The FDA on Monday approved a new Covid vaccine booster produced by ModernaTX Inc. and Pfizer Inc. to combat emerging strains of the virus which together account for the majority of existing cases around the world.
“Consistent with the totality of the evidence and input from the FDA’s expert advisors, these vaccines have been updated to include a monovalent (single) component that corresponds to the Omicron variant XBB.1.5,” a statement from the agency read.
People 12 and older can receive the new shot without restriction. It is available to children six months old through eleven years old only via emergency-use authorization. The original bivalent vaccines developed at the start of the pandemic by the two pharmaceutical giants are no longer authorized for use in the U.S. under the new update. The new vaccine is monovalent, the statement said.
“Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in the statement Monday. “The public can be assured that these updated vaccines have met the agency’s rigorous scientific standards for safety, effectiveness, and manufacturing quality. We very much encourage those who are eligible to consider getting vaccinated.”
In preparation for an expected fall and winter surge in Covid cases, as is typical with other seasonal illnesses, the companies have been manufacturing the 2023-2024 version of the vaccine to make sure demand is met.
“With today’s 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,” Dr. Ugur Sahin, CEO and co-founder of BioNTech, said in statement obtained by CNN. “Studies about confirmed viral infections suggest that COVID-19 adopts a seasonal pattern with peaks in fall and winter, similar to other respiratory viruses. Our goal is to provide people worldwide with COVID-19 vaccines that are adapted to circulating virus variants or sublineages.”
The Advisory Committee on Immunization Practices, a group within the CDC that provides advice on effective control of vaccine-preventable diseases, will review the new vaccines and advise on their recommended use. The vaccines can then be delivered to the public after the CDC director agrees to the guidance, which could come out in the next week.