A Food and Drug Administration official said Tuesday it will be vital to get the “best possible match” between COVID-19 shots and circulating strains during a booster campaign that could kick off by October to stave off a surge in disease by winter.
Dr. Peter Marks, director of the FDA’s director of the Center for Biologics Evaluation and Research, said his agency needs input from outside advisers because drugmakers and regulators are trying to catch up with a rapidly evolving virus.
Omicron devastated the country last winter, but fast-moving lineages of the variant have taken over, so drugmakers and regulators must decide whether it is possible and prudent to reformulate the vaccines to target a specific variant.
Dr. Marks told advisers to consider whether drugmakers should stick to existing shots or reformulate them to target the original omicron variant or a specific lineage. Companies also are devising “bivalent” shots that combine the original vaccine with omicron-specific material.
“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 start of Tuesday’s meeting of FDA’s Vaccine and Related Biological Products Advisory Committee.
Dr. Marks said the FDA also will 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.
Pfizer and Moderna have begun testing vaccines that combine the original vaccines with omicron-specific content.
The companies say the shots produced a better immune response, but the companies and FDA will have to decide whether they are keeping pace with the changing virus.
For instance, they must decide if attempts to target a specific variant will thin out the shots’ overall effectiveness against a range of strains.
For more information, visit The Washington Times COVID-19 resource page.