by Maryanne Demasi, PhD
In May 2021, Pfizer submitted an application for licensure – or full approval – of its covid-19 vaccine, which only had “emergency use” (EUA) status at the time.
Uptake of the vaccine was slow in the US and a growing chorus of scientists were calling on the FDA to approve the vaccine as a way of combatting vaccine hesitancy.
“The urgency of full approvals cannot be overstated,” wrote Eric Topol, professor of molecular medicine at Scripts Research, in the New York Times.
“The number one thing in the US right now that would help the covid pandemic would be for the FDA to fully approve the Moderna and Pfizer vaccines,” said Shane Crotty, a professor at the La Jolla Institute for Immunology.
To add to the pressure, one of the most visible and wide-reaching consequences of a fully approved vaccine would be the increase in vaccine mandates.
Dozens of jurisdictions, including a pending military mandate on 1.4 million active-duty service members, were waiting on full licensure before instituting a mandate.
Now, internal documents obtained by a freedom of information request, reveal FDA leadership may have sped up approval of the vaccine to aid vaccine mandates.
The speed of the approval process caused friction among top FDA officials and ultimately, two high-profile resignations.
A hyper-accelerated timeline
Tensions between top FDA officials intensified during a meeting on July 19, 2021.
Marion Gruber, then head of the office of vaccines research and review (OVRR), and her deputy Philip Krause, met with Janet Woodcock, acting commissioner, Peter Marks, head of the agency’s Center for Biologics Evaluation and Research, and Julia Tierney, acting chief of staff, to discuss Pfizer’s application.
Two days after the meeting, Gruber penned a long email to Woodcock and Marks, summarising her recollection of the meeting.
Evidently, Gruber felt pressured to speed up the review process, describing Woodcock’s timeline as “hyper-accelerated,” fearing it would backfire.
Gruber advocated for completing the review by Sept 15, 2021, an “already very rapid” target date which would represent a third of the time of a normal licensure application. She said her staff could not compress the review any further, but Woodcock insisted on a faster timeline.
Gruber wrote, “Our concern is that a review that is hyper-accelerated beyond the already very rapid September 15 target date and as a consequence, may be less thorough than our typical review seems more likely to undermine confidence in the vaccine (and, indeed, in FDA’s credibility) than to increase it.”
Gruber outlined some of Woodcock’s concerns, including that “absent a license, states cannot require mandatory vaccination and that people hesitant to get an EUA vaccine would be more inclined to get immunized if the product is licensed.”
Jay Bhattacharya, professor of health policy at Stanford University School of Medicine said, “Full approval of a vaccine requires safety and efficacy testing to a very high standard. It should not be motivated to increase uptake of the vaccine or by a desire for mandates. It sounds to me like the approval was based on arbitrary and inappropriate policy decision-making by FDA leadership.”
“In the end, vaccine mandates were a destructive policy. They did little to boost uptake in the key groups, such as the elderly, and did a lot to harm confidence in vaccines – not just the covid vaccine – but vaccines generally,” said Bhattacharya.
Aaron Siri, attorney at Siri & Glimstad law firm, agreed. “The decision on whether to license a vaccine should not turn on whether it will encourage mandates of that product. Communications among members of the FDA indicate that mandates were a factor in the approval process,” said Siri.
“The FDA needs to act like a regulator, not the marketing arm of the pharmaceutical companies selling these products. The FDA’s promotion of covid-19 vaccines prior to licensure, biased its objectivity in deciding whether to license them,” added Siri, who represents ICAN, a group that fights for transparency and informed consent.
Peter Marks to oversee
Peter Marks was bothered by Gruber’s unwillingness to further compress the review deadline. He emailed Woodcock directly, taking a swipe at Gruber’s integrity.
“I am happy to go on the record here to note that, though I understand the exhaustion that some are feeling, the lack of urgency and responsiveness to the public health imperative to save lives that seems to be felt by some in leadership of the Office of Vaccines is highly disappointing to me,” wrote Marks.
Adding to tensions, Gruber planned to be out of the office temporarily, and wanted her deputy Krause to step in her place – but Woodcock delegated Peter Marks to oversee the approval process instead.
In her memo, Gruber wrote, “I expressed my disagreement with these decisions because standard procedures are for the deputy Office Director to assume an Acting role when the Office Director is out of the office.”
Later, Gruber also wrote directly to Marks. “I am concerned and disappointed about the apparent lack of confidence and trust that Dr Woodcock has in the OVRR team and that she has asked you to verify the information that we have provided to you.”
Political pressure at play
In another internal FDA memo penned by the acting chief of staff, Gruber is said to have raised concerns about “political pressure at play” in FDA regulatory decisions, but Woodcock denied feeling any political pressure.
Bhattacharya said, “It would not surprise me one bit to learn that there was political pressure on the FDA. We know the Biden administration put tremendous political pressure on the CDC, essentially coercing the agency into making decisions in favour of its own policies of closing schools in 2021.”
In fact, a 2022 Governmental Accountability Office report found that agency staff did not report possible political interference due to fear of retaliation and said it “may have resulted in the politically motivated alteration of public health guidance or delayed publication of covid-19-related scientific findings.”
Back in the 1970’s the FDA withheld the delivery of Defoliators to Hospitals over Paperwork Delays and they banned Blue Coloring that cause cancer in lab rats and the stuff was used to make Rat Poison and can anyone remember when they tried to replace the Skull and crossbones Poison warning with hat Mr. Yuck which was nothing but a fake with the tongue out