FDA approves Pfizer/BioNTech and Moderna’s adapted COVID-19 vaccines

The updated vaccines more closely target current circulating variants

The US Food and Drug Administration (FDA) has granted approval for Pfizer/BioNTech and Moderna’s updated COVID-19 vaccines, to tackle currently circulating variants.

As previously recommended by the FDA, both vaccines have been adapted to closely target the XBB.1.5. Omicron variant by including a monovalent component.

Both companies’ mRNA vaccines are approved for use in individuals aged 12 years and older and authorised for emergency use in those aged six months to 11 years.

The FDA has said that it is “confident in the safety and effectiveness” of the two updated vaccines and that its risk assessment demonstrated that the benefits of both vaccines for individuals aged six months and older outweighed the risks.

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

The approvals follow the World Health Organization’s announcement, designating the E.G.5 strain as a ‘variant of interest’, which both Pfizer/BioNTech and Moderna’s updated vaccines responded strongly to.

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

Albert Bourla, chairman and chief executive officer at Pfizer, said: “We expect this season’s vaccine to be available in the coming days… to prevent severe disease later, when respiratory viruses are at their peak.”

“With [the] decision, 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,” said Professor Ugur Sahin, chief executive officer and co-founder of BioNTech.

Stéphane Bancel, chief executive officer of Moderna, said in a blog post: “This timely approval helps ensure everyone will have the tools they need to do their part in protecting themselves and slowing the spread of the virus as we head into the [autumn] and winter months in the US.”