Debate rages over whether FDA should use emergency powers to clear a coronavirus vaccine early

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Thu, 2020-09-03 13:36 — mike kraft

Debate rages over whether FDA should use emergency powers to clear a coronavirus vaccine early Speeding the process could save thousands of lives, but some say it might also make it easier for the White House to push regulators to clear an unproven vaccine before Election Day. Laurie McGinley, Carolyn Y. Johnson Washington Post

A fierce debate has erupted over whether the Food and Drug Administration should use its emergency authority to clear a coronavirus vaccine before it is formally approved — a move opponents warn could pose safety dangers and inflame anti-vaccination sentiment but others say could save thousands of lives by speeding protection from the virus.

With concerns growing about the politicization of the FDA amid a botched White House rollout of the agency’s emergency authorization of convalescent plasma and sharply criticized comments by FDA Commissioner Stephen Hahn, some scientists and bioethicists are demanding the agency forgo use of its emergency authority for a vaccine. They worry its very flexibility, which gives FDA officials broad latitude, could make it easier for the White House to pressure the agency into clearing an unproven vaccine before Election Day, Nov. 3.

Trump’s repeated promise to deliver a safe and effective vaccine this year, “or maybe even sooner,” has become central to his reelection campaign and has sparked concerns in the scientific community in particular that the White House could pressure regulators to cut corners.

A recent report by Morgan Stanley said the most likely timing for data from one or more of the trials is November. But others say it’s possible some results might be available in October if the vaccines prove spectacularly effective and there are enough viral infections in the community to prove the shots are protecting patients who receive them.

The CDC has told state and local health officials to be ready to distribute a vaccine to health-care workers and other high-risk groups as early as Nov. 1 — part of an elaborate planning process happening while clinical trials are underway that has spurred anxieties in some quarters.

“I think it’s extremely critical that we have rigorous evidence of safety and effectiveness supporting a vaccine before the FDA gives its okay,” said Patricia Zettler, a former FDA associate chief counsel who is a law professor at Ohio State University.

Because vaccines, unlike treatments, are given to healthy people, she and others said, they should be held to a higher standard and go through the full approval process, which can take several months. ...

In a letter dated Aug. 26, the nation’s infectious-disease doctors demanded that vaccine safety and effectiveness data be “reviewed by internal, as well as independent experts,” if the agency uses an emergency use authorization process.

The FDA’s emergency use authorization is a temporary approval used to accelerate the availability of medical products during a public health emergency. Since February, the FDA used the power to authorize hundreds of coronavirus tests and a few treatments; it has authorized a vaccine that way only once in its history, in 2005, against anthrax. For months, the agency has said it may use the authority for a coronavirus vaccine if it is safe and sufficiently effective. ...

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