Within a few weeks, the Food and Drug Administration is expected to review the safety and efficacy data for what may be the first Covid-19 vaccine in the United States, with the hope of immunizing some Americans soon after.
But about half a dozen states and the District of Columbia have an additional layer of control planned: committees that would review any FDA-approved vaccine, a move many public health experts and officials consider given a state review process they consider meticulous for hold unnecessarily.
The committees – most of them in states led by Democratic governors – are in part a response to the Trump administration’s handling of the pandemic and fear that political considerations would affect vaccine approval.
“The people of this country don’t trust this federal government with this vaccination process,” New York Governor Andrew Cuomo said in September when he announced his state’s vaccination committee, which was headed by a Nobel Prize winner.
The reviews are designed to help convince a reluctant public to take pictures once they are approved, several state officials said in interviews. Recent polls show that between a third and a half of Americans would be reluctant to receive a coronavirus vaccine.
However, some health officials and experts fear that the government reviews could instead lead to inconsistencies and cast doubts about a critical tool to contain global contagion.
Paul Mango, deputy chief of staff for policy at the US Department of Health, said heads of state are undermining the expertise of the FDA, which he called “the world’s toughest organization”.
“We want to be shot in the arms within 24 hours,” Mango said at a press conference last month about Operation Warp Speed, the federal effort to secure a vaccine. “Any delay that the state wants to impose will be a delay in getting its citizens – its most vulnerable citizens – to come. We think it’s counterproductive to talk about it. “
State officials said they didn’t think they would slow down any vaccinations. They hoped to review clinical trial data as soon as it became available and conduct their reviews with the federal government.
It may not even be possible for states to stop a vaccine. While they have some authority to control how drugs are dispensed within their borders, three former FDA attorneys said states could not thwart distribution during a pandemic.
In addition to New York, officials in California, Connecticut, West Virginia, and the District of Columbia have set up committees to review the coronavirus vaccines being offered for FDA approval. Governors in Nevada, Oregon, and Washington have joined the effort of California, with each state adding one representative to the panel.
Safety and effectiveness data are also checked by two independent federal advisory boards of medical experts. A committee advises the FDA; The other provides recommendations to the Centers for Disease Control and Prevention, which set guidelines and priorities for who should receive a vaccine.
“It’s an incredibly rigorous and intense process that is evidence- and science-based,” said Dr. Julie Morita, who served on the CDC’s advisory board and is executive vice president of the Robert Wood Johnson Foundation, a public health philanthropy.
Dr. Morita said she thinks state committees would ultimately come to the same conclusions as the federal government, but was concerned about a lack of consistent news.
“The last thing we need now is any kind of misunderstanding about the recommendations,” she said. “The more everyone is aligned, the better for the public.” Dr. Morita is now a member of the Covid-19 Task Force of President-Elect Joseph R. Biden Jr ..
To address the concerns of state officials, the FDA said last week that it would provide information about its review process and the basis for any decision to approve 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 was told by FDA Commissioner Dr. Stephen Hahn felt “buffered” because of any interference by the White House. He added that FDA doctors and researchers evaluating vaccines are “officials” and “not political candidates”.
During the pandemic, Mr Trump and his administration were criticized for putting pressure on federal health officials – including the FDA and CDC – to relax restrictions and speed up the approval of vaccines and undetected treatments like hydroxychloroquine.
The White House initially opposed FDA guidelines that required the collection of comprehensive safety data before the agency would issue emergency approval for a vaccine. (The guidelines would have made it nearly impossible to get one approved before the election.) Then in early October the government gave in.
Dr. Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, said the FDA’s transparency and guidance had helped allay the fears of many public health experts who believed that “the White House put their thumbs on the scales a very big way. “
Now he is “absolutely confident in the FDA process” and considers the state review committees to be “absolutely unnecessary”. Last week he was appointed to Mr Biden’s coronavirus task force.
State officials have said the loss of Mr Trump in the election will not change their plans for scrutiny. In fact, the first FDA approvals could come under Mr. Trump’s scrutiny. Pfizer announced last week that its vaccine developed with German company BioNTech appeared to be more than 90 percent effective in early data from clinical trials and that Moderna’s vaccine is lagging behind in the development process.
Trust issues
Tensions between states and the federal government show heightened politicization of vaccines and their approvals, a process that is routinely accepted by doctors and health departments across the country.
“This has become a bit of a political conversation,” said Dr. Mark Ghaly, California’s Minister of Health, in an interview. He said the state review was intended “to give Californians additional confidence in the system”.
The state committee named in October is still deciding on a process, but plans to evaluate some of the same data used by the federal advisory boards, said Dr. Arthur Reingold, chairman of the group.
Dr. Reingold, director of epidemiology at the University of California’s Berkeley School of Public Health, served on the CDC’s advisory board less than two years ago and said he had “the greatest respect” for it.
“We have unusual circumstances and we are trying to respond to these circumstances,” said Dr. Pure gold. “Ultimately, these vaccines won’t help us if people don’t accept them.”
Dr. Reingold said he thinks the group will quickly complete its review given the experience of its members, some of whom also serve on the CDC’s advisory committee.
Similarly, the New York state committee would be working ASAP, said Gareth Rhodes, a member of Cuomo’s coronavirus task force and special advisor to the Treasury Department.
The group will “gather all the information they need to safely make a recommendation to the Department of Health,” Rhodes said. This includes reviewing data released through the CDC and FDA advisory groups, as well as obtaining information directly from vaccine manufacturers.
Speaking to CNN on Friday, Mr. Cuomo said the goal was “to give people confidence”, adding, “Once the FDA approves this, our panel will approve it.”
In an interview with the New York Times, Mr Cuomo said that if his state board showed confidence in the vaccine, he would be the first New York City resident to receive it and his adult children would be vaccinated on television for the To ensure public safety.
Earlier that day, Mr Trump attacked New York’s proposed review, claiming that the state would not receive vaccines if they were first introduced across the country.
A strict process
Health experts involved in recommending other vaccines said there was little reason for the public to doubt the regulatory process, which takes into account extensive clinical studies conducted by universities and other independent agencies.
Pfizer has announced that it will be asking the FDA for an emergency clearance this month. The application would include two months of safety data from phase 3 studies. Phase 3 is one of the final steps in the development process, where tens of thousands of volunteers are given a vaccine and wait to see if they get infected compared to others who got a placebo.
These studies are large enough to reveal some rarer side effects or more serious problems that may not have occurred before. As of September, Pfizer’s study had 44,000 participants and no serious safety concerns were reported.
Once the FDA receives an emergency application application, it begins reviewing the data and sends a summary of the information to its advisory committee, which will eventually make a recommendation to the agency.
When the FDA approves the vaccine, the CDC advisory group meets to decide how the vaccines should be used and allocated.
In interviews, members of several states recognized the committees’ expertise and insisted that their own assessments would not be duplicated.
Officials in West Virginia and the District of Columbia said their goal is to make the public aware of the safety and effectiveness of a vaccine, not necessarily to approve or deny its use.
“We recognize that these institutions have expertise and assets that we do not have. It’s not about repeating this process, ”said Dr. Deidre Gifford, Connecticut’s senior public health officer and co-chair of the vaccines committee.
Dr. Gifford said her group – made up of a dozen governor-appointed doctors and health professionals – would review the approval process to confirm that it was typical or as typical as it might be during a pandemic.
One of the main goals is to “reassure the public and the governor that it is free from political interference,” she said.
Dr. Ezekiel Emanuel, a professor of medical ethics and health policy at the University of Pennsylvania and a member of Mr Biden’s coronavirus team, described the state reviews as “a symbol of total loss of confidence in the process” and said he didn’t think they were anything would reveal what the federal exams did not.
“From a practical point of view, it probably won’t be that important,” he said. “It can be helpful from a trust standpoint.”
Sheila Kaplan contributed to the coverage.
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