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The Readout Damian Garde & Meghana Keshavan

What are we to make of this J&J situation?

Yesterday, the U.S. paused distribution of Johnson & Johnson’s Covid-19 vaccine after observing six serious cases of clotting problems, one of which was fatal.

As STAT’s Helen Branswell reports, experts generally agreed it was the prudent thing to do. While the clotting issue appears to be vanishingly rare, “FDA and scientists need time to better understand what is going on, which means a pause is the right course of action,” said John Moore, an immunologist at Weill Cornell Medicine.

The other outstanding question is just what’s going on biologically. AstraZeneca’s vaccine, based on a similar technology to J&J, ran into similar issues. And as STAT’s Matthew Herper reports, scientists see some clues as to what’s driving the rare side effects. Patients appeared to have developed antibodies to a key protein found in the blood, which might cause the clotting. What remains unclear is just what role the vaccines play in the production of those antibodies.

Read more.

Moderna’s flu vaccine will start human trials this year

The unprecedented speed at which mRNA delivered highly effective Covid-19 vaccines brought up a natural question: What can it do about seasonal influenza?

Moderna, whose Covid-19 vaccine proved to be more than 90% effective, intends to find out. The company said today that it will start human trials of a quadrivalent flu vaccine before the end of the year, testing multiple candidates before picking one to take into late-stage development. The announcement is part of Moderna’s vaccine pipeline presentation, which starts at 8 a.m. ET.

Current flu vaccines tend to be only around 50% effective, leaving plenty of room for improvement. There’s also plenty of room for profit. Drug companies sell about $5 billion worth of flu vaccines every year. If Moderna can prove that mRNA is a better, faster alternative, it could claim a sizable portion of that market. But it’s not alone. Partners Pfizer and BioNTech are planning to translate their success in Covid-19 into an mRNA flu vaccine, and could start a human trial as early as this year.

The fate of Biogen’s Alzheimer’s drug is ‘an unvettable situation’ for Wall Street

Biogen’s years-long saga with the Alzheimer’s disease treatment aducanumab has had enough twists and turns to make nearly any prediction seem plausible. That makes it “kind of an unvettable situation” for the stock analysts who get paid to predict these things, said Paul Matteis, who covers biotech companies at Stifel.

“I’ve never understood the people on Wall Street who think this is either extremely likely to get approved or extremely unlikely,” Matteis said in the latest STAT+ Conversation, covering all things neuroscience in biotech. “Because I think the right move here is to change your mind a million times.”

Every new development can be twisted to support either side of the debate, Matteis said. That includes the FDA’s recent decision to extend its review of aducanumab by three months, which could be a way to gather more justification for an inevitable approval — or a matter of kicking the can down the road until there’s a permanent commissioner to deal with the inevitable rejection.

For more on Biogen, Acadia Pharmaceuticals, UniQure, and “the geneticization of neuroscience,” watch the full conversation.

J&J’s delay could be a boon to Covid vaccine latecomers

It’s unclear just how long Johnson & Johnson’s Covid-19 vaccine will sit on shelves in the U.S., or what effect that’ll have on the rest of the world. But the whole affair underlines just how unpredictable the vaccine market will be, which creates an opportunity for the next generation of contenders.

As the analysts at SVB Leerink noted, J&J’s delay will increase demand for the mRNA vaccines from Pfizer and Moderna. But it could also drive countries to order more doses of vaccines that are yet to win authorization, including the protein-based injection from Novavax and the mRNA shot from Curevac, both of which should have pivotal data this quarter.

The lesson from the J&J situation, and the AstraZeneca one before it, could be that countries are best served by diversifying their vaccine supply. And that’s good news for the market’s many latecomers.

More reads

  • PhRMA chief talks strategy — and he’s surprisingly optimistic about drug pricing reform. (STAT+)
  • Novavax vaccine-ingredient supplier PolyPeptide plans IPO. (Bloomberg)
  • A U.S. appeals court upholds the FTC view of controversial pay-to-delay settlements. (STAT+)
  • Massachusetts biotech boss tells feds ‘Breaking Bad’ inspired quest for ricin. (Boston Herald)

Thanks for reading! Until tomorrow,

Wednesday, April 14, 2021

STAT

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