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Science Must Lead: Reaction to FDA Commissioner Opening Door to Authorizing Vaccine Before Completing Phase Three Trials

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August 31, 2020

***For Immediate Release***

FOR IMMEDIATE RELEASE

August 31, 2020

Contact: Kate Stotesbery(link sends email)

202-225-4865

Science Must Lead: Reaction to FDA Commissioner Opening Door to Authorizing Vaccine Before Completing Phase Three Trials

Washington, D.C. – U.S. Representative Lloyd Doggett (D-TX), Chair of the House Ways and Means Health Subcommittee and vocal advocate for science-led development of safe, affordable, COVID-19 vaccines and treatments, reacted to Food and Drug Administration (FDA) Commissioner Stephen Hahn telling the Financial Times(link is external) that "his agency was prepared to authorise a vaccine before Phase Three clinical trials were complete," raising concerns of political interference. Rep. Doggett's statement:

"We cannot afford for Trump to hinder or sidetrack science in developing a safe, effective vaccine. Under the Trump Administration, both the FDA and the CDC appear increasingly to have been guided by political science rather than medical science. This new report that the FDA may follow Russia in authorizing a vaccine before its efficacy and safety have been established in Phase Three clinical trials is very troubling. Once again, FDA Commissioner Hahn seems to be saying that he will not permit Trump to influence his rush to release the vaccine so long as the FDA takes the very action that Trump is urging. While we are all certainly eager for this vaccine as soon as possible, public confidence will be shaken without scientific assurance of a high likelihood of immunity lasting for more than a few months with no harmful side effects.

Meanwhile, the Trump Administration has spent over $10 billion in taxpayer funds to finance the costs of development and manufacture of vaccines and is committing billions more to purchase back the same vaccines it fully financed—with no apparent restraint on the manufacturers' charges to others. And the Administration continues to defy congressional requests and secret its agreements with pharmaceutical companies from public disclosure. Unfortunately, we have no way to immunize against Trump interference and manipulation that has already caused so much unnecessary pain and suffering."

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