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

Public health emergency response and other updates from FDA since our last MCMi email 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 

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.

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.

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:

• Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised)
• FAQs on Testing for SARS-CoV-2 (updated)

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:

• September 21, 2022: Laboratorio Clinico Toledo SARS-CoV-2 Assay (PDF) (Laboratorio Clinico Toledo)

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  

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.

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.)

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 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.