The US Food and Drug Administration decided Thursday to advise manufacturers that when they update the Covid-19 vaccine booster they should add an Omicron BA.4/5 component to the current vaccine mix. This would create what’s known as a bivalent, or two component, booster.
The committee felt that a modified vaccine would offer broader protection to match the coronavirus strains that are in circulation now. The committee was not asked to vote on what sublineage to include or whether the booster should be monovalent vaccine or a bivalent vaccine, which would include two strains.
Marks said Tuesday that there will be a conversation going forward to determine who needs another booster and what that booster will look like.
The FDA said in May that the “new normal” may include an annual Covid-19 and flu shot for people in the fall. Cases are expected to rise again in the fall and winter.
Figuring out what goes in the next vaccines are a tricky decision, because as Dr. Arnold Monto, the acting chair of the independent vaccine advisers committee, suggested, this is a virus that changes quickly and puts scientists in “uncharted territory”
“Looking in the past doesn’t help us a great deal to look in the future for this virus which has baffled a lot of us and made predictions almost irrelevant,” Monto added.
The new formulation would instead go into a booster shot that may be introduced in the fall.
Vaccine makers have already been testing new versions of their vaccines and presented the data at the independent advisers meeting on Tuesday.
Moderna’s presented details about its bivalent booster vaccine candidate that contains components of both Moderna’s original Covid-19 vaccine and a vaccine that targets the original Omicron variant.
Pfizer/BioNTech also presented data to the committee that showed that their two Covid-19 vaccine boosters targeting Omicron showed a substantially higher immune response than its current Covid-19 vaccine. Preliminary lab studies suggest the vaccines could also neutralize the Omicron BA.4 and BA.5.
“Based on the strength of our initial data from our Omicron BA.1 bivalent candidates, we believe we have a strong solution with a bivalent BA.4/BA.5 subvariant booster as we head into this next chapter of the pandemic, and will continue to share our available data with health experts and regulators. We are ready to distribute a vaccine to the world by early October 2022, pending regulatory authorizations,” said a Pfizer spokesperson in a statement to CNN.
On Thursday, the FDA encouraged the vaccine makers to submit the latest data on these modified vaccines to the FDA for evaluation prior to the authorization of an Omicron BA.4/5 component vaccine.
The FDA also said it would ask vaccine makers to begin clinical trials with modified vaccines with the Omicron BA.4/5 component, because the agency said the data would be helpful as the pandemic “further evolves.”
At Tuesday’s meeting, the World Health Organization told the FDA’s independent committee that the vaccination strategy going forward should probably be based around a vaccine that would offer as broad a kind of protection as possible, rather than just continuing with the vaccines that were made against the original strain that is no longer in circulation.
“I still think there’s value in increasing the breath of immunity and I will reiterate that we’re not trying to match what may circulate,” said Dr. Kanta Subbarao with the World Health Organization Collaborating Center for Reference and Research on Influenza and the University of Melbourne. “It is not so much to match what is likely to circulate because there’s so much uncertainty about the trajectory of this evolution.”