FDA Approves Updated mRNA Vaccines for 2023-2024

September 13, 2023

The U.S. Food and Drug Administration announced on Monday, September 11, 2023 that it has approved updated mRNA vaccines for 2023-2024. These vaccines target the XBB.1.5 Omicron subvariant as well as EG.5 and BA.2.86, the currently circulating viral variants causing COVID-19. Some larger pharmacies may have the new vaccines within the next week.

The updated mRNA vaccines are manufactured by ModernaTX Inc. and Pfizer Inc. The FDA has approved each vaccine for individuals 12 years of age and older. The vaccines are also authorized under emergency use for individuals 6 months through 11 years of age. These actions mean that the bivalent Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer authorized for use in the United States; only the updated vaccines are available.

“Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “The public can be assured that these updated vaccines have met the agency’s rigorous scientific standards for safety, effectiveness, and manufacturing quality.”

Vaccination Recommendations

• Everyone 6 years and older should get 1 updated Pfizer-BioNTech or Moderna COVID-19 vaccine, regardless of whether they’ve received any original COVID-19 vaccines.
• Individuals aged 65 years and older may get 1 additional dose of COVID-19 vaccine 4 or more months after the 1st updated COVID-19 vaccine
• Individuals who are moderately or severely immunocompromised may get 1 additional dose of updated COVID-19 vaccine 2 or more months after the last updated COVID-19 vaccine.
• Children aged 6 months to 4 years who have been vaccinated before can receive one or two doses of a new mRNA COVID-19 vaccine, depending on their previous vaccine.
• Children aged 6 months to 4 years who have not been vaccinated can get three doses of the updated Pfizer-BioNTech vaccine or two doses of the updated Moderna vaccine.

Please see the CDC website for more specific information about vaccination schedules and how to ensure you are up to date on COVID vaccines.

People who get the new mRNA COVID-19 vaccine may experience similar side effects to those reported with previous vaccines.

The CDC notes that the composition of COVID-19 vaccines may need to be updated yearly, similar to the flu vaccine.

As we enter the fall, the CDC also advises to remain vigilant about other respiratory viruses, such as RSV and flu. The CDC recommends that all people aged 6 months and older receive a seasonal flu vaccine. People aged 60 years and older should talk to their healthcare provider to see if an RSV vaccination is recommended. The CDC also recommends nirsevimab, a monoclonal antibody product, for all infants younger than 8 months who are born during – or entering – their first RSV season, as well as some older babies.

References:

1. Stay Up to Date with COVID-19 Vaccines – Centers for Disease Control and Prevention
2. COVID-19, Flu, and RSV: FDA Resources for the Fall Respiratory Illness Season – FDA
3. COVID Data Tracker – Centers for Disease Control and Prevention
4. C.D.C. Recommends New Covid Vaccines for All Americans
5. COVID & SpA – SAA’s COVID Hub