Trump’s Vaccine Rush vs. the FDA: Inside Stephen Hahn’s “Existential Crisis”

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Whether or not Hahn opened the FDA’s door to political interference, the White House has been running through it. As the New York Times reported on Tuesday evening, President Trump, his chief of staff, Mark Meadows, and his son-in-law and special adviser, Jared Kushner, have all called Dr. Hahn directly, urging him to accelerate emergency authorization of vaccines and treatments.

A senior administration official told Vanity Fair, “No one has pressured the FDA to rush through an approval. They have all just noted the urgency of the situation and encouraged FDA to work expeditiously.” White House spokesperson Sarah Matthews said the administration has done everything it can to streamline the vaccine-approval process “while ensuring it is fully backed by the science.”

For medical and public health experts, nothing has loomed more horribly in the last few months than the prospect that the Trump administration, for purely political reasons, would turn a COVID-19 vaccine into an October surprise, offering a potentially unsafe shot to millions of healthy Americans. Such politicization, they have feared, could feed already-burgeoning vaccine hesitancy, and disrupt ongoing clinical trials of a vaccine that could serve as the only real exit ramp from a devastating pandemic.

In the last few months, as the president and his surrogates have pressed for speed, the FDA’s career scientists have battled back, using abstruse FDA guidances to pharmaceutical companies and acronym-laden advisory committees to build a bulwark against political interference. Their efforts to increase transparency and guarantee safety have tacked several months onto the accelerated timetable. They understand that the stakes could not be higher, as the agency’s actions in the coming weeks will undoubtedly have a global impact. According to notes obtained by Vanity Fair, Dr. Marion Gruber, director of the agency’s Office of Vaccines Research and Review, underscored this point on a group call with the European Medicines Agency on September 24. “What will happen is not entirely foreseeable, but the data submitted,” she said, “will be important for the entire world.”

The drama escalated today in the highly anticipated first public meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee, comprised of more than a dozen independent experts allegedly free of conflicts of interest, assembled to review the FDA’s own assessment standards. The meeting, broadcast publicly, is “landmark,” a vaccine expert formerly with the FDA told me, as it is the first visible demonstration of scientific impartiality, intended to assuage public alarm that the development process is taking place in the shadows.

Stoking the scientific freakout is Operation Warp Speed, $10 billion government program that is essentially unprecedented in modern medicine: a partnership between the Department of Health and Human Services, the Defense Department, and pharmaceutical companies to develop and distribute a COVID-19 vaccine on a previously unheard of timetable.

In the Trump administration’s chaotic response to the coronavirus, which has now infected more than 8 million Americans and killed more than 222,000, Operation Warp Speed stands out as a singular effort actually commensurate with the scale of the crisis. It has funded leading vaccine candidates, including those being developed by Moderna, Novavax, Emergent BioSolutions, Johnson & Johnson, and AstraZeneca. It made an advance purchase of 100 million doses of Pfizer’s vaccine, which is furthest along in the development process. (Both Johnson & Johnson’s and AstraZeneca’s clinical trials have been temporarily paused due to safety concerns.)

Operation Warp Speed has built a distribution infrastructure for a future vaccine and underwritten the building of factories and the manufacturing of millions of doses in advance. For vaccines that don’t win FDA approval, the shots now stockpiled will be discarded. Dr. Jonathan Quick, managing director for pandemic response, preparedness, and prevention at the Rockefeller Foundation, explained to Vanity Fair how remarkable an achievement this has been. If you assembled the world’s vaccine leaders this time last year, he said, and told them to imagine having more than a dozen clinical trials in phase three—typically the final step before approval—eight months into a new pandemic virus, “they would have said, ‘Absolutely not.’… It’s been a stunning achievement.”

On the other hand, the program’s secrecy, as well as President Trump’s bullish comments essentially goading the companies to deliver on his preferred timetable, have fed deep concern that the White House would try to short-circuit the science. With Trump as a vaccine pitchman, public health experts fear the creation of a new generation of anti-vaxxers. As one senior HHS official put it, “All the efforts we have on vaccine confidence and trust are being undermined by him.”

Given the potential perils, caution is in order, said Dr. Paul Offit, co-inventor of the rotavirus vaccine and director of the Vaccine Education Center at the Children’s Hospital of Philadelphia: “The history of drug regulation is built on tombstones.”

Operation Warp Speed was initially conceived of by Dr. Peter Marks, who directs the FDA’s Center for Biologics Evaluation and Research, which oversees vaccine approvals. Marks, a workaholic hematologist-oncologist doctor and Star Trek fan, also came up with its quirky moniker. “The name was meant to capture quickly moving forward with both care and precision,” said an FDA spokesperson.

However, his initial foray into the White House to pitch the program, on April 29, went badly, Vanity Fair has learned. At a meeting held inside a secure room, Marks, who was supposed to present details of his concept for the program, was not even given a chair at the conference table. He sat against the wall until someone gave up their chair for him, according to one attendee. Dr. Deborah Birx, the coronavirus response coordinator for the White House task force, who was there, did not seem to understand that Marks was not the program’s director, but had conceived of it from his post at the FDA. She peppered him with questions regarding operational details that had yet to be resolved, said the attendee.

Also in the meeting, Dr. Robert Redfield, director of the Centers for Disease Control and Prevention, kept bringing up the example of the Manhattan Project, the U.S. government’s top secret program to develop a nuclear weapon during the Second World War, and how it was essentially co-run by an Army general and a scientist. As the attendee recalled, “He had just read a book about the Manhattan Project and liked the idea.”

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