The U.S. Food and Drug Administration approved a formula change to Moderna and Pfizer-BioNTech’s COVID-19 vaccines on Sept.11. The updated vaccines, designed to better protect against currently circulating virus strains, will be available in the fall, according to manufacturers. 

The updated mRNA vaccines are approved for people 12 years of age and up. Vaccines for individuals 6 months through 11 years old and are authorized under emergency use. The FDA has yet to release their official recommendation regarding the demographics that most urgently need the updated vaccine. 

The updated vaccines include a formula change that corresponds to the new Omicron variant. The FDA expects that the makeup of the COVID-19 vaccine will change annually, similar to that of the influenza vaccine.

The FDA also approved a change that will reduce BioNTech’s Comirnaty vaccine and Moderna’s Spikevax vaccine from a two-dose series to a single dose. As part of this authorization, the bivalent Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer authorized for use in the United States. 

Vaccines will continue to be free for most Americans through their health insurance, but as of fall 2023 the Federal Retail Pharmacy Program for COVID-19 Vaccination will end, shifting vaccines to the commercial market. Uninsured Americans, or those whose insurance does not cover the COVID-19 vaccination, may still access free vaccinations through the Bridge Access Program.

“Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death,” said Dr. Peter Mark, director of the FDA’s Center for Biologics Evaluation and Research in a Sept. 11 press release. “The public can be assured that these updated vaccines have met the agency’s rigorous scientific standards for safety, effectiveness and manufacturing quality. We very much encourage those who are eligible to consider getting vaccinated.”

The CDC’s Advisory Committee on Immunization Practices met Sept. 12 to discuss clinical recommendations on who should receive an updated vaccine, as well as further considerations for immunocompromised and older individuals. 

Edited by Sophia Anderson | sanderson@themaneater.com
Copy Edited by Sterling Sewell | ssewell@themaneater.com