Moderna is breathing a sigh of relief now that the Food and Drug Administration said on Wednesday that it will review the company’s application for a new flu vaccine — a dramatic reversal from the agency’s refusal to do so just a week ago. But for the rest of the pharmaceutical industry, the damage might already be done.
Vanay Prasad, the FDA’s top vaccine regulator, justified the initial decision not to review Moderna’s application by claiming that the trial for its shot, which uses the same mRNA technology that made the covid-19 vaccines possible, was not “adequate and well-controlled” for participants older than 65. That was an about-face. The FDA said before the trial began that its design would be “acceptable.”
Now the agency has relented. After meeting with Moderna, it agreed to split the application into two age groups to address its concerns, with Moderna agreeing to conduct a study on seniors who take the shot later, assuming it’s approved.
All’s well that ends well? Hardly. The brouhaha exposes two problems: The first is that pharmaceutical companies — especially vaccine manufacturers — can’t be as confident they can jump through the FDA’s hoops without regulators changing the ground rules mid-circus act. Drug trials are hugely expensive and take a lot of time, so this unpredictability discourages innovation.
The second problem is that the FDA has signaled that it might raise its threshold for approving vaccines. The regulator complained that Moderna’s study should have compared its shot for seniors to a high-dose flu vaccine, which is recommended for the age group in the United States. But the trial was conducted in European countries where those stronger vaccines are harder to access. Moderna attempted to address this by conducting a separate, smaller trial specifically for that age group, but that wasn’t good enough for the FDA.
The FDA has gone to great lengths in recent years to reduce this sort of red tape that merely slows down lifesaving medical innovations. Lamentably, it seems to be returning to its old ways under Health Secretary Robert F. Kennedy Jr.’s leadership.
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