Former Vice President Joe Biden said Monday that President Donald Trump must allow the coronavirus vaccine development process to play out "free of political pressure" and called on the president to adhere to three rules as scientists rush to develop one.
Dubbing them the "three principles of integrity" in developing a vaccine, Biden, the presumptive Democratic presidential nominee, demanded that Trump allow scientists and public health experts to make decisions on safety and efficacy — not politicians.
"As we enter the height of election season, President Trump should assure us all that the White House will respect the independent authority of the Food and Drug Administration (FDA) to decide, free from political pressure, if the vaccine is safe and effective," Biden said in a statement.
"The White House should not weigh in on these matters or push the FDA to provide emergency authorizations prematurely, as it did for hydroxychloroquine," Biden said. "The President should not 'hype' treatments or vaccines, overstate their results, or undermine confidence in scientific findings."
Trump repeatedly promoted the antimalarial drug hydroxychloroquine this year as a preventive or curative treatment for the coronavirus, even as evidence piled up that the drug may cause more harm than good. Trump said he had completed a two-week course of the drug, even as the FDA warned against using the drug for COVID-19 outside hospital settings because of a risk of serious heart problems.
Trump also at one point suggested exploring disinfectants as a possible treatment for coronavirus infections — an extremely dangerous proposition that medical experts warned could kill people.
Biden, who said he would follow his guidelines if elected, said that any clinical data for a vaccine approved by the FDA must be made available to the public "for independent expert review" and that the FDA should convene the Vaccines and Related Biological Products Advisory Committee for public session before any final FDA decisions.
In addition, Biden asked Trump for "full transparency on recommendations by career staff."
"The career staff in the Center for Biologics Evaluation and Research should be authorized to write a written report for public review. If the FDA Commissioner decides to reverse the career staff's findings, he must explain the basis of the decision in a public report," Biden said.
Biden added that "senior career scientists and public health experts should be allowed to make public, uncensored statements and appear before Congress unconstrained to speak the truth."
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A top official at the Department of Health and Human Services who says he was ousted from a key pandemic response job for pushing back against demands to sign off on the hydroxychloroquine treatment said last month that he had been retaliated against by the head of the department.
Moderna Therapeutics, a Cambridge, Massachusetts-based biotech company, began the first phase 3 trial of a COVID-19 vaccine candidate in the U.S. on Monday.
CORRECTION (July 27, 2020, 9:40 p.m. ET): An earlier version of this article misstated when a former Department of Health and Human Services official said he was retaliated against for refusing to sign off on using hydroxychloroquine to treat the coronavirus. He made the allegation June 25, not last week.