FDA Approves Vaccine for Post-Exposure Prophylaxis of Anthrax

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

• July 27, 2023: FDA announces new steps to help facilitate innovation in devices intended to treat opioid use disorder.
• July 25, 2023: FDA Roundup including FDA recognition of certain sterilization standards and Technical Information Reports (TIRs) to help advance innovation in medical device sterilization processes. 
• July 21, 2023: FDA update regarding storm damage at Pfizer facility in North Carolina.
• July 21, 2023: FDA Roundup including the approval of Cyfendus, a vaccine for post-exposure prophylaxis of disease following suspected or confirmed exposure to Bacillus anthracis (anthrax).
• July 18, 2023: FDA Roundup including an update to the Medical Device Shortages List web page to remove certain product codes.
• July 17, 2023: FDA Approves New Drug to Prevent RSV in Babies and Toddlers
• July 14, 2023: FDA Roundup including the release of a public inventory of certain food ingredients that the FDA has determined to have unsafe uses in food.

• On July 27, 2023, FDA issued draft guidance to help sponsors design clinical studies to evaluate devices intended to treat opioid use disorder (OUD) to help further the FDA’s Overdose Prevention Framework goal of advancing evidence-based treatment for those with substance use disorders. 
• The draft guidance, Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder, outlines key considerations intended to aid sponsors in designing clinical studies for devices intended to treat OUD that address some of the complex challenges associated with these studies.

• On July 20, 2023, FDA approved Cyfendus, a vaccine for post-exposure prophylaxis of disease following suspected or confirmed exposure to Bacillus anthracis (anthrax) in persons 18 through 65 years of age when administered in conjunction with recommended antibacterial drugs.  

• On July 17, 2023, FDA approved Beyfortus (nirsevimab-alip) for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in neonates and infants born during or entering their first RSV season, and in children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.

EUA revocations

FDA revoked the following EUA for the reasons noted in the revocation letter (PDFs): 

• July 11, 2023: BD Vacutainer Plus Citrate Plasma Tubes (UK Manufacturing Site) (Becton, Dickinson and Co.)

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.

EUA quick links

• Emergency Use Authorization - about EUAs, and links to current EUAs
• EUAs for Drugs and Non-Vaccine Biological Products (CDER)
• EUAs for Medical Devices (CDRH)
• COVID-19 Vaccines, including vaccine-specific pages with EUA info (CBER)
• Emergency Use Authorization--Archived Information - EUAs that are no longer in effect because they have been terminated or revoked
• Historical Information about Device EUAs

Expiration date extension

Did you know? You can find information about shelf-life extensions of COVID-19 vaccines, therapeutics, and in vitro diagnostic (IVD) tests, and other medical countermeasures, on our web page: Expiration Dating Extension, under MCM Expiration Dating Extensions. 

Quick COVID-19 resources

• Check expiration date extensions for your COVID-19 tests 
• Get the latest on COVID-19 vaccines
• Know your treatment options for COVID-19

What happens to EUAs when a public health emergency ends? There are several types of declarations and determinations related to emergencies, including public health emergencies, which serve different purposes. Learn more in this FAQ. Also see, from HHS, Fact Sheet: End of the COVID-19 Public Health Emergency

List of hand sanitizers consumers should not use
Some hand sanitizers have been recalled and there are more than 450 hand sanitizers the FDA recommends you stop using right away. Bookmark www.fda.gov/handsanitizerlist for the latest, and learn more about safely using hand sanitizer.