California to independently review FDA-approved coronavirus vaccines
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.
- New York Gov. Andrew Cuomo (D) made a similar announcement last month.
- Newsom's announcement comes days after NAID director Anthony Fauci said he had "strong confidence" in FDA-approved vaccines.
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: Fauci told "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.