More about the first FDA COVID-19 vaccine approval | EUA and shelf-life extension updates

U.S. Food and Drug Administration sent this bulletin at 08/25/2021 08:05 AM EDT

If your email program has trouble displaying this email, view as a webpage.

Coronavirus Disease 2019 (COVID-19) updates

Actions by FDA in our ongoing response to the COVID-19 pandemic since our last MCMi email update include:

August 24, 2021: COVID-19 Update including an update to the Pfizer-BioNTech EUA to support the extension of shelf-life of the Pfizer-BioNTech COVID-19 Vaccine stored at -90 degrees to -60 degrees Celsius from 6 months to 9 months
August 23, 2021: FDA Approves First COVID-19 Vaccine
August 20, 2021: COVID-19 Update including a warning letter regarding sale of unapproved products with unproven COVID-19 claims and a stakeholder call in recognition of National Immunization Awareness Month to discuss vaccines for younger children and adolescents in preparation for the school year
August 18, 2021: Joint Statement from HHS Public Health and Medical Experts on COVID-19 Booster Shots

Bookmark www.fda.gov/coronavirus for the latest.

COVID-19 vaccine updates

FDA approves first COVID-19 vaccine

On August 23, 2021, FDA approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under Emergency Use Authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.

Learn more

Related links

Comirnaty prescribing information (package insert, approval letter, Q&A)
Comirnaty and Pfizer-BioNTech COVID-19 Vaccine (regulatory information, EUA fact sheets, and more)
Summary Basis for Regulatory Action - Comirnaty (PDF)
EUA letter of authorization (PDF, 372 KB), reissued August 23, 2021
Recording of a media call with FDA leadership about this approval (24 minutes)
Infographic: FDA Vaccine Facts: The Path for Vaccines from Research to FDA Approval (PDF)

ICYMI: 5 things you need to know about the COVID-19 vaccine for adolescents 12 through 17

This back-to-school season parents have questions about COVID-19 vaccination for kids 12 and older. Get answers from the FDA. Vaccination is one of the best ways to protect everyone 12 and older from COVID-19.

Get the facts

Emergency Use Authorization (EUA) updates

Shelf life extension - bamlanivimab

FDA and HHS ASPR announced the authorization of an extension to the shelf-life from 12 months to 18 months for the refrigerated Eli Lilly monoclonal antibody, bamlanivimab, which is currently authorized for emergency use only when administered together with etesevimab. As a result of this extension, unopened vials of bamlanivimab, injection, 700 mg/20 mL, should be stored under refrigerated temperature at 2°C to 8°C (36°F to 46°F), and may be stored for an additional 6 months from the labeled date of expiry (See Table 1 here). FDA granted this extension following a thorough review of data submitted by Eli Lilly. This extension applies to all unopened vials of bamlanivimab that have been held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers (PDF) and the Letter of Authorization (PDF) for bamlanivimab and etesevimab, administered together.

The national pause on distribution of bamlanivimab and etesevimab announced June 25, 2021, remains in effect. We recommend that providers use alternative authorized monoclonal antibody therapies until further notice. (August 20, 2021)

EUA reissuance and shelf-life extension - Comirnaty and Pfizer-BioNTech COVID-19 Vaccine

On August 23, 2021, having concluded that revising this EUA is appropriate to protect the public health or safety under section 564(g)(2) of the FD&C Act, FDA reissued (PDF) the August 12, 2021 letter of authorization in its entirety with revisions incorporated to clarify that the EUA will remain in place for the Pfizer-BioNTech COVID-19 vaccine for the previously-authorized indication and uses, and to authorize use of COMIRNATY (COVID-19 Vaccine, mRNA) under this EUA for certain uses that are not included in the approved BLA.

In addition, the Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) (PDF) was revised to provide updates on expiration dating of the authorized Pfizer-BioNTech COVID-19 Vaccine (also see this August 22, 2021 Concurrence Letter) and to update language regarding warnings and precautions related to myocarditis and pericarditis. The Fact Sheet for Recipients and Caregivers was updated as the Vaccine Information Fact Sheet for Recipients and Caregivers (PDF), which comprises the Fact Sheet for the authorized Pfizer-BioNTech COVID-19 Vaccine and information about the FDA-licensed vaccine, COMIRNATY (COVID-19 Vaccine, mRNA).

Other EUA updates

The REGEN-COV EUA fact sheet for health care providers (PDF) was revised to update resistance information. (August 17, 2021)

In vitro diagnostic (test) EUAs

As of August 24, 2021, 403 tests and sample collection devices are authorized by FDA under EUAs. These include 283 molecular tests and sample collection devices, 87 antibody and other immune response tests, and 33 antigen tests. There are 58 molecular authorizations and 1 antibody authorization that can be used with home-collected samples. There is 1 molecular prescription at-home test, 3 antigen prescription at-home tests, 6 antigen over-the-counter (OTC) at-home tests, and 2 molecular OTC at-home tests. FDA has authorized 13 antigen tests and 8 molecular tests for serial screening programs. The FDA has also revised 612 test EUAs. Also see: Coronavirus Testing Basics

Events

August 25, 2021: Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation, 12:15 p.m. - 1:15 p.m. ET, hosted by FDA's Center for Devices and Radiological Health (CDRH). FDA will host additional webinars in this series in September.
August 25, 2021: Manufacturing, Supply Chain, and Inspections during the COVID-19 Public Health Emergency webinar, 9:00 a.m. - 1:00 p.m. ET, hosted by FDA's Center for Drug Evaluation and Research (CDER)
August 30 - September 1, 2021: Science and Regulation of Bacteriophage Therapy public workshop, hosted by FDA CBER and the National Institutes of Health, National Institute of Allergy and Infectious Diseases (NIH/NIAID)
September 1-2, 2021: FDA-M CERSI: Advancing the Development of Pediatric Therapeutics Complex Innovative Trial Design Public Workshop, hosted by FDA’s Division of Pediatrics and Maternal Health and Complex Innovative Trial Design Pilot Meeting Program in CDER and The University of Maryland CERSI
September 20-21, 2021: Pharmacodynamic Biomarkers for Biosimilar Development and Approval public workshop, hosted by FDA and Duke-Margolis, 10:00 a.m. - 2:30 p.m. ET both days - advance registration required
September 30, 2021: The Vaccines and Related Biological Products Advisory Committee will meet in open session (8:30 a.m. - 3:40 p.m. ET, virtual) to hear an overview of the research programs in the Laboratory of Bacterial Polysaccharides, Division of Bacterial, Parasitic, and Allergenic Products, Office of Vaccines Research and Review, and the Center for Biologics Evaluation and Research (CBER), and to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2021 to 2022 southern hemisphere influenza season.

Information for industry

Medical Device Development Tools (MDDT)

FDA has updated the MDDT program information to include information about qualified tools, the MDDT qualification process, and how to participate in the MDDT program. (August 24, 2021)

FDA is committed to providing timely recommendations, regulatory information, guidance, and technical assistance necessary to support rapid COVID-19 response efforts. FDA has issued more than 75 COVID-19-related guidances to date.

In case you missed it

Find a COVID-19 vaccine near you
An FDA Consumer Update, Learn More About COVID-19 Vaccines From the FDA, is now available in five additional languages: Spanish, Chinese, Korean, Tagalog, and Vietnamese. See the evidence for each COVID-19 vaccine and the reasoning behind the FDA’s Emergency Use Authorizations.

List of hand sanitizers consumers should not use
Some hand sanitizers have been recalled and there are more than 250 hand sanitizers the FDA recommends you stop using right away. Bookmark www.fda.gov/handsanitizerlist for the latest, and use our step-by-step search guide to find out if your product is on the list.

Did someone forward you this email? Subscribe.
(Select Emergency Preparedness and Response,
FDA Medical Countermeasures Initiative (MCMi) News)

Manage Subscriptions | Unsubscribe All | Help