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# Add Omicron BA.4/5 Component to Boosters: FDA
- URL: https://www.fdaweb.com/add-omicron-ba-4-5-component-to-boosters-fda/
- Published: 2022-06-30T12:00:00.000Z
- Updated: 2026-09-14T17:50:44.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5152209

FDA has told Covid-19 vaccine manufacturers seeking to update their vaccines that they should develop modified vaccines that add an omicron BA.4/5 spike protein component to the current vaccine composition to create a two-component (bivalent) booster vaccine. This follows advice from the agency’s Vaccines and Related Biological Products Advisory Committee 6/28 recommending an omicron variant component for use this fall and winter ([see earlier story](https://www.fdaweb.com/panel-recommends-omicron-based-covid-booster-vaccines/)). During the meeting, FDA officials predicted another late-year Covid infection wave as people remain indoors again during the colder months.

“As we expect this coming year to be a transitional period when this modified booster vaccine may be introduced, we have not advised manufacturers to change the vaccine for primary vaccination, since a primary series with the FDA-authorized and approved Covid-19 vaccines provides a base of protection against serious outcomes of Covid-19 caused by circulating strains of SARS-CoV-2,” an [agency notice](https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-recommends-inclusion-omicron-ba45-component-covid-19-vaccine-booster?ref=fdaweb.com) says.

The agency also says vaccine manufacturers have already studied modified vaccines containing an omicron BA.1 component and they have been asked to submit this for further review before seeking a potential authorization of a modified vaccine containing an omicron BA.4/5 component. “Manufacturers will also be asked to begin clinical trials with modified vaccines containing an omicron BA.4/5 component, as these data will be of use as the pandemic further evolves,” it says.