Exclusive: Leading FDA official says would resign if agency rubber-stamps an unproven COVID-19 vaccine
Peter Marks, manager of the Food and Drug Administration's Center for Biologics Evaluation and Research, made the statement in reaction to concerns raised on a conference call late last week of police officers, pharmaceutical executives and professors who serve on a vaccine working group coordinated by the National Institutes of Health, according to three sources knowledgeable about the matter.
Scientists, public health officials and lawmakers are worried that the Trump government will pressure the FDA to authorize a COVID-19 vaccine ahead of the November presidential elections, even if data from clinical trials don't encourage its widespread use.
Marks told Reuters he has not faced any political pressure and the FDA will be guided by science alone. Should this change,"that I could not stand by and see anything that was dangerous or inefficient that was being put through," Marks said.
"You've got to decide where your reddish line is, and that's my red line," he said. "I would feel obligated (to resign) because in doing this, I would indicate to the American public that there's something wrong."
He added that he would equally object if somebody searched political advantage by holding up approval of a vaccine that was demonstrated to work, which was secure.
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 yet another FDA regulator who wouldn't resign over unsuitable pressure, and that is how America knows their seal of approval is the gold standard"
President Donald Trump's approval ratings have fallen sharply in the aftermath of a pandemic that has killed more than 173,000 Americans and infected over 5.5 million. The race to make a vaccine has become the centerpiece of his administration's response.
Earlier this month, Trump said that a vaccine was possible prior to the Nov. 3 vote.
In a statement on Thursday, FDA Commissioner Stephen Hahn reported that beneath Marks' direction, the agency's scientists are monitoring the COVID-19 vaccine trials,"the data from which will be the deciding factor for any FDA approval."
Anthony Fauci, the nation's leading infectious disease specialist, has also said publicly that political factors will not affect any decision on a coronavirus vaccine.
OCTOBER SURPRISE?
Large-scale clinical trials of the top vaccine candidates in Moderna Inc (MRNA.O), Pfizer Inc (PFE.N) and AstraZeneca Plc (AZN.L) were established lately.
The FDA has scheduled a meeting of its advisory committee of outside experts on coronavirus vaccines on Oct. 22.
Marks said the trials were enrolling volunteers"reasonably well" and that it was"possible" data could be available to interpret as early as October. If not, the committee could discuss broader regulatory issues regarding a vaccine,'' he explained.
About the NIH phone with all members of its vaccine working team on Aug. 14, a few participants asked if it was sensible to anticipate adequate safety and effectiveness data from these trials prior to the election, the sources knowledgeable about the matter said.
The discussion then turned to questions about a so-called October surprise statement, in which the Trump administration rushes to unveil a vaccine candidate, the sources said.
At that point, they said, Marks told participants about the telephone that when the FDA were pressured to approve a vaccine with no proof of it being safe and successful, he would resign.
"It was pretty dramatic," one of the sources mentioned. "It was a bold statement."
EMERGENCY USE
The U.S. government has spent nearly $11 billion to help develop and produce more than half a dozen coronavirus vaccine candidates. Fauci has stated the project, dubbed Operation Warp Speed, could determine an effective vaccine by January 2021 and supply tens of millions of doses early in the year.
Marks, a hematologist, has worked in FDA since 2012 and oversees a branch responsible for regulating cutting biotech remedies, vaccines and gene therapies.
The agency's commissioner Hahn, a political appointee, typically gets the capability to issue an emergency authorization to get a vaccine, expediting the standard approval procedure in situations like the present pandemic.
Marks is your top FDA scientist engaged with the process, charged with making a recommendation on any potential vaccine candidate.
Earlier this season, the FDA gave emergency consent for hospitals to utilize malaria drug hydroxychloroquine for a COVID-19 treatment after it was touted by Trump. The agency later withdrew the consent after data revealed hydroxychloroquine was of no benefit and may harm some patients.
Hahn, Marks and yet another FDA official authored an article in the Journal of the American Medical Association this past month imagining public anxiety about lowering regulatory criteria to approve a coronavirus vaccine.
"FDA is committed to ensuring that any vaccine is produced in line with all of FDA's quality standards and that its safety and effectiveness are confirmed before being licensed or licensed," they wrote.
The officials also pledged the FDA's vaccine advisory committee would run a"transparent discussion" in advance of any vaccine consent or permit.
It is uncertain whether any of these vaccine trials will register enough topics and yield significant data for the FDA to review in front of their U.S. election.
AstraZeneca could provide the first doses of its vaccine to the United States when October,"imagining FDA approval of efficacy and safety or emergency use consent of the vaccine," a company spokesman said in a statement to Reuters. He declined to address if AstraZeneca would have enough data to submit to the FDA by then.
"It is very important to remember that -- although the data so much is definitely encouraging -- there is not any guarantee that this vaccine will ultimately be approved or given an emergency use authorization," the spokesman said.
Pfizer said in a statement that it expects to file with the FDA for emergency consent or"any form of regulatory approval" as early as October.
Kathryn Edwards, former chairwoman of the FDA's vaccine advisory committee and also scientific director in the Vanderbilt Vaccine Research Program, said she does not believe the group would allow itself to be strong-armed into urging a candidate if the information is insufficient. "If it isn't done right, there will be such a hue and cry from the scientific community that it will be clearly heard," she said.
Scientists, public health officials and lawmakers are worried that the Trump government will pressure the FDA to authorize a COVID-19 vaccine ahead of the November presidential elections, even if data from clinical trials don't encourage its widespread use.
Marks told Reuters he has not faced any political pressure and the FDA will be guided by science alone. Should this change,"that I could not stand by and see anything that was dangerous or inefficient that was being put through," Marks said.
"You've got to decide where your reddish line is, and that's my red line," he said. "I would feel obligated (to resign) because in doing this, I would indicate to the American public that there's something wrong."
He added that he would equally object if somebody searched political advantage by holding up approval of a vaccine that was demonstrated to work, which was secure.
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 yet another FDA regulator who wouldn't resign over unsuitable pressure, and that is how America knows their seal of approval is the gold standard"
President Donald Trump's approval ratings have fallen sharply in the aftermath of a pandemic that has killed more than 173,000 Americans and infected over 5.5 million. The race to make a vaccine has become the centerpiece of his administration's response.
Earlier this month, Trump said that a vaccine was possible prior to the Nov. 3 vote.
In a statement on Thursday, FDA Commissioner Stephen Hahn reported that beneath Marks' direction, the agency's scientists are monitoring the COVID-19 vaccine trials,"the data from which will be the deciding factor for any FDA approval."
Anthony Fauci, the nation's leading infectious disease specialist, has also said publicly that political factors will not affect any decision on a coronavirus vaccine.
OCTOBER SURPRISE?
Large-scale clinical trials of the top vaccine candidates in Moderna Inc (MRNA.O), Pfizer Inc (PFE.N) and AstraZeneca Plc (AZN.L) were established lately.
The FDA has scheduled a meeting of its advisory committee of outside experts on coronavirus vaccines on Oct. 22.
Marks said the trials were enrolling volunteers"reasonably well" and that it was"possible" data could be available to interpret as early as October. If not, the committee could discuss broader regulatory issues regarding a vaccine,'' he explained.
About the NIH phone with all members of its vaccine working team on Aug. 14, a few participants asked if it was sensible to anticipate adequate safety and effectiveness data from these trials prior to the election, the sources knowledgeable about the matter said.
The discussion then turned to questions about a so-called October surprise statement, in which the Trump administration rushes to unveil a vaccine candidate, the sources said.
At that point, they said, Marks told participants about the telephone that when the FDA were pressured to approve a vaccine with no proof of it being safe and successful, he would resign.
"It was pretty dramatic," one of the sources mentioned. "It was a bold statement."
EMERGENCY USE
The U.S. government has spent nearly $11 billion to help develop and produce more than half a dozen coronavirus vaccine candidates. Fauci has stated the project, dubbed Operation Warp Speed, could determine an effective vaccine by January 2021 and supply tens of millions of doses early in the year.
Marks, a hematologist, has worked in FDA since 2012 and oversees a branch responsible for regulating cutting biotech remedies, vaccines and gene therapies.
The agency's commissioner Hahn, a political appointee, typically gets the capability to issue an emergency authorization to get a vaccine, expediting the standard approval procedure in situations like the present pandemic.
Marks is your top FDA scientist engaged with the process, charged with making a recommendation on any potential vaccine candidate.
Earlier this season, the FDA gave emergency consent for hospitals to utilize malaria drug hydroxychloroquine for a COVID-19 treatment after it was touted by Trump. The agency later withdrew the consent after data revealed hydroxychloroquine was of no benefit and may harm some patients.
Hahn, Marks and yet another FDA official authored an article in the Journal of the American Medical Association this past month imagining public anxiety about lowering regulatory criteria to approve a coronavirus vaccine.
"FDA is committed to ensuring that any vaccine is produced in line with all of FDA's quality standards and that its safety and effectiveness are confirmed before being licensed or licensed," they wrote.
The officials also pledged the FDA's vaccine advisory committee would run a"transparent discussion" in advance of any vaccine consent or permit.
It is uncertain whether any of these vaccine trials will register enough topics and yield significant data for the FDA to review in front of their U.S. election.
AstraZeneca could provide the first doses of its vaccine to the United States when October,"imagining FDA approval of efficacy and safety or emergency use consent of the vaccine," a company spokesman said in a statement to Reuters. He declined to address if AstraZeneca would have enough data to submit to the FDA by then.
"It is very important to remember that -- although the data so much is definitely encouraging -- there is not any guarantee that this vaccine will ultimately be approved or given an emergency use authorization," the spokesman said.
Pfizer said in a statement that it expects to file with the FDA for emergency consent or"any form of regulatory approval" as early as October.
Kathryn Edwards, former chairwoman of the FDA's vaccine advisory committee and also scientific director in the Vanderbilt Vaccine Research Program, said she does not believe the group would allow itself to be strong-armed into urging a candidate if the information is insufficient. "If it isn't done right, there will be such a hue and cry from the scientific community that it will be clearly heard," she said.