Senate Health Committee chair asks Cuomo, Newsom to ‘stop second guessing’ FDA on vaccine efficacy

Sen. Lamar Alexander (R-Tenn.), chairman of the Senate Health Committee, on Saturday issued a call for New York Gov. Andrew Cuomo (D) and California Gov. Gavin Newsom (D) to “stop second guessing” analysis by scientists on the effectiveness of COVID-19 vaccines after the governors announced the creation of their own independent review boards. 

“The career scientists at the FDA set strict standards for safety and efficacy for COVID-19 vaccines,” Alexander said in a press release. “Every day Americans take the word of these scientists’ approval of safety and efficacy when we purchase 3.8 billion prescriptions each year.”

“Undermining the FDA’s gold standard of safety and efficacy by setting up state vaccine review panels could delay approval, discourage Americans from taking the vaccine, and cost lives,” Alexander continued. 

The senator added in his statement that he hopes “these Democratic Governors would instead focus their time and resources on planning to distribute the vaccine, and improving testing and contact tracing with the resources Congress has provided, rather than second guessing the efforts of FDA scientists.”

The statement comes after Newsom announced in a press conference Monday that California is planning to review federally approved coronavirus vaccines independently before distributing them to residents. 

“The question I often get is ‘Are you going to take someone’s word for it?’ Of course, we don’t take anyone’s ‘word for it,'” Newsom said. “We will do our own independently reviewed process with our world-class experts.”

Last month, Cuomo announced plans for a similar New York board that would independently review FDA-approved vaccines. 

Michigan, West Virginia and Washington, D.C., are also in the early stages of creating independent vaccine boards amid concerns that President Trump may be politically interfering with the FDA vaccine approval process as the administration pushes to get a vaccine ready as soon as possible with its Operation Warp Speed. 

However, Alexander said in his statement Saturday that he had urged White House chief of staff Mark Meadows in an October phone call to not interfere with the FDA approval process. 

“The White House did exactly what I had urged,” the senator argued. “They respected those decisions and did not change a word. The governors of New York and California should show the same respect to the FDA career scientists that the White House did.” 

This comes as several pharmaceutical companies are conducting late-stage trials for coronavirus candidate vaccines. 

On Friday, AstraZeneca announced that the FDA had allowed the company to restart its phase three COVID-19 vaccine trial in the U.S. just days after a volunteer in the company’s Brazil trial died. 

Johnson & Johnson also announced on Friday that it is preparing to restart its trial following consultation with the FDA.

The company became the second to pause its trial earlier this month after a person suffered an “unexplained illness,” although it said in a statement that there was “no evidence that the vaccine caused the event.” 

While Trump suggested in Thursday’s presidential debate that a COVID-19 vaccine could be available in a matter of weeks, experts have said one likely will not be available for public use until well into 2021.