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Scientists inside the federal government are scrambling to throw up safety measures around coronavirus vaccines as President Donald Trump, bent on reelection and grappling with a failed response to the pandemic, applies mounting pressure on them to push a vaccine out to the public.
The result is an ongoing and unprecedented clash between politics and science during an incredibly consequential time, just weeks before an uncertain election.
On Wednesday afternoon, Moncef Slaoui, head of Operation Warp Speed, the $10 billion public-private partnership to fast-track a coronavirus vaccine, confirmed a proposed FDA measure that could slow down its pace, requiring pharmaceutical companies to provide two months of safety results before candidate vaccines can be authorized for emergency use by the public.
Hours later, Trump, who has repeatedly stated that a vaccine could be ready as early as October, told reporters at the White House that he might overrule the FDA’s precautionary stance. He called the move “political,” a stunning statement to career scientists who don’t work to satisfy a political party but out of public service.
“That has to be approved by the White House,” Trump said of the safety rule, first raised by FDA scientists two weeks ago. “I think that was a political move more than anything else.”
Trump’s threat to the new safety rule — coming after more than 200,000 Americans have died of a virus he has said “will go away” — is the latest turn in a monthslong battle with scientists over vaccine safety. In response to this, New York Gov. Andrew Cuomo announced his state would become the first to independently vet any vaccines waved through by the FDA before it is distributed to New Yorkers.
On Wednesday, top health officials in the Trump administration, led by chief US infectious disease scientist Anthony Fauci and the heads of the CDC and FDA, took the unusual step of pledging to the public that coronavirus vaccines will be vetted without political interference and promising to get the shots themselves.
And on Thursday, the heads of the National Academy of Sciences and National Academy of Medicine took the rare step of denouncing the politicization of science, particularly regarding vaccines. “Any efforts to discredit the best science and scientists threaten the health and welfare of us all,” they said in their statement.
In yet another major sign of the scientific community’s discomfort with Trump’s push for a speedy vaccine, an HHS advisory panel voted unanimously this week to recommend COVID-19 vaccines be approved for the public through the FDA’s “gold standard” licensing process, rather than the emergency avenues now being contemplated.
“Great caution should be exercised,” the panel’s statement read. Any expedited decisions from the FDA should only come with the recommendation of outside expert panels at both that agency and the CDC, the statement added. Those panels typically advise the heads of HHS agencies, though their votes on vaccines are not legally binding. Both advisory groups are scheduled to meet toward the end of October, just ahead of Election Day.
For decades, scientific advisory panels have been the bedrock of safety advice on new drugs given to Americans, said science historian Marcel Chotkowski LaFollette. A face-off between a president and vaccine panel safety experts in an election year is unprecedented, she added, noting that scientists generally avoid getting involved with politics to avoid criticisms of bias.
"Some of the scientists have come to a point where they realize they have to speak out as a matter of life and death," said LaFollette. "It's an in-your-face moment."
Vaccine experts have grown increasingly worried about public acceptance of a coronavirus vaccination shot; polls show the public’s willingness to receive one has fallen, down from 72% in May to 51% in September, according to the Pew Research Center. The heads of all the major makers of candidate vaccines pledged earlier this month to only seek the use of their products after enough safety data is gathered to satisfy the FDA, in another unprecedented move from the pharmaceutical companies. In response to calls for greater transparency, in the last week the frontrunners in the vaccine race released their trial protocols to the public.
Since June, when the FDA revoked its emergency authorization for the drug hydroxychloroquine after pressure to approve it from Trump, vaccine safety experts have warned of the possibility that a similar scenario could play out with a vaccine.
Slaoui confirmed the new safety requirement at a presentation before an external science board advising the US Department of Health and Human Services on Wednesday. Since 90% of health complaints about a new vaccine come in the first 60 days after a shot, Slaoui said, requiring experimental vaccine makers to gather safety data from the midpoints of large-scale trials is a reasonable way to make sure they are safe.
“I’m learning the hard way that politics is very different from ethics,” Slaoui told the HHS panel in response to a question about pharmaceutical firm leaders promising not to release an unsafe vaccine. He added that only pharmaceutical firms could legally request the emergency use of their vaccines, and acknowledged that it is "impossible to predict" when the first coronavirus vaccines might rollout, estimating some time between November and December. "We'll know it when it happens," he said.
Just last week, however, Trump increased concerns about inappropriate political interference in the vaccine approval process by again claiming that one would be ready by mid-October, rebuking CDC Director Robert Redfield’s Senate testimony that most people wouldn’t be able to get a vaccine until next summer.
“Political interference in scientific issues is not new,” science policy expert Albert Teich of George Washington University told BuzzFeed News. “But the willingness of the Trump administration to twist science to serve what the president regards as his interests, and the impact on matters of life and death to the nation and its citizens, is unprecedented.”
During the AIDS crisis, President Ronald Reagan resisted calls for more research funding from Robert Gallo, then the chief of the National Cancer Institute. And the George W. Bush administration enacted blocks on funding of human embryonic stem cell research. But attacks on vaccine safety rules proposed by federal scientists are another level of political intrusion into science.
“The willingness of scientists, inside and outside of government, to speak up in opposition to such interference is vital to the future of the US," Teich added.
Enough doses of the four US coronavirus vaccines now in large trials will be manufactured by the end of the year to vaccinate around 38 million people, according to figures Slaoui released to the panel. That would require all four of the candidate vaccines now in large-scale testing to prove safe and effective by the end of 2020.
CDC official Sara Oliver warned the HHS panel that the first three to six weeks of any vaccine’s rollout are likely to see shortfalls in doses before production ramps up. Both the HHS panel and a similar CDC one that met this week to prioritize who should get the first doses decided to hold off on voting until they had more information on the safety and effectiveness of the candidate vaccines.
“Frankly, if this same process was happening outside of this particular period in the political agenda, then the reactions would be different,” Slaoui said at the end of his presentation, responding to questions about the safety of the candidate vaccines. “I think everybody intervening here needs to keep that in mind.”