FDA approves and approves updated COVID-19 mRNA vaccines to improve protection against currently circulating variants

In English

SILVER SPRING, Md., August 23, 2024 /PRNewswire-HISPANIC PR WIRE/ – United States Food and Drug Administration (FDA) agreed and granted Emergency Use Authorization (EUA) for updated COVID-19 mRNA vaccines (formulation 2024-2025) to include a monovalent (single) component that corresponds to the vaccine type KP.2 omicron variant of SARS-CoV-2 . The COVID-19 mRNA vaccines have been updated with this formulation to more closely target currently circulating variants and provide better protection against adverse outcomes of COVID-19, including hospitalization and death Today’s actions are related to the updated mRNA COVID-19 vaccines produced by ModernaTX Inc. and Pfizer Inc.

In early June, the FDA notified authorized and licensed manufacturers of COVID-19 vaccines that COVID-19 vaccines (formula 2024-2025) must be monovalent vaccines of the JN.1 line. Based on the subsequent evolution of SARS-CoV-2 and the increase in cases of COVID-19, the group subsequently decided and advised manufacturers, if possible, using the line JN.1 preferred for COVID-19 vaccines (formula 2024-2025) The strain KP.2.

“Vaccination is the best measure to prevent COVID-19,” the doctor said. Peter Marksdirector of the FDA’s Center for Biologics Evaluation and Research. “These updated vaccines meet the agency’s rigorous scientific standards for safety, efficacy and manufacturing quality. Given the decline in population immunity from exposure to the virus and prior vaccination, we strongly encourage those eligible to consider receiving an updated COVID-19 vaccine to provide better protection against the variations that are currently circulating.”

Updated mRNA COVID-19 vaccines include Comirnaty and Spikevax, both approved for people age 12 and older, and Moderna’s COVID-19 vaccine and Pfizer-BioNTech’s COVID-19 vaccine, both authorized for emergency use for people 6 months to 11 years of age.

What you should know

• Unvaccinated persons between the ages of 6 months and 4 years are eligible to receive three doses of the updated and authorized Pfizer-BioNTech COVID-19 vaccine or two doses of the updated and authorized Moderna COVID-19 vaccine.
• People between 6 months and 4 years of age who have previously been vaccinated against COVID-19 are eligible for one or two doses of the updated and authorized Moderna or Pfizer-BioNTech COVID-19 vaccines (time and number of doses to be). given depending on their previous COVID-19 vaccination).
• Persons aged 5 to 11, regardless of previous vaccination, may receive one dose of the updated and authorized Moderna or Pfizer-BioNTech COVID-19 vaccines; if previously vaccinated, the dose will be given at least 2 months after the last dose of any COVID-19 vaccine.
• People 12 years of age and older will receive one dose of the updated and approved Comirnaty vaccine or the updated and approved Spikevax vaccine; if previously vaccinated, the dose will be given at least 2 months after the last dose of any COVID-19 vaccine.
• Additional doses are approved for certain vaccinated individuals between 6 months and 11 years of age, as described in the fact sheets for Moderna COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine.

People who receive the updated COVID-19 mRNA vaccine may experience side effects similar to those reported by people who received previous COVID-19 mRNA vaccines and as described in the individual prescribing information or information sheets. The updated vaccines are expected to protect against COVID-19 caused by the currently circulating variants. Unless a significantly more infectious variant of SARS-CoV-2 emerges, the FDA anticipates that the composition of the COVID-19 vaccines will need to be evaluated annually, as is the case with seasonal flu vaccines.

For today’s approvals and approval of the COVID-19 mRNA vaccine, the FDA evaluated manufacturing and non-clinical data to support the change to include the 2024-2025 formulation in the mRNA vaccines COVID-19. 19. The updated mRNA vaccines are made using a similar process to previous forms of these vaccines. COVID-19 mRNA 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 additional COVID-19 vaccine applications submitted to the agency and take appropriate regulatory action.

A license for Comirnaty (a COVID-19 mRNA vaccine) (formula 2024-2025) has been granted to BioNTech Manufacturing GmbH. The EUA amendment for the Pfizer-BioNTech COVID-19 vaccine (formula 2024-2025) was granted to Pfizer Inc.

A license for Spikevax (COVID-19 mRNA Vaccine) (formula 2024-2025) has been granted to ModernaTX Inc. and an EUA amendment for Moderna’s COVID-19 vaccine (formula 2024-2025) was granted to ModernaTX Inc.

The FDA, an agency of the US Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and security of human and veterinary drugs, vaccines, and other biological products for human use. , and medical devices. The agency is also responsible for the safety of our nation’s food supply, cosmetics, dietary supplements, electronic products that emit radiation, and for regulating tobacco products.

Media information: Gloria Sánchez-Contreras, 301-796-7686, [email protected]

Consumer information: 888-INFO-FDA

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FUENTE US Food and Drug Administration