Several states have announced that they want to independently review a coronavirus vaccine when one becomes available before distributing it to the public.
The initiatives come as state health officials worry if vaccine developers and the Food and Drug Administration alike are dedicated to ensuring a vaccine is safe and effective, despite pressure from the Trump administration to push one out in record speed.
Colorado, California, New York, Washington, Michigan, Oregon, West Virginia, Nevada and the District of Columbia have all said they are planning on analyzing data from the ongoing clinical trials before allowing vaccine distribution within their borders, according to media reports.
A September Gallup poll revealed that Americans’ willingness to receive a COVID-19 vaccine has dropped 11 percentage points — falling to 50% — since earlier polls. There was a previous drop from 66% in July to 61% in August.
Trust in a vaccine has dwindled the most among Democrats, according to the poll, while Republicans have gained some over time.
California Democratic Gov. Gavin Newsom named a group of 11 physician scientists in October who specialize in immunization and public health to “review any vaccine that receives federal approval and verify its safety, before California makes a COVID-19 vaccine available to those most at risk.”
Democrat Andrew Cuomo, governor of New York, also formed “an independent Clinical Advisory Task Force” of health experts to review “every COVID-19 vaccine authorized by the federal government,” he said in a September statement.
“The federal government’s response to COVID and the White House’s dispute with the FDA raises serious questions about whether or not the vaccine has become politicized,” Cuomo said. “Frankly, I’m not going to trust the federal government’s opinion and I wouldn’t recommend (it) to New Yorkers based on the federal government’s opinion.”
Health officials in Tennessee, a historically Republican state, said they are considering a similar independent review of a vaccine when one comes out.
The idea is “not off the table,” Health Commissioner Lisa Piercey said Oct. 28, the Associated Press reported.
Can states vet a vaccine themselves?
Dr. Kelly Moore, associate director of immunization education for the Immunization Action Coalition, told NBC News that states cannot overrule the FDA’s approval of a vaccine, but they can refuse to place orders for vaccines.
That’s because states distribute vaccines through contracts they make with the CDC, Moore told the outlet.
However, residents may still be able to get vaccinated even if their state does not agree it’s safe because private companies like pharmacy chains can still distribute them, global health law expert Lawrence Gostin told NBC News.
The big picture: If states are publicly doubting the federal government’s ability to vet a coronavirus vaccine, experts fear the back and forth might confuse people even more, despite the extra efforts to ensure its safety and efficacy.
Why are some states so hesitant about a COVID-19 vaccine?
Experts’ concerns stem from President Donald Trump’s contradicting claims about a vaccine timeline, one that goes against many of his own public health team’s statements.
During the second and last debate before the Nov. 3 election, Trump said again that a coronavirus vaccine will be ready “within weeks.” He said he doesn’t think his own health officials are “counting on the military the way I do,” McClatchy News reported last week.
Operation Warp Speed, a public–private partnership initiated by the Trump administration, was designed “to produce and deliver 300 million doses of safe and effective vaccines with the initial doses available by January 2021,” according to the U.S. Department of Health and Human Services.
A fact sheet on the initiative says, “rather than eliminating steps from traditional development timelines, steps will proceed simultaneously, such as starting manufacturing of the vaccine at industrial scale well before the demonstration of vaccine efficacy and safety as happens normally.”
“This increases the financial risk, but not the product risk,” the sheet reads.
But vaccine developers and the FDA have promised the public that a vaccine will not be released unless it is safe and effective.
In a “historic pledge,” nine biopharmaceutical companies vowed to ensure that the coronavirus vaccines they develop are safe and effective before submitting them for approval to federal health officials.
“We pledge to only submit for approval or emergency use authorization after demonstrating safety and efficacy through a Phase 3 clinical study that is designed and conducted to meet requirements of expert regulatory authorities such as [the U.S. Food and Drug Administration],” they said in a statement.
New FDA Rules make it more difficult for them to speed up vaccines for approval before Election Day. Just another political hit job! @SteveFDA
— Donald J. Trump (@realDonaldTrump) October 7, 2020
This month, the FDA also announced stricter guidelines for vaccine manufacturers, who it says are required to follow tens of thousands of study participants for at least two months to make sure they catch any safety issues.
This means a vaccine will not be available by the Nov. 1 deadline Trump has been pushing for weeks.