FDA says vaccine makers should add omicron to COVID-19 boosters
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The FDA has told COVID-19 vaccine manufacturers that they should add a spike protein component for the omicron subvariants BA.4 and BA.5 to their existing vaccines to create bivalent boosters.
The FDA made the announcement on Thursday, days after an advisory committee voted 19-2 in favor of the change.
The FDA specified that the boosters should also include the original strain and that manufacturers should have these new formulations ready for use by early to mid-fall.
“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,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in a press release.
“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,” Marks said.
Combined, BA.4 and BA.5 now account for more than half of U.S. cases — 15.7% and 36.6% of cases, respectively — according to the CDC. Marks said that as fall and winter approach, it is critical to have safe and effective boosters to provide protection against circulating and emerging variants.
Marks noted that vaccine manufacturers have already reported data from clinical trials of modified vaccines containing an omicron BA.1 component and have been advised to submit these data to the FDA for evaluation before any potential authorization of a modified vaccine containing BA.4 and BA.5 components.
“The FDA has been planning for the possibility that vaccines would need to be modified to address circulating variants and previously provided guidance to industry on how to do so efficiently,” Marks said. “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.”
References:
CDC. COVID data tracker. https://covid.cdc.gov/covid-data-tracker/#variant-proportions. Accessed on June 30, 2022.
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