Announcements
Paul G. Allen Frontiers Group [to 2 Jan 2021]
https://alleninstitute.org/what-we-do/frontiers-group/news-press/
News
No new digest content identified.
BARDA – U.S. Department of HHS [to 2 Jan 2021]
https://www.phe.gov/about/barda/Pages/default.aspx
BARDA News
No new digest content identified.
BMGF – Gates Foundation [to 2 Jan 2021]
http://www.gatesfoundation.org/Media-Center/Press-Releases
Press Releases and Statements
No new digest content identified.
Bill & Melinda Gates Medical Research Institute [to 2 Jan 2021]
https://www.gatesmri.org/
The Bill & Melinda Gates Medical Research Institute is a non-profit biotech organization. Our mission is to develop products to fight malaria, tuberculosis, and diarrheal diseases—three major causes of mortality, poverty, and inequality in developing countries. The world has unprecedented scientific tools at its disposal; now is the time to use them to save the lives of the world’s poorest people
No new digest content identified.
CARB-X [to 2 Jan 2021]
https://carb-x.org/
News
No new digest content identified.
Center for Vaccine Ethics and Policy [to 2 Jan 2021]
https://centerforvaccineethicsandpolicy.net/
News/Analysis/Statements
An Informed Choice/Consent/Right-to-Refuse Imperative :: Statement on Immunization Involving COVID-19 Vaccines Under Emergency Use Authorization/Listing [EUA/L]
1 January 2021 The GE2P2 Global Foundation’s Center for Vaccine Ethics and Policy has developed a statement that argues that immunization involving COVID-19 vaccines available under emergency use mechanisms or expanded access/compassionate use triggers an imperative to assure that individuals receive the information required to support free exercise of meaningful informed choice/consent, with a right to refuse such vaccination for any reason or no reason. The full statement is available here: http://www.ge2p2.org/the-informed-choice/consent/right-to-refuse-imperative
CEPI – Coalition for Epidemic Preparedness Innovations [to 2 Jan 2021]
http://cepi.net/
Latest News
CEPI-supported COVID-19 vaccine, developed by University of Oxford/ AstraZeneca, receives authorisation in the UK
30 Dec 2020
Statement from Dr. Richard Hatchett, CEO of CEPI, welcoming the announcement from the UK’s independent regulatory authority, MHRA:
“We were delighted to hear today’s (30 December) announcement that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted emergency authorisation for the University of Oxford/AstraZeneca COVID-19 vaccine.
“MHRA’s determination that the University of Oxford/AstraZeneca COVID-19 vaccine is safe and effective paves the way, we hope, for similar determinations by other stringent regulatory authorities and for WHO Prequalification in the days and weeks ahead.
“The Oxford/AstraZeneca COVID-19 vaccine is extremely attractive in that it is inexpensive, scalable, and can be stored at 2-8 degrees Celsius. These attributes will enable its use worldwide, including in low-income and middle-income countries, alongside other safe and effective COVID-19 vaccines, and the large supplies that will become available in 2021 mean that this vaccine could be a gamechanger in terms of our efforts to end the acute phase of the pandemic.
“Today’s authorization of a vaccine based on viral vector technology, as opposed to the mRNA approach employed by the Pfizer and Moderna vaccines, solidifies our belief that we will soon have a diverse array of vaccines with which to fight this devastating pandemic.
CEPI partners with Biological E Limited to advance development and manufacture of COVID-19 vaccine candidate
29 December 2020, Oslo, Norway and Hyderabad, India—
CEPI, the Coalition for Epidemic Preparedness Innovations and Biological E Limited, India (Bio E), a Hyderabad-based vaccines and pharmaceutical company, today announced a collaboration to advance the development and manufacture of Bio E’s COVID-19 subunit vaccine candidate. CEPI will initially contribute up to $5m toward the cost of scaling up the process for manufacturing the vaccine, and will explore providing additional funding to Bio E with the goal of potentially enabling the production of 100 million doses in 2021. The candidate has also received seed funding from Department of Biotechnology, Govt of India…
EDCTP [to 2 Jan 2021]
http://www.edctp.org/
The European & Developing Countries Clinical Trials Partnership (EDCTP) aims to accelerate the development of new or improved drugs, vaccines, microbicides and diagnostics against HIV/AIDS, tuberculosis and malaria as well as other poverty-related and neglected infectious diseases in sub-Saharan Africa, with a focus on phase II and III clinical trials
No new digest content identified.
Emory Vaccine Center [to 2 Jan 2021]
http://www.vaccines.emory.edu/
Vaccine Center News
No new digest content identified.
European Medicines Agency [to 2 Jan 2021]
http://www.ema.europa.eu/ema/
News & Press Releases
Update on rolling review of AstraZeneca’s COVID-19 vaccine
News 30/12/2020
EMA’s assessment of the COVID-19 vaccine being developed by AstraZeneca and Oxford University has been progressing over the past weeks. The Agency is currently assessing data on the vaccine as part of a rolling review.
So far, some evidence has been assessed on safety and efficacy coming from a pooled analysis of interim clinical data from four ongoing clinical trials in the UK, Brazil and South Africa. The latest clinical package was received on 21 December and is currently being assessed. CHMP has already assessed data from laboratory studies (non-clinical data) and is currently assessing data on the vaccine’s quality (on its ingredients and the way it is manufactured).
Additional scientific information on issues related to quality, safety and efficacy of the vaccine is deemed necessary to support the rigour required for a conditional marketing authorisation and this has been requested from the company.
Further information from the ongoing clinical trials is also expected from January. Interim data from a large trial ongoing in the USA are expected in Q1 2021.
EMA is aware that the UK MHRA has granted a temporary authorisation of supply of the vaccine in the emergency use setting, which is distinct from a marketing authorisation. EMA, its European experts and the European Commission are working towards conditional marketing authorisation of COVID-19 vaccines, with all the safeguards, controls and obligations that this imposes. It guarantees that the vaccine meets rigorous EU standards for safety, efficacy and quality…
European Vaccine Initiative [to 2 Jan 2021]
http://www.euvaccine.eu/
Latest News
Website not responding at inquiry
FDA [to 2 Jan 2021]
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
Press Announcements /Selected Details
December 30, 2020 – Coronavirus (COVID-19) Update: December 30, 2020
December 28, 2020 – Coronavirus (COVID-19) Update: December 28, 2020
FDA – COVID-19 Vaccines [to 2 Jan 2021]
www.fda.gov/covid19vaccines
News and Updates; Upcoming Events
12/28/2020
Coronavirus (COVID-19) Update
The FDA posts an updated letter of authorization, health care provider fact sheet and frequently asked questions regarding the number of Pfizer-BioNTech doses in a vial, updated the Device Shortage List, and provides a testing update.
12/28/2020
Video Discussion: COVID-19 VaccinesExternal Link Disclaimer
In this 30-minute video discussion, FDA Commissioner Dr. Stephen Hahn and Center for Biologics Evaluation and Research (CBER) Director Dr. Peter Marks talk with WebMD about what we know, what we don’t know, and what we might learn in the future about COVID-19 vaccines.
Fondation Merieux [to 2 Jan 2021]
http://www.fondation-merieux.org/
News, Events
Press Releases
No new digest content identified.
Gavi [to 2 Jan 2021]
https://www.gavi.org/
News releases
Gavi welcomes final approval of U.S. support for global immunisation in Year-End Omnibus and COVID Supplemental Package
Geneva, 28 December 2020
See Milestones above for detail
GHIT Fund [to 2 Jan 2021]
https://www.ghitfund.org/newsroom/press
GHIT was set up in 212 with the aim of developing new tools to tackle infectious diseases that
Press Releases
No new digest content identified.
Global Fund [to 2 Jan 2021]
https://www.theglobalfund.org/en/news/
News
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Global Research Collaboration for Infectious Disease Preparedness [GloPID-R] [to 2 Jan 2021]
https://www.glopid-r.org/news/
News
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Hilleman Laboratories [to 2 Jan 2021]
http://www.hillemanlabs.org/
No new digest content identified.
Human Vaccines Project [to 2 Jan 2021]
http://www.humanvaccinesproject.org/media/press-releases/
Press Releases
No new digest content identified.
IAVI [to 2 Jan 2021]
https://www.iavi.org/newsroom
PRESS RELEASES/FEATURES
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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 2 Jan 2021]
http://media.ifrc.org/ifrc/news/press-releases/
Selected Press Releases, Announcements
No new digest content identified.
Institut Pasteur [to 2 Jan 2021]
https://www.pasteur.fr/en/press-area
Press documents
No new digest content identified.
IRC International Rescue Committee [to 2 Jan 2021]
http://www.rescue.org/press-release-index
Media highlights [Selected]
No new digest content identified.
IVAC [to 2 Jan 2021]
https://www.jhsph.edu/research/centers-and-institutes/ivac/index.html
Updates; Events
No new digest content identified.
IVI [to 2 Jan 2021]
http://www.ivi.int/
Selected IVI News, Announcements, Events
No new digest content identified.
JEE Alliance [to 2 Jan 2021]
https://www.jeealliance.org/
Selected News and Events
No new digest content identified.
Johns Hopkins Center for Health Security [to 2 Jan 2021]
https://www.centerforhealthsecurity.org/news/center-news/
Center News
No new digest content identified.
MSF/Médecins Sans Frontières [to 2 Jan 2021]
http://www.msf.org/
Latest [Selected Announcements]
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National Vaccine Program Office – U.S. HHS [to 2 Jan 2021]
https://www.hhs.gov/vaccines/about/index.html
Upcoming Meetings/Latest Updates
No new digest content identified.
NIH [to 2 Jan 2021]
http://www.nih.gov/news-events/news-releases
News Releases
Peer-reviewed report on Moderna COVID-19 vaccine publishes
December 30, 2020 — Data from Phase 3 clinical trial confirm vaccine is effective.
LR Baden, et al. Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine. The New England Journal of Medicine. DOI: 10.1056/NEJMoa2035389.
NIH study uncovers blood vessel damage and inflammation in COVID-19 patients’ brains but no infection
December 30, 2020 — Results from a study of 19 deceased patients suggests brain damage is a byproduct of a patient’s illness.
In an in-depth study of how COVID-19 affects a patient’s brain, National Institutes of Health researchers consistently spotted hallmarks of damage caused by thinning and leaky brain blood vessels in tissue samples from patients who died shortly after contracting the disease. In addition, they saw no signs of SARS-CoV-2 in the tissue samples, suggesting the damage was not caused by a direct viral attack on the brain. The results were published as a correspondence in the New England Journal of Medicine…
Phase 3 trial of Novavax investigational COVID-19 vaccine opens
December 28, 2020 — NIH- and BARDA-funded trial will enroll up to 30,000 volunteers.
People 18 years of age and older who are interested in participating in this trial can visit coronaviruspreventionnetwork.org(link is external), ClinicalTrials.gov and search identifier NCT04611802, or Novavax.com/PREVENT-19(link is external) for details. Please do not contact the NIAID media phone number or email to enroll in this trial.
PATH [to 2 Jan 2021]
https://www.path.org/media-center/
Press Release
No new digest content identified.
Sabin Vaccine Institute [to 2 Jan 2021]
http://www.sabin.org/updates/pressreleases
Statements and Press Releases
No new digest content identified.
UNAIDS [to 2 Jan 2021]
http://www.unaids.org/en
Selected Press Releases/Reports/Statements
No new digest content identified.
UNICEF [to 2 Jan 2021]
https://www.unicef.org/media/press-releases
Selected Press releases, Statements
Press release
12/31/2020
New Year’s Babies: Over 370,000 children will be born worldwide on New Year’s Day – UNICEF
With the calendar flipping to 2021, UNICEF dedicates its 75th year to reimagining a better world for children.
Press release
12/30/2020
An estimated 10.4 million children in the Democratic Republic of the Congo, northeast Nigeria, the Central Sahel, South Sudan and Yemen will suffer from acute malnutrition in 2021
UNICEF warns numbers could rise further without urgent action
Unitaid [to 2 Jan 2021]
https://unitaid.org/
Featured News
No new digest content identified.
Vaccination Acceptance Research Network (VARN) [to 2 Jan 2021]
https://vaccineacceptance.org/news.html#header1-2r
Announcements
No new digest content identified.
Vaccine Confidence Project [to 2 Jan 2021]
http://www.vaccineconfidence.org/
News, Research and Reports
No new digest content identified.
Vaccine Education Center – Children’s Hospital of Philadelphia [to 2 Jan 2021]
http://www.chop.edu/centers-programs/vaccine-education-center
News
No new digest content identified.
Wellcome Trust [to 2 Jan 2021]
https://wellcome.ac.uk/news
News
No new digest content identified.
The Wistar Institute [to 2 Jan 2021]
https://www.wistar.org/news/press-releases
Press Releases
No new digest content identified.
WFPHA: World Federation of Public Health Associations [to 2 Jan 2021]
https://www.wfpha.org/
Latest News
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World Organisation for Animal Health (OIE) [to 2 Jan 2021]
https://www.oie.int/en/for-the-media/press-releases/2020/
No new digest content identified.
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ARM [Alliance for Regenerative Medicine] [to 2 Jan 2021]
https://alliancerm.org/
Press Releases
No new digest content identified.
BIO [to 2 Jan 2021]
https://www.bio.org/press-releases
Press Releases
Injunction Placed on Punitive and Political Maneuver by Administration
December 29, 2020
A judge in the United States District Court for the Northern District of California yesterday issued a preliminary injunction blocking the Administration’s “Most Favored Nation” reimbursement policy for certain drugs administered by Medicare Part B…
DCVMN – Developing Country Vaccine Manufacturers Network [to 2 Jan 2021]
http://www.dcvmn.org/
News; Upcoming events
First Sabin Inactivated Poliovirus Vaccine (sIPV) Achieved WHO Prequalification
Geneva, 21st December 2020
ICBA – International Council of Biotechnology Associations [to 2 Jan 2021]
https://internationalbiotech.org/news/
News
No new digest content identified.
IFPMA [to 2 Jan 2021]
http://www.ifpma.org/resources/news-releases/
Selected Press Releases, Statements, Publications
No new digest content identified.
PhRMA [to 2 Jan 2021]
http://www.phrma.org/
Selected Press Releases, Statements
No new digest content identified.
vaccines and global health :: ethics and policy 