Health

Scientists Worry About Political Influence Over Coronavirus Vaccine Project


He also said regulators would certify that any vaccine would meet the agency’s rigorous standards, adding, “My job as commissioner is to make sure to the fullest extent possible that any pressure that comes to the agency is not reflected downward” onto regulators and scientists studying the vaccines.

At the same time, a senior administration official refused to promise that any emergency approval of a vaccine would be vetted through the Food and Drug Administration’s outside advisory panel of experts, scheduled to meet on Oct. 22.

Operation Warp Speed got its start in April, the brainchild of Dr. Peter Marks, a pencil-thin, bespectacled physician who leads the regulatory unit at the Food and Drug Administration that approves vaccines and therapies.

A “Star Trek” fan, Dr. Marks named the initiative Warp Speed and pitched it in an April 10 phone call to Alex M. Azar II, the secretary of health and human services, who quickly embraced it. In a follow-up phone call a few days later, according to a person familiar with the discussions, several health officials said the October deadline was unrealistic; over the next few months, officials began publicly citing the end of the year or early 2021 as a target.

With his job on the line, Mr. Azar, the target of Mr. Trump’s wrath over the virus, was especially eager to prove his worth to the White House. He teamed up with Defense Secretary Mark T. Esper, whose department has long experience with vaccine development and distribution to protect troops. An expert in complex logistics, Gen. Gustave F. Perna, became the operation’s chief operating officer.

Mr. Kushner, Dr. Deborah L. Birx, the White House coronavirus coordinator, and others interviewed Dr. Moncef Slaoui, a pharmaceutical industry veteran, and orchestrated his appointment as chief scientific adviser despite concerns within the Food and Drug Administration about conflicts of interest because of his financial ties to two companies that are developing a vaccine. Rather than being bothered by the conflict, Mr. Kushner and others reasoned that it took someone with such industry experience to oversee the effort.



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