The U.S. Food and Drug Administration
Jacquelyn Martin | AP
A top US health regulator that will help decide the fate of a coronavirus vaccine has promised to resign if the Trump administration approves a vaccine before it is shown safely and effectively, Reuters has learned.
Peter Marks, director of the Food and Drug Administration’s Center for Biologics Evaluation and Research, made the statement in response to concerns raised at a conference call late last week by government officials, pharmaceutical executives and academics who serve on a working group for faxes organized by the National Institutes of Health, according to three sources familiar with the matter.
When contacted by Reuters, Marks confirmed the account.
Scientists, public health officials and lawmakers are worried that the Trump administration will pressure the FDA to authorize a Covid-19 vaccine ahead of the November presidential election, even if clinical trial data do not support widespread use.
Marks told Reuters he had not faced any political pressure and that the FDA would be led by science alone. Should that change, “I could not keep up and see what was unsafe or ineffective,” Marks said.
“You have to decide where your red line is, and that’s my red line,” he said. “I would feel obligated (to resign), because if I did, I would be telling the American public that something is wrong.”
He added that he would make the same objection if someone sought political gain by keeping approval of a fax that turned out to work, and that was safe.
Michael Caputo, assistant secretary of public affairs at the Department of Health and Human Services, which oversees the FDA and NIH, said the government aims to identify a fair and effective vaccine by January 2021.
Speculation about the FDA approving a vaccine under political pressure “only undermines confidence in the public health system,” Caputo said in a statement. “I have never met a single FDA regulator who would not apologize for invalid pressure, and that is how America knows that its seal of approval is the gold standard.”
The FDA declined to comment at the meeting.
President Donald Trump’s approval ratings have plummeted in the wake of a pandemic that has killed more than 173,000 Americans and infected more than 5.5 million. The race to produce a vaccine has become the focus of his administration’s response.
Earlier this month, Trump said a fax was possible before Nov. 3.
In a statement on Thursday, FDA commissioner Stephen Hahn said that under Marks’ leadership, the agency’s scientists are checking the Covid-19 vaccine tests, “the data will be the deciding factor for any FDA approval.”
Anthony Fauci, the nation’s leading expert, has also said publicly that political considerations will not influence a decision on a coronavirus vaccine.
October surprise?
Large-scale clinical trials of the leading vaccine candidates of Moderna Inc, Pfizer Inc and AstraZeneca Plc were launched in recent weeks.
The FDA has scheduled a meeting of its advisory committee from outside experts on coronavirus vaccines on October 22.
Marks said the subjects enrolled volunteers “reasonably well” and that “possible” data were available to interpret as early as October. If not, the commission could discuss even broader regulatory issues regarding a fax machine, he said.
At the NIH call with members of its working group for faxes on August 14, some participants asked whether it was realistic to expect sufficient data on safety and effectiveness from those trials before the election, sources familiar with the matter said.
The discussion then turned to concerns about a so-called announcement of the surprise in October, in which the Trump administration is set to unveil a fax candidate, the sources said.
At that point, they said, Marks told participants in the call that if the FDA was put under pressure to approve a vaccine without enough evidence that it was safe and effective, he would resign.
“It was pretty dramatic,” said one of the sources. “It was a bold statement.”
Emergency use
The U.S. government has invested nearly $ 11 billion to help develop and produce more than half a dozen coronavirus vaccine candidates. Fauci said the project, called Operation Warp Speed, was able to identify a successful vaccine in January 2021 and deliver tens of millions of doses early in the year.
Marks, a hematologist, has worked at the FDA since 2012 and oversees a division responsible for regulating leading-edge biotech treatments, vaccines and gene therapies.
The Hahn’s commissioner, a political appointee, typically has the power to issue an emergency authorization for a vaccine, speeding up the traditional approval process in situations such as the current pandemic.
Marks is the top FDA scientist involved in the process, accused of making a recommendation about any potential vaccine candidate. The Secretary of Health and Human Services could also overturn any FDA decision, Marks said.
Earlier this year, the FDA granted emergency authorization for hospitals to use malaria drug hydroxychloroquine as a Covid-19 treatment after it was approved by Trump. The agency later withdrew the authorization, after data showed that hydroxychloroquine was of no benefit and could harm some patients.
Hahn, Marks and another FDA official penned an article in the Journal of the American Medical Association this month, acknowledging public fears about lowering regulatory standards to approve a coronavirus vaccine.
“The FDA is committed to ensuring that each vaccine is produced in compliance with all FDA quality standards and that its safety and effectiveness are checked before it is authorized as a license,” she wrote.
Officials also argued that the FDA’s advisory committee for a vaccine should conduct a “transparent discussion” prior to any authorization or license for vaccines.
It is unclear if any of the fax tests will enroll enough subjects and provide significant data for the FDA to check ahead of the U.S. election.
AstraZeneca was able to deliver the first doses of its vaccine to the United States as early as October, “adopting FDA approval of safety and efficacy as authorization for emergency use of the vaccine,” a company spokesman said in a statement to Reuters. He declined to comment on whether AstraZeneca would have enough data to submit to the FDA at that time.
“It is important to remember that – although the data to date have been very encouraging – there is no guarantee that this vaccine will eventually be approved as an emergency use authorization,” the spokesman said.
Pfizer said in a statement that it expects to submit to the FDA as early as October for emergency authorization as “some form of regulatory approval.” Moderna did not immediately respond to a request for comment.
Kathryn Edwards, former chair of the FDA’s advisory committee and scientific director at the Vanderbilt fax research program, said she did not believe the group would strongly allow itself to recommend a candidate if the data were insufficient.
“If it is not done properly, there will be such a tint and cry from the scientific community that it is clearly audible,” she said.
.
