Vaccine News

• FDA authorizes changes to simplify use of bivalent mRNA COVID-19 vaccines. (4/18/2023)

• Bivalent Pfizer-BioNTech COVID-19 Vaccine authorized as booster dose for certain children 6 months through 4 years of age (3/14/2023)

• Janssen COVID-19 Vaccine Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) was revised to include a warning... (3/13/2023)

• Updated (bivalent) COVID-19 vaccines authorized for children down to 6 months of age (12/8/2022)

• Stakeholder Call: Updated COVID-19 Vaccine Boosters (9/2/2022)

• More COVID-19 Vaccine News

Therapeutics News

• FDA authorizes Gohibic (vilobelimab) injection for the treatment of COVID-19 (4/4/2023)

• Evusheld is not currently authorized for emergency use in the U.S. (1/26/2023)

• Shelf-Life Extension for Specific Lots of Paxlovid (1/18/2023)

• FDA approved Actemra (tocilizumab) injection for treatment of COVID-19 in certain hospitalized adults (FAQs - PDF, 173 KB) (12/21/2022)

• COVID-19 Therapeutics Expiration Dating Extensions

Testing News

• FDA authorizes first over-the-counter at-home test to detect both influenza and COVID-19 viruses (2/24/2023)

• Extended expiration dates for BinaxNOW, MaximBio ClearDetect, and iHealth COVID-19 tests (1/19/2023)

• SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests (1/12/2023)

• FDA revised the emergency use authorizations (EUAs) of all COVID-19 antigen tests: Repeat or serial testing (11/1/2022)

• FDA updates COVID-19 test policy, encourages developers to seek traditional premarket review (9/27/2022)

Safety News

• Medical Device Safety: Letters to Health Care Providers, Recalls, and Safety Communications 

• Safety Communications: 

  • Risk of Protection Failure with Certain O&M Halyard Surgical N95 Respirators, Surgical Masks, and Pediatric Face Masks (4/21/2023)

  • Pulse Oximeter Accuracy and Limitations (9/15/2022)

• Do Not Use Animal Products to Treat Humans:

  • Ivermectin

  • Chloroquine Phosphate

• Consumers should not use: Hand Sanitizer List

Shortages

• Medical Device Shortages

• Drug Shortage Database

• Animal Drug Shortage Information

COVID-19 Emergency Use Authorizations (EUAs)

• Vaccines

• Drugs and Non-Vaccine Biological Products

  • Spanish-language information (when available)

• Medical Devices

FDA-Approved COVID-19 Vaccines

• Comirnaty COVID-19 Vaccine

• Spikevax COVID-19 Vaccine

FDA-Authorized COVID-19 Vaccines

• Pfizer-BioNTech COVID-19 Vaccine, Bivalent

• Moderna COVID-19 Vaccine, Bivalent

• Novavax COVID-19 Vaccine, Adjuvanted

• Janssen COVID-19 Vaccine

COVID-19 Vaccine Safety

• Report a Vaccine Serious Adverse Event online

• COVID-19 Vaccine Safety Surveillance

• EUAs for COVID-19 Vaccines Explained

• Considerations for Selecting Respirators for Your Health Care Facility

• Face Masks, Barrier Face Coverings, Surgical Masks, and Respirators

• Medical Gloves

• Medical Gowns

• PPE Emergency Use Authorizations