New COVID-19 Vaccine Boosters Approved by FDA

The newly approved vaccines from Moderna and Pfizer are updated formulations to address current circulating COVID-19 variants.

On September 11, the FDA approved updated Pfizer and Moderna mRNA vaccines for 2023-2024. The new COVID vaccines are updated to include a monovalent component resembling the Omicron variant XBB.1.5.

The new formulations are approved for people 12 years or older and fall under emergency use authorization for individuals 6 months through 11 years.

The FDA approval of the new vaccines means that bivalent Moderna and Pfizer COVID-19 vaccines are no longer authorized for use in the United States.

According to the agency's press release, these new COVID vaccines should provide protection against the latest circulating variants unless a more virulent variant emerges. The FDA also says vaccine formulations may need annual updates to keep up with the changing nature of SARS-CoV-2.

Who can get the new updated COVID vaccines?

The FDA notes that people five years old and older are eligible to receive a single dose of an updated COVID-19 vaccine at least two months after the last dose of any COVID vaccine — regardless of previous vaccination status.

Infants and children six months through four years of age, previously vaccinated against COVID, can receive one or two doses of an updated mRNA COVID-19 vaccine. However, the timing and number of doses administered depends on previous vaccination status.

Individuals six months through four years of age who are unvaccinated can receive three doses of the updated authorized Pfizer COVID-19 vaccine or two doses of the updated authorized Moderna COVID-19 shot.

Side effects of the new boosters are expected to be similar to previous COVID vaccines. The agency notes the safety and effectiveness of these updated vaccines, and the benefit-risk assessments suggest that the benefits of the new COVID boosters for people 6 months of age and older outweigh their risks.

The FDA expects the updated formulations will be available soon to those who want to get vaccinated.

Peter Marks, M.D., Ph.D., director of the FDA's Center for Biologics Evaluation and Research, said, "Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death."

Marks adds, 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."

In light of the FDA's approval, the CDC's Advisory Committee on Immunization Practices will meet on September 12 to determine clinical recommendations on who should receive the new COVID vaccine. The committee will also discuss vaccine recommendations for specific populations, including immunocompromised individuals and older people.