What did the research discover?
The U.S. Food and Drug Administration (FDA) has approved and authorized updated mRNA COVID-19 vaccines from Moderna and Pfizer for the 2023-2024 season. These vaccines have been modified to better protect against currently circulating COVID-19 variants, including Omicron XBB.1.5. The update aims to reduce serious outcomes like hospitalization and death.
The new vaccines are designed as a monovalent formula, meaning they target a single strain of the virus, rather than the previous bivalent vaccines, which targeted two strains. Clinical and laboratory data suggest that these vaccines should provide good protection against the latest COVID-19 variants, including EG.5 and BA.2.86.
The FDA based its decision on manufacturing data and immune response studies, showing that the updated vaccines produce a similar level of protection as previous formulations did against earlier variants. The safety of mRNA COVID-19 vaccines is well-established, as hundreds of millions of doses have been administered in the U.S.
How can I apply this information?
If you are 5 years or older, you are eligible to receive a single dose of the updated COVID-19 vaccine, as long as it has been at least two months since your last dose.
For children ages 6 months to 4 years, the number of doses depends on their previous vaccinations:
- If previously vaccinated, they may receive one or two doses of the updated vaccine.
- If unvaccinated, they are eligible for three doses of Pfizer’s vaccine or two doses of Moderna’s vaccine.
The FDA is confident in the safety and effectiveness of these updated vaccines and encourages eligible individuals to consider vaccination to help prevent severe illness, hospitalization, and death.
Because this is ongoing research, the FDA anticipates that COVID-19 vaccines may need yearly updates, similar to seasonal flu vaccines. The CDC’s Advisory Committee on Immunization Practices will provide further guidance on who should receive the updated vaccine, particularly for older adults and immunocompromised individuals.
Source:
U.S. Food and Drug Administration [Internet]. FDA Takes Action on Updated mRNA COVID-19 Vaccines to Better Protect Against Currently Circulating Variants. 11 Sep 2023. https://www.fda.gov/news-events/press-announcements/fda-takes-action-updated-mrna-covid-19-vaccines-better-protect-against-currently-circulating
