Daily News
FDA Approves Updated mRNA COVID-19 Vaccines
FDA authorizes updated mRNA COVID-19 vaccines targeting circulating variants for enhanced protection.
In a significant move, the U.S. Food and Drug Administration (FDA) has taken action to approve and authorize updated COVID-19 vaccines that specifically target the currently circulating variants of the virus. These updated mRNA vaccines, manufactured by ModernaTX Inc. and Pfizer Inc., aim to provide better protection against severe outcomes, such as hospitalization and death, associated with COVID-19.
The updated vaccines have been formulated to include a monovalent component that corresponds to the Omicron variant XBB.1.5, based on comprehensive evidence and expert advice. The FDA’s decision reflects its confidence in the safety and effectiveness of these vaccines, with a clear benefit-risk assessment indicating that the benefits outweigh the risks for individuals aged 6 months and older.
Here’s what you need to know: Individuals aged 5 and older, regardless of their previous vaccination status, are eligible to receive a single dose of the updated mRNA COVID-19 vaccine, provided at least two months have passed since their last COVID-19 vaccine dose. For children aged 6 months to 4 years, the number and timing of doses depend on their previous vaccination history.
Unvaccinated children aged 6 months to 4 years are eligible to receive three doses of the updated Pfizer-BioNTech COVID-19 Vaccine or two doses of the updated Moderna COVID-19 Vaccine. Similar to previous mRNA vaccines, individuals may experience side effects as outlined in the respective prescribing information or fact sheets.
The updated vaccines are expected to offer robust protection against currently circulating variants, with the FDA suggesting that annual updates may be necessary, similar to the seasonal influenza vaccine. The U.S. Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will convene to discuss clinical recommendations and considerations for specific populations.
Manufacturers have announced that the updated vaccines will be available this fall, reinforcing the importance of vaccination in safeguarding public health. The FDA assures the public that these updated vaccines meet rigorous scientific standards for safety, effectiveness, and manufacturing quality.
The updated mRNA vaccines are approved for individuals aged 12 and older and authorized for emergency use in children aged 6 months to 11 years. As a result of these actions, the previous bivalent Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer authorized for use in the United States.
The FDA’s decision is backed by the evaluation of manufacturing data and non-clinical immune response data on the updated formulations, including the XBB.1.5 component. This marks a significant step in the ongoing fight against COVID-19, emphasizing the importance of staying informed and considering vaccination as a critical tool for protecting ourselves and our communities.