White House chief of staff Mark Meadows blacked the Food and Drug Administration from issuing new federal guidelines on a coronavirus vaccine that would have prevented it from becoming available ahead of the election, The New York Times reports.
The FDA had planned to set tougher standards for an emergency authorization for a coronavirus vaccine, requiring manufacturers to monitor participants in large-scale clinical trials for two months after their second dose. But the White House is blocking their guidelines, forcing to the FDA to seek “other avenues to ensure that vaccines meet the guidelines,” according to the Times.
The FDA is expected to share its standards with an outside advisory committee that will weigh in before any vaccine is authorized in hopes that the committee will enforce the guidelines.
White House undercuts vaccine reassurance:
The White House move comes as top health officials seek to reassure the public about the safety of an eventual vaccine amid rising concerns that it will be rushed to boost Trump’s election chances.
“The public must have full faith in the scientific process and the rigor of F.D.A.’s regulatory oversight if we are to end the pandemic,” a group of biotech firms said in a letter to Health Secretary Alex Azar on Thursday.
The FDA submitted the guidelines to the White House Office of Management and Budget more than two weeks ago but Meadows’ intervention has made their approval “highly unlikely.”
Meadows questioned need for tougher standards:
The big sticking point is that the guidelines would preclude manufacturers from making the vaccine available before the election, though it is not expected to be widely available for more than a year either way.
Meadows raised concerns about the need for follow-up data and suggested that the FDA was overly influenced by career scientists.
FDA officials said the follow-up period was necessary to identify potentially harmful side effects.
“What the commissioner is proposing to put out is public emergency use authorization guidance on a vaccine that would be consistent with letters already sent to the manufacturers,” Azar said Friday. “The F.D.A. has already told the manufacturers what they’re going to look for.”