Medical countermeasure updates: COVID-19 and mpox

Important public health and other updates from FDA since our last MCMi email include:

• FDA posted new videos in the “FDA In Your Day” series. In these videos, Chief Medical Officer, Dr. Hilary Marston discusses Lyme disease and hurricane preparedness. 
• September is National Preparedness Month. Learn more about how you can prepare for severe weather and other potential disasters.
• Updates on Highly Pathogenic Avian Influenza (HPAI) 

More FDA press announcements

On August 22, 2024, FDA approved and granted Emergency Use Authorization (EUA) for updated mRNA COVID-19 vaccines (2024-2025 formula) to include a monovalent (single) component that corresponds to the Omicron variant KP.2 strain of SARS-CoV-2. The mRNA COVID-19 vaccines have been updated with this formula to more closely target currently circulating variants and provide better protection against serious consequences of COVID-19, including hospitalization and death. These actions relate to updated mRNA COVID-19 vaccines manufactured by ModernaTX Inc. and Pfizer Inc.

On August 30, 2024, FDA granted an EUA for an updated version of the Novavax COVID-19 Vaccine, Adjuvanted that more closely targets currently circulating variants to provide better protection against serious consequences of COVID-19, including hospitalization and death. The updated vaccine is authorized for use in individuals 12 years of age and older. It includes a monovalent (single) component that corresponds to the Omicron variant JN.1 strain of SARS-CoV-2. 

“Vaccination continues to be the cornerstone of COVID-19 prevention,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “These updated vaccines meet the agency’s rigorous, scientific standards for safety, effectiveness, and manufacturing quality. Given waning immunity of the population from previous exposure to the virus and from prior vaccination, we strongly encourage those who are eligible to consider receiving an updated COVID-19 vaccine to provide better protection against currently circulating variants.

The CDC recommends COVID-19 vaccination for everyone ages 6 months and older. Individuals should speak with their health care provider if they have questions about receiving a COVID-19 vaccine.

On August 29, 2024, FDA approved a new indication for ACAM2000, to include the prevention of mpox disease in individuals determined to be at high risk for mpox infection. ACAM2000 has been approved since 2007 for the prevention of smallpox disease in individuals determined to be at high risk for smallpox infection. ACAM2000 is a live replicating vaccinia virus vaccine.

Every person who receives ACAM2000 is required to receive the Medication Guide (PDF) approved by FDA. A Medication Guide is necessary for safe and effective use of the vaccine because it could help prevent serious adverse events and inform the vaccine recipient of serious risks relative to benefit that could affect their decisions to be vaccinated.

Pemgarda update

On August 26, 2024, FDA revised the EUA (PDF) for Pemgarda (pemivibart) to limit its use to when the combined national frequency of variants with substantially reduced susceptibility to Pemgarda is less than or equal to 90%. This revision is based on available information including variant susceptibility to Pemgarda and national variant frequencies. FDA is proactively incorporating this Limitation of Authorized Use in the event that variants with substantially reduced susceptibility to Pemgarda reach this threshold. Pemgarda remains authorized for emergency use for pre-exposure prevention of COVID-19, consistent with its terms and conditions as detailed in the Letter of Authorization, at this time.  Also see: Frequently Asked Questions on the EUA for Pemgarda (pemivibart) for Pre-exposure Prophylaxis (PrEP) of COVID-19 (PDF)

Expiration date extension

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.

Visit At-Home OTC COVID-19 Diagnostic Tests and At-Home COVID-19 Diagnostic Tests: Frequently Asked Questions for more information about expiration date extensions of at-home COVID-19 tests.

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

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