Unprecedented vaccine trials on track to begin delivering results

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Fri, 2020-10-23 13:20 — mike kraft

Unprecedented vaccine trials on track to begin delivering results Carolyn Y. Johnson Washington Post

In a matter of weeks, one of the most closely watched human experiments in history will start to report results, with early data on prospective coronavirus vaccines possibly coming this month or next from pharmaceutical giant Pfizer and biotechnology company Moderna.

Amid the turmoil, chaos and misinformation that have defined the U.S. response to the pandemic, progress toward a vaccine, or vaccines, has been steady, reassuring and scientific. Political meddling has so far been largely deflected. Drug companies, working closely with the U.S. government and fueled by an infusion of more than $10 billion of taxpayer money, have developed, tested and scaled up a half-dozen potential vaccines at unprecedented speed.

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

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. ...

The Pfizer and Moderna vaccines could be — albeit with a low probability — approvable in the month of November, when we would have a few single digit million doses of vaccine,” but odds of regulatory clearance rise dramatically in December and January, Moncef Slaoui, the vaccine veteran leading Warp Speed, said in an interview.

If a vaccine is authorized, Slaoui said, the United States will have enough doses to immunize 100 million people with their first dose, including elderly people and front-line workers at high risk, by January....

ALso see: https://news.yahoo.com/moderna-just-finished-recruiting-30-135400190.html