Announcements

Announcements

 

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

 

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

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

 

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

 

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

 

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

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

 

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

 

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

 

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

 

GHIT Fund [to 26 Dec 2020]
https://www.ghitfund.org/newsroom/press
GHIT was set up in 212 with the aim of developing new tools to tackle infectious diseases that
Press Releases
No new digest content identified.

 

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

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

 

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

 

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

 

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

 

IAVI [to 26 Dec 2020]
https://www.iavi.org/newsroom
PRESS RELEASES/FEATURES
No new digest content identified.

 

 

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

 

 

International Generic and Biosimilar Medicines Association [IGBA]
https://www.igbamedicines.org/
News
No new digest content identified.

 

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

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

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

 

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

 

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

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

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

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

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

 

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

 

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

 

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

 

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

 

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

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

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

 

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

 

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

 

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

 

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

 

 

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

 

 

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

 

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

 

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

 

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

 

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

 

 

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

 

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

 

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

 

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

 

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

 

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