Within weeks, the Food and Drug Administration is expected to review the safety and efficacy data of what may be the first Covid-19 vaccine in the United States, with hopes of vaccinating some Americans soon after. .
But about half a dozen states and the District of Columbia have provided for an extra layer of scrutiny: committees that would review any vaccine reviewed by the FDA, a step many experts and public health officials deem unnecessary given a federal review process which they describe as meticulous.
The committees – most of which are located in states run by Democratic governors – are in part a response to the Trump administration’s handling of the pandemic and fears that political considerations are influencing vaccine approvals.
“The people of this country do not trust this federal government for this vaccination process,” said Governor Andrew Cuomo of New York in September when announcing his state’s vaccination committee, headed by an award-winning virologist of the Nobel Prize.
The reviews aim to help persuade a hesitant public to get vaccinated once they are approved, several state officials said in interviews. Recent polls show that between a third and a half of Americans are reluctant to be vaccinated against the coronavirus.
But some health officials and experts fear that state reviews may instead create inconsistencies and cast doubt on a crucial tool to stop the global contagion.
Paul Mango, deputy chief of staff for policy at the US Department of Health and Human Services, said state leaders were undermining the expertise of the FDA, which he called “the most rigorous organization in the world “.
“We want shots fired within 24 hours,” Mango said at a press briefing last month for Operation Warp Speed, the federal effort to obtain a vaccine. “Any delay the state wants to impose will be a delay in immunizing its citizens – its most vulnerable citizens. We think it’s actually counterproductive for them to talk about it. “
State officials said they didn’t think they would slow down the vaccinations. They hoped to review clinical trial data once it becomes available, by conducting their reviews alongside the federal government.
It may not even be possible for states to block a vaccine. While they have some authority to control how drugs are dispensed within their borders, three former FDA lawyers have said states would not be able to thwart distribution during a pandemic.
Besides New York, officials from California, Connecticut, West Virginia and the District of Columbia have appointed committees to review coronavirus vaccines proposed for FDA approval. The governors of Nevada, Oregon and Washington have joined California’s efforts, with each state adding a representative to the panel.
Safety and efficacy data will also be reviewed by two independent federal advisory committees of medical experts. A panel advises the FDA; the other offers recommendations to the Centers for Disease Control and Prevention, which establish guidelines and priorities for who should get the vaccine.
“It’s an incredibly rigorous and intense process based on evidence and scientific data,” said Dr. Julie Morita, who has served on the CDC advisory board and is executive vice-president of the Robert Wood Johnson Foundation, an organization philanthropic public health.
Dr Morita said she believed state committees would eventually come to the same conclusions as the federal government, but worried about the lack of consistent messages.
“The last thing we need right now is any kind of miscommunication about recommendations,” she said. “The more everyone is aligned, the better it is for the public.” Dr Morita is now part of President-elect Joseph R. Biden Jr.’s Covid-19 task force.
In an effort to address concerns from state officials, the FDA said last week it would offer information on its verification process and on the basis of any decision to authorize a vaccine.
Dr Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, which reviews vaccines, said he wanted the process to be transparent and welcomed questions from state officials. He also said he felt “buffered” by FDA Commissioner Dr. Stephen Hahn from any White House interference. He added that doctors and FDA researchers who evaluated vaccines were “officials” and “not officials.”
Throughout the pandemic, Mr. Trump and his administration have come under fire for pressuring federal health agencies – including the FDA and CDC – to ease restrictions and speed up approvals for vaccines and unproven treatments, such as hydroxychloroquine.
The White House initially opposed FDA guidelines that called for the collection of comprehensive safety data before the agency issues an emergency clearance for a vaccine. (The guidelines would have made it nearly impossible to get one approved before the election.) Then, in early October, the administration gave in.
Dr Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, said transparency and the FDA guidance had helped allay the fears of many public health experts who felt that “the House Blanche put her thumb on the scales in a very big way.
Now, he said, he was “absolutely confident in the FDA process” and thought state review boards were “absolutely unnecessary.” Last week, he was appointed to Mr. Biden’s coronavirus task force.
State officials have said losing Mr Trump in the election will not alter their overhaul plans. Indeed, the first FDA approvals could fall under Mr. Trump’s watch. Pfizer announced last week that its vaccine, developed with German company BioNTech, appeared to be over 90% effective in early clinical trial data, and Moderna’s vaccine is behind in the development process.
The tension between states and the federal government illustrates increased politicization of vaccines and their approvals, a process commonly accepted by physicians and public health departments across the country.
“It became a bit of a political conversation,” said Dr. Mark Ghaly, California health secretary, in an interview. He said the state’s review was aimed at “giving Californians extra confidence in the system.”
The state committee, appointed in October, still decides on a process, but it plans to evaluate some of the same data used by federal advisory committees, according to Dr. Arthur Reingold, chairman of the group.
Dr Reingold, chief of epidemiology at the University of California, Berkeley School of Public Health, served on the CDC advisory board less than two years ago and said he had “the utmost respect” for that.
“We have an unusual set of circumstances and we are trying to respond to those circumstances,” Dr Reingold said. “At the end of the day, these vaccines won’t help us if people don’t accept them.”
Dr Reingold said he believes the group will complete its review quickly, given the experience of its members, some of whom also sit on the CDC’s advisory board.
Likewise, in New York, the state committee would work as quickly as possible, said Gareth Rhodes, a member of Mr. Cuomo’s coronavirus task force and special counsel at the Department of Financial Services.
The group will gather “all the information it needs to confidently make a recommendation to the Ministry of Health,” said Rhodes. This would include reviewing data made public through CDC and FDA advisory groups, as well as obtaining information directly from vaccine manufacturers.
Mr Cuomo, speaking to CNN on Friday, said the goal was to “give people confidence,” adding, “As soon as the FDA approves it, we will ask our panel to approve it.”
In an interview with the New York Times, Mr Cuomo said if his state panel expressed confidence in the vaccine, he would be the first New York resident to receive it and his adult children would be vaccinated on television for reassurance. the public he was sure. .
Earlier today, Trump attacked the scheduled New York exam, saying the state would not receive vaccines when they first deployed across the country.
A rigorous process
Health experts who had been involved in recommending other vaccines said the public had little reason to doubt the approval process, which takes into account full clinical trials conducted by universities and universities. other independent bodies.
Pfizer announced plans to seek emergency clearance from the FDA this month. The request would include two months of follow-up safety data from “phase 3” trials. Phase 3 marks one of the last stages in the development process, when tens of thousands of volunteers get vaccinated and wait to see if they are infected, compared to others who have received a placebo.
These trials are large enough to reveal rarer side effects or more serious problems that may not have appeared sooner. In September, the Pfizer trial had 44,000 participants and no serious safety concerns were reported.
Once the FDA receives an emergency use request, it begins a review of the data and sends a summary of the information to its advisory committee, which eventually makes a recommendation to the agency.
If the FDA clears the vaccine, the CDC’s advisory group meets to decide how the vaccines should be used and allocated.
In interviews, members from several states acknowledged the expertise of the committees, stressing that their own assessments would not duplicate.
Officials in West Virginia and the District of Columbia have said their goal is to communicate the safety and effectiveness of a vaccine to the public, not necessarily to approve or deny its use.
“We recognize that these institutions have expertise and strengths that we don’t have. It’s not about duplicating that process, ”said Dr. Deidre Gifford, a senior Connecticut public health official and co-chair of his vaccines committee.
Dr Gifford said his group – made up of a dozen doctors and governor-appointed health experts – would review the approval process to confirm that it has been typical or as typical as it might be for a pandemic.
One of the main goals is to “reassure the public and the governor that he was free from political interference,” she said.
Dr. Ezekiel Emanuel, professor of medical ethics and health policy at the University of Pennsylvania and a member of Mr. Biden’s coronavirus team, described the state journals as “a symbol of total disruption confidence in the process, ”and said they didn’t think they’d reveal anything that federal reviews didn’t reveal.
“From a practical standpoint, it probably won’t be that important,” he said. “From a trust point of view, it can be helpful.”
Sheila Kaplan contributed reporting.