Joe Biden said Monday that President Donald Trump should allow the coronavirus vaccine development process to unfold “free of political pressure” and called on the president to adhere to three rules as scientists rush to develop one.
Naming them “the three principles of integrity” in developing a vaccine, the former vice president and presumptive Democratic candidate demanded that Trump allow scientists and public health experts to make decisions about safety and efficacy, not political ones.
“As the heyday of the election season hits, 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 of political pressure, whether the vaccine is safe and effective, Biden said in a statement.
“The White House should not influence these issues or pressure the FDA to provide emergency authorizations prematurely, as they did with hydroxychloroquine,” Biden said in a statement. “The president should not” exaggerate “treatments or vaccines, exaggerate their results, or undermine confidence in the scientific findings.”
This spring, Trump repeatedly promoted the antimalarial drug hydroxychloroquine 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 even completed a two-week course of the drug, even amid FDA warnings against using the drug for COVID-19 outside of hospital settings due to a risk of serious heart problems.
Trump also suggested at some point exploring disinfectants as a possible treatment for coronavirus infections, an extremely dangerous proposition that medical experts warn could kill people.
Biden, who said he would follow the same guidelines if chosen, added that any clinical data for an FDA-approved vaccine should be made available to the public “for independent expert review” and that the FDA should call for Vaccines and related Biologics. Advisory Committee for Public Session Before Any Final FDA Decision
In addition, Biden asked Trump “full transparency in career staff recommendations.”
“Career staff at the Center for Evaluation and Research of Biological Products must 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 for the decision in a public report, “Biden said.
Biden added that “career scientists and public health experts should be able to make uncensored public statements and appear before Congress without restriction to tell the truth.”
Earlier this year, a senior official with the Department of Health and Human Services who says he was kicked out of a key pandemic response job for rejecting demands to sign the hydroxychloroquine treatment the president had recommended, said Thursday that he had retaliated against him. by the head of the department.
Biden’s announcement on Monday came as Moderna Therapeutics, a biotechnology company based in Cambridge, Massachusetts, began the first phase 3 trial of a COVID-19 vaccine candidate in the U.S.
