Biotech Business Pushes Trump Administration to Launch New Vaccine Pointers

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 an emergency coronavirus vaccine approval is fueling growing fear in the biotech industry, whose trade organization is urging the Department of Health and Human Services to move the guidelines quickly and make them available to the public.

The new guidelines, drawn up by experts from the Food and Drug Administration and subject to White House approval, would set specific criteria for clinical trials and safety data, and add another layer of caution to the vaccine screening process. The F.D.A. appeared ready to release them last week, but the process appears to have stalled as Mr Trump said last Wednesday that the White House "may or may not" approve of the new stricter criteria.

Now industry officials fear the guidelines they believe will restore confidence in the vaccine regulatory process may never be published.

"We cannot allow a lack of transparency to undermine confidence in the vaccine development process," wrote Michelle McMurry-Heath, president and chief executive officer of trading group BIO, in a letter sent to Trump's Health Secretary Alex M. Azar II on Thursday evening The public must have full confidence in the scientific process and the strict supervision of the FDA if we are to end the pandemic. "

Members of BIO include many of the major pharmaceutical companies, including all coronavirus vaccine manufacturers with the exception of AstraZeneca.

In an interview, Dr. McMurry-Heath, who is also a former F.D.A. Officials said she and her members are “deeply concerned” about the delay, adding, “I know the incredible dedication of FDA staff, but I also know the importance of not politicizing the process. And any sign of it, for the White House – any White House – to intervene in the process will simply undermine public confidence. "

With Mr Trump insisting that a vaccine will be ready before the elections, public health experts, government scientists and industry leaders have increasingly tried to reassure the public that a vaccine will not be approved if it is not safe and effective. A poll published last month by the Pew Research Center found that 51 percent of Americans would likely or definitely be using a vaccine, compared with 72 percent in May.

More than 180 vaccines are in development and four have entered final phase clinical trials in the United States. Dr. McMurry-Heath said vaccine manufacturers are demanding clarification from the government about what safety and efficacy data are prior to the F.D.A. will consider emergency approval.

She said members were also concerned that "political jockeying around the F.D.A." could lead states to impose their own safety criteria and add additional red tape that could delay distribution if officials do not believe the vaccine is safe. In New York, Governor Andrew Cuomo has already announced that his state would do so.


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