FDA deploying 'fast-track' arsenal against COVID-19

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fairly difficult
Food and Drug Administration officials said in July that Pfizer's application for full approval of its COVID-19 vaccine would enjoy "priority review," and set a target deadline for finishing by January 2022.
They beat the deadline easily, licensing the shots in late August. That's faster than other vaccines and drugs that have been marked as priorities for the agency.

Merck's pneumococcal vaccine took six months and its Ebola vaccine took three months, while certain cancer drugs were vetted for four to five months, according to Aaron Lottes, an associate professor of engineering practice at Purdue University who tracks the issue.

For one thing, there was plenty of data available to the FDA on the Pfizer shots, which have been given to tens of millions of people, instead of tens of thousands.

Pfizer and another COVID-19 vaccine maker, Moderna, also have enjoyed "fast-track" status since the summer of 2020, allowing frequent interaction with regulators and real-time submission of data as the FDA deploys all its tools to cope with the pandemic.

Regulators saw data as it rolled in over the course of months, instead of cramming in the mid-summer for the Pfizer approval.

"The fast-track process allows for more frequent communication and discussion with FDA, eligibility for priority review, and eligibility for a rolling review," Mr. Lottes said. "The shorter timeline also reflects the tremendous effort put in by the FDA review team. Based on the urgent need, FDA diverted extensive resources to focus on this review and ensure that safety and effectiveness were thoroughly evaluated while also completing the review as timely as possible."

Drugmakers and the FDA continue to work at a frantic pace as the U.S. tries to wrangle a virus that's killed over 680,000 Americans and mutated into fast-moving forms, prolonging an unprecedented vaccine effort that began with speedy development under the Trump administration.

The situation is forcing drugmakers and regulators to walk a fine line as they pivot from the "warp speed" approval of three vaccines to frenzied work on booster shots and vaccines for school-aged kids — while maintaining faith in the process.

The FDA late…
Tom Howell Jr.
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