U.S. FDA will decide on redesigned COVID vaccines by early July

Both Moderna and Pfizer with partner BioNTech have said that their respective redesigned vaccines generate a better immune response against BA.1 than their current shots that were designed for the original virus that emerged from China. They have said that their new vaccines also appear to work against the more recently circulating BA.4 and BA.5 Omicron subvariants, even though that protection is not as strong as against BA.1.

U.S. regulators plan to decide by early July whether to change the design of COVID-19 vaccines this fall in order to combat more recent variants of the coronavirus, with hopes of launching a booster campaign by October, a top Food and Drug Administration official said on Tuesday. "The better the match of the vaccines to the circulating strain we believe may correspond to improve vaccine effectiveness, and potentially to a better durability of protection," Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said at a meeting of outside expert advisers to the agency.

The committee is scheduled to vote on a recommendation on whether to make the change later on Tuesday. The updated shots are likely to be redesigned to fight the Omicron variant of the coronavirus, experts say. The exact composition of the retooled shots and whether they will include some of the original vaccine alongside new components will be considered at the meeting.

Pfizer Inc, Moderna Inc and Novavax Inc also presented data at the meeting. All three companies have been testing versions of their vaccines updated to combat the BA.1 Omicron variant that led to a massive surge in infections last winter. Both Moderna and Pfizer with partner BioNTech have said that their respective redesigned vaccines generate a better immune response against BA.1 than their current shots that were designed for the original virus that emerged from China.

They have said that their new vaccines also appear to work against the more recently circulating BA.4 and BA.5 Omicron subvariants, even though that protection is not as strong as against BA.1. One issue being considered is whether the manufacturers should update their vaccines to more closely match the BA.4 and BA.5 subvariants.

Dr. Kanta Subbarao, a presenter representing a World Health Organization advisory committee that also considered the issue, suggested that BA.1-based vaccines would generate a broader immune response because that variant is more distinct from the original version than its successor subvariants. "Our goal here is to achieve broader immunity against circulating and emerging variants," Subbarao said, noting that trying to match what variant might be circulating in the fall is difficult because of uncertainty about the trajectory of the evolution of the virus.

 

(This story has not been edited by Devdiscourse staff and is auto-generated from a syndicated feed.)