FDA approves, authorizes updated mRNA COVID-19 vaccines

The Food and Drug Administration has approved and granted emergency use authorization for updated mRNA COVID-19 vaccines (2024-2025 formula) to include a monovalent (single) component that corresponds to the Omicron variant KP.2 strain of SARS-CoV-2. The mRNA COVID-19 vaccines have been updated with this formula to more closely target currently circulating variants and provide better protection against serious consequences of COVID-19, including hospitalization and death. The FDA's actions relate to updated mRNA COVID-19 vaccines manufactured by Moderna  and Pfizer.

In early June, the FDA advised manufacturers of licensed and authorized COVID-19 vaccines that the COVID-19 vaccines (2024-2025 formula) should be monovalent JN.1 vaccines. Based on the further evolution of SARS-CoV-2 and a rise in cases of COVID-19, the agency subsequently determined and advised manufacturers that the preferred JN.1-lineage for the COVID-19 vaccines (2024-2025 formula) is the KP.2 strain, if feasible.

"Vaccination continues to be the cornerstone of COVID-19 prevention," said Peter Marks,  director of the FDA's Center for Biologics Evaluation and Research. "These updated vaccines meet the agency's rigorous, scientific standards for safety, effectiveness, and manufacturing quality. Given waning immunity of the population from previous exposure to the virus and from prior vaccination, we strongly encourage those who are eligible to consider receiving an updated COVID-19 vaccine to provide better protection against currently circulating variants."

The updated mRNA COVID-19 vaccines include Comirnaty and Spikevax, both of which are approved for individuals 12 years of age and older, and the Moderna COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine, both of which are authorized for emergency use for individuals 6 months through 11 years of age.

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The FDA offers the following information:

• Unvaccinated individuals 6 months through 4 years of age 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.
• Individuals 6 months through 4 years of age who have previously been vaccinated against COVID-19 are eligible to receive one or two doses of the updated, authorized Moderna or Pfizer-BioNTech COVID-19 vaccines (timing and number of doses to administer depends on the previous COVID-19 vaccine received).
• Individuals 5 years through 11 years of age regardless of previous vaccination are eligible to receive a single dose of the updated, authorized Moderna or Pfizer-BioNTech COVID-19 vaccines; if previously vaccinated, the dose is administered at least 2 months after the last dose of any COVID-19 vaccine.
• Individuals 12 years of age and older are eligible to receive a single dose of the updated, approved Comirnaty or the updated, approved Spikevax; if previously vaccinated, the dose is administered at least 2 months since the last dose of any COVID-19 vaccine.
• Additional doses are authorized for certain immunocompromised individuals ages 6 months through 11 years of age as described in the Moderna COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine fact sheets.

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Individuals who receive an updated mRNA COVID-19 vaccine may experience similar side effects as those reported by individuals who previously received mRNA COVID-19 vaccines and as described in the respective prescribing information or fact sheets. The updated vaccines are expected to provide protection against COVID-19 caused by the currently circulating variants. Barring the emergence of a markedly more infectious variant of SARS-CoV-2, the FDA anticipates that the composition of COVID-19 vaccines will need to be assessed annually, as occurs for seasonal influenza vaccines.

For the approvals and authorizations of the mRNA COVID-19 vaccines, the FDA assessed manufacturing and nonclinical data to support the change to include the 2024-2025 formula in the mRNA COVID-19 vaccines. The updated mRNA vaccines are manufactured using a similar process as previous formulas of these vaccines. The mRNA COVID-19 vaccines have been administered to hundreds of millions of people in the U.S., and the benefits of these vaccines continue to outweigh their risks, the FDA said.

On an ongoing basis, the FDA will review any additional COVID-19 vaccine applications submitted to the agency and take appropriate regulatory action.

The approval of Comirnaty (COVID-19 Vaccine, mRNA) (2024-2025 Formula) was granted to BioNTech Manufacturing GmbH. The EUA amendment for the Pfizer-BioNTech COVID-19 Vaccine (2024-2025 Formula) was issued to Pfizer.

The approval of Spikevax (COVID-19 Vaccine, mRNA) (2024-2025 Formula) was granted to Moderna and the EUA amendment for the Moderna COVID-19 Vaccine (2024-2025 Formula) was issued to Moderna.

Moderna said its updated vaccines are expected to be available in the coming days. The company developed a vaccine finder which people can use to identify nearby vaccination locations.

"COVID-19 remains a significant health risk and is the leading cause of respiratory illness-related hospitalization, regardless of age or health condition. In the 2023-24 season, we saw more than 600,000 hospitalizations due to COVID in the U.S. Staying up to date with your COVID-19 vaccine remains one of the best ways for people to be protected and prevent severe illness," said Stéphane Bancel, CEO of Moderna. "We appreciate the U.S. FDA's timely review and encourage individuals to speak to their healthcare providers about receiving their updated COVID-19 vaccine alongside their flu shot this fall."

"We know that this virus is constantly changing, and that your protection from previous infection or from previous vaccines declines over time,” said James Mansi, vice president medical affairs, U.S. at Moderna. "Ensuring that you receive the updated vaccine to better match what is circulating in the US will ensure that you are protected through the winter months when cases typically increase.”

“In our second year as a U.S. commercial organization, we have focused on building a robust supply chain, with the goal of getting products out in a timely and efficient manner. In the U.S., we expect Spikevax to be at pharmacies and care settings in the coming days. Our team is fully prepared to deliver on our commitments for the upcoming season,” said David Jimenez, senior vice president and general manager of North America at Moderna. “Delivering the greatest possible impact to our patients and public health remains our top priority.” 

“With the upcoming fall respiratory season just around the corner, it's important for families to stay up to date on their routine vaccines, including COVID-19, to reduce the spread of respiratory illness and protect their individual health,” said Mitchel Rothholz, consultant to the profession of pharmacy and globally recognized expert on pharmacy-based immunization delivery. “Keep in mind that your local pharmacist is here to help. Getting vaccinated isn’t just about self-protection, it’s also about protecting those who can’t and are not vaccinated,”

“Even if you’ve already received a previous COVID-19 vaccine, getting the latest version helps your immune system keep pace with the everchanging characteristics of the virus which is crucial to prevent severe consequences of an acute infection and protect you from the lasting and often devastating impacts such as Long COVID,” said Phillip Levy, professor of emergency medicine and associate vice president of translational science at Wayne State University.