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A top official from Food and Drug Administration (FDA) has said he will resign if the Trum administration meddles in the affairs of the FDA and approes a vaccine before it is proved to be safe and effectivw for the general public.
Peter Marks, Director of the Food and Drug Administration`s Center for Biologics Evaluation and Research, confirmed to a news agency that scientists, researchers, government officials and executives are worried that the Trump administration will try to rush the process and/or release of the COVID-19 vaccine to have a lead in the upcoming Presidential elections in November.
Also read: Australia locks in coronavirus vaccine deal as new cases ease
The statement came after Marks, on a NIH call with members of its vaccine working group on August 14, reacted to some participants’ questions of whether it was realistic to expect sufficient safety and efficacy data from those trials before the election.
Marks said he can not stand by and see something ineffective — or probably unsafe — being handed out to the general public for a political agenda.
“You have to decide where your red line is, and that`s my red line,” he said. “I would feel obligated (to resign) because in doing so, I would indicate to the American public that there’s something wrong.”
Also read: Can the world overcome vaccine nationalism?
He is not just against Trump administration using the vaccine. Marks established that he would be against anyone using the vacacine for personal or political gains, even if the vaccine was proven to be medicaly safe for public.
Michael Caputo, assistant secretary for public affairs at the Department of Health and Human Services, which oversees FDA and NIH, said the government aims to identify a safe and effective vaccine by January 2021.
Meanwhile, there have been speculations of the FDA approving a vaccine under political pressure for the upcoming November elections. However, Caputo rejected such claims saying, “I’ve never met one FDA regulator who wouldn’t resign over improper pressure, and that’s how America knows their seal of approval is the gold standard.” He added that such speculations “only undermines confidence in the public health system.”
The FDA has scheduled a meeting of its advisory committee of outside experts on coronavirus vaccines on October 22. Marks claimed that the trials were doing well and the data could be available for interpretation by October.
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