State plans to independently vet COVID-19 vaccine data
California will conduct its own independent review of potential COVID-19 vaccines, signaling its distrust of the Trump administration’s accelerated “Operation Warp Speed” initiative.
To vet a vaccine before distribution to state residents, California Health and Human Services Secretary Dr. Mark Ghaly said Friday that the state will assemble a “review board” of leading scientists at academic institutions to assess the safety and effectiveness of any vaccine candidate.
“We think it is an appropriate approach to take, especially because things are moving so quickly,” Ghaly said. “We want to make sure — despite the urge and interest in having a useful vaccine — that we do it with the utmost safety of Californians in mind.”
The announcement came at a press conference in which Ghaly also expressed concern that California’s coronavirus numbers are beginning to move in the wrong direction after weeks of declines. Based on current trends, he projected an 89% increase in COVID-19 hospitalizations over the next month. That would still be far below hospital capacity and the worst rates in other states.
As of Monday morning, Yolo County was reporting a positivity rating of 3.35%. It has been falling steadily for the past week. If it continues falling or remains stable, then the county could start reopening businesses in another week or so. As for case numbers, there were 2,803 people diagnosed with the virus, which was eight more than the day earlier. In Woodland, there have been 1,188 people diagnosed, which was three more than a day earlier. There have been 55 deaths since the outbreak of the pandemic in March.
On the vaccine testing issue, several other states, including New York, have signaled that they’ll also take the unusual step that Ghaly outlined.
“Frankly, I’m not going to trust the federal government’s opinion, and I wouldn’t recommend to New Yorkers, based on the federal government’s opinion,” New York Gov. Andrew M. Cuomo announced at a Thursday news briefing, according to the New York Times.
President Trump has insisted a vaccine will be ready as early as next month, an assertion that other federal authorities say is unlikely.
California is already building a rollout plan for distribution of the vaccine, including whom to prioritize in the process, said Ghaly.
Led by the state’s Department of Public Health, members of a new Vaccine Task Force include other state agencies, as well as academic experts, community groups and individuals.
Once the state confirms the safety of the vaccine, this task force will advise distribution “in an equitable and smart way, to serve all the needs of Californians,” said Ghaly. “That absolutely is our plan.”
Conflicting information about the timing of the vaccine and whether it will be safe and adequately tested has created growing concern that people are hesitant to take it, despite its importance in stopping the pandemic.
The share of Americans who say they would get vaccinated for the coronavirus has declined sharply since earlier this year, according to a survey conducted this month by the Pew Research Center. About half of U.S. adults (51%) now say they would definitely or probably get a vaccine to prevent COVID-19 if it were available today, down from 72% in May.
Only about 21% said they would definitely get a coronavirus vaccine, half as many as in May.
While it is the federal government’s role to approve a vaccine, states have authority for actual distribution — and could, in theory, reject a vaccine they think is unsafe.
“Each state, indeed, has that sort of responsibility,” said Vanderbilt University’s Dr. William Schaffner, an internist and infectious disease specialist who formerly worked for the U.S. Public Health Service and the Centers for Disease Control and Prevention, at a Sept. 24 National Press Foundation program. “Some may be more ready to independently evaluate the data than others.”
An FDA committee — called the Vaccines and Related Biological Products Advisory Committee comprising 15 authorities selected by the FDA commissioner — reviews the safety and effectiveness data at a public meeting. The FDA commissioner usually follows the committee’s recommendation, but not always.
Typically, states follow the decision of the Advisory Committee on Immunization Practices, or ACIP, an independent committee that assesses data on FDAapproved vaccines and makes recommendations to the CDC.
But there is growing worry that the federal regulators may feel pressure from the White House to activate “Emergency Use Authorization” of an unlicensed vaccine, which would not require completion of a full “Phase 3” trial, during which efficacy is tested in thousands of people.