The U.S. Food and Drug Administration (FDA) recently said that a change to the current vaccine strain composition of COVID-19 vaccines for booster doses is necessary for the fall and winter seasons.
The agency’s advisory committee voted to include a SARS-CoV-2 omicron component in COVID-19 vaccines that would be used for boosters in the U.S. beginning in fall 2022.
“The COVID-19 vaccines that the FDA has approved and authorized for emergency use have made a tremendous difference to public health and have saved countless lives in the U.S. and globally,” said the agency.
“However, SARS-CoV-2, the virus that causes COVID-19, has evolved significantly, with recent surges around the world associated with the rapid spread of highly transmissible variants such as omicron.”
Vaccine manufacturers have already reported data from clinical trials with modified vaccines containing an omicron component, said the FDA.
Additionally, they will use the data to evaluate the potential authorization of a modified vaccine that includes omicron variants.
While the FDA has approved modifications for the booster vaccines, they have not authorized any changes to the vaccine for primary vaccination.
The FDA said it’s been planning for the possibility that vaccines would need to be modified to address circulating variants and previously provided guidance to manufacturers on how to do so efficiently.
“As has been the case with all COVID-19 vaccines throughout the pandemic, the agency will evaluate all relevant data to inform the safety, effectiveness and manufacturing quality of modified vaccines under consideration for authorization or approval to ensure that they meet the FDA’s standards,” the agency said.
“The American public can be assured that any COVID-19 vaccine authorized or approved by the FDA meets our standards for safety and effectiveness. We encourage those who are currently eligible for a booster to get one.”