US FDA advisers recommend changing composition of COVID vaccine for fall

June 28 (Reuters) – U.S. Food and Drug Administration advisers on Tuesday recommended a change in the design of COVID-19 booster shots this fall to combat more recently circulating variants of the coronavirus.

The FDA’s Vaccines and Related Biologics Advisory Committee voted 19 to 2 that the next wave of COVID recalls should include a component that targets the Omicron variant of the coronavirus.

The FDA plans to decide in early July on the design of the boosters.

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FDA scientists present at the meeting suggested they preferred vaccines that would target the BA.4 and BA.5 Omicron subvariants that are currently dominant rather than the BA.1 Omicron variant that has led to a massive increase infections last winter.

Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said the regulator hopes to launch a recall campaign with a revamped vaccine by October.

“The closer the match of vaccines to the circulating strain, we believe, can correspond to improved vaccine efficacy, and potentially better durability of protection,” Marks said at the external expert meeting with the agency.

Pfizer Inc (PFE.N), Moderna Inc (MRNA.O) and Novavax Inc (NVAX.O) presented data at the meeting. All three companies tested updated versions of their vaccines to combat the BA.1 Omicron variant.

Moderna said it would be ready with “a few hundred million” bivalent or dual-target vaccines designed to fight BA.1 by September. It would be late October or early November if it were to design a vaccine targeting the new subvariants, the company said.

Pfizer said it and its partner BioNTech (22UAy.DE) already have a significant amount of BA.1 vaccine ready and are preparing to produce a large amount of vaccine targeting BA.4 and BA.5. He said either could be ready for deployment in early October.

Dr Kanta Subbarao, representing a World Health Organization advisory committee that has also looked into the matter, said she preferred BA.1-based vaccines, suggesting they could generate a broader immune response as this variant is more distinct from the original virus than its successor subvariants. .

“Our goal here is to achieve broader immunity against circulating and emerging variants,” Subbarao said, noting that trying to match which variant might be circulating in the fall is difficult due to uncertainty over to the evolutionary trajectory of the virus.

Both Moderna and Pfizer said their respective BA.1-inclusive vaccines generated a better immune response against Omicron than their current vaccines designed for the original virus that emerged from China.

They said their new vaccines also appear to work against BA.4 and BA.5, but the protection is not as strong as against BA.1.

The International Coalition of Drug Regulators, a group of global drug regulators that includes the FDA, will meet on Thursday to discuss the issue.

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Reporting by Michael Erman; Additional reporting by Julie Steenhuysen in Chicago and Leroy Leo in Bangalore; Editing by Bill Berkrot

Our standards: The Thomson Reuters Trust Principles.

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