FDA Approves and Authorizes Updated COVID-19 mRNA Vaccines to Enhance Protection against Circulating Variants
SOURCE: US Food and Drug Administration
SILVER SPRING, Md./PRNewswire-HISPANIC PR WIRE/ — The U.S. Food and Drug Administration (FDA) has approved and granted emergency use authorization (EUA) for the updated mRNA COVID-19 vaccines (2024-2025 formulation) to include a monovalent (single) component that corresponds to the SARS-CoV-2 omicron KP.2 variant strain. The mRNA COVID-19 vaccines have been updated with this formulation to more closely target currently circulating variants and provide better protection against severe COVID-19 outcomes, including hospitalization and death. Today’s actions relate to the updated mRNA COVID-19 vaccines manufactured by ModernaTX Inc. and Pfizer Inc.
In early June, the FDA advised manufacturers of authorized and licensed COVID-19 vaccines that COVID-19 vaccines (formula 2024-2025) must be monovalent vaccines of the JN.1 lineage. Based on the subsequent evolution of SARS-CoV-2 and the increase in COVID-19 cases, the agency subsequently determined and advised manufacturers that if feasible, the preferred JN.1 lineage for COVID-19 vaccines (formula 2024-2025) is the KP.2 strain.
“Vaccination remains the best measure of prevention against COVID-19,” said Dr. 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 the waning population immunity from prior exposure to the virus and prior vaccination, we strongly encourage those who qualify 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 approved for people 12 years of age and older, and the Moderna COVID-19 vaccine and the Pfizer-BioNTech COVID-19 vaccine, both authorized for emergency use for people 6 months to 11 years of age.
What you should know
Unvaccinated individuals between 6 months and 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 between 6 months and 4 years of age who have been previously 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 depends on the previous COVID-19 vaccine they received).
Individuals 5 through 11 years of age, regardless of whether they have been previously vaccinated, may 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.
People 12 years of age or older may receive a single dose of the updated, approved Comirnaty vaccine or the updated, approved Spikevax vaccine; if previously vaccinated, the dose is administered at least 2 months after the last dose of any COVID-19 vaccine.
Additional doses are authorized for certain immunocompromised individuals between 6 months and 11 years of age, as described in the fact sheets for the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine.
People who receive an updated mRNA COVID-19 vaccine may experience side effects similar to those reported by people 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 currently circulating variants. Unless a significantly more infectious SARS-CoV-2 variant emerges, the FDA anticipates that COVID-19 vaccines will need to be evaluated annually for composition, as is the case for seasonal flu vaccines.
For today’s approvals and authorizations of mRNA COVID-19 vaccines, the FDA evaluated manufacturing and nonclinical data to support the change to include the 2024-2025 formulation for mRNA COVID-19 vaccines. The updated mRNA vaccines are manufactured using a process similar to the previous formulations of these vaccines. The mRNA COVID-19 vaccines have been administered to hundreds of millions of people in the United States, and the benefits of these vaccines continue to outweigh their risks.
On an ongoing basis, the FDA will review any additional COVID-19 vaccine applications submitted to the agency and take appropriate regulatory action.
Consumer information: 888-INFO-FDA. www.FDA.gov/English
