The U.S. Food and Drug Administration (FDA) has moved to approve and authorize the emergency use of updated COVID-19 vaccines formulated to more closely target currently circulating variants. and provide better protection against the serious consequences of COVID-19, including hospitalization and death.
The shares correspond to the updated 2023-2024 mRNA vaccines manufactured by ModernaTX Inc. and Pfizer Inc. Based on the totality of the evidence and the review of FDA expert advisors, these vaccines have been updated to include a component monovalent (single) that corresponds to the Ómicron XBB.1.5 variant.
What you need to know
• People 5 years of age and older, regardless of whether they have been vaccinated before, are eligible to receive a single dose of an mRNA COVID-19 vaccine updated at least 2 months after the last dose of any COVID-19 vaccine. .
• People ages 6 months to 4 years who have previously been vaccinated against COVID-19 qualify to receive one or two doses of an updated mRNA COVID-19 vaccine (the date and number of doses to be administered depend on the COVID-19 vaccine received previously).
• Unvaccinated individuals ages 6 months to 4 years qualify 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 .
• The FDA is confident in the safety and effectiveness of these updated vaccines, and the agency’s risk-benefit assessment demonstrates that the benefits of these vaccines for people 6 months of age and older outweigh their risks.
• 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, as described in the respective prescribing information or on the leaflets. informative.
• The updated vaccines are expected to provide good protection against COVID-19 against the variants currently circulating. Unless a significantly more virulent variant emerges, the FDA anticipates that the composition of COVID-19 vaccines may need to be updated annually , as is done with the seasonal influenza vaccine.
• The U.S. Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) meets to discuss clinical recommendations on who should receive an updated vaccine, as well as additional considerations for specific populations, such as people who have weakened immune systems and the elderly.
• Manufacturers have publicly announced that updated vaccines will be ready this fall and the FDA anticipates they will be available in the near future.
"Vaccination remains critical for public health and continued protection against the serious consequences of COVID-19, including hospitalization and death," said Dr. Peter Marks , director of the Center for Biologics Evaluation and Research at the FDA. “The public can be assured that these updated vaccines have met the agency’s rigorous scientific standards for safety, efficacy and manufacturing quality. “We strongly encourage people who qualify to consider getting vaccinated,” he added.
Each of the updated mRNA vaccines are approved for people 12 years of age and older and are authorized for emergency use for people 6 months to 11 years of age. As part of recent FDAA actions, the bivalent COVID-19 vaccines from Moderna and Pfizer-BioNTech are no longer authorized for use in the United States.
Data Supporting Updated mRNA COVID-19 Vaccines (2023-2024 Formula)
The newly approved and authorized mRNA COVID-19 vaccines are supported by FDA’s evaluation of manufacturing data to support the change to the 2023-2024 formulation and non-clinical immune response data from the updated formulations including component XBB.1.5.
• The updated mRNA vaccines are manufactured using a similar process as previous formulations. In recently conducted studies, the degree of neutralization observed in nonclinical studies with updated vaccines against currently circulating viral variants that cause COVID-19, including EG.5 and BA.2.86, appears to be of a magnitude similar to the degree of neutralization observed with previous versions of the vaccines against corresponding previous variants against which they had been developed to provide protection. This suggests that the vaccines are adequate to protect against the COVID-19 variants currently circulating.
• The full set of benefit-risk features of the previously authorized and approved mRNA COVID-19 vaccines is well understood, as these vaccines have been administered to hundreds of millions of people in the United States.
Based on an evaluation of the totality of the evidence, the set of risk-benefit features is favorable for people 6 months of age and older to receive an updated mRNA COVID-19 vaccine. Although severe outcomes from COVID-19 are less common in younger people, they do occur, and recent receipt of a COVID-19 vaccine has been shown to reduce the risk of serious health consequences.
Additional information about new actions
Specifically, the actions of September 11 include:
• Approval of Comirnaty (mRNA COVID-19 vaccine ) to include the 2023-2024 formulation and switch to a single dose for people 12 years of age and older. Comirnaty was previously approved as a two-dose primary vaccination schedule for people 12 years of age and older.
• Approval of Spikevax (mRNA COVID-19 vaccine) to include the 2023-2024 formulation, and move to a single dose for people 18 years and older, and approval of a single dose for people 12 to 17 years. Spikevax was previously approved as a two-dose primary vaccination schedule for people 18 years of age and older.
• Authorizing the Moderna COVID-19 vaccine for emergency use in people 6 months to 11 years of age and including the 2023-2024 formula and lowering the single-dose eligibility age from 6 to 5 years. old. Additional doses are also authorized for certain immunocompromised individuals ages 6 months to 11 years, as described in the fact sheets.
• The authorization of the Pfizer-BioNTech COVID-19 vaccine for emergency use in people 6 months to 11 years of age and include the 2023-2024 formula. Additional doses are also authorized for certain immunocompromised individuals ages 6 months to 11 years, as described in the fact sheets.
Approval for Comirnaty (mRNA COVID-19 vaccine) (formula 2023-2024) was granted to BioNTech Manufacturing GmbH. The emergency use authorization (EUA) amendment for the Pfizer-BioNTech COVID-19 Vaccine (2023-2024 formulation) was granted to Pfizer Inc.
Approval for Spikevax (mRNA COVID-19 Vaccine) (formula 2023-2024) was granted to ModernaTX Inc. and the EUA amendment for Moderna’s COVID-19 Vaccine (formula 2023-2024) was granted issued to ModernaTX Inc.
