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The Readout Damian Garde & Meghana Keshavan

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Pfizer's Covid-19 vaccine is 95% effective

Partners Pfizer and BioNTech have wrapped up the efficacy portion of their Covid-19 vaccine study, concluding that the vaccine prevented 95% of cases of the disease.

Here's how the numbers break down: There were 170 cases of Covid-19 observed in the trial, and only eight in people who received the vaccine. There were no serious safety concerns, Pfizer said, and the most common severe side effect was fatigue, which occurred in less than 4% of patients.

The news, which came just 48 hours of Moderna said its rival vaccine was 94.5% effective, means Pfizer is days away from asking the FDA for an emergency use authorization.

Read more.

A disappointing day for ALS patients

Three spinal injections of a bespoke stem cell treatment called NurOwn failed to slow the neurological decline of ALS patients compared to placebo injections. The negative outcome of this Phase 3 clinical trial, reported by Brainstorm Cell Therapeutics, is another setback for efforts to develop effective treatments against the progressive and fatal nervous system disorder.

Brainstorm hopes that a sliver of data from its study, suggesting a possible benefit from NurOwn for ALS patients with less severe disease, might be good enough to secure an FDA approval. ALS experts told STAT, however, that Brainstorm’s best hope for NurOwn is probably to run another clinical trial.

Investors cast their own skeptical verdict, slashing the company’s stock price by 66%.

Read more.

The SEC has noticed all those pre-planned stock sales

Below the unreservedly good vaccine news from Moderna and Pfizer is the slightly more complicated fact that company executives sold millions of shares as their stock prices soared. And with so much scrutiny on those pre-planned sales, the head of the SEC believes there should be a “cooling-off period” between trades.

Jay Clayton, speaking at a Senate hearing yesterday, advocated for a change to SEC rules that would force executives to wait a matter of months between setting up a trading plan and actually selling stock.

That might have saved Pfizer last week’s PR headache, which stemmed from CEO Albert Bourla’s planned sale of $5.6 million worth of shares. That was done under a plan set up in August, according to SEC records, meaning it might have been impossible under revised rules. But Clayton’s proposal wouldn’t appear to affect Tal Zaks, the Moderna chief medical officer who makes about $1 million a week selling company shares. His trading plan took effect in March, according to SEC filings.

First criticism of the EUA process, and then reform

The FDA has been intensely criticized over some of the emergency use authorizations it has issued during the Covid-19 pandemic — including, most notably, the now-revoked EUA for hydroxychloroquine.

A government watchdog report issued yesterday found the agency has failed to “uniformly disclose its scientific review of safety and effectiveness data” for emergency use authorization as it does for medicines undergoing the normal review process. That's contributed to waning public confidence in the FDA itself, as STAT's Ed Silverman writes.

Coincidentally, the FDA yesterday pledged to start publicly sharing the reviews of scientific data and other information that they use to grant, revise, or revoke an EUA. Joshua Sharfstein, a former top FDA official, told STAT the move is a step toward transparency. "We’ll have to see what this means in practice, but I do think it’s the right principle," he says.

Read more.

More reads

  • Health systems are using AI to predict severe Covid-19 cases. But limited data could produce unreliable results. (STAT)
  • Regeneron says Roche successfully tested manufacture of COVID-19 drug used on Trump. (Reuters)
  • CEO of biotech group says lawsuits are on the table to stop Trump drug proposal. (The Hill)
  • Biden team ramps up outreach to public health groups. (STAT+)

Thanks for reading! Until tomorrow,

Wednesday, November 18, 2020

STAT

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