set of technical adaptations and methodological refinements to address key challenges in the appraisal of cell and gene therapies’ value, including the assessment of efficiency and affordability. We also discuss the potential role of alternative financing mechanisms. Ultimately, uncertainties associated with cell and gene therapies can only be meaningfully addressed by improving the evidence base supporting their approval and adoption in healthcare systems.

PLoS One
http://www.plosone.org/
[Accessed 26 Dec 2020]

A cost/benefit analysis of clinical trial designs for COVID-19 vaccine candidates
Donald A. Berry, Scott Berry, Peter Hale, Leah Isakov, Andrew W. Lo, Kien Wei Siah, Chi Heem Wong
Research Article | published 23 Dec 2020 PLOS ONE
https://doi.org/10.1371/journal.pone.0244418
Abstract
We compare and contrast the expected duration and number of infections and deaths averted among several designs for clinical trials of COVID-19 vaccine candidates, including traditional and adaptive randomized clinical trials and human challenge trials. Using epidemiological models calibrated to the current pandemic, we simulate the time course of each clinical trial design for 756 unique combinations of parameters, allowing us to determine which trial design is most effective for a given scenario. A human challenge trial provides maximal net benefits—averting an additional 1.1M infections and 8,000 deaths in the U.S. compared to the next best clinical trial design—if its set-up time is short or the pandemic spreads slowly. In most of the other cases, an adaptive trial provides greater net benefits.

PLoS One
http://www.plosone.org/
[Accessed 26 Dec 2020]

Americans’ perceptions of privacy and surveillance in the COVID-19 pandemic
Baobao Zhang, Sarah Kreps, Nina McMurry, R. Miles McCain
Research Article | published 23 Dec 2020 PLOS ONE
https://doi.org/10.1371/journal.pone.0242652

PLoS One
http://www.plosone.org/
[Accessed 26 Dec 2020]

Public policy and economic dynamics of COVID-19 spread: A mathematical modeling study
Uri Goldsztejn, David Schwartzman, Arye Nehorai
Research Article | published 22 Dec 2020 PLOS ONE
https://doi.org/10.1371/journal.pone.0244174

PLoS One
http://www.plosone.org/
[Accessed 26 Dec 2020]

Decreased diarrheal and respiratory disease in HIV exposed uninfected children following vaccination with rotavirus and pneumococcal conjugate vaccines
Gbolahan Ajibola, Kara Bennett, Kathleen M. Powis, Michael D. Hughes, Jean Leidner, Samuel Kgole, Oganne Batlang, Mompati Mmalane, Joseph Makhema, Shahin Lockman, Roger Shapiro
Research Article | published 21 Dec 2020 PLOS ONE
https://doi.org/10.1371/journal.pone.0244100

Public Health
Volume 189 Pages 1-162 (December 2020)
https://www.sciencedirect.com/journal/public-health/vol/189/suppl/C

Review article Full text access
Psychological impact of infectious disease outbreaks on pregnant women: rapid evidence review
S.K. Brooks, D. Weston, N. Greenberg
Pages 26-36

Public Health
Volume 189 Pages 1-162 (December 2020)
https://www.sciencedirect.com/journal/public-health/vol/189/suppl/C

Letter to the Editor
Correspondence Full text access
Delays in polio vaccination programs due to COVID-19 in Pakistan: a major threat to Pakistan’s long war against polio virus
M. Din, M. Asghar, M. Ali
Pages 1-2

Public Health Ethics
Volume 13, Issue 3, November 2020
http://phe.oxfordjournals.org/content/current

Original Articles
Against the Public Goods Conception of Public Health
Justin Bernstein, Pierce Randall
Public Health Ethics, Volume 13, Issue 3, November 2020, Pages 225–233, https://doi.org/10.1093/phe/phaa021

Revista Panamericana de Salud Pública/Pan American Journal of Public Health (RPSP/PAJPH)
https://www.paho.org/journal/en

23 Dec 2020
The landscape of COVID-19 clinical trials in Latin America and the Caribbean: assessment and challenges
Current topic | English |
21 Dec 2020
Carracedo et al.
A considerable number of clinical trials is being conducted globally in response to the COVID-19 pandemic, including in low- and middle-income countries such as those in the Latin America and Caribbean region (LAC). Yet, an abundance of studies does not necessarily shorten the path to find safe and efficacious interventions for COVID-19. We analyze the trials for COVID-19 treatment and prevention that are registered from LAC countries in the International Clinical Trials Registry Platform, and identify a trend towards small repetitive non-rigorous studies that duplicate efforts and drain limited resources without producing meaningful conclusions on the safety and efficacy of the interventions being tested. We further assess the challenges to conducting scientifically sound and socially valuable research in the LAC region in order to inform recommendations to encourage clinical trials that are most likely to produce robust evidence during the pandemic.

Revista Panamericana de Salud Pública/Pan American Journal of Public Health (RPSP/PAJPH)
https://www.paho.org/journal/en

Large scale use of SARS-CoV-2 antigen-based detection tests: a three-month experience in Guatemala, June-August 2020
Brief communication | English |

Social Science & Medicine
Volume 266 December 2020
https://www.sciencedirect.com/journal/social-science-and-medicine/vol/266/suppl/C

Review article Full text access
Health risks and outcomes that disproportionately affect women during the Covid-19 pandemic: A review
Jade Connor, Sarina Madhavan, Mugdha Mokashi, Hanna Amanuel, … Deborah Bartz
Article 113364

Social Science & Medicine
Volume 266 December 2020
https://www.sciencedirect.com/journal/social-science-and-medicine/vol/266/suppl/C

Short communication Full text access
Physicians’ rhetorical strategies for motivating HPV vaccination
Melissa B. Gilkey, Brigid K. Grabert, Teri L. Malo, Megan E. Hall, Noel T. Brewer
Article 113441

Vaccines — Open Access Journal
http://www.mdpi.com/journal/vaccines
(Accessed 26 Dec 2020)

Open Access Editorial
Genomic Medicine and Advances in Vaccine Technology and Development in the Developing and Developed World
by Rossella Cianci and Laura Franza
Vaccines 2021, 9(1), 9; https://doi.org/10.3390/vaccines9010009 – 24 Dec 2020

Vaccines — Open Access Journal
http://www.mdpi.com/journal/vaccines
(Accessed 26 Dec 2020)

Open Access Article
Sustained Vaccination Coverage during the Coronavirus Disease 2019 Epidemic in the Republic of Korea
by Jeong Hee Yu et al
Vaccines 2021, 9(1), 2; https://doi.org/10.3390/vaccines9010002 – 22 Dec 2020
Abstract
Amid the COVID-19 pandemic, vaccination coverage may decline due to limited accessibility to healthcare. We assessed the impact of the COVID-19 pandemic on vaccination coverage and the incidence of vaccine-preventable diseases (VPDs) in the Republic of Korea. National vaccination coverage of 10 essential vaccines administered to children between January–June 2019 and January–June 2020 was analyzed. The national incidence of selected VPDs was compared for the corresponding periods. During the COVID-19 outbreak, the vaccination rate in children aged 0–35 months in Korea did not decrease significantly, whereas the vaccination rate for children aged 4–6 years decreased by 1.4–1.9%. The overall incidence of VPDs decreased by 10–50% between 2019 and 2020, especially with varicella. Thus, the COVID-19 pandemic did not result in a decrease in vaccination coverage among Korean children, which prevented a surge in VPD incidence. Maintaining essential vaccination coverage without interruption is important during the response to the COVID-19 pandemic.

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 26 Dec 2020
Ideas
Anti-vaxxers Think This Is Their Moment
Society’s well-being depends on how well public-health officials and average internet users combat misinformation.
December 20, 2020
Renée DiResta
Technical research manager at the Stanford Internet Observatory

BBC
http://www.bbc.co.uk/
Accessed 26 Dec 2020
[No new, unique, relevant content]

The Economist
http://www.economist.com/
Accessed 26 Dec 2020
[No new, unique, relevant content]

Financial Times
https://www.ft.com/
Accessed 26 Dec 2020
Hong Kong
Hong Kong faces public scepticism over mainland Chinese jabs
December 27, 2020
Hong Kong’s preparations for a coronavirus vaccine have become the latest battleground between its government and part of the public sceptical about Beijing’s rising influence in the city. A year after Hong Kong experienced its worst anti-government protests in more than two decades, the administration of Hong Kong’s leader Carrie Lam is facing a struggle to convince citizens it will not force them to take vaccines developed in mainland China. “The political situation in Hong Kong is very sensitive so the Hong Kong government is trying to play this very carefully,” said Ronny Tong, a top adviser to Ms Lam, in an interview with the Financial Times.

The FT View
The editorial board
Triumph of science is cause for festive cheer
December 24, 2020

Coronavirus treatment
UK vaccine lottery ‘overlooks’ vulnerable minorities
Emphasis on over-80s leads to concerns about fairness and efficiency of programme
December 24, 2020
Bottom of Form

Forbes
http://www.forbes.com/
Accessed 26 Dec 2020
Dec 26, 2020
Hawaii Begins Public Debate Over Whether To Allow Vaccinated Travelers To Skip Quarantine
How will the vaccine be implemented into the travel industry? Hawaii has started to talk about it.
By Will McGough Contributor

Dec 24, 2020
The Vaccination Rollout Will Only Work If It’s Driven By Technology
Verifying who is vaccinated and who is not should mean creating apps, secure and reliable databases, scannable codes, authenticated and unbreakable record keeping, and above all, communication between different systems at different levels and across different countries.
By Enrique Dans Senior Contributor

Dec 23, 2020
Singapore Airlines Launches Digital Verification Of COVID-19 Testing And Vaccination
New COVID-19 vaccines reaching the market are shaping the way in which travelers will soon take to the skies.
By Grant Martin Contributor

Dec 22, 2020
DeSantis Will Not Prioritize Florida’s Essential Workers For Covid Vaccine, Breaking With CDC Panel Guidance
DeSantis has not followed many federal guidelines.
By Nicholas ReimannF orbes Staff

Foreign Affairs
http://www.foreignaffairs.com/
Accessed 26 Dec 2020
[No new, unique, relevant content]

Foreign Policy
http://foreignpolicy.com/
Accessed 26 Dec 2020
Argument
The Vaccine Has a Serious Side Effect—A Positive One
It could make 2021 the year Americans rediscover science.
Jonathan Tepperman

Morning Brief
WTO Meeting Pits Rich Against Poor In Fight For Vaccines
Poorer countries say intellectual property laws are exacerbating the pandemic, but wealthy countries won’t budge.
Colm Quinn

The Guardian
http://www.guardiannews.com/
Accessed 26 Dec 2020
[No new, unique, relevant content]

New Yorker
http://www.newyorker.com/
Accessed 26 Dec 2020
Medical Dispatch
As the Vaccine Arrives, Death and Denial Rage in a California Coronavirus Epicenter
In the San Joaquin Valley, medical professionals fear that many in the public still fail to grasp the dangers of COVID-19.
By James Ross Gardner
December 22, 2020

Letter from the U.K.
The Immense Relief of Health-Care Workers Receiving the COVID-19 Vaccine
Amid a surge, doctors and nurses on the front lines have begun getting “the jab.” A surgeon said, “You just had a sense that, actually, here was the light at the end of the tunnel.”
By Anna Russell
December 21, 2020

New York Times
http://www.nytimes.com/
Accessed 26 Dec 2020
Dec 26 Europe
3 European Countries Begin Coronavirus Vaccinations Early
Germany, Hungary and Slovakia began administering the Pfizer-BioNTech coronavirus vaccine on Saturday, one day ahead of the European Union’s official rollout.
By Reuters

Health
Early Vaccine Doubters Now Show a Willingness to Roll Up Their Sleeves
Polls show that pervasive skepticism is melting, partly because of the high efficacy rates in trials and the images of real people getting the shot.
By Jan Hoffman
PRINT EDITION Early Doubters On Inoculation Roll Up Sleeves|December 27, 2020, Page A1

Health
Turkey and Brazil Say Chinese Vaccine Effective, With Sparse Supporting Data
The clinical trial in Turkey was much smaller than those of other major vaccine candidates, making the researchers’ claims for it less certain.
By Carl Zimmer and Ernesto Londoño
PRINT EDITION December 26, 2020

Business
One Vaccine Side Effect: Global Economic Inequality
As Covid inoculations begin, the economic downturn stands to be reversed, but developing countries are at risk of being left behind.
By Peter S. Goodman
PRINT EDITION Poorer Nations At Back of Line For the Vaccine| December 26, 2020, Page A1

Americas
Mexico Begins Vaccinations Amid Virus Surge
Mexico is the first country in Latin America, a region hard hit by the coronavirus, to begin delivering vaccines. A head nurse at a Mexico City hospital was the first to get a shot.
By Oscar Lopez
Dec. 24

Opinion
Some Said the Vaccine Rollout Would Be a ‘Nightmare.’ They Were Right.
There are already signs that distribution will be messy, confusing and chaotic.
By Elisabeth Rosenthal
Dec. 23

Washington Post
https://www.washingtonpost.com/
Accessed 26 Dec 2020
How Vaccine Nationalism Could Extend the Pandemic’s Run
By James Paton | Bloomberg
Dec 26, 2020

Pope on COVID-19 vaccine: Needy, vulnerable must come first
Dec 25, 2020

Vaccine opponents outline online campaigns to sow distrust in coronavirus vaccine
The pandemic has catalyzed anti-vaccine advocates with huge social media followings, new report finds
Elizabeth Dwoskin · Technology · Dec 23, 2020

Think Tanks et al
 
 
Brookings
http://www.brookings.edu/
Accessed 26 Dec 2020
[No new relevant content]
 
 
Center for Global Development [to 26 Dec 2020]
http://www.cgdev.org/page/press-center
[No new relevant content]

Chatham House [to 26 Dec 2020]
https://www.chathamhouse.org/
Accessed 26 Dec 2020
[No new relevant content]

CSIS
https://www.csis.org/
Accessed 26 Dec 2020
Upcoming Event
Online Event: Trusting a Covid-19 Vaccine: Who’s Left Unheard?
January 8, 2021

Council on Foreign Relations
http://www.cfr.org/
Accessed 26 Dec 2020
December 18, 2020
Pharmaceuticals and Vaccines
December 22, 2020
COVID-19: Why Vaccination Coverage Is Important
Vaccines are a major public health success story, but the COVID-19 pandemic underscores the many challenges involved in getting a vaccine to everyone who needs it.
In Brief by Claire Felter
 
 
Pharmaceuticals and Vaccines
December 21, 2020
What Is the World Doing to Distribute COVID-19 Vaccines?
Governments and researchers have been working with an extremely ambitious timetable to provide billions of people with immunity to the new coronavirus. Now, the first vaccines are being distributed,
Backgrounder by Claire Felter

 
 
Kaiser Family Foundation
https://www.kff.org/search/?post_type=press-release
Accessed 26 Dec 2020
[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

Milestones :: Perspectives :: Research

Call to Action On Routine and Life-Course Immunization in the Context of the COVID-19 Pandemic
09 December 2020
PDF: https://www.ifpma.org/wp-content/uploads/2020/12/Call_to_Action_Routine__Life-Course_Immunization.pdf
[Test bolding from original; referenced at PDF link above]

A call to action for global and regional stakeholders and governments to strengthen pandemic preparedness and responsiveness by taking a lifecourse immunization (LCI) approach which will expand access to vaccines, improve uptake, and ensure optimal protection of all populations.

People everywhere have been devasted by the loss of loved ones and impacted by economic and social disruptions caused by the COVID-19 pandemic. Policies that strengthen health systems will be critical for staving off additional harm and rebuilding economies.1 This is particularly the case for countries with limited healthcare capacity, but even in countries with robust health systems, COVID-19 has caused interruptions in immunization services. The WHO and UNICEF warn that 2020 could be the first time in 28 years that the world sees a reduction in the annual childhood immunization coverage rate.2

Despite the widespread availability of many safe and effective vaccines across the life course, disease outbreaks, disability and deaths from vaccine-preventable diseases continue to occur due to poor vaccine coverage at all ages. The disruption in immunization services as a result of the pandemic may lead to more outbreaks of vaccine-preventable diseases, if not redressed quickly, and this will add further strain to healthcare systems already overburdened because of COVID-19. In addition, the potential for co-circulation of influenza, or any other epidemic pathogens (for example, measles, respiratory syncytial virus, and meningitis), and COVID-19 could further burden healthcare systems in the upcoming months.3

Significant efforts are being put into the development of safe and effective COVID-19 vaccines. Until these vaccines become available, we urge governments everywhere to follow guidance from the World Health Organization to urgently make efforts to safely resume routine immunization4 and conduct urgent catch-up vaccinations as soon as possible, prioritizing those most at risk (including children, adolescents, older adults, healthcare workers, and pregnant women).5 6 7 8 We call attention to the role of vaccination in protecting the health and well-being of all people around the world, and to the importance of health system capacity and resilience to deliver immunization services across the life span.9

We urge governments and all global and regional stakeholders to:
Strengthen public health systems for future mass vaccination with COVID-19 vaccines by expanding
vaccination delivery channels to include pharmacies.
:: Governments should reduce access barriers to vaccines and vaccination across all
populations, in order to recover from the negative impacts of the pandemic on routine
vaccination coverage, and in order to be able to implement effective vaccination campaigns
against COVID-19 when a vaccine becomes available.
:: Governments should expand vaccine delivery channels to include pharmacy-based,
community-based, employer-based, residential-care-based, and school-based delivery
of vaccinations, to support a successful implementation of life-course immunization.
Developing additional channels for delivery of life-course immunization provides
governments with an ideal platform on which to build delivery of mass vaccination for
pandemics. Additional vaccination access points can also facilitate the conduct of vaccination
catch-up campaigns, which may be needed because of the disruptions to routine vaccination
services caused by the COVID-19 pandemic.
:: Since pharmacies are often the entry point to the health system for many10 for whom
pharmacists are the most accessible healthcare professionals, pharmacy-based delivery of
vaccination can play a critical role in expanding access to immunization services.11
:: Increased community delivery of immunization may also have a role to play in countering
vaccine hesitancy by increasing the linkages with communities and improving trust,12
particularly for routine vaccines that have a long, well-established, record of safety.
: Maintaining and growing confidence in vaccination is an urgent public health issue; crucial
to preventing the spread of disease, recovering vaccination coverage rates following the
COVID-19 pandemic, and ensuring that vaccination continues to protect and enhance the
health and well-being of the public.

We urge governments and all global and regional stakeholders to:
Safeguard immunization budgets that cover adolescent and all appropriate adult populations to preserve the full benefits of country investments in disease prevention, and where feasible to progressively invest in life-course immunization.
:: Governments should allocate appropriate budgets for immunization of adolescents and
adults. Insufficient targeted budget allocations have been identified as one of the main
barriers to the implementation of life-course immunization.13 Immunization may save the
health system 10 times more than it costs14 but prevention and immunizations represent
a fraction of total health spending and may be particularly susceptible to cuts in times of
economic crisis.
:: The economic fallout from the COVID-19 pandemic will make it even more critical
for governments to protect or expand immunization budgets to include life-course
immunization as a means to strengthen the resilience of the health system.
:: Adults with chronic conditions and older adults are disproportionately affected by the COVID-19 pandemic. It is critical that they have access to vaccination, a cornerstone of primary health care, not just to emergency care,15 during the COVID-19 pandemic. Access to life-course immunization, including against influenza, pneumococcal and other epidemic pathogens, will help to prevent further detrimental impacts of COVID-19 on healthcare systems.16
:: Life-course immunization will help governments to ensure parity in immunization coverage
at all stages of life and enhance the ability of governments to deliver immunization services,
both during and outside of pandemics.

We urge governments and all global and regional stakeholders to:
Encourage catch-up campaigns for all interrupted vaccine schedules (adolescent, college, travel, adults
and the elderly) not just childhood schedules.
:: Emphasis is often placed on pediatric immunization coverage; however, vaccination can prevent
an overall great number of deaths in older adults and is essential to living healthier lives.17
:: Healthcare workers should assess the vaccination status of all persons at each contact with
the healthcare system, and ensure that all age-appropriate recommended vaccines, including
influenza vaccine, are administered, as long as vaccine is available, to reduce the burden on
health systems and healthcare workers.5
:: Governments should provide healthcare providers with emergency guidance on how to maintain
routine immunization coverage, conduct catch-up campaigns, and expand immunization access
during the COVID-19 pandemic,5 other future pandemics or major disruptive events.
:: Many countries are making concerted efforts to resume disrupted immunization programs with
precautionary measures in place.7 Governments should exchange frequently on best practices
for the management of immunization catch-up campaigns to ensure that immunization services
are delivered safely with minimum disruption during the COVID-19 pandemic.

Milestones :: Perspectives :: Research

Gavi Board approves new push to reach unvaccinated children worldwide
:: Gavi Board approves more than US$ 600 million in new funding to help accelerate efforts to reach ‘zero-dose’ and under-immunised children in the face of the COVID-19 pandemic
:: The Board also made several key decisions related to the COVAX Facility, including the approval of a package of support for India
:: The Board approved a Risk and Assurance report and discussed risk strategies for the COVAX Facility, ensuring key risks associated with this unprecedented global effort are fully assessed and mitigated ahead of time

Geneva, 17 December 2020 – The Board of Gavi, the Vaccine Alliance has approved an increase in funding of more than US$ 600 million over the next five years to help reach the millions of children still not receiving routine vaccines in Gavi-supported countries.

Over 50% more children were immunised in 68 of the world’s poorest countries in 2019 than in 2000, yet 10.6 million children in Gavi-supported countries still miss out on even a single dose of basic, routine vaccinations every year – a figure which is at risk of increasing due to the COVID-19 pandemic. Half of all deaths from vaccine-preventable diseases in Gavi-supported countries occur among these ‘zero-dose’ children, although they account for only 13% of children.

Gavi will increase its support for health systems in lower-income countries by US$ 500 million in the 2021-25 period to a total of US$ 1.7 billion. In addition it will increase its support to improve the capacity of key Alliance partners, such as WHO and UNICEF, by US$ 128 million.

“As we rightly focus on the fight against COVID-19, we cannot afford to take our eyes off the ball when it comes to other deadly, preventable diseases,” said Dr Ngozi Okonjo-Iweala, Chair of the Gavi Board. “We have made incredible progress in the past two decades boosting access to lifesaving vaccines in the world’s poorest countries, yet too many children are still missing out. The cost to reach each of these ‘zero-dose’ children can be three to four times higher than those who are already being immunised, which is why this new funding will be so vital.”…

Further outcomes of the Gavi Board meeting
As well as new funding to help reach unvaccinated children, several other decisions were made during the three-day virtual Board meeting, including many regarding efforts to ensure equitable global distribution of COVID-19 vaccines.

:: The Gavi Board approved a number of measures to strengthen the COVAX Facility – the global effort to ensure the equitable, rapid distribution of COVID-19 vaccines worldwide. These include:
:: A tailored package of support for India. The Board agreed that India will receive approximately 20% of the total doses available to AMC-eligible countries through the COVAX Facility – estimated at between 190 and 250 million fully-subsidised doses – subject to vaccine prices and available funds. The country will also receive 20% of the total funding available to AMC-eligible countries for urgent technical assistance and cold chain equipment, or US$ 30 million. This tailored support takes into account the country’s disease burden and related mortality, subnational inequities and a growing economic crisis on one hand, and the country’s population size and its role as a global vaccine supplier on the other.
:: An envelope of US $150 million to provide exceptional support, if required and on a case-by-case basis, to AMC-eligible countries to address critical COVID-19 vaccine delivery gaps for which no other funding is available, subject to this funding being mobilised from AMC donors. This is in addition to the US$ 150 million already approved to support improvements to cold chain infrastructure and technical assistance to support the introduction of COVID-19 vaccines.
:: A Risk and Assurance report looking ahead to key risks Gavi is set to face in 2021. This includes key risks associated with the COVAX Facility. Gavi takes a strongly proactive approach to assessing and mitigating risk – an exercise which takes on all the more importance with a project of the scale and ambition of COVAX. Gavi will now work with partners on a set of strong risk mitigation measures to ensure the success of the Facility.

:: In addition, the Board approved an approach to middle-income countries to prevent backsliding in vaccine coverage in countries that have transitioned out of Gavi support, as well as to drive the sustainable introduction of key missing vaccines in both former Gavi-eligible countries and never Gavi-eligible Lower- Middle countries and other IDA eligible middle income economies. Gavi will make US$ 281 million available for this purpose during the 2021 to 2025 period, with specific targeted engagement over the next 18 months…