FDA Authorizes Updated COVID-19 Vaccine Formulations for Current Variants

The FDA has approved updated COVID-19 vaccine formulations for emergency use, targeting currently circulating variants of COVID-19 to better protect against serious infection. The action addresses mRNA vaccines for the 2023-2024 season by Moderna Inc (Spikevax; 2023-2024 formulation) and Pfizer-BioNTech (Comirnaty; 2023-2024 formulation).¹

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The vaccines have been updated to include monovalent components against the Omicron variant XBB.1.5 based on evidence from clinical trials and input from FDA expert advisors, according to a statement by the agency. The vaccines are currently approved for individuals aged 12 years and older and are authorized under emergency use for individuals aged 6 months through 11 years of age.¹

“Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in the statement. “The public can be assured that these updated vaccines have met the agency’s rigorous scientific standards for safety, effectiveness, and manufacturing quality. We very much encourage those who are eligible to consider getting vaccinated.”¹

For the updated vaccines, individuals aged 5 years and older, regardless of previous vaccination, are eligible to receive a single dose of the updated vaccine at least 2 months since the last dose of any COVID-19 vaccine. Those aged 6 months through 4 years of age who have been previously vaccinated are eligible for 1 or 2 doses of the updated vaccine, depending on the timing and number of doses previously administered to the individual.¹

Unvaccinated individuals aged 6 months through 4 years of age are eligible to receive 3 doses of the updated Pfizer-BioNTech vaccine or 2 doses of the updated Moderna vaccine. The agency supports the safety and efficacy of the updated vaccines, with the benefit-risk assessment supporting the use of the vaccine for those aged 6 months and older.¹

The agency reports that those who receive the updated vaccine could experience similar adverse effects previously associated with the mRNA COVID-19 vaccines. Due to the continuous circulation of more virulent variants, the FDA expects that the COVID-19 vaccines may need to be updated annually, similarly to the seasonal influenza vaccine.¹

Manufacturers anticipate that the updated vaccines will be ready for the fall season.As of the new authorization and FDA action, the bivalent Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer authorized for use in the United States, according to the FDA.¹

Pfizer stated that its updated vaccine is tailored specifically to the SARS-CoV-2 XBB.1.5 variant, with pre-clinical data demonstrating that the updated COVID-19 vaccine elicits improved neutralizing antibody responses against XBB.1.5, BA.2.86, and EG.5.1.²

Earlier this month, Moderna announced that the updated vaccine generated an 8.7-fold increase in neutralizing antibodies against BA.2.86.³

Furthermore, the CDC’s Advisory Committee on Immunization Practices will meet September 12, 2023, to discuss clinical recommendations for the updated vaccines and further considerations for immunocompromised and older individauls.¹

References

1. FDA takes action on updated mRNA COVID-19 vaccines to better protect against currently circulating variants. News release. FDA. September 11, 2023. Accessed September 11, 2023. https://www.fda.gov/news-events/press-announcements/fda-takes-action-updated-mrna-covid-19-vaccines-better-protect-against-currently-circulating
2. Pfizer and BioNTech receive US FDA approval for 2023-2024 COVID-19 Vaccine. News release. Pfizer. September 11, 2023. Accessed September 11, 2023. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-receive-us-fda-approval-2023-2024-covid
3. Gallagher, A. Moderna’s mRNA vaccine shows promise against the Pirola variant of COVID-19. September 7, 2023. Accessed September 11, 2023. https://www.pharmacytimes.com/view/moderna-s-mrna-vaccine-shows-promise-against-the-pirola-variant-of-covid-19