FDA clears the way for additional bivalent boosters for certain vulnerable individuals

The U.S. Food and Drug Administration (FDA) has updated the emergency use authorization for Pfizer and Moderna’s bivalent vaccines, permitting individuals aged 65 and older and certain immunocompromised individuals to receive additional doses before the upcoming fall vaccination campaigns.

The bivalent vaccines target both the original strain of the COVID-19 virus and the Omicron variant. They have been available under emergency use authorizations since September, which limited their administration.

Now, adults aged 65 and older who have received a single dose of a bivalent vaccine may receive an additional dose at least four months later. Immunocompromised individuals can receive a second dose at least two months after their first, with healthcare providers able to administer further doses at their discretion.

The FDA has also revised its recommendations for unvaccinated individuals, allowing them to receive a single bivalent dose, simplifying the process due to the growing immunity across the U.S. population from vaccination or previous infections.

For young children aged 6 months to 5 years, the eligibility for additional bivalent doses will depend on their vaccination history. They may receive either a two-dose series of the Moderna vaccine or a three-dose series of the Pfizer-BioNTech vaccine, depending on their age and initial vaccinations.

Recent data indicate that only 17% of eligible individuals have received the recommended dose of a bivalent vaccine. The FDA has also stated that it will consider future vaccinations based on recommendations regarding fall strain composition from its advisory committee.

The FDA’s changes may lead to new recommendations from the CDC and its Advisory Committee on Immunization Practices, with a meeting scheduled to discuss the COVID-19 vaccines.

Source: Reported based on publicly available information from www.cnn.com.