Announcements

Announcements

 

Paul G. Allen Frontiers Group [to 14 Nov 2020]
https://alleninstitute.org/what-we-do/frontiers-group/news-press/
News
No new digest content identified.

 

BARDA – U.S. Department of HHS [to 14 Nov 2020]
https://www.phe.gov/about/barda/Pages/default.aspx
BARDA News
No new digest content identified.

 

BMGF – Gates Foundation [to 14 Nov 2020]
http://www.gatesfoundation.org/Media-Center/Press-Releases
Press Releases and Statements
NOVEMBER 12, 2020
Gates Foundation announces new funds to develop COVID-19 vaccines and increase access to affordable vaccines in low-income countries
Speaking at the Paris Peace Forum today, Melinda Gates will commit an additional $70 million and urge accelerated global action to end pandemic for everyone, everywhere
…Gates will say the foundation will commit an additional $50 million to the COVAX Advance Market Commitment (AMC) of Gavi, the Vaccine Alliance, a financing mechanism through which Gavi aims to secure equitable access to COVID-19 vaccines for 92 low- and middle-income countries. The foundation’s pledge to the AMC will unlock an additional £12.5 million (approximately US $16.2 million) from the UK government, which in September committed to matching other contributions to the AMC.
Gates will also announce a $20 million grant to the Coalition for Epidemic Preparedness Innovations (CEPI) to advance research and jumpstart the development for an additional slate of promising vaccine candidates as the first wave conclude their clinical trials and file for approval. Because they have greater potential for large-scale manufacturability, temperature stability, and low-cost production, this next group of candidate vaccines may be better suited to the needs of low- and middle-income settings and, therefore, able to increase equitable access to affordable vaccines..

 

Bill & Melinda Gates Medical Research Institute [to 14 Nov 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 14 Nov 2020]
https://carb-x.org/
News
11.10.2020  |
CARB-X is funding Locus Biosciences to develop an innovative CRISPR Cas-3-enhanced bacteriophage targeting antibiotic-resistant Klebsiella pneumoniae infections
CARB-X is awarding up to US$2.05 million to Locus Biosciences to develop a new precision medicine to treat serious recurring urinary tract infections (rUTI) caused by the bacterial pathogen Klebsiella pneumoniae.

 

CEPI – Coalition for Epidemic Preparedness Innovations [to 14 Nov 2020]
http://cepi.net/
Latest News
CEPI receives funding for development of ‘next generation’ of COVID-19 vaccine candidates
12 Nov 2020
CEPI will receive a grant of up to $20m from the Bill & Melinda Gates Foundation to expand its portfolio of COVID-19 vaccines to include candidates that are differentiated from those already in advanced development. The world is likely to be living with COVID-19 for many years to come, so the grant will accelerate the development of the next generation of vaccines (‘Wave 2 vaccines’) that could address gaps in the current global vaccine development landscape, helping to ensure vaccines are available in the future that are easier to deliver and address the specific needs of a diverse range of populations and settings…

CEPI welcomes launch of new Plague Inc. game to show the world how to stop the next pandemic
With scientific input from infectious disease experts, including CEPI, Plague Inc: The Cure shows one of the most detailed and interactive representations of a pandemic.
11 Nov 2020

CEPI welcomes announcement from Pfizer / BioNTech of positive interim data from Phase III trial of COVID-19 vaccine candidate
09 Nov 2

 

EDCTP [to 14 Nov 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
Latest news
11 November 2020
EDCTP and The Global Health Network launch the EDCTP Knowledge Hub
EDCTP and The Global Health Network have launched the EDCTP Knowledge Hub, an online platform with open-access resources for researchers conducting clinical research in low-resource settings. With financial support from the European Union and the Swedish government, EDCTP commissioned The Global Health Network to develop this digital knowledge hub to provide researchers with tools and guidance that enable them to undertake high-quality health research.

 

Emory Vaccine Center [to 14 Nov 2020]
http://www.vaccines.emory.edu/
Vaccine Center News
No new digest content identified.

 

European Medicines Agency [to 14 Nov 2020]
http://www.ema.europa.eu/ema/
News & Press Releases
News: EMA publishes safety monitoring plan and guidance on risk management planning for COVID-19 vaccines
Last updated: 13/11/2020
[See COVID above for detail]

 

 

News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 9-12 November 2020
CHMP, Last updated: 13/11/2020

 

European Vaccine Initiative [to 14 Nov 2020]
http://www.euvaccine.eu/
Latest News
No new digest content identified.

 

FDA [to 14 Nov 2020]
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
Press Announcements /Selected Details
November 13, 2020 – Coronavirus (COVID-19) Update: November 13, 2020

November 12, 2020 – Coronavirus (COVID-19) Update: November 12, 2020
:: On November 10, the FDA updated the dashboard on the Coronavirus Treatment Acceleration Program (CTAP) webpage. As of October 31, more than 560 drug development programs were in planning stages, over 370 trials had been reviewed by FDA, 5 COVID-19 treatments were currently authorized for emergency use, and 1 treatment was approved by FDA for use in COVID-19.

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

November 9, 2020 – Coronavirus (COVID-19) Update: November 9, 2020
:: Today, the FDA issued an emergency use authorization (EUA) for the investigational monoclonal antibody therapy bamlanivimab for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients…
:: In addition today, the FDA issued final guidance with the agency’s recommendations on designing and executing clinical trials of drugs and biologics that include people with different demographic characteristics (e.g., sex, race, ethnicity, age) and non-demographic characteristics (e.g., patients with organ dysfunction, comorbid conditions, and disabilities.) The final guidance provides the agency’s current thinking on steps to broaden eligibility criteria in clinical trials through inclusive trial practices, trial designs, and methodological approaches, as well as recommendations for how sponsors can increase enrollment of underrepresented populations in their clinical trials…

November 9, 2020 – Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibody for Treatment of COVID-19
Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the investigational monoclonal antibody therapy bamlanivimab for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients. Bamlanivimab is authorized for patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40 kilograms (about 88 pounds), and who are at high risk for progressing to severe COVID-19 and/or hospitalization. This includes those who are 65 years of age or older, or who have certain chronic medical conditions.
While the safety and effectiveness of this investigational therapy continues to be evaluated, bamlanivimab was shown in clinical trials to reduce COVID-19-related hospitalization or emergency room visits in patients at high risk for disease progression within 28 days after treatment when compared to placebo…

 

FDA – COVID-19 Vaccines [to 14 Nov 2020]
www.fda.gov/covid19vaccines
Upcoming Events
No new digest content identified.

 

Fondation Merieux [to 14 Nov 2020]
http://www.fondation-merieux.org/
News, Events
No new digest content identified.

 

Gavi [to 14 Nov 2020]
https://www.gavi.org/
News releases
13 November 2020
Over US$ 2 billion raised to support equitable access to COVID vaccines with additional US$ 5 billion needed in 2021
[See COVAX above for detail]

 

GHIT Fund [to 14 Nov 2020]
https://www.ghitfund.org/newsroom/press
GHIT was set up in 2012 with the aim of developing new tools to tackle infectious diseases that No new digest content identified.

 

Global Fund [to 14 Nov 2020]
https://www.theglobalfund.org/en/news/
News
Germany signs EUR150 million contribution to the Global Fund’s COVID-19 response
12 November 2020
The German Federal Ministry of Economic Cooperation and Development and the Global Fund signed an additional contribution agreement of EUR150 million to mitigate the impact of COVID-19 in low- and middle-income countries, signaling a strong partnership in the fight against the pandemic.

News
Global Fund Board signals strong commitment to sustain the fight against HIV, TB, malaria while supporting the global response to COVID-19
12 November 2020
The Board of the Global Fund to Fight AIDS, Tuberculosis and Malaria met virtually for the 44th Board meeting this week to discuss the organization’s response to the COVID-19 pandemic, development of the next Global Fund strategy and progress in the fight against HIV, TB and malaria.

 

Global Research Collaboration for Infectious Disease Preparedness [GloPID-R] [to 14 Nov 2020]
https://www.glopid-r.org/news/
News
No new digest content identified.

 

Hilleman Laboratories [to 14 Nov 2020]
http://www.hillemanlabs.org/
No new digest content identified.

 

Human Vaccines Project [to 14 Nov 2020]
http://www.humanvaccinesproject.org/media/press-releases/
Press Releases
No new digest content identified.

 

IAVI [to 14 Nov 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
Innovative and generic & biosimilar pharmaceutical industries unite on commitment to equitable access to COVID-19 medicines and vaccines, while flagging where further help is needed from others (November 2020)
Geneva 10 November 2020 – On the occasion of the World Health Assembly, the world’s research-based and generic & biosimilar pharmaceutical industry bodies delivered a statement declaring their shared commitment to equitable access to COVID-19 medicines and vaccines. In their joint statement…
[See COVID above for detail]

 

 

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

 

IFRC [to 14 Nov 2020]
http://media.ifrc.org/ifrc/news/press-releases/
Selected Press Releases, Announcements
Czechia, Europe, France, Georgia, Italy, Monaco, Netherlands, Slovakia
COVID-19: Red Cross Red Crescent steps up European response, urges Governments to strengthen testing, tracing and isolation measures
IFRC is urging Governments to strengthen their “test-trace-quarantine” systems to help prevent future surges of COVID-19. This call comes as multiple European countries put in place new restrictions to stop community transmission and to avoid the collapse of health systems.
11 November 2020

 

Institut Pasteur [to 14 Nov 2020]
https://www.pasteur.fr/en/press-area
Press documents
No new digest content identified.

 

IRC International Rescue Committee [to 14 Nov 2020]
http://www.rescue.org/press-release-index
Media highlights [Selected]
Press Release
As COVID cases surpass 120,000 in Jordan, refugees struggle to feed their families
November 12, 2020

 

IVAC [to 14 Nov 2020]
https://www.jhsph.edu/research/centers-and-institutes/ivac/index.html
Updates; Events
No new digest content identified.

 

IVI [to 14 Nov 2020]
http://www.ivi.int/
Selected IVI News, Announcements, Events
No new digest content identified.

 

JEE Alliance [to 14 Nov 2020]
https://www.jeealliance.org/
Selected News and Events
No new digest content identified.

 

MSF/Médecins Sans Frontières [to 14 Nov 2020]
http://www.msf.org/
Latest [Selected Announcements]
Mediterranean migration
Carnage in the Mediterranean is the direct result of European state …
Press Release 13 Nov 2020

Coronavirus COVID-19 pandemic
MSF supports COVID-19 response in nursing homes in Czech Republic
Project Update 13 Nov 2020

Non-communicable diseases
Eight reasons why diabetes is a humanitarian emergency
Project Update 13 Nov 2020

Coronavirus COVID-19 pandemic
MSF supports nursing home staff as urgent appeal for medical personnel in …
Project Update 11 Nov 2020

Syria
Taking risks to survive as COVID-19 spreads in the northwest
Project Update 11 Nov 2020

Coronavirus COVID-19 pandemic
Governments must demand pharma make all COVID-19 vaccine deals public
Press Release 11 Nov 2020
:: Deals from pharmaceutical companies to develop COVID-19 vaccines are shrouded in secrecy, and details from them that are released reveal worrying terms.
:: At the same time, the six front running vaccine candidates have had a total of over US$12 billion of tax payer and public money poured into them.
:: MSF urges governments – which have provided funding to these companies – to demand transparency on vaccine licensing deals and on trial costs and data.

Geneva – Governments must urgently demand transparency from pharmaceutical corporations on all COVID-19 vaccine licensing agreements, as well as clinical trial costs and data, says Médecins Sans Frontières (MSF). The call comes as billions of dollars of taxpayer money have gone towards the development of these potential vaccines, and recently disclosed deals from pharmaceutical company AstraZeneca reveal worrying terms.

AstraZeneca has committed not to profit off any COVID-19 vaccines ‘for the duration of the pandemic’ and to sell the vaccine at cost, in a deal with Oxford University. However, another deal to develop a COVID-19 vaccine with Brazilian public research body Fundação Oswaldo Cruz (Fiocruz), recently revealed that AstraZeneca has given itself the power to declare the pandemic over as soon as July 2021. This means that, after July 2021, AstraZeneca could charge governments and other purchasers high prices for a vaccine that was entirely funded by public money.

Pharmaceutical corporations have a very poor track record of transparency across the board, from licensing deals and technology transfers to costs of R&D and clinical trial data. The little information that has been revealed around AstraZeneca’s not-for-profit promises should be a warning sign that pharma cannot be trusted to act in the interest of public health.

“As long as we don’t know what’s in these deals, pharma will continue to hold the power to decide who gets access when, and at what price,” said Kate Elder, Senior Vaccines Policy Advisor for MSF’s Access Campaign. “Without decisive action from governments demanding more transparency from companies, equitable access to COVID-19 vaccines is in jeopardy.”
“The public has the right to know what’s in these deals,” said Elder. “There is no place for secrets during a pandemic; there is too much at stake.”

The licensing deals struck for a number of other companies racing to develop COVID-19 vaccines also remain cloaked in secrecy, despite unprecedented levels of public funding. Over US$12 billion has been poured into the research and development (R&D), clinical trials and manufacture of six front-runner candidate COVID-19 vaccines…

 

National Vaccine Program Office – U.S. HHS [to 14 Nov 2020]
https://www.hhs.gov/vaccines/about/index.html
No new digest content identified.

 

NIH [to 14 Nov 2020]
http://www.nih.gov/news-events/news-releases
News Releases
Treatments for people with early COVID-19 infection is an urgent research focus
November 11, 2020 — Effective, early interventions would benefit individual patients and healthcare system.

Hydroxychloroquine does not benefit adults hospitalized with COVID-19
November 9, 2020 — The trial began after lab studies and preliminary reports suggested that hydroxychloroquine might have promise in treating SARS-CoV-2.

 

PATH [to 14 Nov 2020]
https://www.path.org/media-center/
Press Release
No new digest content identified.

 

Sabin Vaccine Institute [to 14 Nov 2020]
http://www.sabin.org/updates/pressreleases
Statements and Press Releases
No new digest content identified.

 

UNAIDS [to 14 Nov 2020]
http://www.unaids.org/en
Selected Press Releases/Reports/Statements
13 November 2020
Interactive TV series about HIV launched in Kyrgyzstan

12 November 2020
Updated dashboard supports differentiated HIV testing services

9 November 2020
Little progress in increasing comprehensive knowledge of HIV among young women in eastern and southern Africa

9 November 2020
“Someone has to start”: how a Haitian transgender activist is inspiring hope through visibility

 

UNICEF [to 14 Nov 2020]
https://www.unicef.org/media/press-releases
Selected Press releases, Statements
Press release
11/12/2020
Worldwide Measles Deaths Climb 50% from 2016 to 2019 Claiming Over 207,500 Lives in 2019

Press release
11/12/2020
Severe pneumonia leaves 4.2 million children desperate for oxygen each year

News note
11/11/2020
UNICEF and PAHO launch joint COVID-19 vaccine tender on behalf of COVAX Facility
[See COVID above for detail]

Press release
11/10/2020
100 days on from Beirut explosions, children and families affected remain in need of sustained support – UNICEF
Just one-third of UNICEF’s US$50 million appeal received, with increased funding vital to ensure long-term assistance for children

 

Unitaid [to 14 Nov 2020]
https://unitaid.org/
Featured News
11 November 2020 | Press releases
UnitaidExplore invests in second award to improve oxygen access
Geneva – Access to oxygen is one of the defining health equity issues of our time – and the COVID-19 pandemic has thrown this into sharp relief.
Healthcare facilities in low- and middle-income countries suffer from chronic shortages of medical oxygen, resulting in more than 2000 children dying every day from pneumonia.
On World Pneumonia Day 2020, Unitaid is pleased to announce the latest recipient of funding from its agility mechanism UnitaidExplore, following a call for innovations that expand access to oxygen.
The EssentialTech Centre, part of the Swiss Federal Institute of Technology (EPFL) in Lausanne, will become the second organisation to take forward an exciting innovation with backing from UnitaidExplore, following the first award to Vayu Global Health.
The $1.6 million funding will be used to develop a new, affordable oxygen concentrator designed for use in remote health centres, as well as an integrated oxygen delivery service…

 

Vaccination Acceptance Research Network (VARN) [to 14 Nov 2020]
https://vaccineacceptance.org/news.html#header1-2r
Announcements
No new digest content identified.

 

Vaccine Confidence Project [to 14 Nov 2020]
http://www.vaccineconfidence.org/
Research and Reports
No new digest content identified.

 

Vaccine Education Center – Children’s Hospital of Philadelphia [to 14 Nov 2020]
http://www.chop.edu/centers-programs/vaccine-education-center
No new digest content identified.

 

Wellcome Trust [to 14 Nov 2020]
https://wellcome.ac.uk/news
Explainer | 13 November 2020
Seven vital questions about the Pfizer-BioNTech Covid-19 vaccine
Preliminary data from phase three clinical trials has shown the Pfizer-BioNTech Covid-19 vaccine to be 90% effective – it is the first vaccine candidate to produce such positive results.
This is great news, but it raises lots of questions including, how does the vaccine work, is it safe, and when will it be available?

 

The Wistar Institute [to 14 Nov 2020]
https://www.wistar.org/news/press-releases
Press Releases
Nov. 13, 2020
The Wistar Institute Announces the Appointment of Scott Cooper, Ph.D., Richard G. Phillips, Jr., and Steven V. Abramson to Its Board of Trustees
PHILADELPHIA — (Oct. 13, 2020) — The Wistar Institute is pleased to welcome Scott Cooper, Ph.D., Richard G. Phillips Jr., Esq., and Steven V. Abramson, to its Board of Trustees. The new trustees bring diverse expertise and perspectives to the mission of the Institute…

 

WFPHA: World Federation of Public Health Associations [to 14 Nov 2020]
https://www.wfpha.org/
Latest News
16th World Congress on Public Health Came to a Close!
Nov 13 2020
More than 3,750 public health professionals and policymakers from 125 countries gathered online at a time when sharing science is more important than ever.
After 3 years of anticipation, the 16th World Congress on Public Health (WCPH) finally came to a close. The virtual event, which was co-organized by the World Federation of Public Health Associations (WFPHA), the European Public Health Association (EUPHA), and the Italian Society of Hygiene, Preventative Medicine, and Public Health (SItI) saw an incredible turnout as 3,750 participants tuned in virtually from across 125 countries. Inspiring presentations and meaningful discussions brought together public health professionals as they navigated challenges under the theme of “Public Health for the Future of Humanity: Analysis, Advocacy, and Action”.
309 total sessions were dedicated to covering topics under a 12-track scientific programme. Sessions related to topics including COVID-19, infectious diseases, public health advocacy, health workforce training, digital health, and environmental health were led by various leaders and experts across multiple sectors…

 

World Organisation for Animal Health (OIE) [to 14 Nov 2020]
https://www.oie.int/en/for-the-media/press-releases/2020/
Press Releases
OIE statement on COVID-19 and mink
Paris, 12 November 2020 – The risk of susceptible animals, such as mink, becoming a SARS-CoV-2 reservoir generates worldwide concern, as it could pose a continued public health risk and lead to future spillover events to humans. Recent surveillance findings in Denmark suggest that the SARS-CoV-2 virus, introduced into minks through contact with humans, is evolving through viral mutation and has been reintroduced to humans.

The OIE acknowledges that such events could have important public health implications. While the COVID-19 pandemic is currently sustained through human-to-human transmission, there are concerns that the introduction and circulation of new virus strains in humans could result in modifications of transmissibility or virulence and decreased treatment and vaccine efficacy. Yet, the full consequences remain unknown, and further investigation is needed to fully understand the impact of these mutations.

Close collaboration between animal and public health authorities is imperative to better identify and reduce the impact of this disease. Furthermore, a global One Health approach is needed to understand risks for animal and human health, as well as ecosystem health as a whole.

The OIE calls on countries to protect animal health and welfare, and consequently public health, by implementing effective risk management measures. Actions should be taken to:
:: Prevent the transmission of SARS-CoV-2 between humans and susceptible animals, by implementing national risk reduction strategies;

:: Monitor susceptible animals, such as mink and racoon dogs, as well as humans in close contact with them, for SARS-CoV-2 infection adopting a One Health approach. Active monitoring is recommended as it might be difficult to detect early infections in these animals, especially mink;

:: Report animal cases to the OIE through the World Animal Health Information System (WAHIS);

:: Share genetic sequences of SARS-CoV-2 viruses isolated from animals and other research findings with the global health community.

To support countries in the implementation of these measures, the OIE has developed guidelines for people working with susceptible farmed animals, as well as with wild mammals in the era of the COVID-19 pandemic.

The OIE will continue to engage with its members, experts and partners   notably the World Health Organization (WHO) and the Food and Agriculture Organization of the United Nations (FAO) to update technical guidance as new scientific findings and information become available.

 

 

::::::

 

ARM [Alliance for Regenerative Medicine] [to 14 Nov 2020]
https://alliancerm.org/press-releases/
Press Releases
No new digest content identified.

 

BIO [to 14 Nov 2020]
https://www.bio.org/press-releases
Press Releases
No new digest content identified.

 

DCVMN – Developing Country Vaccine Manufacturers Network [to 14 Nov 2020]
http://www.dcvmn.org/
News; Upcoming events
No new digest content identified.

 

ICBA – International Council of Biotechnology Associations [to 14 Nov 2020]
https://internationalbiotech.org/news/
News
No new digest content identified.

 

IFPMA [to 14 Nov 2020]
http://www.ifpma.org/resources/news-releases/
Selected Press Releases, Statements, Publications
Innovative and generic & biosimilar pharmaceutical industries unite on commitment to equitable access to COVID-19 medicines and vaccines, while flagging where further help is needed from others
Published on: 10 November 2020
[See COVID above for detail]

Statement
IFPMA/IGBA “Considerations on equitable access to COVID-19 medicines and vaccines”
09 November 2020

Statement
IFPMA Statement for the resumed 73rd WHA on agenda item 13.3 Influenza preparedness
09 November 2020

 

PhRMA [to 14 Nov 2020]
http://www.phrma.org/
Selected Press Releases, Statements
Press Release
Understanding the emergency use authorization process for COVID-19 vaccines
November 12, 2020
Richard Moscicki, M.D. Executive vice president, Science and Regulatory Advocacy and chief medical officer at PhRMA

As the world continues to feel the impact of the COVID-19 pandemic, the biopharmaceutical industry is working around the clock to develop safe and effective vaccines to prevent infection, as well as new therapies to treat the coronavirus. A wide range of approaches are currently being tested in robust clinical trials, with participants from all walks of life, to improve the odds that one or more vaccine candidates will be successful in meeting this pressing need. These trials look at how the immune system responds to a vaccine, its effectiveness in producing immunity and the safety profile.

Recently, there have been a number of conversations about the role of the U.S. Food and Drug Administration (FDA) in reviewing different COVID-19 vaccine candidates, and exactly how they may be available for use outside the context of a clinical trial, including through the issuance of an emergency use authorization (EUA). An EUA is important to helping provide access to medical products during a public health emergency like COVID-19.

As vaccines continue being robustly tested for safety and efficacy, here are three things to keep in mind:
1) An Emergency Use Authorization is different than FDA licensure of a vaccine.
EUAs are used in certain types of emergencies, like COVID-19, when there is no adequate, approved and available alternative to the EUA product. During these situations, the Federal Food, Drug and Cosmetic Act permits the FDA to issue EUAs to facilitate access to medical interventions, such as vaccines. Importantly, however, an EUA is not the same as an FDA approval or licensure. For example, there are different evidentiary requirements for licensure of a Biologics License Application (BLA) and issuance of an EUA for a vaccine. Furthermore, an EUA expires upon termination of the relevant emergency declaration, whereas there is no “termination” of a BLA.

The FDA may issue an EUA, when, among other things, the agency determines that based on all of the available scientific evidence, the known and potential benefits of the vaccine outweigh the known and potential risks. To underscore this, FDA Commissioner Stephen Hahn has said repeatedly in recent weeks and months that the agency would only consider an EUA if it felt the risks associated with the vaccine were “much lower than the risks of not having a vaccine and the potential benefit of having a vaccine.”

The agency has further taken steps to ensure the robust vaccine candidate review process by engaging the Vaccines & Related Biological Products Advisory Committee (VRBPAC) to discuss the development and potential authorization of vaccines to prevent COVID-19 after issuing guidance on FDA’s recommendations for an EUA submission for a COVID-19 vaccine.

 

 

2) COVID-19 Emergency Use Authorization standards are robust.
Recently, the FDA issued guidance specifically on EUAs for COVID-19 vaccines. The recommendations include key information and data that FDA recommends to support issuance of an EUA, including chemistry, manufacturing and controls information, nonclinical and clinical data and regulatory and administrative information.

This FDA guidance clarifies that an assessment regarding any potential EUA for COVID-19 vaccines would be made on a case-by-case basis considering the target population, the characteristics of the vaccines, and the totality of the relevant available scientific evidence, including preclinical and human clinical study data on the vaccine’s safety and effectiveness. The FDA plans to convene an open session of its VRBPAC (in addition to the general session held on October 22) prior to issuance of any EUA for a COVID-19 vaccine to discuss the request and whether the available safety and effectiveness data support the authorization.

 

 

3) EUAs last only as long as the HHS declaration justifying EUAs and may be revised or revoked at any time.
An EUA may only be issued after the Secretary of Health and Human Services makes a declaration that certain emergency circumstances exist justifying an EUA. EUAs issued under such declaration last only so long as the declaration is in effect; the EUA ceases to be effective upon termination of such declaration.

The FDA also has the authority revoke or revise an EUA at any time. The agency is directed to “periodically review the circumstances and the appropriateness” of an EUA, and the “progress made with respect to approval” or licensure of a product authorized under an EUA. The FDA may revise or revoke an EUA if the criteria for issuance are no longer met or other circumstances make such revision or revocation “appropriate to protect the public health or safety.”

America’s biopharmaceutical companies are supportive of the FDA’s robust new EUA guidance that brings greater scientific transparency to the COVID-19 vaccine review process and have pledged ‘to make the safety and well-being of vaccinated individuals the top priority in development’ of these first vaccines.