Africa CDC [to 12 Dec 2020]
http://www.africacdc.org/
News
Press Releases
European Union and African Union sign partnership to scale up preparedness for health emergencies
BRUSSELS, BELGIUM, 7 DECEMBER 2020. Today, the European Centre for Disease Prevention and Control (ECDC) and the Africa Centres for Disease Control and Prevention (Africa CDC) launched a new partnership initiative to strengthen the capacity of Africa CDC to prepare for and respond to public health threats in Africa. The four-year project, ‘EU for health security in Africa: ECDC for Africa CDC’, funded by the EU, will also facilitate harmonised surveillance and disease intelligence, and support the implementation of the public health workforce strategy of Africa CDC…

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

National Health Commission of the People’s Republic of China [to 12 Dec 2020]
http://en.nhc.gov.cn/
News
Dec 12: Daily briefing on novel coronavirus cases in China
On Dec 11, 31 provincial-level regions and the Xinjiang Production and Construction Corps on the Chinese mainland reported 13 new cases of confirmed infections.

National Medical Products Administration [to 12 Dec 2020]
http://english.nmpa.gov.cn/news.html
News
No new digest content identified.

Announcements

Paul G. Allen Frontiers Group [to 12 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 12 Dec 2020]
https://www.phe.gov/about/barda/Pages/default.aspx
BARDA News
December 11, 2020: Trump Administration purchases additional 100 million doses of COVID-19 investigational vaccine from Moderna

BMGF – Gates Foundation [to 12 Dec 2020]
http://www.gatesfoundation.org/Media-Center/Press-Releases
Press Releases and Statements
DECEMBER 09, 2020
Bill and Melinda Gates call for collaboration, continued innovation to overcome challenges of delivering COVID-19 scientific breakthroughs to the world
Gates Foundation pledges additional $250 million to accelerate development and equitable distribution of COVID-19 tests, treatments, and vaccines to end the pandemic
[See Milestones above for detail]

Bill & Melinda Gates Medical Research Institute [to 12 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
NEWS RELEASE 12/9/20
MEDICINES PATENT POOL SUBLICENSES SUTEZOLID, AN INVESTIGATIONAL DRUG FOR TB TREATMENT, PAVING THE WAY FOR CLINICAL DEVELOPMENT
Geneva and Cambridge MA– (Wednesday 9 December 2020) –The Medicines Patent Pool (MPP) and the Bill & Melinda Gates Medical Research Institute (Gates MRI) signed an agreement today to advance the development of investigational sutezolid-containing TB drug regimens, especially for low- and middle-income countries, where most people with TB live. The drug candidate sutezolid, in combination with other drugs, could potentially be used as an all-oral, shortened regimen for all forms of TB, including multidrug-resistant TB (MDR-TB).
In October 2019, MPP and Pfizer entered into a license agreement, which granted MPP rights to sublicense to third parties the patents and know-how relating to the use of sutezolid (formerly known as PNU-100480), a promising antibiotic drug candidate, in combination with other agents for the prevention and/or treatment of TB. Gates MRI is the first recipient of such a sublicense. The sublicence allows Gates MRI to access Pfizer’s existing preclinical, phase 1 and phase 2a clinical study data and results with the aim of further developing this potential component of future TB regimens, should the data be supportive…

CARB-X [to 12 Dec 2020]
https://carb-x.org/
News
12.08.2020  |
CARB-X honored with award from the Global Health Technologies Coalition for progress made in accelerating R&D to combat drug-resistant bacteria
CARB-X has been awarded the 2020 Partnership Award by the Global Health Technologies Coalition (GHTC) for its work in accelerating R&D. The award recognizes CARB-X’s progress in expanding the pipeline of innovation that address one of the world’s most pressing public health crises, antibiotic-resistant bacteria.

CEPI – Coalition for Epidemic Preparedness Innovations [to 12 Dec 2020]
http://cepi.net/
Latest News
CEPI statement on University of Queensland and CSL COVID-19 vaccine candidate
10 Dec 2020

CEPI and SK bioscience extend collaboration to develop ‘next generation’ COVID-19 vaccine
This collaboration represents CEPI’s first next-generation or ‘Wave 2’ vaccine investment
09 Dec 2020

EDCTP [to 12 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 12 Dec 2020]
http://www.vaccines.emory.edu/
Vaccine Center News
No new digest content identified.

European Medicines Agency [to 12 Dec 2020]
http://www.ema.europa.eu/ema/
News & Press Releases
News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 7-10 December 2020
CHMP, Last updated: 11/12/2020

News: Joint strategy sets direction for EMA and EU medicines regulatory agencies to 2025
Last updated: 08/12/2020
… The European medicines agencies network strategy to 2025 outlines six priority areas for the network:
:: the availability and accessibility of medicines;
:: data analytics, digital tools and digital transformation;
:: innovation;
:: antimicrobial resistance and other emerging health threats;
:: supply chain challenges; and
:: the sustainability of the network and operational excellence…

European Vaccine Initiative [to 12 Dec 2020]
http://www.euvaccine.eu/
Latest News
Dec 10 2020
Value of Vaccines campaign 2020: Collaboration- the key to efficient vaccine development

FDA [to 12 Dec 2020]
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
Press Announcements /Selected Details
December 11, 2020 – FDA Takes Key Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for First COVID-19 Vaccine
… “The FDA’s authorization for emergency use of the first COVID-19 vaccine is a significant milestone in battling this devastating pandemic that has affected so many families in the United States and around the world,” said FDA Commissioner Stephen M. Hahn, M.D. “Today’s action follows an open and transparent review process that included input from independent scientific and public health experts and a thorough evaluation by the agency’s career scientists to ensure this vaccine met FDA’s rigorous, scientific standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization. The tireless work to develop a new vaccine to prevent this novel, serious, and life-threatening disease in an expedited timeframe after its emergence is a true testament to scientific innovation and public-private collaboration worldwide.”…

December 11, 2020 – FDA Statement on Vaccines and Related Biological Products Advisory Committee Meeting
Following yesterday’s positive advisory committee meeting outcome regarding the Pfizer-BioNTech COVID-19 vaccine, the U.S. Food and Drug Administration has informed the sponsor that it will rapidly work toward finalization and issuance of an emergency use authorization. The agency has also notified the U.S. Centers for Disease Control and Prevention and Operation Warp Speed, so they can execute their plans for timely vaccine distribution…

December 10, 2020 – Coronavirus (COVID-19) Update: December 10, 2020

December 10, 2020 – Coronavirus (COVID-19) Update: FDA Holds Advisory Committee Meeting to Discuss Authorization of COVID-19 Vaccine Candidate as Part of Agency’s Review of Safety and Effectiveness Data

December 9, 2020 – Coronavirus (COVID-19) Update: FDA Authorizes First Direct-to-Consumer COVID-19 Test System

December 8, 2020 – Coronavirus (COVID-19) Update: December 8, 2020

FDA – COVID-19 Vaccines [to 12 Dec 2020]
www.fda.gov/covid19vaccines
Upcoming Events
12/17/2020:
Vaccines and Related Biological Products Advisory Committee Meeting

12/12/2020:
Virtual Press Conference: First COVID-19 Vaccine External Link Disclaimer
As part of the FDA’s commitment to transparency, we invite you to watch our virtual press conference, to be live streamed over the FDA’s YouTubeExternal Link Disclaimer, FacebookExternal Link Disclaimer and TwitterExternal Link Disclaimer accounts on December 12, 2020, at 9:00 AM ET.

12/11/2020:
FDA Takes Key Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for First COVID-19 Vaccine
Today, the FDA issued the first emergency use authorization (EUA) for a vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older.

[See Regulatory Calendar above for details]

Fondation Merieux [to 12 Dec 2020]
http://www.fondation-merieux.org/
News, Events
Mérieux Foundation co-organized event
Vaccine Acceptance Virtual Event Series – How to maintain and build trust in immunization
December 16, 2020 – 2:00pm – 4:30pm (CET) Virtual
An event to continue the dialogue and increase multi-sectoral efforts to promote vaccination acceptance and immunization programs resilience, now particularly challenged by the ongoing COVID-19 pandemic.
The erosion in vaccination trust and additional disruptions in routine immunization programs caused by the current pandemic is becoming an increasing threat to public health. How to tackle it?
To keep the momentum in this critical topic, we would like to bring together the vaccine acceptance public in this 2.5-hour webinar.

Gavi [to 12 Dec 2020]
https://www.gavi.org/
News releases
What do immunity passports and vaccination certificates mean for COVID-19 restrictions?
Here’s why continuing to physically distance and wear masks is vital until we can be sure how long vaccine-acquired immunity lasts.
11 December 2020
An immunity passport is an official document that certifies “an individual has been infected and is purportedly immune to SARS-CoV-2.” In principle, this can then give an individual more freedom to travel and socialise, allowing people to enter a country if they can provide evidence that they have already recovered from COVID-19.
The theory is that by providing proof of a positive and then a negative test, the person will have had the disease and is expected to have developed antibodies or other forms of immune memory to protect them from getting ill again.
Hungary has introduced a policy allowing people to enter the country if they can provide evidence that they have already recovered from COVID-19. Iceland is planning on introducing a similar policy that will allow people who have already had COVID-19 to be exempt from the nationwide mask mandate. This raises difficult questions as some people with underlying health conditions, including autism, panic disorders and breathing difficulties, are already exempt from wearing a mask but have not necessarily recovered from infection or have any immunity to it.
In April, the World Health Organization (WHO) cautioned against the use of immunity passports saying: “there is not enough evidence about the effectiveness of antibody-mediated immunity to guarantee the accuracy of an ‘immunity passport’ or ‘risk-free certificate’.” It recently confirmed that this position has not changed.
WHO also suggested that immunity passports could in fact increase the risks of continued transmission, because those carrying one would ignore public health advice about physically distancing.
Immunity passports also raise ethical issues due to concerns that documentation could be fraudulently reproduced, and could even incentivise otherwise healthy people to “willfully seek out infection” so they could enjoy more freedom….

GHIT Fund [to 12 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
December 8, 2020
GHIT Fund Announces New Investments: A Total of 230 Million Yen in Drugs for Malaria and Chagas Disease
The Global Health Innovative Technology (GHIT) Fund announced today a total of approximately 230 million yen (US$2.2 million*) to invest in four partnerships to develop new lifesaving drugs for malaria and Chagas disease. This includes three new projects and one that will receive continued funding.

Global Fund [to 12 Dec 2020]
https://www.theglobalfund.org/en/news/
News
No new digest content identified.

Global Research Collaboration for Infectious Disease Preparedness [GloPID-R] [to 12 Dec 2020]
https://www.glopid-r.org/news/
News
GloPID-R appoints new Chair and Vice Chairs to lead the network’s Board
05/11/2020
GloPID-R is delighted to announce that Dr. Charu Kaushic has been appointed Chair of the network following the excellent work carried out by Prof. Yazdan Yazdanpanah over the past two years. Prof. Yazdanpanah will continue to serve GloPID-R as a Vice Chair.

Hilleman Laboratories [to 12 Dec 2020]
http://www.hillemanlabs.org/
No new digest content identified.

Human Vaccines Project [to 12 Dec 2020]
http://www.humanvaccinesproject.org/media/press-releases/
Press Releases
No new digest content identified.

IAVI [to 12 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 12 Dec 2020]
http://media.ifrc.org/ifrc/news/press-releases/
Selected Press Releases, Announcements
Global
WHO, IFRC sign memorandum of understanding on emergency medical teams
The World Health Organization and the International Federation of Red Cross and Red Crescent Societies (IFRC) today launched a new collaboration to strengthen the delivery of emergency medical and health services during humanitarian crises.
WHO Director-General Dr Tedros Adhanom Ghebreyesus and IFRC Secretary-General Mr Jagan Chapagain signed a memorandum of understanding to cooperate on implementing the Emergency Medical Team (EMT) initiative.
“We thank the IFRC for their support from the onset of the EMT Initiative and we look forward to this continued partnership in improving the quality of care in emergencies,” said Dr Tedros. “With the COVID-19 pandemic and the significant increase in emergencies around the world, this agreement could not come at a better time.”
Mr Chapagain said IFRC was committed to working side-by-side with WHO in providing life-saving health services to communities affected by humanitarian emergencies.
“This MoU will allow us to standardize our emergency health response work and provide increased support for National Red Cross and Red Crescent Societies which play such a crucial role in emergency response,” Mr Chapagain said. “We are very committed to working together with WHO to provide quality emergency health services that communities desperately need in times of crisis.”
The MoU, also known as the Red Channel Agreement, is the culmination of years of collaboration between IFRC and the WHO Emergency Medical Team Initiative.
The new agreement will bring more synergies to health emergency response between the two international organizations, particularly in technical standards, accountability, and coordination.
It aligns the IFRC’s system with that of the WHO Emergency Medical Teams global classification system, in doing so recognizing the IFRC’s Emergency Response Units as EMTs and heightens the involvement of IFRC teams and National Red Cross and Red Crescent Societies in the capacity building efforts of the EMT network.

Campaign showcases how cash assistance helps refugees in Turkey regain control of their lives
Ankara/Berlin/Geneva, 8 December 2020 – A digital campaign that connects inspiring and talented refugees in Turkey with influencers across Europe has been launched today by the International Federation of Red Cross Red Crescent Societies (IFRC). The ca …
8 December 2020

Institut Pasteur [to 12 Dec 2020]
https://www.pasteur.fr/en/press-area
Press documents
09.12.2020
Gut microbiota plays a role in brain function and mood regulation
Depression is a mental disorder that affects more than 264 million people of all ages worldwide. Understanding its…

IRC International Rescue Committee [to 12 Dec 2020]
http://www.rescue.org/press-release-index
Media highlights [Selected]
Statement
IRC statement on death of staff member in Ethiopia
December 10, 2020

Press Release
Experts declare ‘famine like conditions’ for almost 17,000 people in Yemen, warns IRC
December 3, 2020

IVAC [to 12 Dec 2020]
https://www.jhsph.edu/research/centers-and-institutes/ivac/index.html
Updates; Events
Webinar Recording: How will COVID-19 Vaccines be Deployed in Maryland and the U.S.?
December 2020
The International Vaccine Access Center (IVAC) hosted a webinar on October 21 2020 , “How will COVID-19 Vaccines be Deployed in Maryland and the U.S.? A conversation with state and local leaders working to equitably allocate vaccines in 2020 and beyond.” Description: This online panel about COVID-19 vaccine allocation in Maryland and the U.S. was […]

IVI [to 12 Dec 2020]
http://www.ivi.int/
Selected IVI News, Announcements, Events
No new digest content identified.

JEE Alliance [to 12 Dec 2020]
https://www.jeealliance.org/
Selected News and Events
No new digest content identified.

MSF/Médecins Sans Frontières [to 12 Dec 2020]
http://www.msf.org/
Latest [Selected Announcements]
Photo Story
A year in pictures 2020
11 Dec 2020

National Vaccine Program Office – U.S. HHS [to 12 Dec 2020]
https://www.hhs.gov/vaccines/about/index.html
Upcoming Meetings/Latest Updates
December 2020:
Preparing for COVID-19 Vaccination: Recommendations from the National Vaccine Advisory Committee – PDF
Approved December 4, 2020 :: 15 pages
…CONCLUSION
The COVID-19 pandemic has created an unprecedented need for safe and effective vaccines, among other valuable public health interventions, to prevent further disease transmission and return society fully to normal activities. Many lessons have already emerged from the pandemic that showcase needs to innovate our processes for developing new and improved vaccines, as well as strengthen vaccine communication efforts and confidence in vaccines. Likewise, as the vaccine development process progresses, planning to include children and pregnant women in vaccination clinical trials poses special considerations. The NVAC reviewed, discussed, and approved the recommendations in this report to help ensure these efforts related to COVID-19 vaccination are successful and that we build on efforts to improve the U.S. vaccination system.

NIH [to 12 Dec 2020]
http://www.nih.gov/news-events/news-releases
News Releases
Baricitinib plus remdesivir shows promise for treating COVID-19
December 11, 2020 — Peer-reviewed results of NIH clinical trial published.

NIH’s All of Us Research Program returns first genetic results to participants
December 10, 2020 — Personalized insights include genetic ancestry and traits, with health-related results to come.

NIH to fund cohort recruitment and development program to enhance diversity and inclusion among biomedical faculty
December 8, 2020 — Groups include underrepresented racial and ethnic groups, individuals with disabilities, individuals from disadvantaged backgrounds, and women.

NIH-funded tool helps organizations plan COVID-19 testing
December 7, 2020 — Online calculator computes costs of testing and offers strategies for preventing infections in schools and businesses.

PATH [to 12 Dec 2020]
https://www.path.org/media-center/
Press Release
Advancing Zambia’s goal to end malaria, PATH receives new award from the President’s Malaria Initiative
A new cooperative agreement will accelerate malaria burden reduction and elimination goals in Zambia.
December 8, 2020 by PATH

Sabin Vaccine Institute [to 12 Dec 2020]
http://www.sabin.org/updates/pressreleases
Statements and Press Releases
No new digest content identified.

UNAIDS [to 12 Dec 2020]
http://www.unaids.org/en
Selected Press Releases/Reports/Statements
11 December 2020
The shero of Butha-Buthe: Matšeliso Setoko

9 December 2020
PrEP in the City: campaign for transgender women aims to increase PrEP uptake in Thailand

7 December 2020
New HIV infections among gay men and other men who have sex with men increasing

UNICEF [to 12 Dec 2020]
https://www.unicef.org/media/press-releases
Selected Press releases, Statements
Press release 12/11/2020
Update on UNICEF’s response for Ethiopian refugees in Sudan and host communities

Press release 12/11/2020
Child poverty will remain above pre-COVID levels for at least five years in high-income countries – UNICEF
In high-income countries, only 2 per cent of fiscal stimulus was allocated specifically to support children during the first wave of COVID-19; a better balance of spending that provides more direct support to children is urgently needed

Statement 12/10/2020
Life a ‘waking nightmare’ for 12 million children in Yemen
UNICEF Executive Director Henrietta Fore’s remarks at the Averting famine in Yemen: What can we do now and in 2021 event

Press release 12/07/2020
COVID-19: UNICEF warns of continued damage to learning and well-being as number of children affected by school closures soars again
UNICEF calls on governments to prioritize the reopening of schools, take all actions possible to make classrooms as safe as possible and avoid nationwide school closures

Unitaid [to 12 Dec 2020]
https://unitaid.org/
11 December 2020
Strategy development launched and new areas for intervention agreed at 37th meeting of Unitaid’s Executive Board
…The Board has approved an external review as an important step towards the development of Unitaid’s next strategy. As a key component of this process, extensive stakeholder engagement will be undertaken throughout 2021, to gain the thoughts and inputs of Unitaid’s partners, grant implementers and civil society groups.
The new areas for intervention agreed by the Board focus on challenges that are deeply relevant to Unitaid’s core work, namely reducing the number of women who die in pregnancy or childbirth, and increasing the detection of TB…

09 December 2020
Annual report: Advancing global health in the age of COVID-19

08 December 2020
Unitaid ranked as one of the world’s leaders in funding tuberculosis research

Vaccination Acceptance Research Network (VARN) [to 12 Dec 2020]
https://vaccineacceptance.org/news.html#header1-2r
Announcements
No new digest content identified.

Vaccine Confidence Project [to 12 Dec 2020]
http://www.vaccineconfidence.org/
Research and Reports
No new digest content identified.

Vaccine Education Center – Children’s Hospital of Philadelphia [to 12 Dec 2020]
http://www.chop.edu/centers-programs/vaccine-education-center
News
Five ways to build confidence in vaccines
Heidi Larson, Director, Vaccine Confidence Project
With potential new vaccines for COVID-19 on the horizon, we need to engage with public to understand their concerns and build vaccine confidence.

“Vaccinate, liberate!” That could be the rally cry to mobilise public enthusiasm around the remarkable and rapid scientific progress that has made it possible to have not just one, but multiple, new COVID-19 vaccines. Vaccines which will finally help the world get back to some semblance of “normal” – or at least start the COVID-19 recovery path to a “new normal.”

Just think – we would be able to go back to work, get the economy back on track, spend cherished time with friends and families, attend sports events, go to concerts, and travel!

Addressing the challenges around vaccination
But not everyone is celebrating the value of vaccines. Some of the same people protesting against lockdown, and even masks, are also seeing vaccination as a form of control; ironically the one thing that has the potential to free us from the constraints of lockdown as well as, most importantly, freedom from disease.

This is one of many examples – including, but beyond COVID-19 – where there are vastly different, often polarised, interpretations of vaccines and vaccination.

Most people believe in the value of vaccines more broadly, with some having questions or concerns around one vaccine, but not others. There are some who are staunchly against vaccines, or at least opposed to the ways in which vaccines are regulated, recommended sometimes required by government.

These sentiments are not new to vaccines. The first organised “anti-vaccine” movement in the 1800s was actually call the “anti-compulsory vaccine league.” The protest was not against the vaccine, per se, but about the mandate requiring it.

The impact of coronavirus on routine vaccination
The pandemic has been a time when most governments have called for exceptional measures, limiting freedom of movement and socialisation, stopping some workplaces, even schools from opening – all to protect the public’s health.

In the meantime, many routine vaccines have fallen behind with all the restrictions and difficult access, alongside fear of contagion.

I propose five ways to build confidence, not only in a COVID-19 vaccine but pave the way for a new relationship around vaccines and the public.
1) Listen: There are many different experiences, histories, beliefs, perceptions and genuine questions around vaccines. Listen to them, they may reveal more than you expected and help understand what is driving those beliefs.
2) Engage: Make communication a dialogue, engage multiple people in the community outside of the health services to be listeners, and help address concerns and questions.
3) Innovate: Try something different than you have ever tried before. Try to think of anything else that is like a vaccine, think of metaphors. Does anything come close?
4) Co-create: Involve those who are meant to get vaccines in designing the best strategy to reach them and their peers.
5) Vaccinate Liberate: Think of all the ways that vaccination is a passport to freedom.

Wellcome Trust [to 12 Dec 2020]
https://wellcome.ac.uk/news
No new digest content identified.

The Wistar Institute [to 12 Dec 2020]
https://www.wistar.org/news/press-releases
Press Releases
No new digest content identified.

WFPHA: World Federation of Public Health Associations [to 12 Dec 2020]
https://www.wfpha.org/
Latest News
Being Rich and Sick Is Much Better than Being Poor and Sick!
Dec 10, 2020
Being Rich and Sick Is Much Better than Being Poor and Sick! With more vaccines on the way, we can see an end to the COVID-19 pandemic. But it remains to be seen how the vaccines will be distributed.

COVID-19 Vaccination: A Question about Global Equity in Health
Dec 8, 2020
COVID-19 Vaccination: A Question about Global Equity in HealthCOVID-19 has had no respect for borders! Vaccines against COVID-19 will be a scarce good, at least for some time ahead. Therefore, both in order to achieve the best possible population…

16th World Congress on Public Health: Personal Experiences
Dec 7, 2020
16th World Congress on Public Health: Personal ExperiencesIn October, several interns from the World Federation of Public Health Associations (WFPHA) were invited to help organize and attend the virtual 16th World Congress on Public Health (WCPH…

World Organisation for Animal Health (OIE) [to 12 Dec 2020]
https://www.oie.int/en/for-the-media/press-releases/2020/
No new digest content identified.

::::::

ARM [Alliance for Regenerative Medicine] [to 12 Dec 2020]
https://alliancerm.org/
Press Releases
No new digest content identified.

BIO [to 12 Dec 2020]
https://www.bio.org/press-releases
Press Releases
No new digest content identified.

DCVMN – Developing Country Vaccine Manufacturers Network [to 12 Dec 2020]
http://www.dcvmn.org/
News; Upcoming events
No new digest content identified.

ICBA – International Council of Biotechnology Associations [to 12 Dec 2020]
https://internationalbiotech.org/news/
News
No new digest content identified.

IFPMA [to 12 Dec 2020]
http://www.ifpma.org/resources/news-releases/
Selected Press Releases, Statements, Publications
Speak Up Africa and IFPMA launch the “Africa Young Innovators for Health Award” to fuel
08 December 2020

Pharma innovation delivers COVID-19 solutions beyond expectations, but calls for the dilution of intellectual property rights are counterproductive
08 December 2020

A broad alliance, a crucial mission: A new multi-stakeholder association to combat falsified medicines
07 December 2020

PhRMA [to 12 Dec 2020]
http://www.phrma.org/
Selected Press Releases, Statements
New analysis finds stark difference in coverage of breast cancer medicines for seniors in the United States and England
Nicole Longo   |     December 10, 2020

Eli Lilly and Company Chairman and CEO David Ricks Becomes PhRMA Board Chairman
December 9, 2020
The Pharmaceutical Research and Manufacturers of America (PhRMA) is pleased to announce that David Ricks, chairman and CEO of Eli Lilly and Company, has assumed the role of chairman of the PhRMA board of directors.

Guest post: How COVID-19 underscores the importance of public confidence in vaccines
Guest Contributor   |     December 7, 2020
Serese Marotta, Chief Operating Officer for Families Fighting Flu, about the importance of influenza vaccination.

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

BMJ Global Health
December 2020 – Volume 5 – 12
https://gh.bmj.com/content/5/12

Original research
Infection and mortality of healthcare workers worldwide from COVID-19: a systematic review (4 December, 2020)
Soham Bandyopadhyay, Ronnie E Baticulon, Murtaza Kadhum, Muath Alser, Daniel K Ojuka, Yara Badereddin, Archith Kamath, Sai Arathi Parepalli, Grace Brown, Sara Iharchane, Sofia Gandino, Zara Markovic-Obiago, Samuel Scott, Emery Manirambona, Asif Machhada, Aditi Aggarwal, Lydia Benazaize, Mina Ibrahim, David Kim, Isabel Tol, Elliott H Taylor, Alexandra Knighton, Dorothy Bbaale, Duha Jasim, Heba Alghoul, Henna Reddy, Hibatullah Abuelgasim, Kirandeep Saini, Alicia Sigler, Leenah Abuelgasim, Mario Moran-Romero, Mary Kumarendran, Najlaa Abu Jamie, Omaima Ali, Raghav Sudarshan, Riley Dean, Rumi Kissyova, Sonam Kelzang, Sophie Roche, Tazin Ahsan, Yethrib Mohamed, Andile Maqhawe Dube, Grace Paida Gwini, Rashidah Gwokyala, Robin Brown, Mohammad Rabiul Karim Khan Papon, Zoe Li, Salvador Sun Ruzats, Somy Charuvila, Noel Peter, Khalil Khalidy, Nkosikhona Moyo, Osaid Alser, Arielis Solano, Eduardo Robles-Perez, Aiman Tariq, Mariam Gaddah, Spyros Kolovos, Faith C Muchemwa, Abdullah Saleh, Amanda Gosman, Rafael Pinedo-Villanueva, Anant Jani, Roba Khundkar

BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles

Research article
Systematic literature review of the impact and effectiveness of monovalent meningococcal C conjugated vaccines when used in routine immunization programs
Monovalent meningococcal C conjugate vaccine (MCCV) was introduced into the routine immunization program in many countries in Europe and worldwide following the emergence of meningococcal serogroup C (MenC) in…
Authors: Myint Tin Tin Htar, Sally Jackson, Paul Balmer, Lidia Cristina Serra, Andrew Vyse, Mary Slack, Margarita Riera-Montes, David L. Swerdlow and Jamie Findlow
Citation: BMC Public Health 2020 20:1890
Published on: 9 December 2020

Clinical Pharmacology & Therapeutics
Volume 108, Issue 6 Pages: 1107-1325 December 2020
https://ascpt.onlinelibrary.wiley.com/toc/15326535/current

Reviews
The Drug Shortage Era: A Scoping Review of the Literature 2001–2019
Emily L. Tucker, Yizhou Cao, Erin R. Fox, Burgunda V. Sweet
Pages: 1150-1155
First Published:10 June 2020

EMBO Reports
Volume 21 Issue 12 3 December 2020
https://www.embopress.org/toc/14693178/current

Review 8 December 2020
Antibiotic resistance and persistence—Implications for human health and treatment perspectives
Markus Huemer, Srikanth Mairpady Shambat, Silvio D Brugger, Annelies S Zinkernagel
Bacteria that survive antibiotics challenges are one of the greatest threats to human health. While antibiotic resistance has been well studied, the survival and re‐growth of fully susceptible bacteria, called antibiotic persistence, is less well understood. This review discusses the mechanisms and implications of antibiotic resistance and persistence.

Globalization and Health
http://www.globalizationandhealth.com/
[Accessed 12 Dec 2020]

Research
Public health and corporate social responsibility: exploratory study on pharmaceutical companies in an emerging market
Corporate social responsibility (CSR) is studied from many perspectives and has gained unprecedented importance in recent years, especially in emerging economies. Pharmaceutical companies play a very important role in a population’s well-being and health through the CSR and corporate governance practices that they apply.
Authors: Tatiana Dănescu and Maria-Alexandra Popa
10 December 2020

Health and Human Rights
Volume 22, Issue 2, December 2020
https://www.hhrjournal.org/volume-22-issue-2-december-2020/

Special Section: Big Data, Technology, Artificial Intelligence and the Right to Health
Analyzing the Human Rights Impact of Increased Digital Public Health Surveillance during the COVID-19 Crisis
Sharifah Sekalala, Stéphanie Dagron, Lisa Forman, and Benjamin Mason Meier
The COVID-19 pandemic has led policy makers to expand traditional public health surveillance to take advantage of new technologies, such as tracking apps, to control the spread of SARS-CoV-2. This article explores the human rights dimensions of how these new surveillance technologies are being used and assesses the extent to which they entail legitimate restrictions to a range of human rights, including the rights to health, life, and privacy. We argue that human rights offer a crucial framework for protecting the public from regulatory overreach by ensuring that digital health surveillance does not undermine fundamental features of democratic society…

Health and Human Rights
Volume 22, Issue 2, December 2020
https://www.hhrjournal.org/volume-22-issue-2-december-2020/

Human Rights and Digital Health Technologies
Nina Sun, Kenechukwu Esom, Mandeep Dhaliwal, and Joseph J. Amon
…The COVID-19 pandemic has led policy makers to expand traditional public health surveillance to take advantage of new technologies, such as tracking apps, to control the spread of SARS-CoV-2. This article explores the human rights dimensions of how these new surveillance technologies are being used and assesses the extent to which they entail legitimate restrictions to a range of human rights, including the rights to health, life, and privacy. We argue that human rights offer a crucial framework for protecting the public from regulatory overreach by ensuring that digital health surveillance does not undermine fundamental features of democratic society.

Health and Human Rights
Volume 22, Issue 2, December 2020
https://www.hhrjournal.org/volume-22-issue-2-december-2020/

VIEWPOINTS
From Information to Valuable Asset: The Commercialization of Health Data as a Human Rights Issue
Amy Dickens
Health data is a valuable source of knowledge that states can use to advance or undermine the right to health. But the sources and use of health data are changing in our emerging global data economy. Novel forms of digitized health information are fueling a booming industry for algorithmic technologies in health care, rendering it a huge source of scientific and commercial value. To date, the tech giants—Google, Apple, Microsoft, Facebook, and Amazon—are way ahead of public health systems in capitalizing on this value. There is an urgent need for states to recognize the value of health data and use it to advance human rights. Failing to do so risks private actors gaining ever more expansive monopoly powers that threaten patients’ social and economic rights.

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 8, 2020, Vol 324, No. 22, Pages 2238-2334
https://jamanetwork.com/journals/jama/currentissue

Viewpoint
A Proposed Framework and Timeline of the Spectrum of Disease Due to SARS-CoV-2 InfectionIllness Beyond Acute Infection and Public Health Implications
S. Deblina Datta, MD; Amish Talwar, MD, MPH; James T. Lee, MD, MSc
free access has active quiz
JAMA. 2020;324(22):2251-2252. doi:10.1001/jama.2020.22717
This Viewpoint uses clinical observations of the natural course of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection to propose 3 phases of illness: acute infection (what people commonly refer to with the COVID-19 designation); postacute hyperinflammatory illness (referred to clinically as multisystem inflammatory syndrome); and late inflammatory sequelae, manifest as enduring cardiac, neurological, and psychological symptoms.

JAMA
December 8, 2020, Vol 324, No. 22, Pages 2238-2334
https://jamanetwork.com/journals/jama/currentissue

Science Denial and COVID Conspiracy TheoriesPotential Neurological Mechanisms and Possible Responses
Bruce L. Miller, MD
free access has active quiz
JAMA. 2020;324(22):2255-2256. doi:10.1001/jama.2020.21332
This Viewpoint discusses possible parallels between the distortion in sensory information and faulty monitoring of ideas characteristic of some patients with neurodegenerative diseases (dementia with Lewy bodies and Capgras syndrome, frontotemporal dementia) and the creation and maintenance of false conspiratorial beliefs about the COVID-19 pandemic in healthy populations that has hobbled an effective national response in the US.

Journal of Pediatrics
December 2020 Volume 227p1-330
http://www.jpeds.com/current

Editorials
Transparency and Accountability of Pediatric Trials: Should Consent Rate Reporting Be Mandatory?
Ana Marušić, Ivan Buljan
Published online: August 05, 2020
p9-10

Journal of Pediatrics
December 2020 Volume 227p1-330
http://www.jpeds.com/current

Consent Rates Reported in Published Pediatric Randomized Controlled Trials
Julia A. Lonhart, Ashley R. Edwards, Swati Agarwal, Brian P. Lucas, Alan R. Schroeder
Published online: June 26, 2020
p281-287

Journal of Pediatrics
December 2020 Volume 227p1-330
http://www.jpeds.com/current

Barriers to Pretransplant Immunization: A Qualitative Interview Study of Pediatric Solid Organ Transplant Stakeholders
Amy G. Feldman, Rebekah Marsh, Allison Kempe, Megan A. Morris
Published online: July 14, 2020
p60-68

The Lancet
Dec 12, 2020 Volume 396N umber 10266 p1861-1940
https://www.thelancet.com/journals/lancet/issue/current

Editorial
Facing up to long COVID
The Lancet
… Although vaccination has become the immediate focus of the pandemic response for many countries, patients with long COVID must not be forgotten or sidelined as countries begin to consider the end of the pandemic. Acknowledging the potential scale of the problem now and the complexities and variabilities of the disease course, and pressing for better research and care, could avoid years of struggle and mismanagement for patients with long COVID.

Nature
Volume 588 Issue 7837, 10 December 2020
http://www.nature.com/nature/current_issue.html

Editorial | 08 December 2020
COVID vaccines: the world’s medical regulators need access to open data
The global race to produce COVID vaccines is a chance for regulators and drug companies to create a more harmonized approvals process.
The roll out of COVID-19 vaccines is under way, but without, it seems, much global coordination. China, Russia and the United Arab Emirates began administering vaccines before the conclusion of clinical trials. Last week, the United Kingdom issued emergency approval for a vaccine developed by the US biopharmaceutical company Pfizer and BioNTech of Mainz, Germany, following positive results from phase III testing. The US Food and Drug Administration (FDA) has needed longer to make its decision on the same vaccine. And the regulatory agencies of Australia, the European Union and Switzerland are taking longer still.

This patchwork of approvals processes, despite COVID-19 being a common enemy, has revived a long-standing question about how to accelerate harmonization in vaccine regulation. Researchers reviewing the regulatory landscape found at least 51 pathways to various types of accelerated vaccine approval in a group of 24 countries¹.

Greater harmonization would bring many benefits. Drug companies could look forward to agreed definitions for different types of approval, and would benefit from agreed guidelines for criteria that their vaccine candidates would need to meet. If regulators were to ask for broadly the same things, companies could cut the time needed to prepare their drug applications. Companies, for their part, would need to allow — or help to create — a secure way for regulators to share data, which they are often not permitted to do at present.

By assessing the same data, regulators could more easily compare their findings and analyses with those of others, and their decisions would not only be more robust, but also be seen to be more robust. That, in turn, would shore up public confidence in a world in which vaccine hesitancy is rising and in which many citizens already have the means to compare regulatory verdicts. This would be an evolutionary shift, not a revolutionary one, because in recent years — and particularly since the 2014–16 Ebola crisis — regulators have made unprecedented efforts to discuss, coordinate and begin to harmonize some of their processes.

The FDA, which was set up in 1906, is the world’s oldest national medicines regulator. But the world has been moving towards greater regulatory coordination for some time. Europe’s regulatory system comprises a network of 50 national bodies from 31 European countries. The European Medicines Agency (EMA), created in 1995, sits at the centre of this network. All countries have their own medical regulators, but the EMA provides manufacturers with a single place for scientific evaluation of drug applications, if they want Europe-wide approval.

Although EMA and FDA verdicts are often broadly similar, the authorities differ in key ways. For example, the FDA requires drug companies to submit all the raw data from laboratory, animal and human trials so that it can do its own statistical analysis. By contrast, the EMA relies more on drug companies’ own analyses.

In other regions — Africa, for example — countries are also inching towards an approach that allows for the pooling of regulatory expertise. This is the purpose of the African Vaccine Regulatory Forum, set up in 2006.

And at the global level, in 2012, the member states of the World Health Organization (WHO) agreed to establish the International Coalition of Medicines Regulatory Authorities (ICMRA) to allow regulators to share information and agree on approaches. The ICMRA has 29 members, including regulators from China, Europe and the United States. Through it, members have been able to reach a consensus on the best animal models for testing COVID-19 vaccines, the ideal clinical-trial end points and the complicated issue of continuing placebo-controlled trials after vaccine roll out begins. The coalition’s COVID-19 working group is now trying to harmonize the monitoring of vaccines once they have been deployed, because faint signals of adverse effects might be too weak to spot in any one country.

And then there is the WHO itself. Low- and middle-income countries can now benefit from the work that goes into its Emergency Use Listing (EUL) process. On 13 November, the agency issued its first ever such vaccine listing, for a polio vaccine. National regulators still need to decide whether this vaccine is right for their country, but a recommendation from the WHO — and confidence in its assessment process — means that most are likely to follow its advice.

Around the end of October, the WHO requested that both the FDA and the EMA assess the suitability of COVID-19 vaccines for low- and middle-income countries as they consider whether to issue emergency authorizations. It is not clear whether the regulators will agree — but if either does, the WHO can draw on that analysis and issue its own EUL within days of the decision. That would be collaboration indeed.

These are all important and necessary efforts. The need now is to go one step further and find a path through the many different types of vaccine approval. Before the pandemic, the Coalition for Epidemic Preparedness Innovations, a global group of funding agencies, companies and non-governmental organizations, set up a working group to map out obstacles to better global regulatory alignment, in anticipation of a new infectious disease. This process confirmed how regulatory agencies differ on issues such as the use of genetic modification in vaccine development, clinical trials in pregnant women, and even vial labelling. But it also meant that inconsistencies were already mapped out and under discussion when the pandemic struck. COVID-19 has intensified these discussions.
The next step will not be easy. Regulators want to be able to exchange data. Their experiences during the pandemic have convinced many that they are moving towards a point at which this will be possible. They want to be able to talk to each other in the same units and about the same end points, and to make decisions based on the same data.

Ultimately, each country must make its own decisions about what’s best. But the goal of a harmonized regulatory dossier for vaccines, conforming to an agreed set of international regulatory requirements, would be transformative.

World View | 14 October 2020
Institutions can retool to make research more rigorous
Big moves to rebuild the scientific infrastructure are possible.
Ulrich Dirnagl

New England Journal of Medicine
December 10, 2020 Vol. 383 No. 24
http://www.nejm.org/toc/nejm/medical-journal

Perspective
History of Medicine: The Discovery of Hepatitis C — The 2020 Nobel Prize in Physiology or MedicineJ.H. Hoofnagle and S.M. Feinstone

New England Journal of Medicine
December 10, 2020 Vol. 383 No. 24
http://www.nejm.org/toc/nejm/medical-journal

Original Articles
Phase 1–2 Trial of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine C. Keech and Others

New England Journal of Medicine
December 10, 2020 Vol. 383 No. 24
http://www.nejm.org/toc/nejm/medical-journal

Editorial
Dec 10, 2020
SARS-CoV-2 Vaccination — An Ounce (Actually, Much Less) of Prevention
E.J. Rubin and D.L. Longo

New England Journal of Medicine
December 10, 2020 Vol. 383 No. 24
http://www.nejm.org/toc/nejm/medical-journal

Original Article
Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine
December 10, 2020
DOI: 10.1056/NEJMoa2034577
Fernando P. Polack, M.D….Kathrin U. Jansen, Ph.D., and William C. Gruber, M.D. for the C4591001 Clinical Trial Group*
Abstract
Background
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and the resulting coronavirus disease 2019 (Covid-19) have afflicted tens of millions of people in a worldwide pandemic. Safe and effective vaccines are needed urgently.
Methods
In an ongoing multinational, placebo-controlled, observer-blinded, pivotal efficacy trial, we randomly assigned persons 16 years of age or older in a 1:1 ratio to receive two doses, 21 days apart, of either placebo or the BNT162b2 vaccine candidate (30 μg per dose). BNT162b2 is a lipid nanoparticle–formulated, nucleoside-modified RNA vaccine that encodes a prefusion stabilized, membrane-anchored SARS-CoV-2 full-length spike protein. The primary end points were efficacy of the vaccine against laboratory-confirmed Covid-19 and safety.
Results
A total of 43,548 participants underwent randomization, of whom 43,448 received injections: 21,720 with BNT162b2 and 21,728 with placebo. There were 8 cases of Covid-19 with onset at least 7 days after the second dose among participants assigned to receive BNT162b2 and 162 cases among those assigned to placebo; BNT162b2 was 95% effective in preventing Covid-19 (95% credible interval, 90.3 to 97.6). Similar vaccine efficacy (generally 90 to 100%) was observed across subgroups defined by age, sex, race, ethnicity, baseline body-mass index, and the presence of coexisting conditions. Among 10 cases of severe Covid-19 with onset after the first dose, 9 occurred in placebo recipients and 1 in a BNT162b2 recipient. The safety profile of BNT162b2 was characterized by short-term, mild-to-moderate pain at the injection site, fatigue, and headache. The incidence of serious adverse events was low and was similar in the vaccine and placebo groups.
Conclusions
A two-dose regimen of BNT162b2 conferred 95% protection against Covid-19 in persons 16 years of age or older. Safety over a median of 2 months was similar to that of other viral vaccines. (Funded by BioNTech and Pfizer; ClinicalTrials.gov number, NCT04368728. opens in new tab.)

PLoS One
http://www.plosone.org/

Research Article
Influenza vaccination hesitancy in five countries of South America. Confidence, complacency and convenience as determinants of immunization rates
Miguel Ángel González-Block, Emilio Gutiérrez-Calderón, Blanca Estela Pelcastre-Villafuerte, Juan Arroyo-Laguna, Yamila Comes, Pedro Crocco, Andréa Fachel-Leal, Laura Noboa, Daniela Riva-Knauth, Berenice Rodríguez-Zea, Mónica Ruoti, Elsa Sarti, Esteban Puentes-Rosas
Research Article | published 11 Dec 2020 PLOS ONE
https://doi.org/10.1371/journal.pone.0243833

PLoS One
http://www.plosone.org/

Vaccines safety and maternal knowledge for enhanced maternal immunization acceptability in rural Uganda: A qualitative study approach
Dan Kajungu, Michael Muhoozi, James Stark, Daniel Weibel, Miriam C. J. M. Sturkenboom
Research Article | published 10 Dec 2020 PLOS ONE
https://doi.org/10.1371/journal.pone.0243834

PLoS One
http://www.plosone.org/

Timeliness of immunisation with the pentavalent vaccine at different levels of the health care system in the Lao People’s Democratic Republic: A cross-sectional study
Lisa Hefele, Sengdavanh Syphan, Dalouny Xayavong, Anousin Homsana, Daria Kleine, Phetsavanh Chanthavilay, Phonethipsavanh Nouanthong, Kinnaly Xaydalasouk, Outavong Phathammavong, Somxay Billamay, Anonh Xeuatvongsa, Daniel Reinharz, Antony P. Black, Claude P. Muller
Research Article | published 08 Dec 2020 PLOS ONE
https://doi.org/10.1371/journal.pone.0242502

PNAS – Proceedings of the National Academy of Sciences of the United States of America
http://www.pnas.org/content/early/

Articles
The spread of COVID-19 shows the importance of policy coordination
Joshua Graff Zivin and Nicholas Sanders
PNAS first published December 11, 2020.
https://doi.org/10.1073/pnas.2022897117

Risk Management and Healthcare Policy
https://www.dovepress.com/risk-management-and-healthcare-policy-archive56
[Accessed 12 Dec 2020]

Original Research
Hepatitis B Vaccination Uptake Rate and Predictors in Healthcare Professionals of Ethiopia
Getnet MA, Bayu NH, Abtew MD, W/Mariam TGM
Risk Management and Healthcare Policy 2020, 13:2875-2885
Published Date: 8 December 2020

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

Feature
China’s vaccine gambit
By Jon Cohen
Science11 Dec 2020 : 1263-1267 Full Access
With its global campaign to test and promote COVID-19 vaccines, China aims to win friends and cut deals.
Summary
On 29 February, less than 2 months after the world awakened to the threat of the pandemic coronavirus, virologist Chen Wei, a major general in China’s army, and six military scientists on her team received injections of an experimental COVID-19 vaccine. Chen, a national hero for her work on Ebola vaccines, had come to the initial center of the pandemic, Wuhan, with her group from the Academy of Medical Military Sciences, in part to help make the candidate vaccine with pharmaceutical company CanSino Biologics. In the United States, the Trump administration’s $10.8 billion Operation Warp Speed accelerated vaccine R&D faster than many researchers thought possible. But an equally massive effort has unfolded in China. CanSino and two other Chinese companies are investing substantial resources and testing four candidates in tens of thousands of volunteers around the world. They are likely only days or weeks away from announcing the outcomes of efficacy trials, just behind the encouraging early results recently announced by a brace of companies and institutions outside China.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Media/Policy Watch
This watch section is intended to alert readers to substantive news, analysis and opinion from the general media and selected think tanks and similar organizations on vaccines, immunization, global public health and related themes. Media Watch is not intended to be exhaustive, but indicative of themes and issues CVEP is actively tracking. This section will grow from an initial base of newspapers, magazines and blog sources, and is segregated from Journal Watch above which scans the peer-reviewed journal ecology.
We acknowledge the Western/Northern bias in this initial selection of titles and invite suggestions for expanded coverage. We are conservative in our outlook in adding news sources which largely report on primary content we are already covering above. Many electronic media sources have tiered, fee-based subscription models for access. We will provide full-text where content is published without restriction, but most publications require registration and some subscription level.

The Atlantic
http://www.theatlantic.com/magazine/
Accessed 12 Dec 2020
Ideas
How to Build Trust in the Vaccines
To succeed in immunizing the population against COVID-19, the United States must draw on the resources it already has.
12 Dec 2020
Brendan Nyhan, Professor of government at Dartmouth College

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

– pdf version:  A pdf of the current issue is available here: 

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

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

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

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

Milestones :: Perspectives :: Research

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

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

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

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

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

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

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

Milestones :: Perspectives :: Research

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

::::::

Week of 30 November 2020

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

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

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

::::::

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

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

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

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

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

::::::

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

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

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

::::::

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