FDA Approves, CDC Panel Recommends New COVID-19 Vaccines to Protect against Variants

Yesterday, the US Food and Drug Administration (FDA) approved and authorized updated COVID-19 vaccines formulated to target currently circulating variants, and today, the Centers for Disease Control and Prevention (CDC) vaccine advisory panel has recommended the new vaccines for all American 6 months and older. The new vaccines are expected to provide better protection than current versions. The update applies to the Moderna and Pfizer mRNA vaccines and includes a monovalent component corresponding to the Omicron variant XBB.1.5. The updated mRNA vaccines are each approved for individuals 12 years of age and older and are authorized under emergency use for individuals 6 months through 11 years of age.

“Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death,” said Peter Marks, MD, PhD, director of the FDA 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. We very much encourage those who are eligible to consider getting vaccinated.”

Update: CDC Director Mandy K. Cohen, MD, MPH, has signed off on the panel's recommendation, which will allow the vaccines to be distributed and used throughout the US. 

"We have more tools than ever to prevent the worst outcomes from COVID-19,” Dr. Cohen said. “CDC is now recommending updated COVID-19 vaccination for everyone 6 months and older to better protect you and your loved ones.”

This version, which is not referred to as a booster but an updated vaccine, is available for:

• Individuals 5 years of age and older regardless of previous vaccination
• Individuals 6 months through 4 years of age who have previously been vaccinated
• Unvaccinated individuals 6 months through 4 years of age

Per the FDA website, recent studies have shown that the updated vaccines also are a good match for protecting against the currently circulating COVID-19 variant, including EG.5 (“Eris”) and the recently discovered BA.2.86.