Unprecedented vaccine trials on track to begin delivering results

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And on Thursday, independent advisers to the Food and Drug Administration will convene their first full-day meeting to lay the groundwork for their coming consequential deliberations on whether to recommend specific vaccines for public use. Those votes are not binding, but the FDA typically follows the recommendations of its advisory committees.

“Going from where we were in January and February — where we are going to be hit by this tsunami — to very likely having a vaccine, or more than one vaccine, that is proven safe and effective within a year, is staggeringly impressive, and would only have happened with strong and effective federal action,” said Robert Wachter, the chair of the department of medicine at the University of California at San Francisco.

Wachter has strongly criticized the administration’s response to the pandemic, arguing it has cost tens of thousands of lives. But he called the vaccine effort “nearly flawless” so far — words he said he found difficult to say.

There are no guarantees, of course. No vaccine has yet been proved safe and effective, some trials have been paused, and candidates still may fail. Once a company has gathered what it considers compelling evidence, regulatory review will take a few weeks. Most significant, the challenges of getting successful vaccines to hundreds of millions of people still loom after the science succeeds. So does the job of persuading Americans that vaccines, while powerful tools, are not panaceas and must be regarded as one of several strategies they must use to protect themselves against the novel coronavirus.

Yet Wachter and others say the government’s initiative to speed up vaccines and therapeutics, Operation Warp Speed, may live up to the fantastical moniker plucked from science fiction.

Pfizer, which received a nearly $2 billion preorder of 100 million vaccine doses from the U.S. government, has projected having enough cases of covid-19, the illness caused by the novel coronavirus, among study participants to assess the effectiveness of its vaccine sometime this month and sufficient safety data to seek regulatory clearance by mid-November. Before they authorize a vaccine, regulators will require that the vaccine be at least 50 percent effective, that there be at least five severe cases of covid-19 among people who receive a placebo and that there be at least two months of follow-up on half the study participants.

Backed by about $2.5 billion from the federal government, Moderna is likely to have 53 covid-19 cases among participants by November — enough for a first look at the data — with sufficient safety data available just before Thanksgiving.

AstraZeneca, although its U.S. trial is on pause to investigate a possible adverse reaction, still expects enough data from worldwide trials to determine effectiveness by year’s end. Johnson & Johnson has paused its trial pending an investigation into a potential safety issue. But with a one-dose regimen and 60,000…



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