Two vaccine makers reveal their secret blueprints

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Drug companies making vaccines have been under increasing pressure from independent scientists and public health experts to be more transparent about how they are running their clinical trials.
But none of the nine companies that are testing vaccines in late-stage clinical trials had released detailed blueprints — until today.
Moderna became the first to release detailed protocols for its vaccine trials, and hours later Pfizer followed suit. The disclosures are aimed at addressing growing suspicion among Americans that President Trump’s drive to produce a vaccine before the election on Nov. 3 could result in a product that was unsafe.
Moderna and Prizer revealed how trial participants were selected and monitored, what kinds of problems would prompt the trials to be stopped early, and the evidence researchers would use to determine whether people who got the vaccine were protected from the coronavirus.
AstraZeneca, another leader in the race for a vaccine, did not respond to inquiries about whether it would now disclose its study protocol.
Our reporters are still reviewing Pfizer’s disclosures. Here are a few highlights from Moderna’s:
The blueprint suggests that the first analysis of the trial data may not be conducted until late December, though company officials now say they expect the initial analysis in November. Even so, later analyses in the spring may be needed.
That places the timeline for delivery of the vaccine more in line with the cautionary estimates from many researchers, and stands in sharp contrast to Mr. Trump’s predictions.

Source: The New York Times

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