As reported in an FDA publication of 30 June 2022, the design of booster shots must be altered to integrate components tailored to tackle the currently dominant and highly transmissible Omicron BA.4 and BA.5 subvariants of coronavirus. Worldwide, the FDA-approved COVID-19 vaccines have saved thousands of lives and have made a significant impact on public health.

The currently available vaccines have aided to minimize serious outcomes like death and hospitalization elicited by coronavirus disease. But, post-approval observational studies have shown that primary vaccinations are less effective over time for some variants, which include Omicron.  SARS-CoV-2 has substantially evolved, with a recent rise around the world linked with the rapid spread of highly transmissible variants like omicron.

It is pivotal that there is availability of efficacious and safe vaccine boosters that can offer a shield against emerging variants in order to prevent extreme consequences of coronavirus disease. After a thorough discussion on 28 June 2022, a majority of advisory committee voted in favor of including SARS-CoV-2 omicron component in vaccines that would be utilized for boosters. Even though initial doses of booster vaccines have aided to regain protection against intense disease and hospitalization linked with omicron, trials have also demonstrated fading efficacy of first doses of booster over time.

COVID-19 vaccine manufacturers have been advised to modify the current composition of the vaccine by addition of Omicron BA.4 and BA.5 spike proteins to the current vaccine formulation. This will assist to develop a bivalent (two-component) booster vaccine. Manufacturers have not been recommended to alter the vaccine for primary vaccination. This is because a primary series with FDA-approved vaccines offers a base of protection against severe outcomes triggered by circulating SARS-CoV-2 strains.

Trials with modified vaccines containing omicron BA.1 components have already been reported by vaccine manufacturers. The vaccine producers must submit these trials for FDA review to get approval for modified vaccines encompassing omicron BA.4/5 components. Manufacturers will also be requested to initiate trials with modified vaccines containing