California to independently review FDA-approved coronavirus vaccines – Axios
California will “independently review” all coronavirus vaccines approved by the Food and Drug Administration before allowing their distribution, Gov. Gavin Newsom (D) announced at a news conference Monday.
Why it matters: The move could raise further public concern that the federal government could release a vaccine based on political motives, rather than safety and efficacy. Newsom noted the “political polarization” around the issue.
Of note: Newsom said he considered mid-2021 to be a realistic projection for when a vaccine could be publicly distributed.
“No matter who the next president is, we’re going to maintain our vigilance,” he added.
What else he’s saying: “Of course, we don’t take anyone’s word for it,” Newsom said, announcing the establishment of the Scientific Safety Review Workgroup.
“We will do our own independently reviewed process with our world-class experts.
“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 big picture: Faucitold CBS Evening News last week that scientists should know by November or December whether potential COVID-19 vaccines are safe and effective. Vaccine candidates undergoing clinical trials could be widely available by April if this is proven to be the case, he said.
Health officials testified on Capitol Hill in September that the vaccine approval process would be based on safety and efficacy, not politics.
The FDA also stressed in new guidelines last month it would toughen the requirements for a coronavirus vaccine emergency authorization.
The FDA did not immediately respond to Axios’ request for comment.