U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. Vaccines, Blood & Biologics
  3. Resources for You (Biologics)
  4. Industry (Biologics)
  5. Information About the Updated COVID-19 Vaccines
  1. Industry (Biologics)

Information About the Updated COVID-19 Vaccines

The Fall respiratory virus season is here, and people may have questions about the safety and effectiveness of the updated COVID-19 vaccines. Inaccurate information about these vaccines, particularly the mRNA COVID-19 vaccines, continues to circulate and could result in vaccine hesitancy, which in turn could lead to lower uptake of vaccines that are associated with protecting people from some of the most serious risks of COVID-19.

Based on a thorough assessment of the entire manufacturing process and the totality of clinical data gathered since the initial authorizations and through the most recent updates, the FDA is highly confident in the safety, effectiveness and quality of the mRNA COVID-19 vaccines approved and authorized for use in the United States. Over the past four years, the mRNA vaccines have been associated with a dramatic reduction in the risk of death, hospitalization and serious illness from COVID-19. Information about all of the updated COVID-19 vaccines (2024-2025 formula) available in the United States, including fact sheets, package inserts and supporting documents, can be found here.

Vaccination continues to be the cornerstone of COVID-19 prevention. The updated COVID-19 vaccines meet the FDA’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 any one of the updated COVID-19 vaccines to provide better protection against currently circulating variants. Additionally, CDC recommends everyone ages 6 months and older receive a 2024-2025 COVID-19 vaccine.

If you have questions about receiving an updated COVID-19 vaccine, please do not hesitate to speak with your health care provider.

 

Back to Top