State officials are expressing skepticism about federal reviews of potential COVID-19 vaccines, with some going so far as to plan to independently analyze clinical trial data before distributing a vaccine in a sign of how sharply trust in federal health agencies has fallen this year.
The wariness, which public health experts call highly unusual if not unprecedented, could undercut the goal of a cohesive national immunization strategy and create a patchwork of efforts that may sabotage hopes of containing the coronavirus.
Some red states appear more likely to rely on the Trump administration while blue states may scour the data and be more cautious about vaccinating their residents immediately.
CQ Roll Call contacted state health departments in 50 states and the District of Columbia and received substantive responses from a dozen.
Seven jurisdictions indicated they would analyze the data independently: California, Colorado, the District of Columbia, Michigan, New York, Oregon and West Virginia. Another two — Montana and Wyoming — said they'd only administer a vaccine that completed clinical trials and an outside committee's review. Three states — Arizona, Georgia and Oklahoma — indicated they would accept federal recommendations as usual.
Governors are publicly raising doubts about the Food and Drug Administration and the Centers for Disease Control and Prevention's ability to withstand pressure from President Donald Trump to develop a vaccine with record speed.
“The president says he's going to have a vaccine. CDC is talking about a vaccine in early November. How convenient. It's going to be an Election Day miracle drug,” New York Gov. Andrew Cuomo, a Democrat, said earlier this month.
Cuomo referenced the FDA's emergency use authorization earlier this year of a drug touted by Trump, hydroxychloroquine, which the agency later withdrew after finding the drug was not effective against COVID-19 and could lead to dangerous heart conditions. “Some people are concerned that the vaccine may wind up being hydroxychloroquine," he said, adding that the state health department will review the research before recommending that New Yorkers take any vaccine.
State plans to review the data indicate how deeply any appearance of political meddling could disrupt vaccination and cost lives.
Nearly 200,000 Americans have died of COVID-19, according to the Johns Hopkins University School of Medicine.
Howard Koh, a Harvard T.H. Chan School of Public Health professor and former Obama administration health official, said too much of the pandemic response already varies wildly among states.
“The major challenge has been we’ve had 50 states going in 50 different directions, [with] each state using their own criteria to reopen … even seeing states compete against one another for tests and supplies and PPE. That is not the way to get control of this virus,” he said. “Whenever a vaccine approval occurs, that needs to be accepted by the country, across the country, with implementation as a country.”
Typically, states look to the Advisory Committee on Immunization Practices, or ACIP, an independent committee of medical and public health experts that reviews clinical trial results and advises CDC on vaccines approved by the FDA.
The states' responses to CQ Roll Call "surprised me,” said Vanderbilt University School of Medicine professor Bill Schaffner, an Infectious Diseases Society of America spokesman and nonvoting ACIP member. “The traditional way would be to follow the recommendations of the ACIP. That some states are considering looking at evidence and making decisions that may not conform to those recommendations may be novel.”
“All of the hullabaloo about the FDA potentially cutting corners in the context of a national election has gotten people very concerned,” Schaffner continued. “So some states could be saying, 'Yeah, OK, but show me the data first.’”
The chief medical officer of the Association of State and Territorial Health Officials, Marcus Plescia, said that state health officials are wary of the president’s pledges to make a vaccine available at “warp speed.”
“States are nervous. We’re talking about this now,” he said. “I think that a lot of public health officials in the states are concerned, given the rhetoric from the administration indicating they want a vaccine as quickly as possible. ... That raises their apprehension."
The group is reassuring states that the involvement of ACIP and another independent body, FDA’s Vaccines and Related Biological Products Advisory Committee, will ensure any vaccine is properly vetted.
Plescia said other experts have confirmed that the advisory panels of mostly academics have no vested interest in whether a vaccine is administered.
Political pressure wasn’t a concern in the past, including during the most recent national immunization effort for the H1N1 vaccine a decade ago, Plescia said.
“During that pandemic, the administration and CDC and FDA were more coordinated and on the same page. I think what’s confusing and challenging now is there are a lot of differing opinions coming out of the federal government,” he said.
Claire Hannan, executive director of the Association of Immunization Managers, said states reviewing clinical trial data was very unusual. She said some states may simply closely monitor the recommendations of ACIP and the FDA advisory committee rather than reviewing all the data.
Some states indicated they plan to follow that typical protocol.
The Arizona Department of Health Services’ immunization office “follows all ACIP vaccination recommendations for childhood and adult vaccinations,” department spokesperson Holly Poynter said in an email.
The Wyoming Department of Health indicated its view of a vaccine will depend on the independent panels' review of complete clinical trial results.
“Before we would recommend a vaccine to our residents we will expect it to be recommended by an established and respected independent board or committee following availability of complete data from phase 3 trials,” spokesperson Kim Deti said in an email.
Montana’s public health department similarly indicated that it won't distribute a vaccine without a completed clinical trial.
“Prior to any vaccine, we hope that the safety and efficacy studies will be completed so that the public can have confidence in the vaccine being offered,” department spokesperson Jon Ebelt said in an email. “No major vaccine has completed clinical trials.”
Several states expressed deeper concerns, saying they want the data to be accessible to them.
Michigan’s Department of Health and Human Services typically follows ACIP recommendations, spokesperson Lynn Sutfin said, but will independently analyze this data.
“Before making decisions on the distribution of a COVID-19 vaccine in Michigan, we would need to evaluate the efficacy and safety data regarding any approved vaccine,” she said in an email. “We would hope there would be transparency at the federal level regarding that data so we can make an informed decision.”
A Colorado Department of Public Health and Environment spokesperson echoed that.
“Colorado will review data and information included with any potential vaccine identified for distribution. This will include reviewing an Emergency Use Authorization designation from the FDA and information gained from the clinical trials,” the spokesperson said in an email.
The Oregon Health Authority said in a statement that state health officials will face “difficult decisions” if the federal government cuts corners.
“Any federal action to short-cut established, independent scientific clinical trials, reviews and approvals risks undermining confidence in a COVID-19 vaccine, as well the public’s trust in other vaccines,” the statement reads. “We encourage our federal partners to act responsibly to ensure that only clinically proven COVID-19 vaccines are authorized for production and distribution.”
A divergent approach carries risks, said Jason Schwartz, a Yale School of Medicine assistant professor of public health.
“State-level attempts to review or replace FDA decision-making may be well intended, but would likely do more harm than good, creating confusion and uncertainty that could hinder the deployment of vaccines and their benefits to individuals and communities,” Schwartz said. “There is no substitute for the rigorous, evidence-based, independent assessments of the FDA in ensuring that Covid-19 vaccines are safe and effective.”
It’s rare that ACIP does not recommend an FDA-approved vaccine, but not unprecedented, such as in the case of a Lyme disease vaccine, according to ACIP member Paul Offit, director of the Vaccine Education Center at the Children's Hospital of Philadelphia.
The independent committees advising the CDC and FDA typically review vaccine clinical trial results in public meetings. Their deliberations, materials and votes are open. They are not as vulnerable to political interference as administration officials, according to Amy Pisani, director of the vaccination awareness group Vaccinate Your Family.
“We have faith in the system that is currently used to review safety and efficacy data, including the FDA’s VRBPAC Committee and the CDC’s Advisory Committee on Immunization Practices, and would encourage state leaders who are questioning the administration's speed to focus on supporting this process,” she said.
Koh noted these independent committees were created precisely to minimize political concerns trumping science.
ACIP members also said the potential for involvement by political operatives is low. Any interference by Trump appointees would become very public, the experts said.
“I would be surprised if that could happen,” said Offit. "But these are surprising times."