infectious disease
Pfizer's mRNA-based flu shot offered better protection than standard vaccine
From my colleague Helen Branswell: Pfizer's experimental mRNA-based flu shot showed enhanced effectiveness against influenza A viruses in a Phase 3 trial, the company reported in the New England Journal of Medicine late yesterday.
Adults 18 to 64 who got Pfizer's modified mRNA shot were better protected against flu A than people who got Sanofi's Fluzone shot. There was very little flu B activity in the year the trial was run, so the study can't estimate vaccine efficacy against those viruses.
An editorial on the results noted that the trial also tested the vaccine in adults 65 and older, an important demographic for flu vaccine. Those results were less impressive and were not reported in this paper.
The news comes as public health gears up for what could be a nasty flu season. H3N2 viruses — a flu A subtype — have mutated in ways that may help them evade vaccine-induced antibodies. The new variant, subclade K, emerged over the summer, when it was too late for manufacturers of traditional flu shots to target these viruses in this winter's shot.
Scott Hensley, a University of Pennsylvania microbiologist who is working to develop broader flu vaccines using mRNA, said the subclade K situation illustrates why having mRNA flu shots would be beneficial. The lead time for making mRNA vaccines is substantially shorter than for vaccines grown in eggs or cell culture.
fda
Pazdur faces a big test with Sarepta's Duchenne drugs
In his new role as top drug regulator at the FDA, Richard Pazdur will soon face an early test: how to handle the accelerated approvals the agency has given to Sarepta Therapeutics for its Duchenne muscular dystrophy drugs.
The drugs failed a confirmatory study that recently read out, but Sarepta has still pledged to seek full approval.
How Pazdur acts will be a telling sign of how much independence and scientific rigor he will bring to the job, my colleague Adam Feuerstein writes. This isn't new territory for him — he repeatedly confronted difficult regulatory decisions in his former role as top oncology regulator.
Read more from STAT's Adam Feuerstein.
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