Marks referred questions to the FDA press office, which stated, “We decline to comment on internal deliberative discussions.”
The disaster that ensued at the White House press conference was bad enough. But the announcement was widely viewed as the prelude to a far more consequential one: the upcoming COVID-19 vaccine. Would the FDA capitulate to President Trump and approve a vaccine before the presidential election, possibly before it was proven safe?
Fighting for his reputation, Hahn reached out to one of his most ardent critics. Just after 6 a.m. on September 3, he cold-called Eric Topol, described the pressure he was under, and admitted that he was facing an “existential crisis.” (Hahn denied using those words.)
Some four months earlier, on April 29, Marks had headed to the White House to pitch his idea for what would become, arguably, the Trump administration’s only pandemic success: the breakneck development of a COVID-19 vaccine. Though Trump shunted responsibility for diagnostic testing and shortages of protective equipment to the states, with dire consequences, he embraced the moonshot vaccine effort. As drug companies raced through clinical trials, delivering that win would all come down to the FDA’s say-so.
Marks, a brilliant though prickly hematologist-oncologist, had envisioned a sweeping partnership between the federal government and private drug companies to develop a number of vaccine candidates simultaneously. A longtime Star Trek fan, he had dubbed the concept Operation Warp Speed. Inside the White House that early spring day, as the administration’s top health officials, including Hahn, crowded into a secure room, Marks sat against the wall until someone gave him their chair. As he briefed the group, Deborah Birx aggressively questioned him, not seeming to understand that he was an FDA official outlining an idea, rather than an operational director unprepared to implement a plan.
As Hahn remained silent, Seema Verma, administrator of the Centers for Medicare & Medicaid Services, came to Marks’s defense, saying, “Deb, you’re out of line. Leave him alone.” Hahn, who still did not join her in defending Marks, leaned over to Verma and said approvingly, “You’re a really good egg.”
Even Azar chimed in, asking Hahn, “Aren’t you going to stick up for your guy?” (Birx did not respond to a request for comment.)
Though Marks emerged shaken from the meeting, his idea was a go. Operation Warp Speed soon got underway, a vast—and secretive—$15 billion program run jointly by the departments of Defense and Health and Human Services, with a management structure that seemed intended to deliver political, and not just pharmaceutical, wins. Jared Kushner and his pandemic wingman Adam Boehler were among the five members of a coordinating committee that oversaw the sprawling effort.
Even with Trump intent on a pre-election vaccine approval, Hahn continued his trips to the White House, as dazzled as a “kid in the candy store,” said a senior HHS official.
At the time the FDA was weighing a plan to preliminarily authorize a COVID vaccine for high-risk groups, such as nursing home residents, before the completion of Phase III clinical trials, Vanity Fair has learned. Using a staged approach, the FDA could have balanced risk against benefit: a less-than-thoroughly vetted vaccine, but one more likely than not to protect the most vulnerable Americans. Then, as more data came in, the FDA could have expanded its authorization to include younger, healthier Americans. But the plan had a paradoxical liability: It might meet Trump’s desired timeline, thereby spooking a public already skeptical about the FDA’s independence. (Though an FDA spokesperson denied that a “staged” approach was ever considered, the agency had initially conveyed to drug companies that it could consider authorization based on interim data, a source familiar with the discussions said.)
As it happened, the convalescent plasma disaster derailed any such plan. On August 31, in an open letter to Hahn in the journal Medscape, where he served as editor in chief, Topol called Hahn “subservient to President Trump’s whims” and wrote, “Tell us…that you will not, under any condition, authorize a SARS-CoV-2 vaccine approval before the full Phase 3 completion and read-out of a program. Otherwise, you need to resign.”
Meanwhile, the crisis was widening inside the FDA. On September 10, the agency’s eight top career officials, who directed its scientific centers, published an op-ed in USA Today, attempting to reclaim their independence and reaffirm that science guided their decisions. “If the agency’s credibility is lost because of real or perceived interference,” they wrote, “people will not rely on the agency’s safety warnings.”
Though Hahn said the officials gave him a heads-up and had his blessing, the piece was a “fuck-you” to the commissioner, said a source familiar with its publication. The FDA was officially at war with itself.
Hahn was forced to take a side. He ultimately joined with the agency’s career officials in their call to fully vet a vaccine, regardless of the political fallout. On September 21, the FDA sent the White House’s Office of Management and Budget new vaccine guidance, calling for drug developers to monitor patients enrolled in their clinical trials for roughly two months after their last shot. It would push any vaccine approval beyond the November election.