Flu shot brouhaha

Could cause regulatory chaos.

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Hi, it's Gerry and Bob in New York. Your chances of getting a powerful new weapon against the flu just got slimmer. More on that in a moment, but first ...  Today's must-reads Novo to sell obesity shots in vials that can offer more flexible dosing. Humana's profit outlook adds to health insurance gloom. CSL tumbles on weak vaccine markets and an 81% drop in first-half profit. Enduring Influenza It's been a brutal flu season. The virus has made at least 22 million Americans sick, sent more than 280,000 to the hospital and killed at least 12,000 people. Doctor visits for flu-like illnesses in the US are at their highest level in nearly three decades. It's been so bad partly because the current vaccines aren't well-matched to the strain going around. Moderna, which became a public health hero for its Covid vaccine, says studies show its flu shot is better at keeping people healthy than what's on the market now. Its mRNA technology is also uniquely well-suited to the task. It can produce vaccines months faster than the standard method, which involves growing a live virus in chicken eggs. That difference could make it easier for Moderna to match its efforts to strains that can emerge late in the season. But Moderna's flu shot just hit a major roadblock. The US Food and Drug Administration refused to even consider its application. Moderna and the FDA are now arguing over whether the company should have compared its shot to a different, higher-dose vaccine recommended for seniors. The agency says Moderna didn't follow its recommendation. Moderna says the previous FDA leadership OK'd its approach, and the backtracking has come out of the blue. It all may seem like an esoteric dispute over clinical trial design, but it's a sign of something deeper. There's the chaos it's injecting into a regulatory process that's traditionally been highly orchestrated and predictable. It's also hard to ignore that immunizations have become political under the leadership of Health Secretary Robert F. Kennedy Jr., a vaccine critic. Moderna's vaccines, in particular, have come under steady attack by the Trump administration, which has sought to raise doubts about their safety. Despite its potential in cancer, mRNA technology has become a dirty word in anti-vaccine circles, swept up in the lingering frustration that some people feel about the US response to Covid. Last year, Kennedy terminated about $500 million in federal funding for mRNA vaccine research, and cancelled Moderna's contract to make a shot to protect against bird flu, which could cause the next pandemic. The FDA's refusal to review Moderna's flu vaccine is a win for Vinay Prasad, a top agency official who works for Kennedy. One of his pet peeves is when companies don't compare their treatment to the best available options, which he says Moderna didn't do here. But at a time when US flu cases are rising yet again, Moderna's stalled vaccine is worth watching. Will the FDA show flexibility? Is Moderna willing to run a new trial? One thing that many can agree on: we need better flu shots (last year's were only 56% effective, and that was a pretty good year). The question is how soon Americans will get access to this one. — Gerry Smith and Robert Langreth What we're reading Prasad overruled FDA staff in refusing to review Moderna's flu application, Stat reports. The Forest Service allowed firefighters to wear gear containing "forever chemicals" without giving any warning for years, according to ProPublica. Some Winter Olympics athletes are falling ill with norovirus, CNN reports. Contact Prognosis Health questions? Have a tip that we should investigate? Contact us at AskPrognosis@bloomberg.net. Follow us You received this message because you are subscribed to Bloomberg's Prognosis newsletter. If a friend forwarded you this message, sign up here to get it in your inbox. Unsubscribe Bloomberg.com Contact Us Bloomberg L.P. 731 Lexington Avenue New York, NY 10022 |