FDA authorizes Moderna and Pfizer-BioNTech COVID-19 vaccines for children down to 6 months of age

Updates from FDA in our ongoing response to the COVID-19 pandemic since our last MCMi email update include:

• June 21, 2022: FDA Roundup including approval of a second generic naloxone hydrochloride (HCI) intranasal spray. Naloxone HCI is an opioid antagonist indicated for the emergency treatment of known or suspected opioid overdose. 
• June 17, 2022: FDA Roundup including FDA's 9th annual report (PDF) to summarize major actions taken by the agency to prevent or mitigate drug shortages in the U.S.
• June 16, 2022: Testimony by FDA Commissioner Dr. Robert Califf: An Update on the Ongoing Federal Response to COVID-19: Current Status and Future Planning

Bookmark www.fda.gov/coronavirus for the latest.

On June 17, 2022, FDA authorized emergency use of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 to include use in children down to 6 months of age.

For the Moderna COVID-19 Vaccine, the FDA amended the Emergency Use Authorization (EUA) to include use of the vaccine in individuals 6 months through 17 years of age. The vaccine had been authorized for use in adults 18 years of age and older.

For the Pfizer-BioNTech COVID-19 Vaccine, the FDA amended the EUA to include use of the vaccine in individuals 6 months through 4 years of age. The vaccine had been authorized for use in individuals 5 years of age and older. 

A recording of the June 17, 2022, press conference is available on YouTube (32 minutes). Vaccine providers: Also see Information for industry and health care providers below.

Some perspectives on data science and coronaviruses

FDA Grand Rounds - recording now available

On June 9, 2022, Seshadri S. Vasan from CSIRO, Australia's science agency, presented an FDA Grand Rounds presentation, including updates on some FDA-funded research. A recording of this lecture is now available (1 hour). 

In vitro diagnostic (test) EUAs

As of June 21, 2022, 438 tests and sample collection devices are authorized by FDA under EUAs. These include 303 molecular tests and sample collection devices, 85 antibody and other immune response tests, 49 antigen tests, and 1 diagnostic breath test. There are 80 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, 17 EUAs for antigen over-the-counter (OTC) at-home tests, and 3 EUAs for molecular OTC at-home tests. FDA has authorized 27 antigen tests and 8 molecular tests for serial screening programs. The FDA has also authorized 1,005 revisions to test EUAs. Also see: COVID-19 Test Basics  

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.  

FDA updates on Paxlovid for health care providers
View this CDER Conversation and Paxlovid Patient Eligibility Screening Checklist (PDF) for information that can help health care providers in decision-making regarding Paxlovid. 

List of hand sanitizers consumers should not use
Some hand sanitizers have been recalled and there are more than 300 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.