FDA Greenlights Monovalent COVID-19 Vaccine Updates

The FDA has given its approval and emergency use authorization for updated COVID-19 vaccines, specifically designed to target the current variants of the virus. These updated vaccines are based on mRNA technology and are produced by Moderna (Spikevax) and Pfizer (Comirnaty). They now include a component that specifically targets the Omicron variant XBB.1.5.

The FDA emphasizes that vaccination remains crucial for public health and protection against severe COVID-19 outcomes. Dr. Peter Marks, the director of the FDA's Center for Biologics Evaluation and Research, underlines the safety, effectiveness, and quality of these updated vaccines.

These updates were recommended by the FDA in June 2023 to address the Omicron XBB.1.5 variant for the 2023-2024 vaccination season.

Moderna's clinical data presented at a meeting demonstrated strong immune responses against various Omicron sublineages, including XBB.1.5 and XBB.1.16. Pfizer's approval is based on a comprehensive body of evidence supporting the safety and efficacy of their COVID-19 vaccines, including improved responses against multiple Omicron XBB-related sublineages.

The FDA's evaluation considered manufacturing data and nonclinical immune response data for these updated vaccines. The vaccines show promise in neutralizing current viral variants, including EG.5 and BA.2.86.

These updated mRNA vaccines are approved for individuals aged 12 and older, with emergency use authorization for those aged 6 months to 11 years. Importantly, the previous bivalent COVID-19 vaccines by Moderna and Pfizer are no longer authorized in the United States.

The eligibility guidelines for the updated vaccines are as follows:

• Individuals aged 5 and older can receive a single dose of an updated mRNA COVID-19 vaccine at least 2 months after their last COVID-19 vaccine dose.
•  Individuals aged 6 months through 5 years who have been previously vaccinated can receive 1 or 2 doses depending on their previous vaccination history.
• Unvaccinated individuals aged 6 months to 4 years are eligible for 3 doses of the updated Pfizer-BioNTech vaccine or 2 doses of the updated Moderna vaccine.

The decision to update these vaccines comes as COVID-19 cases are rising again, and the goal is to provide protection during the upcoming fall and winter seasons when respiratory viruses tend to peak.

Manufacturers anticipate having the updated vaccines available in the fall, and the CDC's Advisory Committee on Immunization Practices will discuss clinical recommendations for their use on September 12.