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COVID-19 vaccine updates
Get your updated, bivalent COVID-19 booster
Last month, FDA amended the EUAs of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine to authorize bivalent formulations of the vaccines for use as a single booster dose at least two months following primary or booster vaccination. Based on the data supporting each of these authorizations, the bivalent COVID-19 vaccines are expected to provide increased protection against the currently circulating omicron variant.
Search vaccines.gov, text your ZIP code to 438829, or call 1-800-232-0233 (TTY 1-888-720-7489) to find COVID-19 vaccines and boosters near you in the U.S.
What's new
Check the FDA Moderna COVID-19 Vaccines and Pfizer-BioNTech COVID-19 Vaccines pages for updated information, including:
- Health care providers: Printable wall charts updated to include the bivalent booster presentations are now available:
- The Pfizer-BioNTech COVID-19 Vaccine Fact Sheet for Recipients and Caregivers (PDF) for use in individuals 12 years of age and older, including bivalent booster information, is now also available in Chinese (Simplified), Korean, Spanish, Tagalog, and Vietnamese (PDFs). For more information, and translations of fact sheets for additional populations, see: Pfizer-BioNTech Fact Sheet Translations.
- The Moderna COVID-19 Vaccine Fact Sheet for Recipients and Caregivers (PDF) for use in individuals 12 and older (including the Fact Sheet for the authorized Moderna COVID-19 Vaccine for use in individuals 12 years of age
and older and the authorized Moderna COVID-19 Vaccine, Bivalent for use in individuals 18 years of age and older) is also now available in Chinese (Simplified), Korean, Spanish, Tagalog, and Vietnamese (PDFs). For more information, and translations of fact sheets for additional populations, see: Moderna COVID-19 Vaccine - Translations of the Fact Sheet for Recipients and Caregivers.
Visit our Rumor Control page for the facts, including:
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New: Yes, the FDA evaluated data from studies in people to support the emergency use authorization of the bivalent COVID-19 vaccine boosters.
- Yes, pregnant and breastfeeding people can receive a COVID-19 vaccine.
- Yes, all COVID-19 vaccines are free from metals, eggs, latex and gelatin.
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Monkeypox response updates
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Emergency Use Authorization (EUA) updates
COVID-19 test policy update
Developers encouraged to seek traditional premarket review for most test types
FDA announced updates to its COVID-19 test policy to address public health testing needs during this phase of the COVID-19 public health emergency.
Over the last two years more than 400 COVID-19 tests have been granted EUA and there are generally enough at-home tests, tests that can be used at the point-of-care such as health clinics, and laboratory-based tests to meet testing needs. FDA is revising its COVID-19 test policy to encourage most COVID-19 test developers to pursue a traditional premarket review pathway for their tests, rather than EUA.
FDA intends to prioritize its review of EUA requests on COVID-19 diagnostic tests that are likely to have a significant public health benefit or are likely to fulfill an unmet need. This could include novel technologies like the use of breath samples, or unique features like the ability of a test to detect a new SARS-CoV-2 virus variant.(September 27, 2022)
Also see:
Paxlovid fact sheet updates
On September 26, 2022, FDA authorized changes (PDF) to the Paxlovid EUA fact sheets for health care providers (PDF), and patients, parents, and caregivers (PDF).
EUA revocations
FDA revoked EUAs for this test, for the reasons noted in the revocation letter:
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.
Reminder: Monkeypox test EUA templates
FDA is providing voluntary templates that test developers may use when validating a test or when submitting an EUA request. Also see: Policy for Monkeypox Tests to Address the Public Health Emergency and FAQs on Testing for Monkeypox
In vitro diagnostic (test) EUAs
As of September 27, 2022, 437 tests and sample collection devices are authorized by FDA under EUAs. These include 300 molecular tests and sample collection devices, 85 antibody and other immune response tests, 51 antigen tests, and 1 diagnostic breath test. There are 79 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 1,121 revisions to test EUAs. Also see: COVID-19 Test Basics
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Events
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September 28, 2022: Virtual Town Hall Series - Test Development and Validation During Public Health Emergencies (COVID-19 and Monkeypox) (12:05 - 1:00 p.m. ET) - No registration required. There will be an opportunity to ask questions live on the call, and questions may also be submitted in advance by emailing CDRHWebinars@fda.hhs.gov. The future town hall events scheduled for October 5 and 12, 2022, will be on the topic of monkeypox only.
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October 5, 2022: Study Data Standards Update for CBER: Your Guide to a Successful Submission (webcast, 1:00 - 2:00 p.m. ET) - CBER will discuss CBER’s support and requirement starting March 15, 2023 for the Standard for the Exchange of Nonclinical Data (SEND), which was published in the Federal Register on July 14, 2020, and the addition of SEND for CBER to the FDA Data Standards Catalog.
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October 6, 2022: Vaccines and Related Biological Products Advisory Committee meeting (virtual, 8:30 a.m. - 12:40 p.m. ET) - The committee will meet in open session to discuss strain selection for influenza virus vaccines for the 2023 Southern Hemisphere influenza season.
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October 11, 2022: FDA NanoDay Symposium 2022 (webinar) - To address drug development of products that contain nanomaterials in their formulation and how the guidance to industry for products that contain nanomaterials finalized in April 2022 can be implemented in filings to the FDA. Discussion will include case studies on the development of the COVID mRNA lipid nanoparticle vaccine products.
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October 20, 2022: COVID-19 Evidence Accelerator: What We've Learned, Where We're Headed (webinar, 1:00 p.m. ET) - A public meeting hosted by the Reagan-Udall Foundation for the FDA and Friends of Cancer Research, to highlight accomplishments and share learnings, including how best to leverage real-world data and improve data interoperability, to address current and future health challenges.
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December 6, 2022: Save the date for FDA Broad Agency Announcement Day (webinar) to learn more about how FDA funds research, the types of projects we’re looking for to support regulatory science and innovation, and how you can apply.
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Information for industry and health care providers
COVID-19 vaccines: Bivalent boosters
Reminder: FDA posted to YouTube a recording (45 minutes) of a stakeholder call held on September 2, 2022, to discuss the updated COVID-19 boosters. FDA Commissioner Dr. Robert M. Califf and CBER Director Dr. Peter Marks answer questions from health care providers and other stakeholders.
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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
Are you ready for emergencies? September is National Preparedness Month. Planning for hurricane season and other potential disasters can be stressful. Learn what you can do now to be ready, and get the whole family involved.
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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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List of hand sanitizers consumers should not use Some hand sanitizers have been recalled and there are more than 350 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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