COVID-19 vaccine and therapeutic updates | FDA seeking consumer representatives for advisory committees

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Coronavirus Disease 2019 (COVID-19) updates

Updates from FDA in our ongoing response to the COVID-19 pandemic since our last MCMi email update include: July 5, 2022: FDA Roundup including registration information for the 2022 Public Meeting of the National Antimicrobial Resistance Monitoring System July 1, 2022: FDA Roundup including a request for nominations for consumer representatives to serve on advisory committees and panels for which vacancies currently exist or are expected to occur in the near future June 30, 2022: FDA Recommends Inclusion of Omicron BA.4/5 Component for COVID-19 Vaccine Booster Doses and new web page: Update: COVID-19 Vaccine Booster Composition June 29, 2022: FDA authorizes revisions to Evusheld dosing to recommend repeat dosing every six months with a dose of 300 mg of tixagevimab and 300 mg cilgavimab if patients need ongoing protection Bookmark www.fda.gov/coronavirus for the latest.

COVID-19 vaccine update

FDA recommends inclusion of omicron BA.4/5 component for COVID-19 vaccine booster doses On June 28, 2022, the FDA's independent experts on the Vaccines and Related Biological Products Advisory Committee met to publicly discuss whether a change to the current vaccine strain composition of COVID-19 vaccines for booster doses is necessary for the 2022 fall and winter seasons. As we move into the fall and winter, it is critical that we have safe and effective vaccine boosters that can provide protection against circulating and emerging variants to prevent the most severe consequences of COVID-19. Following a thorough discussion on June 28, 2022, an overwhelming majority of the advisory committee voted in favor of including a SARS-CoV-2 omicron component in COVID-19 vaccines that would be used for boosters in the U.S. beginning in fall 2022. Following the vote, and striving to use the best available scientific evidence, we have advised manufacturers seeking to update their COVID-19 vaccines that they should develop modified vaccines that add an omicron BA.4/5 spike protein component to the current vaccine composition to create a two component (bivalent) booster vaccine, so that the modified vaccines can potentially be used starting in early to mid-fall 2022. (June 30, 2022)

COVID-19 therapeutics update

FDA authorizes revisions to Evusheld dosing

There are different variants (and subvariants) of SARS-CoV-2, and FDA continues to evaluate how well Evusheld (tixagevimab co-packaged with cilgavimab) neutralizes them. Currently, the Omicron BA.2, BA.2.12.1, BA.4, and BA.5 subvariants are circulating in the United States. Nonclinical data and pharmacokinetic modeling suggest that activity against these subvariants may be retained for six months at drug concentrations achieved following an Evusheld dose of 300 mg of tixagevimab and 300 mg cilgavimab.

Therefore, on June 29, 2022, FDA revised the Evusheld Fact Sheet for Healthcare Providers (PDF) to recommend repeat dosing every six months with a dose of 300 mg of tixagevimab and 300 mg cilgavimab if patients need ongoing protection. The previous Fact Sheet for Healthcare Providers did not provide a specific recommendation on the dosing interval.

We continue to monitor the neutralizing activity of Evusheld against emerging SARS-CoV-2 variants and will provide additional updates as needed. For further details please refer to Frequently Asked Questions on the EUA for Evusheld for Pre-exposure Prophylaxis of COVID-19 (PDF). (June 29, 2022) 

Request for advisory committee nominations

Consumer organizations and individuals

At FDA, we rely on our many advisory committees to help us make sound decisions based on the best science available. Advisory committee meetings can include a broad scientific discussion about important topics, such as the development of vaccines for COVID-19. They can also be more focused on a specific product under FDA review. 

FDA is requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or panels for which vacancies currently exist or are expected to occur in the near future. For advisory committee vacancies listed in this notice, and those that may occur through December 31, 2023:

Consumer organizations:

Consumer organizations interested in participating in the selection of an appropriate voting or nonvoting member to represent consumer interests on an FDA advisory committee or panel may send a letter or email (to ACOMSSubmissions@fda.hhs.gov) stating that interest to FDA by August 15, 2022.  

Consumer representatives:

Nominees recommended to serve as a voting or nonvoting consumer representative may be self-nominated or may be nominated by a consumer organization. FDA seeks to include the views of individuals on its advisory committee regardless of their gender identification, religious affiliation, racial and ethnic identification, or disability status and, therefore, encourages nominations of appropriately qualified candidates from all groups. Consumer representative nominations should be submitted electronically through the FDA Advisory Committee Membership Nomination Portal, by August 15, 2022. 

Alternatively, materials may be submitted by mail at the addresses noted in the Federal Register notice.

Learn more

• Federal Register notice: Requests for Nominations: Individuals and Consumer Organizations for Advisory Committees (July 1, 2022)
• Consumer Update: Advisory Committees Give FDA Critical Advice and the Public a Voice
• Applying for Membership on FDA Advisory Committees
• Consumer Representatives on FDA Advisory Committees

Emergency Use Authorization (EUA) updates

In vitro diagnostic (test) EUAs As of June 28, 2022, 438 tests and sample collection devices are authorized by FDA under EUAs. These include 303 molecular tests and sample collection devices, 85 antibody and other immune response tests, 49 antigen tests, and 1 diagnostic breath test. There are 80 molecular authorizations and 1 antibody authorization that can be used with home-collected samples. There is 1 EUA for a molecular prescription at-home test, 2 EUAs for antigen prescription at-home tests, 17 EUAs for antigen over-the-counter (OTC) at-home tests, and 3 EUAs for molecular OTC at-home tests. FDA has authorized 27 antigen tests and 8 molecular tests for serial screening programs. The FDA has also authorized 1,016 revisions to test EUAs. Also see: COVID-19 Test Basics

Events

• July 11-13, 2022: Training Course: Achieving Data Quality and Integrity in Clinical Trials Involving High-Consequence Pathogens (Omaha, Nebraska or virtual) - This course, presented by FDA and the University of Texas Medical Branch, will be held at the National Training, Simulation and Quarantine Center (TSQC) at University of Nebraska Medical Center/Nebraska Medicine, a National Ebola Training and Education Center (NETEC) facility. Advance registration required for in-person and virtual attendance.
• July 14, 2022: FDA Grand Rounds: One Health at FDA: From Concept to Application, 12:00 - 1:00 p.m. ET, presented by CAPT Brianna Skinner, DVM, MPH, DACLAM, of FDA's Office of Counterterrorism and Emerging Threats (OCET) and Annamaria Castiglia, DVM, of FDA's Center for Veterinary Medicine (CVM).
• July 27, 2022: Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation, 12:05 - 1:00 p.m. ET, hosted by FDA's Center for Devices and Radiological Health (CDRH). FDA will host the next event in this series on August 24, 2022.
•  August 11, 2022: 2022 FDA CVM Advanced Manufacturing Public Meeting, 1:00 - 4:00 p.m. EDT - CVM will host a virtual public meeting on the FDA’s oversight of advanced manufacturing technologies for animal drugs. The meeting will be a listening session to provide stakeholders with an opportunity to share information and insight on this topic with CVM. Learn more: FDA Announces Virtual Public Meeting on Advanced Manufacturing for Animal Drugs
• New! August 30, 2022: Virtual public workshop - Drug Development Considerations for the Prevention of Healthcare-Associated Infections - FDA and the Centers for Disease Control and Prevention (CDC) are co-sponsoring this workshop to discuss topics including the current state of development of pathogen-directed products used to prevent healthcare-associated infections, and antimicrobial resistance threats as potential targets for decolonization and pathogen reduction. To attend, register by 12:00 p.m. EDT August 29, 2022. Requests to make oral presentations must be received by August 15, 2022. 

Information for industry and health care providers

Call for industry applications - international pilot programs to streamline regulatory assessments and inspections 

FDA, as a member of the International Coalition of Medicines Regulatory Authorities (ICMRA), is pleased to share the announcement of new pilot programs and the call for industry applications. ICMRA is inviting industry sponsors to participate in pilot programs focusing on 1) collaborative assessments of chemistry, manufacturing and control (CMC) related post-approval changes and 2) hybrid inspections*.

*A facility assessment performed by more than one National Regulatory Authority (NRA) using a combination of on-site inspectorate (by one NRA) and remote inspectorate (by at least one NRA) connecting at the same time to the ongoing activities at the facility using virtual technology.

Further information on the two collaborative pilots, key considerations, and the application procedure is available on the ICMRA website. (June 28, 2022)  

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

Resources to keep yourself and others safe from COVID-19 Find out where to get a COVID-19 vaccine, test, or treatment in your community at COVID.gov. Call 1-800-232-0233 (TTY 1-888-720-7489) with questions. (Also available in Spanish and Simplified Chinese.)

Expiration date extensions of COVID-19 at-home tests Check the Expiration Date column of the List of Authorized At-Home OTC COVID-19 Diagnostic Tests to see if the expiration date for your at-home OTC COVID-19 test has been extended and how to find any new expiration date.

FDA updates on Paxlovid for health care providers View this CDER Conversation and Paxlovid Patient Eligibility Screening Checklist (PDF) for information that can help health care providers in decision-making regarding Paxlovid.

List of hand sanitizers consumers should not use Some hand sanitizers have been recalled and there are more than 300 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.

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