FDA Approves Bivalent COVID Boosters

As the COVID pandemic progresses and new variants appear, clinicians and public health professionals have been concerned about the level of vaccine protection for new variants and subvariants. To combat this, the FDA approved the Moderna and Pfizer Bivalent COVID vaccines.

The FDA press release states that these newly updated boosters “include an mRNA component of the original strain to provide an immune response that is broadly protective against COVID-19 and an mRNA component in common between the Omicron variant BA.4 and BA.5 lineages to provide better protection against COVID-19 caused by the Omicron variant.” 

According to the FDA press release, the new boosters will become available as a single dose soon, with the Moderna vaccine being available to adults over 18 and the Pfizer vaccine being approved for anyone over 12.

In addition to approving these bivalent vaccines, the FDA amended the EUA to stop the monovalent vaccines from being used as boosters. However, they are still in use for the primary vaccine series.

These updated vaccines could potentially help reduce infections. As schools begin again, vaccination with this new booster can provide additional protection for students and teachers.

An article published by the Commonwealth Fund claimed that a fall COVID vaccine booster campaign could potentially prevent 100,000 deaths. The availability of these new vaccines and recommendations by physicians may contribute to this.

While many people have concerns about the testing and research that occurred prior to this approval, FDA officials and healthcare workers assure the public that they believe these vaccines will be effective and safe.

“The FDA has been planning for the possibility that the composition of the COVID-19 vaccines would need to be modified to address circulating variants. We sought input from our outside experts on including an Omicron component in COVID-19 boosters to provide better protection against COVID-19. We have worked closely with the vaccine manufacturers to ensure the development of these updated boosters was done safely and efficiently. The FDA has extensive experience with strain changes for annual influenza vaccines. We are confident in the evidence supporting these authorizations,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, in the FDA Press release.

Patients are urged to discuss the booster with a healthcare provider and sign up for vaccination if they are eligible. As these vaccines become available, health officials will monitor their impact on disease spread and severity.