| 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. | | | COVID-19 vaccine updates  FDA authorizes second booster dose of two COVID-19 vaccines for older and immunocompromised individuals On March 29, 2022, FDA authorized a second booster dose of either the Pfizer-BioNTech or the Moderna COVID-19 vaccines for older people and certain immunocompromised individuals. The FDA previously authorized a single booster dose for certain immunocompromised individuals following completion of a three-dose primary vaccination series. This action will now make a second booster dose of these vaccines available to other populations at higher risk for severe disease, hospitalization and death. Emerging evidence suggests that a second booster dose of an mRNA COVID-19 vaccine improves protection against severe COVID-19 and is not associated with new safety concerns. FDA amended the Emergency Use Authorizations as follows: - A second booster dose of the Pfizer-BioNTech COVID-19 Vaccine or Moderna COVID-19 Vaccine may be administered to individuals 50 years of age and older at least 4 months after receipt of a first booster dose of any authorized or approved COVID-19 vaccine.
- A second booster dose of the Pfizer-BioNTech COVID-19 Vaccine may be administered to individuals 12 years of age and older with certain kinds of immunocompromise at least 4 months after receipt of a first booster dose of any authorized or approved COVID-19 vaccine. These are people who have undergone solid organ transplantation, or who are living with conditions that are considered to have an equivalent level of immunocompromise.
- A second booster dose of the Moderna COVID-19 Vaccine may be administered at least 4 months after the first booster dose of any authorized or approved COVID-19 vaccine to individuals 18 years of age and older with the same certain kinds of immunocompromise.
|  Do I qualify for a COVID-19 vaccine booster and which one? Use this chart to find out if you're eligible for a COVID-19 vaccine booster and which one. A text version and printable PDF are available. (updated March 29, 2022) | | Emergency Use Authorization (EUA) updates  FDA updates sotrovimab EUA On March 25, 2022, FDA announced the COVID-19 treatment sotrovimab is no longer authorized for use at this time in the U.S. Health and Human Services (HHS) regions 1 and 2 due to the high frequency of the omicron BA.2 sub-variant and data showing that the authorized dose of sotrovimab is unlikely to be effective against that sub-variant. Therefore, sotrovimab may not be administered for treatment of COVID-19 in these regions under the emergency use authorization until further notice by the agency: - Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, and Vermont (Health and Human Services [HHS] Region 1)
- New Jersey, New York, Puerto Rico, and the Virgin Islands (HHS Region 2)
For more information, see the updated health care provider fact sheet (PDF) and Frequently Asked Questions on the Emergency Use Authorization of Sotrovimab (PDF). In vitro diagnostic (test) EUAs As of March 29, 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 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 906 revisions to test EUA authorizations. Also see: Coronavirus Testing Basics | | |  Events | | Information for industry and health care providers Reminder: Expiration dating extension Did you know? You can find information about shelf-life extensions of COVID-19 vaccines, therapeutics, and in vitro diagnostic (IVD) tests on our web page: Expiration Dating Extension, under MCM Expiration Dating Extensions. On March 18, 2022, we added additional information about shelf-life extensions for COVID-19 IVDs. FDA reminds manufacturers they cannot distribute hand sanitizers produced consistent with temporary policies after March 31, 2022 FDA is reminding companies that manufactured alcohol-based hand sanitizers consistent with FDA's temporary policies (guidance documents withdrawn on December 31, 2021), they must stop distribution of any remaining hand sanitizer produced consistent with the temporary policies by March 31, 2022. This includes distribution to wholesalers, retailers, and hospitals. In addition, manufacturers are reminded that all hand sanitizer manufactured since January 1, 2022, must be in full compliance with the Federal Food, Drug and Cosmetic Act, including current good manufacturing practice (CGMP) regulations, and alcohol used must be fully compliant with the United States Pharmacopeia monograph and CGMP requirements. Learn more: Q&A for Industry | Withdrawal of Temporary Hand Sanitizer Guidances 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  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. |  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. |  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.
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