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Coronavirus Disease 2019 (COVID-19) 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.
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Monkeypox response updates
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)
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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)
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FACT SHEET: Biden Administration Announces Key Actions and Implementation Plan to Increase Vaccine Supply (White House, August 9, 2022)
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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?
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COVID-19 therapeutics updates
Paxlovid shelf-life extension
When FDA first issued the EUA authorizing Paxlovid (nirmatrelvir tablets and ritonavir tablets co-packaged for oral use), it established a 12-month product shelf-life. Four lots of Paxlovid manufactured prior to the EUA issuance were labeled with a 9-month expiry. FDA has authorized extended expiration dates for these lots to reflect the 12-month product shelf-life (see Table 1: Extended Expiry Dating for Paxlovid (nirmatrelvir tablets and ritonavir tablets co-packaged for oral use) Authorized under EUA 105), when stored according to the storage conditions detailed in the authorized Fact Sheet for Health Care Providers and the Letter of Authorization for Emergency Use Authorization (EUA) 105 for Paxlovid. (July 26, 2022)
Sotrovimab shelf-life extension
FDA and HHS/ASPR authorized an additional extension to the shelf-life for all lots of the refrigerated GSK monoclonal antibody, sotrovimab, from 18 months to 24 months. (July 29, 2022)
August is National Immunization Awareness Month
Multilingual social media toolkit
Share these social media messages and graphics from FDA to help encourage your audiences to get vaccinated against COVID-19 and other infectious diseases. The toolkit is available in English, Spanish, Simplified Chinese, Korean, Tagalog, and Vietnamese. Also see this FDA Voices by Robert M. Califf, M.D., Commissioner of Food and Drugs.
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Emergency Use Authorization (EUA) updates
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:
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
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Events
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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
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August 24, 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).
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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.
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New! September 19, 2022: FDA Workshop: Increasing the Efficiency of Biosimilar Development Programs (virtual) - The workshop will focus on comparative clinical studies associated with biosimilar development programs and will discuss possible innovative ideas that have the potential to streamline and improve the efficiency of biosimilar development. Advance registration required.
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September 21-22, 2022: 2022 Public Meeting of the National Antimicrobial Resistance Monitoring System (NARMS) (virtual) - FDA, in cooperation with the U.S. Centers for Disease Control and Prevention and the U.S. Department of Agriculture’s Food Safety and Inspection Service, its partners in the National Antimicrobial Resistance Monitoring System (NARMS), opened registration for the 2022 Public Meeting of NARMS. The meeting is open to all stakeholders at no cost.
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Information for industry and health care providers
North American Diagnostics recalls Oral Rapid SARS-CoV-2 Rapid Antigen Test Kits that are not authorized, cleared, or approved by the FDA
FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. (August 1, 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.
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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.)
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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.
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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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