FDA Authorizes Bivalent Booster Doses

Agency leaders say they are ‘very confident’ in updated boosters to stem potential COVID-19 wave

August 31, 2022

The FDA today authorized the Moderna, Pfizer-BioNTech bivalent COVID-19 vaccines for use as a booster dose.

The announcement means the bivalent boosters are just one step away from availability for the general public. During meetings this week, the CDC’s vaccine advisory committee will review the available data about the bivalent vaccines and determine if they should be available across the U.S.

Earlier this year, the FDA’s Vaccines and Related Biological Products Advisory Committee voted to include an Omicron component in the fall COVID-19 booster vaccines. Similar to the approach for the flu vaccines, the updated COVID-19 boosters are designed to offer protection against the strains that are expected to circulate this winter, said FDA Commissioner Robert M. Califf, MD.

“As we head into fall and begin to spend more time indoors, we strongly encourage anyone who is eligible to consider receiving a booster dose with a bivalent COVID-19 vaccine to provide better protection against currently circulating variants,” he said.

Here’s what you need to know:

• Who would be eligible:  Moderna’s bivalent booster is authorized for use as a single booster dose for people 18 and older. The Pfizer-BioNTech vaccine is authorized for use as a single booster dose for people 12 and older. The bivalent vaccines have been authorized for use as a single booster dose at least two months following primary or booster vaccination.
• How they work:  The bivalent boosters contain mRNA components for the original COVID-19 strain and for the BA.4 and BA.5 lineages of the Omicron variant.
• Variant proportions:  BA.5 accounts for nearly 89 percent of sequenced cases. Most of the remaining cases are from the BA.4.6 and BA.4 lineages.
• Next steps:  Tomorrow’s CDC advisory meeting is available to stream online. It’s expected Dr. Rochelle Walensky, CDC director, would make a recommendation following this week’s meetings.
• Quotable:  “Based on the data supporting each of these authorizations, the bivalent COVID-19 vaccines are expected to provide increased protection against the currently circulating omicron variant,” the agency said in a statement today. “Individuals who receive a bivalent COVID-19 vaccine may experience side effects commonly reported by individuals who receive authorized or approved monovalent mRNA COVID-19 vaccines.”

About 48.5 percent of eligible Americans have had a booster dose, according to CDC data.

During a press briefing, FDA leaders said the monovalent mRNA COVID-19 vaccines are not authorized as booster doses for individuals 12 years of age and older, but will still be used for primary vaccination. Offering the bivalent booster dose is part of the nation’s strategy to avoid a potential wave of new cases later this year.

HAP continues to encourage everyone who is eligible to get vaccinated against COVID-19 and to stay up to date on your COVID-19 vaccinations. Learn more about the options available in your community.

Additional information about the FDA’s announcement is available online.