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    Biotech Industry Pushes Trump Administration to Release New Vaccine Guidelines

    WASHINGTON — President Trump’s recent suggestion that the White House may not approve stricter criteria for the emergency authorization of any coronavirus vaccine is causing growing angst within the biotech industry, whose trade organization is calling on the Department of Health and Human Services to quickly publish the guidelines and make them available to the public.

    The new guidelines, which have been drafted by experts at the Food and Drug Administration and are subject to White House approval, would set forth specific criteria for clinical trial and safety data, add another layer of caution to the vaccine vetting process. The F.D.A. appeared poised to release them last week, but the process seems stalled since Mr. Trump said last Wednesday that the White House “may or may not” approve the new stricter criteria.

    Now industry officials are worried that the guidelines, which they believe will restore confidence in the vaccine approval process, may never be released.

    “We cannot allow a lack of transparency to undermine confidence in the vaccine development process,” Michelle McMurry-Heath, the president and chief executive officer of the trade group BIO, wrote in a letter sent Thursday evening to Mr. Trump’s health secretary, Alex M. Azar II. “The public must have full faith in the scientific process and the rigor of FDA’s regulatory oversight if we are to end the pandemic.”

    BIO’s members includes many of the major pharmaceutical companies, including all of the coronavirus vaccine makers except AstraZeneca.

    In an interview, Dr. McMurry-Heath, who is also a former F.D.A. official, said she and her members are “deeply concerned,” about the delay, adding, “I know the incredible dedication of the F.D.A. staff but I also know how important it is not to politicize the process. And any sign that the White House — any White House — is interfering in the process will simply erode public confidence.”

    With Mr. Trump insisting a vaccine will be ready before the election, public health experts, government scientists and industry executives have been increasingly trying to reassure the public that no vaccine will be approved unless it is safe and effective. A survey published last month by the Pew Research Center found that 51 percent of Americans would either probably or definitely take a vaccine, down from 72 percent in May.

    There are more than 180 vaccines in development and four have begun the final stage of clinical trials in the United States. Dr. McMurry-Heath said vaccine makers are looking for clarity from the government on what kind of safety and efficacy data will be required before the F.D.A. will consider emergency approval.

    She said members are also concerned that “the political jockeying around the F.D.A.” could lead states to impose their own safety criteria, adding an extra layer of bureaucracy that could delay distribution if officials did not believe the vaccine was safe. In New York, Governor Andrew Cuomo has already said his state would do so.


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