policy
Vaccine changes raise new liability questions for drugmakers
Health secretary Robert F. Kennedy Jr.’s allies are hopeful that his agency’s move to reduce the number of recommended pediatric vaccines opens the door to stripping vaccine makers of the liability shields afforded to them by a landmark decades-old law. Taking down those defenses has been a longtime goal of vaccine critics like Kennedy, who claim the protections de-incentivize manufacturers from making vaccines safe.
Such a defeat could force manufacturers out of the market and undermine vaccine access across the country. But it’s definitely an “if,” not a “when.” Legal experts aren’t sure there’s an immediate opening. “This was a big destabilizing and confusing event,” said Anna Kirkland, who wrote a book on federal vaccine court. “But it doesn’t change so much structural stuff.” Read more from STAT’s Chelsea Cirruzzo and Daniel Payne on why people are worried anyway.
And if you’re still looking for a breakdown of the changes, you can watch a video interview with Helen Branswell, STAT’s in-house vaccine expert, here.
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More data in favor of this year’s flu shot
And in more vaccine news, here’s a report from Helen on a yet-to-be-published paper:
There’s more evidence that this year’s flu vaccine may offer at least some protection against the influenza strain that is wreaking havoc on respiratory tracts across the nation. A new preprint from scientists at the University of Pennsylvania reports that a portion of people who got a flu shot developed what are considered to be protective levels of antibodies against H3N2 viruses of the subclade K variant, even though the vaccine doesn’t target that version of H3N2.
In a group of 76 people ranging in age from 24 to 81, 11% had antibodies that recognized the new subclade K viruses before they were vaccinated. When blood from the same group was tested a month after vaccination, 39% had antibodies against subclade K at levels that normally signal protection. Not ideal, but it could be worse, said flu virologist Scott Hensley, whose lab did the work. "Going into the experiments, I thought we would see less than 10% seropositive after vaccination," he told STAT. There’s more on subclade K here. — Helen Branswell
research
How safe is that psychedelic retreat?
While Kennedy and many others have trumpeted the therapeutic potential of psychedelics, questions remain about how best to provide the drug in clinical settings. In the meantime, as shrooms (psilocybin) and ayahuasca become more popular, psychedelic retreat groups have cropped up in and around the U.S. A study published yesterday in JAMA Network Open analyzed the safety practices of nearly 50 such organizations.
Researchers found “substantial variability” in the safety measures taken by the retreat groups, which offered psilocybin, ayahuasca, or both. All of the groups collected medical histories, and most excluded people with certain conditions like schizophrenia or psychosis. Most (88%) required or recommended that people stop taking any medications before their trip, but for lengths of time that varied from a single day to six weeks beforehand. About 70% worked with a licensed health care professional or someone with emergency response training, while 65% had one of those folks in attendance at least some of the time. All the groups had some type of trained workers in attendance, but the responsibilities of those workers were often vaguely defined.
