The lessons of pharmaceutical history

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The lessons of pharmaceutical history

The Trump administration has never been secretive about wanting to develop a vaccine quickly. It called its program to develop a shot Operation Warp Speed.

Still, in recent days, some officials have been talking so aggressively about the timeline to get an inoculation to Americans that a reminder about how hard it is to make new treatments and vaccines can be—and how often such efforts fail—feels in order.

U.S. President Donald Trump said it could be "mid-October on" in terms of when U.S. is prepared to distribute a vaccine.

Photographer: Al Drago/Bloomberg

To deploy a vaccine widely by early next year, many things must go right. One of the vaccines has to work. The vaccine that works has to be one of the handful that are already in late-stage trials. There can't be a major safety concern or delay. Clinical trials have to generate strong evidence. The FDA has to accept that evidence and review it rapidly. Manufacturing must go near perfectly. Hundreds of millions of doses must be delivered around the country, likely with some degree of low-temperature storage requirements.

Getting Americans to take it may also be a challenge. For the 2017-2018 flu season, just 37% of Americans got a vaccine, according to the CDC. And the flu vaccine has been around for decades, and not been anywhere near as much of a political lightning rod.

Earlier this month, the National Academies of Sciences, Engineering, and Medicine published a report summarizing expert recommendations for distributing a vaccine. On page 11, it cites a key lesson from past mass vaccination efforts: "Under-promise and over-deliver."

Having violated the first half of that advice, the best hope now is that the U.S. delivers on the second.—Drew Armstrong

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