Operation Warp Speed: Are Bad Vaccine Trial Outcomes Good?

Peter Pitts On Operation Warp Speed: Are Bad Vaccine Trial Outcomes Good?

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"I think the experience of COVID-19 will accelerate the FDA’s initiatives to understand and use 21st-century science going forward," says former FDA Assoc Commissioner Peter Pitts

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Peter Pitts on NBC - LX

While everyone is waiting for a vaccine against Coronavirus, it is important to understand that bad outcomes may happen in vaccine trials. The U.S. Food and Drug Administration evaluates these outcomes before approving a vaccine.

The purpose of clinical trials is to find out what can go wrong with a vaccine before it is administered to millions of healthy people.

Operation Warp Speed

The FDA has retained all the normal standards for approval of a vaccine, including four phases of testing trials, but has dramatically expedited the process in an attempt to shorten the process from years to months.

Peter Pitts

In recent years, the FDA has seen changes meant to speed approvals or allow for bypassing reviews when possible.  Yet, free-market advocates think the agency could do much more.

"I think that the experience of COVID-19 will accelerate the FDA’s initiatives to understand and use 21st-century science going forward," Peter Pitts, president of the Center for Medicine in the Public Interest and a former FDA associate commissioner for external relations recently told David Hogberg of the Washington Examiner. "That includes more aggressive use of real-world data and real-world evidence."

That will mean, according to Pitts, greater incorporation of data from more than just randomized controlled trials, considered the gold standard in medical research. He noted that the recent uproar over convalescent plasma as a treatment for COVID-19 centers around the fact that it was not studied using a randomized controlled trial. The study that was conducted examined over 35,000 patients. Pitts said that the FDA needs to give greater consideration to such studies in its analyses.

"I think we are at an inflection point similar to where the FDA was in the early days of HIV/AIDS," Pitts said. In 1988, the members of the activist group ACT UP protested the slow approval process for AIDS drugs by encircling the FDA building. It was a catalyst for reforms that enabled the FDA to expedite approval of drugs for life-threatening conditions.