Makary Says Vaccine Framework Coming Soon
FDA is planning to release in the “coming days” a vaccine development framework for manufacturers, commissioner Marty Makary told the Food and Drug Law Institute (FDLI) at its annual meeting in Washington, DC 5/15. The framework will outline a development roadmap for vaccine makers so they have a “predictable FDA, and where they don’t have to worry about how is this going to be received?” he said.
Presumably, the framework will shed light on recent statements the agency has been making about vaccine development, particularly those for preventing Covid-19. Earlier this month, Makary told the American Hospital Association’s (AHA) 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 to support their use, suggesting that no Covid boosters will be approved in time for this coming winter’s respiratory disease season (see earlier story).
“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,]” Makary told the AHA. “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 told FDLI that the framework is being finalized by new CBER director Vinay Prasad, who has been meeting with industry and Center staff so that it reflects “gold standard science and common sense."
The commissioner also said FDA is working to ratchet up post-marketing surveillance and understanding “what's actually going on” when a new product hits the market. “Is there a safety signal we didn’t see in the trial, and is there a benefit that we didn’t see in the trial? he asked. “We've never been able to do that before, but now, with big data, we are assembling some of the biggest electronic health record databases, and we will be able to query those databases in real time as soon as we approve a drug. And that will also influence our decision as to when to green light something, because if we have eyes on it the second it's approved, we can feel more confident about understanding safety signals. And I think that has implications across the spectrum.”
Makary said that the enhanced surveillance system will give the agency “eyes that we’ve never had before… We should not be learning five years later that Vioxx may have killed 38,000 Americans, or 10 years later that Oxycontin killed perhaps a million Americans. And I’m guilty of that. I prescribed it to people I shouldn’t have as a surgeon, and I'm very honest about that. We should have eyes immediately, so that will change the way we approach things.”