Announcements

Announcements

 

Paul G. Allen Frontiers Group [to 19 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 19 Dec 2020]
https://www.phe.gov/about/barda/Pages/default.aspx
BARDA News
December 15, 2020: HHS, DOD engage Quantum Leap Research Collaborative in search for effective treatments for the sickest COVID-19 patients

 

BMGF – Gates Foundation [to 19 Dec 2020]
http://www.gatesfoundation.org/Media-Center/Press-Releases
Press Releases and Statements
No new digest content identified.

 

Bill & Melinda Gates Medical Research Institute [to 19 Dec 2020]
https://www.gatesmri.org/
The Bill & Melinda Gates Medical Research Institute is a non-profit biotech organization. Our mission is to develop products to fight malaria, tuberculosis, and diarrheal diseases—three major causes of mortality, poverty, and inequality in developing countries. The world has unprecedented scientific tools at its disposal; now is the time to use them to save the lives of the world’s poorest people
No new digest content identified.

 

CARB-X [to 19 Dec 2020]
https://carb-x.org/
News
12.16.2020  |
2020 a year of remarkable progress in supporting the development of new antibiotics, vaccines, diagnostics and other products targeting antibiotic-resistant bacteria
CARB-X has made solid progress in 2020, providing funding and support for innovative products in the race against antibiotic-resistant bacteria, and significantly building the size and scientific diversity of its global portfolio of antibiotics, vaccines, diagnostics and other life-saving products targeting drug-resistant bacteria.

 

CEPI – Coalition for Epidemic Preparedness Innovations [to 19 Dec 2020]
http://cepi.net/
Latest News
18 Dec 2020
Largest-ever Lassa fever research programme launches in West Africa
New research programme, ‘Enable’, aims to increase knowledge of the disease and assess true case count of those infected across the region.

17 Dec 2020
Equitable access to vaccines is the best way out of COVID-19
How CEPI is enabling access to COVID-19 vaccines

14 Dec 2020
Canada boosts funding for CEPI’s COVID-19 vaccine research
Funding comes as part of a wider investment in the WHO’s Access to COVID-19 Tools (ACT) Accelerator

 

EDCTP [to 19 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 19 Dec 2020]
http://www.vaccines.emory.edu/
Vaccine Center News
No new digest content identified.

 

European Medicines Agency [to 19 Dec 2020]
http://www.ema.europa.eu/ema/
News & Press Releases
News: Update on assessment of marketing authorisation application for Moderna’s mRNA-1273 COVID-19 vaccine
CHMP, Last updated: 17/12/2020
[See COVID Regulatory above for detail]

 

 

News: Update on assessment of the BioNTech and Pfizer BNT162b2 vaccine marketing authorisation application
CHMP, Last updated: 15/12/2020
[See COVID Regulatory above for detail]

 

European Vaccine Initiative [to 19 Dec 2020]
http://www.euvaccine.eu/
Latest News
No new digest content identified.

 

FDA [to 19 Dec 2020]
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
Press Announcements /Selected Details
December 18, 2020 – FDA Takes Additional Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for Second COVID-19 Vaccine
Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the second vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The emergency use authorization allows the Moderna COVID-19 Vaccine to be distributed in the U.S. for use in individuals 18 years of age and older.
“With the availability of two vaccines now for the prevention of COVID-19, the FDA has taken another crucial step in the fight against this global pandemic that is causing vast numbers of hospitalizations and deaths in the United States each day,” said FDA Commissioner Stephen M. Hahn, M.D….

December 17, 2020 – FDA Statement on Vaccines and Related Biological Products Advisory Committee Meeting

December 17, 2020 – Coronavirus (COVID-19) Update: December 17, 2020
:: Today, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC), made up of independent scientific and public health experts from around the country, met to discuss a request for emergency use authorization (EUA) for a vaccine for COVID-19 prevention, submitted by ModernaTX, Inc. This meeting is an important step in the review process, providing an opportunity for outside experts to provide valuable advice and input for the agency to consider as part of its review. Importantly, the final decision about whether to authorize the vaccine for emergency use will be made by FDA’s career officials.
:: Also today, the agency posted a new webpage: Pfizer-BioNTech COVID-19 Vaccine Frequently Asked Questions. Questions cover specifics, such as what data did the FDA use to make the decision to authorize the vaccine for emergency use, to more general questions, such as how does a vaccine go from emergency use authorization to licensure.

December 16, 2020 – Coronavirus (COVID-19) Update: December 16, 2020

December 14, 2020 – Coronavirus (COVID-19) Update: December 14, 2020
:: Yesterday, the FDA posted the review memorandum outlining the basis of the agency’s decision to authorize the Pfizer-BioNTech COVID-19 Vaccine. To ensure all Americans can have trust and confidence in the carefulness of FDA’s review, we have made, and will continue to make, the vaccine review process as transparent as possible.

 

FDA – COVID-19 Vaccines [to 19 Dec 2020]
www.fda.gov/covid19vaccines
Upcoming Events
FDA Media Briefing
FDA Commissioner Stephen Hahn and CBER Director Peter Marks discuss the EUA issued for the Moderna COVID-19 Vaccine, December 18, 2020
12/18/2020

FDA Takes Additional Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for Second COVID-19 Vaccine
Today, the FDA issued an emergency use authorization (EUA) for the second vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
12/18/2020

FDA Statement on Vaccines and Related Biological Products Advisory Committee Meeting
Press Release / Public Statement
Following today’s positive advisory committee meeting outcome regarding the Moderna COVID-19 vaccine, the FDA has informed the sponsor that it will rapidly work toward finalization and issuance of an emergency use authorization.
12/18/2020

 

Fondation Merieux [to 19 Dec 2020]
http://www.fondation-merieux.org/
News, Events
Press Releases
No new digest content identified.

 

Gavi [to 19 Dec 2020]
https://www.gavi.org/
News releases
Gavi Board approves new push to reach unvaccinated children worldwide
17 December 2020
[See Milestones above for detail]

COVAX announces additional deals to access promising COVID-19 vaccine candidates; plans global rollout starting Q1 2021
18 December 2020
[See Milestones above for detail]

 

GHIT Fund [to 19 Dec 2020]
https://www.ghitfund.org/newsroom/press
GHIT was set up in 212 with the aim of developing new tools to tackle infectious diseases that
Press Releases
No new digest content identified.

 

Global Fund [to 19 Dec 2020]
https://www.theglobalfund.org/en/news/
News
The Global Fund Appoints Hui C. Yang as Head of Supply Operations
16 December 2020
The Global Fund to Fight AIDS, Tuberculosis and Malaria has appointed Hui C. Yang, a highly experienced procurement and supply chain executive, as Head of its Supply Operations Department. Ms. Yang brings over two decades of experience in both the public and private sector and will join the Global Fund on 1 March 2021.

 

 

Canada Contributes CAD 65 million to Global Fund’s COVID-19 Response
14 December 2020
The Global Fund applauds the government of Canada for allocating CAD 65 million to the Global Fund’s efforts to support low- and middle-income countries to fight COVID-19, including procuring and deploying millions of COVID-19 rapid diagnostics tests as well as reinforcing health systems.

 

Global Research Collaboration for Infectious Disease Preparedness [GloPID-R] [to 19 Dec 2020]
https://www.glopid-r.org/news/
News
No new digest content identified.

 

Hilleman Laboratories [to 19 Dec 2020]
http://www.hillemanlabs.org/
No new digest content identified.

 

Human Vaccines Project [to 19 Dec 2020]
http://www.humanvaccinesproject.org/media/press-releases/
HPV COVID Report
COVID-19 Vaccines are Here; Will People Take Them?
Interview with Julia Wu, S.D., M.S.
Principal Investigator, Research Scientist
Human Immunomics Initiative
Harvard T.H. Chan School of Public Health

 

IAVI [to 19 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 19 Dec 2020]
http://media.ifrc.org/ifrc/news/press-releases/
Selected Press Releases, Announcements
Global
IFRC President: Migrants must not be left stranded at back of COVID-19 vaccine queue
Geneva, 17 December 2020 – The President of the world’s largest humanitarian organisation warns that inclusive action is urgently needed to safeguard the health and dignity of migrants worldwide, and to ensure they are not left behind as the first COVID-19 vaccines start being distributed.
Speaking ahead of International Migrants Day tomorrow, the President of the International Federation of Red Cross and Red Crescent Societies (IFRC), Francesco Rocca, said: “As the first COVID-19 vaccines begin to roll out, migrants – irrespective of their status – must not be left at the back of the queue. The pandemic is having a catastrophic impact on people on the move, who are too often left to fall through the cracks when it comes to accessing essential health services. It is imperative that we address the many barriers to universal health coverage and that migrants are fully included in national vaccination campaigns.”
A recent IFRC report “Least Protected, Most Affected: Migrants and refugees facing extraordinary risks during the COVID-19 pandemic” revealed that migrants have been disproportionately exposed to, and affected by, the virus this year due to often limited access to essential health, water, sanitation and hygiene services, as well as poor and unsafe living and working conditions that make it harder to comply with basic preventative measures. It also showed that migrants are being hit hardest by the economic fallout of COVID-19, are widely neglected from formal protection and safeguarding measures, and regularly face stigma and discrimination – sometimes in the form of violence…

 

Institut Pasteur [to 19 Dec 2020]
https://www.pasteur.fr/en/press-area
Press documents
No new digest content identified.

 

IRC International Rescue Committee [to 19 Dec 2020]
http://www.rescue.org/press-release-index
Media highlights [Selected]
Press Release
IRC’s 2021 Emergency Watchlist: triple threat of COVID, climate change and conflict threatens 200 million people without urgent action
December 16, 2020

 

IVAC [to 19 Dec 2020]
https://www.jhsph.edu/research/centers-and-institutes/ivac/index.html
Updates; Events
No new digest content identified.

 

IVI [to 19 Dec 2020]
http://www.ivi.int/
Selected IVI News, Announcements, Events
IVI-SK’s new typhoid conjugate vaccine meets primary endpoints in phase III study in Nepal
Primary analysis also confirms safety of Vi-DT
December 17, 2020 – SEOUL, South Korea – Vi-DT typhoid conjugate vaccine, developed jointly by the International Vaccine Institute (IVI) and SK bioscience, has met the primary endpoints in a phase III study in Nepal. The primary endpoints were based on immune non-inferiority with the WHO-prequalified typhoid conjugate vaccine, Typbar-TCV®, in terms of serconversion rate, which confirms the new candidate TCV induces an immune response that is not inferior to Typbar-TCV®…

 

JEE Alliance [to 19 Dec 2020]
https://www.jeealliance.org/
Selected News and Events
No new digest content identified.

 

Johns Hopkins Center for Health Security [to 19 Dec 2020]
https://www.centerforhealthsecurity.org/news/center-news/
Center News
New Rapid Research Coalition Announced to Increase Local Community Involvement in an Equitable COVID-19 Vaccination Campaign  
launches CommuniVax, a research coalition funded by the Chan Zuckerberg Initiative
On December 15, the Johns Hopkins Center for Health Security at the Bloomberg School of Public Health announced the launch of CommuniVax, a coalition to strengthen the community’s role and involvement in an equitable vaccination campaign. The coalition will conduct rapid ethnographic research related to COVID-19 vaccination among historically underserved communities of color in the United States. Local research teams will listen to community members and work with them to develop suggestions on how to strengthen COVID-19 vaccine delivery and communication strategies. The coalition will synthesize and disseminate community viewpoints to national stakeholders to develop a more equitable and effective vaccination effort, with an enduring impact on public trust. Read more: https://www.centerforhealthsecurity.org/news/center-news/2020-12-15-CommuniVax.html.

 

MSF/Médecins Sans Frontières [to 19 Dec 2020]
http://www.msf.org/
Latest [Selected Announcements]
Access to medicines
Governments must act fast on consensus supporting historic move to suspend monopoiesduring pandemic
Press Release 15 Dec 2020

 

 

Nigeria
Extra-long malaria season in Borno claims lives
Project Update 14 Dec 2020

 

National Vaccine Program Office – U.S. HHS [to 19 Dec 2020]
https://www.hhs.gov/vaccines/about/index.html
Upcoming Meetings/Latest Updates
No new digest content identified.

 

NIH [to 19 Dec 2020]
http://www.nih.gov/news-events/news-releases
News Releases
Statement from NIH and BARDA on the FDA Emergency Use Authorization of the Moderna COVID-19 Vaccine
December 18, 2020 — The mRNA-1273 vaccine is the second COVID-19 vaccine in the United States to be granted an EUA.

Investigational COVID-19 therapeutics to be evaluated in large clinical trials
December 17, 2020 — NIH trial enrolling people hospitalized with COVID-19.
Two randomized, controlled Phase 3 clinical trials have begun evaluating investigational monoclonal antibodies for their safety and efficacy in treating people hospitalized with moderate COVID-19. The trials are part of the ACTIV-3 master protocol, which has an adaptive design allowing investigators to add new sub-studies of additional investigational agents. ACTIV-3 is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.
One sub-study is evaluating VIR-7831, a monoclonal antibody developed through a partnership between GlaxoSmithKline plc (Brentford, United Kingdom) and Vir Biotechnology, Inc. (San Francisco). The other sub-study is evaluating the combination of BRII-196 and BRII-198, two neutralizing monoclonal antibodies manufactured by Brii Biosciences (Durham, North Carolina and Beijing). Antibodies are infection-fighting proteins naturally made by the immune system. Antibodies can prevent viruses from infecting cells, sometimes by binding to the surface of the viruses. Synthetic versions of these antibodies, prepared in a laboratory, are known as monoclonal antibodies…

NIH observational study of coronavirus infection and multisystem inflammatory syndrome in children begins
December 16, 2020 — Researchers will enroll at least 250 children and young adults ages 20 years or younger from diverse racial and ethnic backgrounds.

NIH-funded COVID-19 home test is first to receive over-the-counter authorization from FDA
December 15, 2020 — Ellume USA’s rapid at-home test was developed through the NIH RADx Initiative.

 

PATH [to 19 Dec 2020]
https://www.path.org/media-center/
Press Release
No new digest content identified.

 

Sabin Vaccine Institute [to 19 Dec 2020]
http://www.sabin.org/updates/pressreleases
Statements and Press Releases
Dr. Regina Rabinovich Succeeds Dr. Axel Hoos as Sabin Vaccine Institute Board Chair, Drs. Norman Baylor and JoAnn Suzich Join the Board
Wednesday, December 16, 2020
Washington, D.C. – The Sabin Vaccine Institute (Sabin) is pleased to announce the Board of Trustees has unanimously elected Regina Rabinovich, MD, MPH, as board chair and elected two new trustees, Dr. Norman Baylor and Dr. JoAnn Suzich, to strengthen the organization’s leadership in global immunization and vaccine research and development.
Dr. Rabinovich has served on the board since November 2015, and as chair of the Governance Committee since 2016.
Dr. Rabinovich brings deep global health expertise to the role, with more than three decades of experience in the health and philanthropic sectors. She is currently the ExxonMobil Malaria Scholar in Residence at the Harvard T.H. Chan School of Public Health. In addition, Dr. Rabinovich is chair of the Malaria Eradication Scientific Alliance at ISGlobal, University of Barcelona, where she also serves as director of the Malaria Elimination Initiative…

 

UNAIDS [to 19 Dec 2020]
http://www.unaids.org/en
Selected Press Releases/Reports/Statements
18 December 2020
Lima joins the Fast-Track cities initiative

15 December 2020
Coming together to address the cost of inequality

14 December 2020
New modelling shows COVID-19 should not be a reason for delaying the 2030 deadline for ending AIDS as a public health threat

 

UNICEF [to 19 Dec 2020]
https://www.unicef.org/media/press-releases
Selected Press releases, Statements
Statement
12/18/2020
Remarks by Henrietta Fore, UNICEF Executive Director, at briefing on COVAX progress to date
As delivered
[See Milestones above for detail]

Press release
12/18/2020
UNICEF outlining plans to transport up to 850 tonnes of COVID-19 vaccines per month on behalf of COVAX, in ‘mammoth and historic’ logistics
UNICEF – in partnership with Gavi and WHO – is also helping low- and lower-middle-income countries prepare to receive COVID-19 vaccines in 2021
[See Milestones above for detail]

Press release
12/18/2020
COVID-19 has led to dramatic reduction in essential services and protection for migrant and displaced children in countries around the world
New survey data show children on the move largely excluded from pandemic response and recovery

Statement
12/14/2020
Teachers should be prioritized for vaccination against COVID-19
Statement by UNICEF Executive Director Henrietta Fore
NEW YORK, 15 December 2020 – “The COVID-19 pandemic has wreaked havoc on children’s education around the globe. Vaccinating teachers is a critical step towards putting it back on track.
“At their peak in late April 2020, nationwide school closures disrupted the learning of almost 90 per cent of students worldwide. While that number has dropped since, there continues to be an unsupported assumption that closing schools may slow the spread of the disease, despite increasing evidence that schools are not a main driver of community transmission. As a result, as cases are skyrocketing in many countries around the world, communities are again closing schools. As of 1 December, classrooms are closed for nearly 1 in 5 schoolchildren globally – or 320 million children.
“UNICEF is calling for teachers to be prioritized to receive the COVID-19 vaccine, once frontline health personnel and high-risk populations are vaccinated. This will help protect teachers from the virus, allow them to teach in person, and ultimately keep schools open.
“While decisions about vaccine allocation ultimately rest with governments, the consequences of extended missed or impaired education are steep, especially for the most marginalized. The longer children remain out of school, the less likely they are to return, and the more difficult it is for their parents to resume work.
“These are difficult decisions that force difficult tradeoffs. But what should not be difficult is the decision to do everything in our power to safeguard the future of the next generation. This begins by safeguarding those responsible for opening that future up for them.”

Statement
12/14/2020
Remarks by UNICEF Executive Director Henrietta Fore at the Nutrition for Growth (N4G) Kick-Off Event
As prepared for delivery

Press release
12/14/2020
Almost 2 billion people depend on health care facilities without basic water services – WHO, UNICEF
Lack of water puts health care workers and patients at higher risk of COVID-19 infection

 

Unitaid [to 19 Dec 2020]
https://unitaid.org/
Featured News
16 December 2020
Unitaid welcomes contribution from Canada
Geneva – Unitaid welcomes contribution of C$15 million (US$11.7 million) from Canada to its ongoing work on COVID-19 therapeutics and diagnostics under the global Access to Covid-19 Tools (ACT) Accelerator.
The funding, which forms part of a C$255 million overall package of support to the ACT-Accelerator, has been allocated to Unitaid to support equitable access to promising COVID-19 treatments and tests…

14 December 2020
Japan joins Unitaid’s Executive Board
Geneva – On the occasion of the 37th meeting of the Unitaid Executive Board on December 9th-10th 2020, members voted unanimously to welcome Japan to join them.
As a key country of innovation, promoter of universal access to quality health coverage and a major player in the fight against infectious diseases, Japan becomes a member of the Executive Board, alongside delegations from African Countries, Brazil, Chile, Communities Living with the Diseases, Foundations, France, NGOs, Norway, Republic of Korea, Spain, the United Kingdom and WHO…

 

Vaccination Acceptance Research Network (VARN) [to 19 Dec 2020]
https://vaccineacceptance.org/news.html#header1-2r
Announcements
No new digest content identified.

 

Vaccine Confidence Project [to 19 Dec 2020]
http://www.vaccineconfidence.org/
News, Research and Reports
Five ways to build confidence in vaccines
11 December 2020
Heidi Larson
Director, Vaccine Confidence Project

 

Vaccine Education Center – Children’s Hospital of Philadelphia [to 19 Dec 2020]
http://www.chop.edu/centers-programs/vaccine-education-center
News
No new digest content identified.

 

Wellcome Trust [to 19 Dec 2020]
https://wellcome.ac.uk/news
News
2020 – a year of science, solutions and solidarity
15 December 2020
In a tumultuous year, Wellcome has been at the heart of the global scientific response to the Covid-19 pandemic, while maintaining support for our broad portfolio of research. Our 2019/20 annual report, published today, reveals Wellcome spent £1.1 billion on research, innovation and advocacy.

A year of Covid-19 – and a year of extraordinary science
15 December 2020
The best of humanity has shone through the gloom of 2020. The dedication of scientists across the globe has been remarkable, not just for producing a string of lifesaving breakthroughs but for doing so at an unprecedented pace. Everyone who has supported the research response to Covid-19 can be proud. But the job isn’t finished yet, so we must redouble our commitments to put an end to the pandemic. Here is a selection of key moments in this great scientific success story.

 

The Wistar Institute [to 19 Dec 2020]
https://www.wistar.org/news/press-releases
Press Releases
No new digest content identified.

 

WFPHA: World Federation of Public Health Associations [to 19 Dec 2020]
https://www.wfpha.org/
Latest News
Statement on COVID-19 Immunization and Equitable Access to Vaccines
Dec 17, 2020
Statement on COVID-19 Immunization and Equitable Access to Vaccines
[See Milestones above for detail]

Equitable Access to COVID-19 Vaccination: A Distant Dream?
Dec 14, 2020
Equitable Access to COVID-19 Vaccination: A Distant Dream?T he race to produce a safe and efficacious vaccine for COVID-19 has been on-going and there are indications that success may not be too far away. Wealthy nations are trying to secure early…

 

World Organisation for Animal Health (OIE) [to 19 Dec 2020]
https://www.oie.int/en/for-the-media/press-releases/2020/
No new digest content identified.

 

 

::::::

 

ARM [Alliance for Regenerative Medicine] [to 19 Dec 2020]
https://alliancerm.org/
Press Releases
No new digest content identified.

 

BIO [to 19 Dec 2020]
https://www.bio.org/press-releases
Press Releases
No new digest content identified.

 

DCVMN – Developing Country Vaccine Manufacturers Network [to 19 Dec 2020]
http://www.dcvmn.org/
News; Upcoming events
No new digest content identified.

 

ICBA – International Council of Biotechnology Associations [to 19 Dec 2020]
https://internationalbiotech.org/news/
News
No new digest content identified.

 

IFPMA [to 19 Dec 2020]
http://www.ifpma.org/resources/news-releases/
Selected Press Releases, Statements, Publications
Call to Action On Routine and Life-Course Immunization in the Context of the COVID-19 Pandemic
09 December 2020
[See Milestones above for detail]

 

PhRMA [to 19 Dec 2020]
http://www.phrma.org/
Selected Press Releases, Statements
Report: More than 1,300 medicines and vaccines in development to help fight cancer
December 15, 2020
Over the last 30 years, significant progress has been made in the fight against cancer. Researchers have expanded their understanding of how cancer develops and how to target medicines for specific cancer types. Since peaking in 1991, cancer death rates have declined by 29%, leading to more than 2.9 million cancer deaths prolonged. The most recent data shows that between 2016 and 2017 alone, cancer death rates declined by 2.2%, the largest single-year drop ever recorded. Despite the challenges imposed by the COVID-19 pandemic, this momentum continues with biopharmaceutical companies focusing on research and development of innovative cancer therapies.