Vaccine News

• COVID-19 Bivalent Vaccine Boosters Now Authorized for Younger Age Groups (10/12/2022)

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

• FDA authorizes bivalent COVID-19 vaccines for use as a booster dose. (8/31/2022)

• FDA authorizes emergency use of the Novavax COVID-19 Vaccine, Adjuvanted. (7/13/2022)

• FDA authorizes Moderna and Pfizer-BioNTech COVID-19 Vaccines for children down to 6 months of age. (6/17/2022) 

• More COVID-19 Vaccine News

Therapeutics News

• Updated Health Care Provider Fact Sheet for bebtelovimab regarding expected reduced activity against certain emerging Omicron subvariants (11/4/2022) 

• Risk of COVID-19 due to certain variants not neutralized by Evusheld (10/3/2022)

• COVID-19 Therapeutics Expiration Dating Extensions

• FDA published the refreshed Know Your Treatment Options for COVID-19 Consumer Update (5/17/2022)

• Stakeholder Call: COVID-19 Therapeutics (1/13/2022)

Testing News

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

• FDA issued an EUA for the first over-the-counter molecular test authorized for use with saliva specimens (10/18/2022)

• Jiangsu Well Biotech Co., Ltd. recalls COVID-19 Ag Rapid Test Devices that are not authorized, cleared, or approved by the FDA (10/12/2022)

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

• SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests (9/14/2022)

Safety News

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

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

  • Virtual Advisory Committee Meeting (11/1/2022): To discuss factors that may affect pulse oximeter accuracy and performance, and related topics.

• Do Not Use Animal Products to Treat Humans:

  • Ivermectin

  • Chloroquine Phosphate

• Consumers should not use: Hand Sanitizer List

Shortages

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COVID-19 Emergency Use Authorizations (EUAs)

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FDA-Approved COVID-19 Vaccines

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FDA-Authorized COVID-19 Vaccines

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• 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

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