At least five states – California, Nevada, New York, Oregon and Washington – and a Black medical group say they’ll conduct independent verification of any COVID-19 vaccines approved by Food and Drug Administration.
These review panels, which began popping up last month, are meant to instill public confidence and counter the political pall cast over COVID-19 vaccine development and approval. In recent weeks, faith has improved in the FDA’s commitment to base COVID-19 vaccines decisions in science, but the growing number of oversight groups seek to add another layer of trust.
And while some worry the independent review boards may hurt the effort, all agree establishing that trust is vitally important. A survey this month found only 58{b5d304c96e94113bdfc523ff4218a1efff4746200bdb9eeb3214a56a1302f2e4} of Americans said they would get vaccinated as soon as a vaccine became available.
“We would like to give Washingtonians the highest confidence that when a COVID-19 vaccine is available that it’s safe and works,” Washington Gov. Jay Inslee said of the pact.
The first push for oversight outside the FDA came Sept. 21, when the National Medical Association announced it would create an expert task force to review any decisions about COVID-19 vaccines and treatments. The association of Black physicians was founded in 1895 at a time when racism in medical groups excluded Black doctors.
“Questions of political influence on scientific process because of Operation Warp Speed (OWS), have threatened the public trust in the FDA that will adversely affect participation in clinical trials, especially in the African-American community,” the association said in its announcement.
The first state to launch an oversight group was New York, on Sept. 24. At the time there was significant concern in the scientific community the FDA was being pressured by the Trump Administration to approve a vaccine quickly in order to have it available by the presidential election.
It was an expectation President Trump has expressed in tweets, news conferences and during campaign rallies.
“The White House’s dispute with the FDA raises serious questions about whether or not the vaccine has become politicized,” New York Gov. Andrew Cuomo said on Sept. 24.
“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. We’re going to put together our own review committee headed by the Department of Health to review the vaccine.”
The climate around vaccines began to shift on Sept. 8, when vaccine developers issued a public letter vowing to keep politics out of science. Soon after, and defying White House pressure, the FDA stood firm in requiring at least two months of safety data before a vaccine could be considered for release.
Still, last week, California Gov. Gavin Newsom announced the state would create an independent 11-member Scientific Safety Review Workgroup to study the safety of COVID-19 vaccines as an added safeguard to any efforts by the Trump administration to rush the vaccine approval process.
“We don’t take anyone’s word for it,” Newsom said at a news conference announcing the decision. “We will do our own, independently reviewed process with our world-class experts.”
On Tuesday, Oregon, Nevada and Washington, announced they were joining the effort.
“We appreciate the opportunity to join with other western states to help build confidence in a COVID-19 vaccine,” said Richard Whitley, director of the Nevada Department of Health and Human Services.
Problematic but possibly useful
While some experts say the additional verification of FDA decisions may be useful, others worry that at least the state’s well-intentioned efforts could cause harm.
Monica Schoch-Spana, a medical anthropologist and scholar at the Johns Hopkins Center for Health Security, said it makes sense to have input on an approved vaccine from Black physicians because of long-term and systemic racist bias in the health care system.
“These are health care practitioners who understand the historical trauma and contemporary and ongoing systemic bias that their Black patients and their families experience,” she said. Hearing from leaders in their own communities will be helpful.
Ideally, said Schoch-Spana, more voices speaking out about the validity of the process will help restore trust and faith in the FDA, which historically has protected the nation against dangerous drugs and treatments.
“It’s understandable that some jurisdictions have decided to go the extra mile to earn the public’s confidence in the vaccine,” she said. “I see this as having state and other authorities help regain trust and faith in the FDA processes
Added layers of oversight, however, could further undermine FDA’s credibility and public trust in the agency’s decisions, some say. There’s a potential more confusion will be created in people’s minds at a dangerous time when the U.S. is approaching 100,000 new COVID-19 cases a day, said Sandra Crouse Quinn, senior associate director of the Maryland Center for Health Equity.
“I understand they’re trying to address a concern that this has been a political process, that it has undermined trust for many people, especially communities of color whose trust has been lower already,” she said. “But I’m not sure this is the way to go about it.”
It’s important to remember the FDA is a world-class agency that has shown it won’t bow to politics, said Lois Privor-Dumm at the Johns Hopkins Bloomberg School of Public Health, where she is director of the adult vaccine program at the International Vaccine Access Center.
“They didn’t bend to pressure to accelerate approval before elections, which is a good thing,” she said. “They’ve brought together independent experts to review this.”
The big question is what happens if any of these review boards say they do not support the release of a given vaccine.
“States don’t have the authority to say they’re going to license or not license in their state, so it’s not clear to me what they would do if they were hesitant,” Quinn said. “Would they say, ‘We won’t accept this vaccine no matter what FDA does?”
The hope, she added, is the groups will endorse the FDA’s findings as sound and spread the word.
“They’d say, ‘We trust the FDA, but let’s trust and verify. Now we’ve verified and we’re ready to go.'”
