The U.S. Food and Drug Administration approved and granted emergency use authorization or EUA for updated Covid vaccines from Pfizer Inc. and ModernaTX Inc. for use against currently circulating variants.
The approval for the updated mRNA COVID-19 vaccines (2024-2025 formula) comes as the Covid cases are surging in the United States.
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.
The approval of updated Comirnaty was granted to BioNTech Manufacturing GmbH, and the EUA amendment for the Pfizer-BioNTech COVID-19 Vaccine (2024-2025 Formula) was issued to Pfizer Inc.
The approval of updated Spikevax as well as the EUA amendment was issued to Moderna.
The vaccines have been updated to include a monovalent (single) component that corresponds to the Omicron variant KP.2 strain of SARS-CoV-2. The agency noted that the mRNA COVID-19 vaccines have been updated with this formula to more closely target currently circulating variants. It would provide better protection against serious consequences of COVID-19, including hospitalization and death.
The FDA noted that in early June, it 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.
On June 27, The Centers for Disease Control and Prevention or CDC Director adopted the ACIPs recommendations for use of 2024-2025 COVID-19 vaccines in people ages 6 months and older as approved or authorized by FDA. The 2024-2025 vaccines are expected to be available in fall 2024.
According to CDC, the virus that causes COVID-19, SARS-CoV-2, is always changing and protection from COVID-19 vaccines declines over time. An updated 2024-2025 COVID-19 vaccine can restore and enhance protection against the current virus variants responsible for most infections and hospitalizations in the U. S. In 2023, more than 916,300 people were hospitalized due to COVID-19 and more than 75,500 people died from COVID-19.
Peter Marks, director of the FDAs Center for Biologics Evaluation and Research, said, Vaccination continues to be the cornerstone of COVID-19 prevention. These updated vaccines meet the agencys 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 agency noted that 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.
Further, 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.
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.
The agency added that 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.
For the latest approvals and authorizations, the FDA said it assessed manufacturing and nonclinical data to support the change to include the 2024-2025 formula in the mRNA COVID-19 vaccines.
The FDA said it will review any additional COVID-19 vaccine applications submitted to the agency on an ongoing basis, and take appropriate regulatory action.
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