Public health emergency response updates from FDA: COVID-19 and monkeypox updates

Updates from FDA since our last MCMi email update include:

• August 9, 2022: Monkeypox Update: FDA Authorizes Emergency Use of JYNNEOS Vaccine to Increase Vaccine Supply
• August 9, 2022: FDA Roundup including a warning letter to a company for selling unapproved and misbranded tincture products as drugs for use in treating or preventing COVID-19
• August 5, 2022: New web page: Rumor Control - The growing spread of rumors, misinformation and disinformation about science, medicine, and the FDA, is putting patients and consumers at risk. We’re here to provide the facts.
• August 5, 2022: FDA Roundup including an FDA Voices post, FDA Recognizes National Immunization Awareness Month
• August 2, 2022: FDA Roundup including a COVID-19 testing update
• July 29, 2022: FDA Roundup including an update to FAQs on Testing for SARS-CoV-2
• July 29, 2022: FDA Provides Update on Agency Response to Monkeypox Outbreak (see more below)
• July 26, 2022: FDA Roundup including an expiration date extension for Paxlovid
• July 22, 2022: FDA Roundup including a warning to consumers about the potential risk of injury associated with the use of certain brands of ultraviolet (UV) wands because they may expose the user or any nearby person to unsafe levels of ultraviolet-C (UV-C) radiation and may cause injury to the skin, eyes, or both after a few seconds of use
• July 22, 2022: FDA updated the SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests web page to include information about genotyping tests authorized for the identification and differentiation of specific SARS-CoV-2 mutations, lineages, or variants
• July 20, 2022: New Q&A with FDA Podcast Series: Conversation on Paxlovid and COVID-19

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

On July 29, 2022, FDA provided an update on its multipronged response to monkeypox in the United States, including its efforts in the areas of diagnostics, vaccines and therapeutics. The agency has also established a dedicated website (also available in Spanish) to provide important information about the FDA’s ongoing regulatory activities related to monkeypox along with frequently asked questions. The FDA will provide updates as developments occur and will continue to work with federal public health partners and industry to ensure timely access to all available medical countermeasures. 

On August 9, 2022, FDA issued an EUA for the JYNNEOS vaccine to allow healthcare providers to use the vaccine by intradermal injection for individuals 18 years of age and older who are determined to be at high risk for monkeypox infection. This will increase the total number of doses available for use by up to five-fold. The EUA also allows for use of the vaccine in individuals younger than 18 years of age determined to be at high risk of monkeypox infection; in these individuals JYNNEOS is administered by subcutaneous injection. Read more: Monkeypox Update: FDA Authorizes Emergency Use of JYNNEOS Vaccine to Increase Vaccine Supply

Related links: 

• Key Facts About Monkeypox Vaccine
• HHS press release - HHS Secretary Becerra issues 564 determination, paving way for emergency use authorization of monkeypox vaccines (August 9, 2022)
• Determination of a Public Health Emergency or Significant Potential for a Public Health Emergency and Declaration that Circumstances Exist Justifying and Authorization Pursuant to Section 564 of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b) (HHS, August 9, 2022)
• FACT SHEET: Biden Administration Announces Key Actions and Implementation Plan to Increase Vaccine Supply (White House, August 9, 2022)
• Is there a vaccine approved to prevent monkeypox? – Just A Minute! with Dr. Peter Marks (YouTube video, August 4, 2022) - also available in Spanish: ¿Hay una vacuna aprobada para prevenir la viruela del mono? 

COVID-19 serology test update

FDA updated the FAQs on Testing for SARS-CoV-2 to note that no tests remain on the commercial manufacturer serology test notification list described in the FDA's Policy for Coronavirus Disease-2019 Tests. All tests previously on the commercial manufacturer serology test notification list have either been issued an EUA or should no longer be distributed, marketed, or offered. (July 26, 2022)

EUA revocations

FDA revoked EUAs for these tests, for the reasons noted in the revocation letters:

• July 19, 2022: Amazon Multi-Target SARS-CoV-2 Real-Time RT-PCR Test (PDF), Amazon Multi-Target SARS-CoV-2 Real-Time RT-PCR DTC Test (PDF), and Amazon Real-Time RT-PCR DTC Test for Detecting SARS-CoV-2 (PDF) (Amazon.com Services LLC)
• July 29, 2022: BD SARS-CoV-2/Flu for BD MAX System (PDF) (Beckton, Dickinson and Company)

Information about revoked EUAs is available on the web page Emergency Use Authorization--Archived Information. For revoked device EUAs, see: Historical Information about Device Emergency Use Authorizations.

In vitro diagnostic (test) EUAs

As of August 9, 2022, 439 tests and sample collection devices are authorized by FDA under EUAs. These include 302 molecular tests and sample collection devices, 85 antibody and other immune response tests, 51 antigen tests, and 1 diagnostic breath test. There are 78 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, 19 EUAs for antigen over-the-counter (OTC) at-home tests, and 3 EUAs for molecular OTC at-home tests. FDA has authorized 31 antigen tests and 8 molecular tests for serial screening programs. The FDA has also authorized 1,072 revisions to test EUAs. Also see: COVID-19 Test Basics  

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 seeking consumer representatives 
FDA is requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees as detailed in this notice, Submit your nomination materials by August 15, 2022. 

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.