/California to independently review FDA-approved coronavirus vaccines – Axios

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: 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.
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