Biologics

Clinical Trials for Covid Boosters: Makary

FDA commissioner Martin Makary told the 5/6 American Hospital Association annual meeting that the agency is encouraging companies seeking approval for Covid-19 vaccine booster shots to use “gold standard science,” including clinical trials involving healthy people. In an online post on Makary’s presentation, Health Day says the agency’s position could mean that no Covid boosters will be approved in time for this coming winter’s respiratory disease season.

“It’s reasonable to say we’d like to see a clinical trial rather than just some antibodies that spike after you give [the vaccine,]” he said. “You can make antibodies spike to anything. That doesn’t tell us that it actually has a clinical benefit. Americans want to know, do we really, is there really a clinical benefit in healthy subjects?” He also indicated the agency is considering whether Covid boosters should be given primarily to high-risk groups.

Makary’s comments track an HHS 4/30 statement saying that under HHS secretary Robert Kennedy, Jr., “all new vaccines will undergo safety testing in placebo-controlled trials prior to licensure, a radical departure from past practice.”

In response to that statement, an HHS spokesperson told FDA Webview that Makary indicated that significant updates for existing vaccines might be considered “new products” requiring additional clinical evaluation.

The agency spokesperson said that four-year-old Covid vaccine trials in people without natural immunity “no longer suffice. A four-year-old trial is also not a blank check for new vaccines each year without clinical trial data, unlike the flu shot, which has been tried and tested for more than 80 years. The public deserves transparency and gold standard science, especially with evolving products.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome