FDA updates COVID-19 test policy | New printable COVID-19 vaccine wall charts including bivalent boosters

U.S. Food and Drug Administration sent this bulletin at 09/28/2022 04:19 PM EDT

If your email program has trouble displaying this email, view as a webpage.

FDA Office of Minority Health and Health Equity

The latest from FDA

Public health emergency response and other updates from FDA since our last email update include:

September 27, 2022: FDA Roundup including a report on the pilot Software Precertification (Pre-Cert) Pilot Program
September 27, 2022: FDA Updates COVID-19 Test Policy, Encourages Developers to Seek Traditional Premarket Review for Most Test Types
September 23, 2022: FDA Roundup including an FDA Voices: FDA Issues New Guidance to Help Facilitate Availability of Naloxone to Prevent Opioid Overdoses and Reduce Death

Quick links: COVID-19 updates from FDA, FDA Monkeypox Response

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:
- Available Pfizer-BioNTech COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) Presentations (PDF)
- Currently Available Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine, Bivalent Presentations (PDF)
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:

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.

COVID-19 Vaccines

Monkeypox response updates

New and updated Just a Minute! videos

When it comes to vaccines, what does intradermal mean? (YouTube) (new, September 21, 2022)
Is there a vaccine to prevent monkeypox? How does it work? (YouTube) (updated, September 19, 2022)

Visit www.fda.gov/monkeypox to learn more, including Fast Facts on the Intradermal Jynneos Monkeypox Vaccine (PDF), available in several languages.

Reminder: Virtual Town Hall Series - Test Development and Validation During Public Health Emergencies

Today, September 28, 2022, from 12:05 to 1:00 p.m. ET, FDA will host the next session of the virtual town hall series on test development and validation during public health emergencies. Topics will cover both SARS-CoV-2 (COVID-19) and monkeypox. 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.

FDA Monkeypox Response

Events

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.
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.
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.
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.
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.
New! December 6, 2022: Save the date for BAA Industry 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.

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.

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.)

COVID.gov - Find COVID-19 guidance for your community

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.

List of hand sanitizers consumers should not use
Some hand sanitizers have been recalled and there are more than 280 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.

Find additional updates on our website and in the Medical Countermeasures Initiative newsletter.

Visit the FDA OMHHE website and follow us on Twitter at @FDAHealthEquity

"Creating a world where health equity is a reality for all." www.fda.gov/healthequity

Manage Subscriptions | Unsubscribe All | Help