The U.S. Food and Drug Administration (FDA) has authorized updated COVID-19 vaccines to better target currently circulating SARS-CoV-2 variants. These updated vaccines are designed to combat the waning immunity observed from previous vaccinations and exposures. The FDA's decision aims to provide enhanced protection against serious consequences of COVID-19, including hospitalization and death, during the upcoming fall and winter seasons when respiratory viruses typically spread more rapidly.
mRNA Vaccines Targeting KP.2
The FDA has approved updated mRNA COVID-19 vaccines from Moderna (Spikevax) and Pfizer-BioNTech (Comirnaty). These vaccines feature a monovalent component that corresponds to the Omicron KP.2 subvariant of SARS-CoV-2. According to the FDA, data indicates that KP.2-adapted vaccines generate a substantially improved neutralizing response against currently circulating Omicron JN.1 sublineages compared with Omicron XBB.1.5-adapted COVID-19 vaccines. These vaccines are approved for individuals aged 6 months and older, with dosing varying based on age and prior vaccination status.
For children aged 6 months to 4 years who are unvaccinated, the recommendation is 3 doses of Pfizer-BioNTech's vaccine or 2 doses of Moderna's vaccine. Previously vaccinated children in this age group may receive 1 or 2 doses of either Moderna or Pfizer-BioNTech's vaccine, depending on the previous vaccine received. Children aged 5 to 11 years, regardless of prior vaccination status, may receive 1 dose of either Moderna or Pfizer-BioNTech's vaccine, administered at least 2 months after any prior COVID-19 vaccination. Individuals aged 12 years and older may receive 1 dose of Comirnaty or Spikevax, also administered at least 2 months after their last COVID-19 vaccine.
Novavax Vaccine Targeting JN.1
In addition to the mRNA vaccines, the FDA has granted emergency use authorization to an updated version of the Novavax vaccine. This protein-based vaccine includes a monovalent component corresponding to the Omicron JN.1 strain of SARS-CoV-2. It is approved for use in individuals 12 years and older. The Novavax vaccine offers an alternative for those who may prefer a more traditional vaccine technology compared to mRNA vaccines.
Expert Commentary
"These updated vaccines meet the agency’s rigorous, scientific standards for safety, effectiveness, and manufacturing quality," said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. He emphasized the importance of considering an updated COVID-19 vaccine for eligible individuals, given the waning immunity from previous exposure or vaccination.
Recommendations and Availability
The Centers for Disease Control and Prevention (CDC) recommends that everyone aged 6 months and older receive a COVID-19 vaccine. This is particularly important for individuals over 65, those at heightened risk for severe COVID-19, and those who have never been vaccinated. Updated vaccines are available at pharmacies and healthcare settings nationwide. Individuals are encouraged to consult with their healthcare provider to determine the most appropriate vaccination schedule based on their individual circumstances and vaccination history.
