F.D.A. to Launch Stricter Tips for Emergency Vaccine Authorization

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F.D.A. to Release Stricter Guidelines for Emergency Vaccine Authorization

The Food and Drug Administration plans to issue stricter guidelines for the emergency approval of a new coronavirus vaccine soon to add a new level of caution to the review process, even if President Trump continues to contradict his own scientific experts and promise that a vaccine will be available will be next month.

The guidelines, which can be officially released this week if approved by the White House, would set more specific criteria for clinical trial data and recommend reviewing the data before the F.D.A. to be verified by a committee of independent experts. approves each vaccine according to information from several people familiar with the draft.

The guidelines would be the most detailed description of the federal government to date on the course of the vaccine testing process.

With the election only six weeks away, Mr Trump has repeatedly promised that a vaccine will soon solve the nation's problems, even though no vaccine has yet been shown to work. Its own scientific experts continue to contradict his statements, telling Congress that it will likely be by the middle of next year, if not later, before a vaccine is available to most Americans.

The guidelines were developed by a small group of career researchers at the F.D.A. designed and stated that participants in late-stage studies should be followed up for a median of two months after receiving the final dose before an emergency approval can be considered. Two companies with vaccine candidates in active Phase 3 studies – Pfizer and Moderna – require two doses.

Vaccine regulators were concerned that a vaccine might only induce short-term immunity. The two-month threshold would make it easier to predict whether a vaccine can produce long-term responses, said one person familiar with the guidelines.

The draft directive also calls for more thorough safety surveillance with participants who would receive a vaccine under emergency approval. The guidelines call on the sponsor – such as the drug manufacturer or Operation Warp Speed, the federal government's crash vaccination program – to submit such a plan.

They are also calling for at least five cases of serious infections in the placebo group of a vaccine study to assess whether participants who receive the vaccine are at lower risk of more complicated cases of Covid-19 caused by the coronavirus. Since about 10 percent of the cases are severe, this threshold of five cases would correspond to about 50 cases of Covid-19 in the placebo group.

The guidelines recommend standards for the manufacture and testing of vaccines that apply for an emergency permit so that the F.D.A. to determine that a vaccine produced after an emergency approval is as safe and effective as the materials tested in clinical studies.

The Washington Post first reported on the upcoming guidelines. The guidelines have already been adopted by the Ministry of Health and Human Services and have been forwarded to various agencies within the Ministry, including the Centers for Disease Control and Prevention. However, changes may be made before they are published. Such policies are routinely reviewed by the White House Bureau of Administration and Housekeeping.

The agency's vaccine advisory board usually reviews the data in a public meeting before the agency grants approval. However, the procedure is not mandatory. By setting out its expectations in written guidelines, the agency appears to be trying to reassure the American public and, as some experts suggest, stave off potential White House political interference.

In June the F.D.A. said a company would need to demonstrate through randomized clinical trials that its vaccine is safe and at least 50 percent effective in order to qualify for approval. Dr. Hahn has publicly promised that any vaccine will be reviewed by the advisory committee, but it could be overridden by Alex M. Azar II, the Minister of Health or the White House.

The F.D.A.'s efforts to build its credibility have followed several missteps. After the president touted the malaria drug hydroxychloroquine, the agency issued emergency approval for the drug as a Covid-19 treatment, only to reverse the decision three months later due to a lack of evidence of the benefits.

The C.D.C. has also bowed under political pressure, including delaying key scientific reports on Covid-19 after officials loyal to Mr Trump objected to it.

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