California Gov. Gavin Newsom on Monday suggested that the process of finding and obtaining FDA approval for a coronavirus vaccine has become too politicized to trust that the agency will only release a safe and effective vaccine to the public—announcing that he’ll assemble a panel of experts to independently verify that any vaccine is suitable for public use.
Newsom said in a news conference that the state government will not “take anyone’s word for it” when the FDA approves a vaccine.
Like our approach to #COVID19, when it comes to a vaccine, CA will be guided by science.
Today, we announced our Scientific Safety Review Workgroup.
These top health experts will independently review FDA-approved vaccines.
— Gavin Newsom (@GavinNewsom) October 19, 2020
“We will do our own independently reviewed process with our world-class experts that just happen to live here in the state of California,” the governor said. “These experts … will independently review and monitor any vaccine trials to guarantee safety, to guarantee equity, and to guarantee the transparency of the distribution of our vaccines.”
The state’s Scientific Safety Review Workgroup will include 11 epidemiologists, biostatisticians, and other public health experts, Newsom said.
Newsom’s comments came weeks after New York Gov. Andrew Cuomo announced he would also use caution before releasing an FDA-approved vaccine to the public after President Donald Trump indicated he would reject strict FDA guidelines.
“New F.D.A. Rules make it more difficult for them to speed up vaccines for approval before Election Day,” tweeted Trump on Oct. 6, after the agency announced it would require comprehensive safety data about any vaccine undergoing clinical trials before it will grant emergency authorization. “Just another political hit job!”
The White House later approved the new guidelines, but it was not the first time Trump has suggested the FDA should be moving as quickly as possible to approve a vaccine and coronavirus treatments in order to help him secure an election victory in November.
In August the president claimed “the deep state, or whoever” at the FDA was intentionally slowing down the approval process for anti-body rich plasma as a Covid-19 treatment.
Comments like Trump’s “continually raise the specter of political interference with a key agency during a severe public health crisis,” STAT News reporter Ed Silverman wrote at the time. “Who would trust a vaccine that is being rushed out the door just so Trump can say he delivered what everyone wants as soon as possible? His tweets are about his reelection, not our well-being.”
Trump has frequently touted the efforts of Operation Warp Speed, his coronavirus vaccine task force, to ensure the public can be immunized against the coronavirus by the end of 2020 if not by the general election, which is now two weeks away.
FDA officials have pledged not to approve any vaccines that are not proven to be safe and effective in the name of speed, and the CEOs of several pharmaceutical companies currently conducting vaccine trials released a statement in September assuring the public they would “stand with science.”
But judging from recent polls about the public’s willingness to take a coronavirus vaccine with FDA approval, the agency’s credibility has been damaged by FDA Commissioner Stephen Hahn’s overstatement of the benefits of convalescent plasma and by his statement in August that the agency may approve a vaccine before Phase 3 trials are completed.
A poll by the New York Times and Siena College, released Tuesday, found that 33% of respondents would definitely not or probably not take a vaccine with FDA approval, and a survey released Monday by STAT News and Harris found the number of people willing to be immunized right away had dropped by 11% since August.
Newsom said Monday that his government would “maintain our vigilance” regardless of who wins the presidential election, as the governor expects a vaccine to be publicly distributed no sooner than mid-2021.
“We are going to do what California is well known to do and that is to make sure that we have a redundancy and that we maintain our vigilance to have a second set of eyes on the things that are being asserted and the information that’s being provided,” Newsom said.
California state Sen. Richard Pan told the Los Angeles Times that his state will likely not be “not the only one who’s going to be raising a lot of questions,” considering Trump’s approach to the search for a vaccine.
Newsom is “calling for scientists to review data so that people have confidence in the vaccine because unfortunately the president has politicized this and therefore has created a level of distrust,” Pan said.