Drugmakers should devise a COVID-19 vaccine that targets omicron and its sub-variants alongside the original strain, advisers to the Food and Drug Administration said Tuesday after a robust debate about how to keep up with the swiftly evolving virus.
The vaccine advisory committee voted, 19 to 2, to reformulate the vaccines ahead of a likely booster campaign this fall.
Advisers did not say which variants would be targeted, specifically, but signaled a preference for the BA.4 and BA.5 that are becoming dominant across the U.S. and could pose the next big threat.
Peter Marks, the director of the FDA’s director of the Center for Biologics Evaluation and Research, said it will be vital to get the “best possible match” between COVID-19 shots and circulating strains in a booster campaign to stave off a winter surge of disease.
Omicron devastated the country last winter but fast-moving lineages of the variant have taken over, so drugmakers and regulators must devise a plan to reformulate the vaccines in the coming weeks and months.
“It takes several months to make these vaccines and then distribute them. If we want these to be available by early fall that [decision] will have to happen very soon,” Dr. Marks said at the meeting of FDA’s Vaccine and Related Biological Products Advisory Committee. “The manufacturers need to know what to put in their vaccines.”
Officials have acknowledged it will be difficult, if not impossible, to keep up with the strain that is circulating at any given time, so the goal will be to increase the breadth of protection as best as they can.
Companies are working on “bivalent” shots that combine the original vaccine with omicron-specific material and monovalent shots that would target omicron’s BA.1 variant.
The advisers worried a targeted, monovalent vaccine would be too limited in scope and give inadequate protection to the range of viral strains out there. They also theorized about whether there was adequate safety data about the effects of generating antibody responses to two spike proteins at once in a bivalent vaccine.
Dr. Marks said moving forward, the FDA will also consider whether the primary series of a vaccine — the first two shots from Pfizer-BioNTech or Moderna — should be reconfigured alongside the boosters.
The FDA is eyeing a shakeup to avoid a harsh winter.
Roughly half of Americans have received a booster — typically a third dose — of a COVID-19 vaccine. Even those who are up to date on vaccinations will face waning immunity.
“At the same time, we’ve seen this rapid evolution of COVID-19 variants and that will undoubtedly continue,” Mr. Marks said.
He said the combination of waning immunity and the advent of new variants this winter, right as the population hunkers inside, “increases our risk of a major COVID-19 outbreak.”
“For that reason, we have to give serious consideration to a booster campaign this fall to help protect us, during this period, from another COVID-19 surge,” Dr. Marks said.
For more information, visit The Washington Times COVID-19 resource page.
• Tom Howell Jr. can be reached at thowell@washingtontimes.com.
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