A Real Vaccine Before the Election? It'd Take a Miracle.

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This story first appeared at ProPublica. ProPublica is a Pulitzer Prize-winning investigative newsroom. Sign up for The Big Story newsletter to receive stories…
This story first appeared at ProPublica. ProPublica is a Pulitzer Prize-winning investigative newsroom. Sign up for The Big Story newsletter to receive stories like this one in your inbox.

Despite President Donald Trump's promises of a vaccine next month and pundits' speculation about how an "October surprise" could upend the presidential campaign, any potential vaccine would have to clear a slew of scientific and bureaucratic hurdles in record time.

In short, it would take a miracle.

We talked to companies, regulators, scientific advisers and analysts and reviewed hundreds of pages of transcripts and study protocols to understand all the steps needed for a coronavirus vaccine to be scientifically validated and cleared for public use. As you'll see, it's a long shot in 38 days.

There are three key milestones that must be met:

A clinical trial would need to observe enough infections to demonstrate that the vaccine is better than a placebo. Right now, Pfizer's trial is the furthest along. Pfizer has said it expects results by the end of October, but analysts who follow the company aren't so sure it'll be that soon or whether the results will be conclusive. Pfizer would have to turn its trial data into an application to the Food and Drug Administration. The company could either apply for full approval — a very high bar for proving the vaccine is safe, effective and able to be reliably manufactured by the millions of doses — or for an emergency use authorization, which is more flexible. Pfizer has said it could submit its application almost immediately. The FDA has to review the data and decide whether the vaccine is ready to go to market. That could take several weeks to a month, said Dr. Mark McClellan, who led the FDA from 2002 to 2004.

"All of this put together makes it more likely that it'll be a late 2020 availability," McClellan said.

None of this is to say that Trump couldn't suddenly call a White House press conference to try to grab headlines and…
John Light
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