FDA Recommends Omicron BA.4, 5 For COVID-19 Booster Dose

The Vaccines and Related Biological Products Advisory Panel of the U.S. Food and Drug Administration gathered on June 30th to evaluate whether a change to the COVID-19 vaccine strain composition for booster doses for the fall and winter seasons of 2022 is required.

The COVID-19 vaccinations that the FDA has licenced 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 monitoring studies have reported that the efficacy of primary vaccination against several variations, particularly omicron, declines over time. Additionally, investigations have shown that the usefulness of initial booster dosages over time is fading, despite the fact that they initially restored resistance 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 the requirements for efficacy and safety. They urge everyone who is qualified to receive a booster to do so. To avoid the worst effects of COVID-19 as they head into the fall and winter, it is crucial that they have effective and safe vaccination boosters that can offer defence against existing 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.

After the vote, and in an effort to use the best available evidence, they have advised manufacturers looking to update their COVID-19 vaccines to start creating modified vaccines by adding an omicron BA.4/5 spike protein element to the current vaccine structure to establish a two-component (bivalent) booster vaccine. This will allow the modified vaccines to possibly be used beginning in early to mid-fall 2022.

Since a principal series with the FDA-authorized and approved COVID-19 vaccines offers a basis of safeguard against serious outcomes of COVID-19 caused by circulating strains of SARS-CoV-2, they have not advised manufacturers to change the vaccine for primary vaccination as they anticipate this coming year to be a transition phase when this altered booster vaccine may be introduced.

Manufacturers of modified vaccines with an omicron BA.1 component have already submitted data from clinical studies, and they have instructed them to do so to the FDA for review before any prospective approval of a customised vaccination with an omicron BA.4/5 element. As the pandemic continues to evolve, manufacturers will also be urged to start clinical studies with modified vaccinations that have an omicron BA.4/5 component.

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 manufacturability of revised vaccines under review for authorisation or clearance to verify 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 clearance of COVID-19 vaccine booster doses with an omicron element as part of their commitment to transparency.