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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:
Bookmark www.fda.gov/coronavirus for the latest.
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COVID-19 vaccine updates
Today! VRBPAC: April 6, 2022
8:30 a.m. - 5:00 p.m. ET
FDA will hold a Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting on April 6, 2022, to discuss considerations for future COVID-19 vaccine booster doses and the process for selecting specific strains of the SARS-CoV-2 virus for COVID-19 vaccines to address current and emerging variants. The meeting will be live-streamed on YouTube.
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 Give your community a boost: Combatting misinformation through communication and research
By: RADM Richardae Araojo, Pharm.D., M.S., Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity
April is National Minority Health Month, and the U.S. Department of Health and Human Services selected “Give Your Community a Boost” as this year’s theme. Over the last two years, FDA has worked and continues working tirelessly with our U.S. government partners, medical product manufacturers, international partners, and additional stakeholders to meet the challenges of COVID-19. Although the pandemic continues, significant strides have been made in efforts to protect the health of Americans. The FDA authorized and approved vaccines, treatments, increased available testing options such as at-home tests, and provided educational resources in a variety of languages.
 Your COVID-19 toolkit at COVID.gov
Find COVID-19 guidance to protect yourself, your family, and your community at https://COVID.gov, a new one-stop resource for the latest information on COVID-19 prevention and reduction methods including masks, treatment, vaccines, and testing.
This site is also available in Spanish and Simplified Chinese. Have toolkit questions? Call 1-800-232-0233 (TTY 1-888-720-7489).
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Emergency Use Authorization (EUA) updates
Evusheld update: Certain patients need an additional dose as soon as possible
On April 1, 2022, FDA updated the Evusheld (PDF) (tixagevimab co-packaged with cilgavimab) fact sheet for health care providers (PDF) and frequently asked questions (PDF) with updated dosing information for patients who had already received the previously authorized initial dose (150 mg of tixagevimab and 150 mg of cilgavimab). These patients should receive an additional Evusheld dose as soon as possible, with the dose based on the following criteria:
- If the patient received their initial dose less than or equal to 3 months ago, the patient should receive a dose of 150 mg of tixagevimab and 150 mg of cilgavimab.
- If the patient received their initial dose longer than 3 months ago, the patient should receive a dose of 300 mg of tixagevimab and 300 mg of cilgavimab.
Sotrovimab is no longer authorized to treat COVID-19 in any U.S. region due to increases in the proportion of COVID-19 cases caused by the omicron BA.2 sub-variant
The CDC Nowcast data from April 5, 2022, estimates that the proportion of COVID-19 cases caused by the omicron BA.2 variant is above 50% in all Health and Human Services (HHS) U.S. regions. Data included in the health care provider fact sheet (PDF) show the authorized dose of sotrovimab is unlikely to be effective against the BA.2 sub-variant. Due to these data, sotrovimab is not authorized in any U.S. state or territory at this time.
Health care providers should use other approved or authorized products as they choose appropriate treatment options for patients. FDA will continue to monitor BA.2 in all U.S. regions and will provide follow-up communication when appropriate.
New FAQs: What happens to EUAs when a public health emergency ends?
Visit our website for answers to frequently asked questions about what happens to EUAs, and products available under EUA, when a public health emergency ends. (posted April 5, 2022)
In vitro diagnostic (test) EUAs
As of April 5, 2022, 425 tests and sample collection devices are authorized by FDA under EUAs. These include 293 molecular tests and sample collection devices, 84 antibody and other immune response tests, and 48 antigen tests. There are 74 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, 15 EUAs for antigen over-the-counter (OTC) at-home tests, and 3 EUAs for molecular OTC at-home tests. FDA has authorized 28 antigen tests and 9 molecular tests for serial screening programs. The FDA has also authorized 911 revisions to test EUA authorizations. Also see: Coronavirus Testing Basics
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 Events
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Information for industry and health care providers
Guidance update: Emergency Use Authorization for Vaccines to Prevent COVID-19
FDA revised the guidance, Emergency Use Authorization for Vaccines to Prevent COVID-19, to update recommendations for the clinical data to support effectiveness of a COVID-19 vaccine that has been modified to target a particular SARS-CoV-2 variant of concern. The revised guidance also provides the most up-to-date recommendations based on lessons learned during the COVID-19 public health emergency and submissions by sponsors.
The FDA also revised Section III (Criteria and Considerations for the Issuance of an EUA for a COVID-19 Vaccine) in the guidance to delete the expectation that sponsors should continue to collect placebo-controlled data after issuance of an EUA. The agency made this revision in recognition that the pandemic has evolved, and safe and effective COVID-19 vaccines have been authorized and approved. Thus, it may not be feasible to continue to collect placebo-controlled data when an effective vaccine is authorized and available for study participants. (March 31, 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
FDA COVID-19 response infographic
View a snapshot of some FDA COVID-19 response actions from the beginning of the public health emergency through the end of FY 2021. A downloadable PDF and text version of this infographic are available.
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Find a COVID-19 vaccine or booster near you
Text your zip code to GETVAX (438829) in English or VACUNA (822862) in Spanish to find out where COVID-19 vaccines are available near you. COVID-19 vaccines are free to all people living in the United States, regardless of their immigration or health insurance status. Learn more at vaccines.gov.
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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.
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FDA Medical Countermeasures Initiative (MCMi) News)
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