The U.S. Food and Drug Administration (FDA) has approved and granted emergency use authorization (EUA) for updated COVID-19 vaccines from Pfizer Inc. and ModernaTX Inc. These vaccines are now formulated to combat the currently circulating variants of the virus. This approval is timely, given the recent surge in COVID-19 cases across the United States.
The updated mRNA COVID-19 vaccines for the 2024-2025 season include Comirnaty and Spikevax, which have been approved for individuals aged 12 and older. Additionally, the Moderna and Pfizer-BioNTech COVID-19 vaccines have received EUA for individuals aged 6 months to 11 years.
The approval for the updated Comirnaty was granted to BioNTech Manufacturing GmbH, while the EUA amendment for the Pfizer-BioNTech COVID-19 Vaccine (2024-2025 Formula) was issued to Pfizer Inc. Similarly, the updated Spikevax and its EUA amendment were issued to Moderna.
These vaccines have been reformulated to include a monovalent component specifically targeting the Omicron variant KP.2 strain of SARS-CoV-2. According to the FDA, this update is intended to provide better protection against severe outcomes of COVID-19, such as hospitalization and death.
In early June, the FDA advised vaccine manufacturers that the COVID-19 vaccines (2024-2025 formula) should be monovalent JN.1 vaccines. However, based on the virus's evolution and an increase in COVID-19 cases, the agency later recommended that the preferred JN.1-lineage is the KP.2 strain, if feasible.
On June 27, the Centers for Disease Control and Prevention (CDC) Director adopted the Advisory Committee on Immunization Practices' (ACIP) recommendations for the use of the 2024-2025 COVID-19 vaccines in individuals aged 6 months and older, as approved or authorized by the FDA. These updated vaccines are expected to be available in Fall 2024.
According to the CDC, the SARS-CoV-2 virus is constantly changing, and the protection offered by COVID-19 vaccines wanes over time. The updated 2024-2025 vaccines aim to restore and enhance immunity against the current virus variants responsible for most infections and hospitalizations in the U.S. In 2023 alone, more than 916,300 people were hospitalized due to COVID-19, and over 75,500 deaths were reported.
Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, emphasized the importance of vaccination in COVID-19 prevention. "These updated vaccines meet the agency’s rigorous scientific standards for safety, effectiveness, and manufacturing quality. Given the waning immunity from previous virus exposure and prior vaccination, we strongly encourage eligible individuals to receive an updated COVID-19 vaccine for better protection against current variants," said Marks.
The FDA specified that unvaccinated individuals aged 6 months to 4 years are eligible to receive three doses of the updated, authorized Pfizer-BioNTech COVID-19 Vaccine or two doses of the updated, authorized Moderna COVID-19 Vaccine. Previously vaccinated individuals in this age group can receive one or two additional doses.
For those aged 5 to 11 years, regardless of prior vaccination status, a single dose of the updated, authorized Moderna or Pfizer-BioNTech COVID-19 vaccines is recommended. If previously vaccinated, the dose should be administered at least two months after the last dose of any COVID-19 vaccine.
Individuals aged 12 and older are eligible to receive a single dose of the updated, approved Comirnaty or Spikevax. For those previously vaccinated, the dose should be administered at least two months after the last dose of any COVID-19 vaccine.
The FDA announced that it reviewed manufacturing and nonclinical data to support the inclusion of the 2024-2025 formula in the mRNA COVID-19 vaccines. The agency will continue to evaluate additional COVID-19 vaccine applications and take appropriate regulatory actions as necessary.
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