FDA批准辉瑞/ BioNTech和现代化的s updated COVID-19 vaccines

The US Food and Drug Administration (FDA) has approved updated COVID-19 vaccines from Pfizer/BioNTech and Moderna to more closely target currently circulating variants.

In line with previous recommendations from the FDA’s vaccines advisory committee, the vaccines have both been adapted to include a monovalent component that corresponds to the XBB.1.5 Omicron variant.

The mRNA vaccines are each approved for individuals aged 12 years and older and are authorised under emergency use for those aged six months to 11 years.

The US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will now meet to discuss who should receive an updated vaccine.

The FDA said it is “confident in the safety and effectiveness” of the updated vaccines and that the agency’s benefit-risk assessment demonstrates that the benefits of these vaccines for individuals aged six months and older outweigh their risks.

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said: “The public can be assured that these updated vaccines have met the agency’s rigorous scientific standards for safety, effectiveness and manufacturing quality.”

Unless a significantly more virulent variant emerges, the FDA said it expects that COVID-19 vaccines will need to be updated annually, as is done for the seasonal flu vaccine.

Earlier this month, Pfizer and Moderna said that their updated vaccines were effective against the 'highly mutated' BA.2.86 subvariant, also known as Pirola, that is currently being tracked by global health authorities.

The vaccines have also been shown to generate strong responses against other currently circulating variants, including the EG.5 ‘Eris’ strain, which wasdesignated by the World Health Organizationas a ‘variant of interest’ in August.

Pfizer/BioNTech and Moderna have said their updated vaccines are expected to be available for most people in the US in “the coming days”.

Professor Ugur Sahin, chief executive officer and co-founder of BioNTech, said: “An updated vaccine will shortly become available that helps address multiple Omicron XBB-related sublineages, which currently account for the vast majority of COVID-19 cases globally.

“Studies about confirmed viral infections suggest that COVID-19 adopts a seasonal pattern with peaks in fall and winter, similar to other respiratory viruses.”