Coronavirus (COVID-19) Update: FDA Recommends Inclusion of Omicron BA.4/5 Component for COVID-19 Vaccine Booster Doses


Independent experts from the Vaccines and Related Biological Products Advisory Committee of the U.S. Food and Drug Administration gathered to debate whether the COVID-19 vaccine’s existing vaccine strain composition should be changed for booster doses for the fall and winter seasons of 2022.

The COVID-19 vaccines that the FDA has allowed for emergency use and approved have significantly improved public health and saved countless lives both domestically and abroad. But SARS-CoV-2, the virus that causes COVID-19, has undergone tremendous evolution, with current global outbreaks linked to the quick transmission of extremely contagious forms like omicron.

The most severe effects (hospitalisation and mortality) brought on by COVID-19 have been reduced thanks to currently available vaccines, however post-authorization observational studies have revealed that the effectiveness of primary vaccination against several variations, particularly omicron, declines over time. Additionally, investigations have shown that the effectiveness of initial booster dosages over time is fading, despite the fact that they initially restored protection against severe illness and hospitalisation brought on by omicron.

The American public can be confident that any COVID-19 vaccination that has received FDA authorization or approval satisfies our requirements for efficacy and safety. We urge everyone who is qualified to receive a booster to do so.

To avoid the worst effects of COVID-19 as we head into the fall and winter, it is crucial that we have safe and effective vaccination boosters that can offer defence against circulating and developing strains. The advisory group unanimously approved the inclusion of a SARS-CoV-2 omicron component in the COVID-19 vaccinations that would be used for boosters in the U.S. starting in the fall of 2022 after a comprehensive debate on June 28, 2022.

Following the vote, and striving to use the best available scientific evidence, we have advised manufacturers seeking to update their COVID-19 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, so that the modified vaccines can potentially be used starting in early to mid-fall 2022.

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.

Vaccine manufacturers have already reported data from clinical trials with modified vaccines containing an omicron BA.1 component and we have advised them that they should submit these data to the FDA for our evaluation prior to any 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.

The FDA has been preparing for the potential need to modify vaccinations to address circulating variations and has already given advice to industry on how to do so successfully. The agency will assess all pertinent data to determine the safety, efficacy, and manufacturing quality of modified vaccines under consideration for authorisation or approval to ensure that they fulfil the FDA’s requirements, as it has done with all COVID-19 vaccines during the pandemic.

The FDA will share future plans about the prospective authorisation or approval of COVID-19 vaccine booster doses with an omicron component as part of our commitment to transparency.

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