“There’s no question that the politics of vaccines and the opinions of people in key positions . . . are influencing the outcomes of FDA decisions,” said Chris Meekins, a health care policy analyst at the investment firm Raymond James and former health official in President Trump’s first term. “Clearly the administration believed that the [Moderna] decision was politically problematic. Whether that influences future decisions or not is something we can’t know yet.”
In a statement, Moderna chief executive Stéphane Bancel expressed appreciation for the FDA engaging in a “constructive” high-priority meeting and moving forward on the application.
“Pending FDA approval, we look forward to making our flu vaccine available later this year so that America’s seniors have access to a new option to protect themselves against flu,” Bancel said.
Health and Human Services spokesperson Andrew Nixon said the meeting and discussions with Moderna led to a revised application that was accepted, and the “FDA will maintain its high standards during review and potential licensure stages as it does with all products.”
But the episode nonetheless sent shock waves through the industry, which relies on some predictability from the FDA to support the significant cost of running trials before an application. Moderna warned after the initial rejection that the move could have an impact on more than just vaccine makers.
“This isn’t necessarily something that would only apply in the case of vaccines,” Moderna president Stephen Hoge said on STAT’s ”The Readout LOUD” podcast last week. “Because once you have this kind of instability, it is very hard to invest for the long term, which is what has to happen in the science and innovation industry.”
The FDA’s decision on Feb. 3 to not review Moderna’s vaccine drew fire even in conservative circles when it became public on Feb. 10.
On Monday, the editorial page of The New York Post, owned by Rupert Murdoch’s News Corp, said that one of Trump’s top regulators, Vinay Prasad, who signed the rejection, “is in the process of killing hundreds, maybe thousands, of senior citizens,” given that the flu takes a disproportionate toll on the elderly. It said the rejection reflected “paranoia against mRNA” shots by people who opposed COVID vaccine mandates.
“Americans will die needlessly — unless the White House steps in to control RFK Jr.’s most crazed tendencies and at the very least overrule Prasad,” the editorial said. Prasad heads the FDA’s Center for Biologics Evaluation and Research.
Vaccine criticism has long been a central focus of Health Secretary Robert F. Kennedy Jr. and his allies, who now hold the top health posts in the administration. They have been particularly skeptical of the mRNA vaccines developed by Moderna and Pfizer that were a centerpiece of the first Trump administration’s Operation Warp Speed that brought COVID shots to market astonishingly quickly.
In May, the administration canceled a $766 million contract with Moderna to develop an mRNA vaccine for the bird flu and other viruses that could cause pandemics, despite positive results from an early-stage trial of the vaccine.
In August, Kennedy announced the federal government would no longer fund work on mRNA vaccines, rocking not only Moderna but also a host of biotechs developing mRNA treatments for cancers, cystic fibrosis, and rare diseases. In the announcement, Kennedy claimed, falsely, that “these vaccines fail to protect effectively against upper respiratory infections like COVID and flu.”
His skepticism has been echoed by others in the administration and in the broader antivaccine community around Kennedy, including the secretary’s hand-picked members of a key advisory committee that would ultimately review a Moderna vaccine, if it gets through the FDA evaluation.
Steven Grossman, a longtime FDA policy and regulatory consultant and author of the FDA Matters blog, said the agency’s backtracking on the application is positive, but should not be over-interpreted.
“The fact that FDA decided that they should play it out according to the traditional process rather than fiat is a good sign, but the company is still seeking approval from FDA leadership that appears to have a very strong bias,” Grossman said. “Moderna is back in the game, but the outcome is still very much in doubt.”
Moderna’s entire business model revolves around mRNA, and not just to protect against infections. The company currently has a pipeline of about 20 experimental mRNA vaccines and medicines, including treatments for cancer, cystic fibrosis, and several rare diseases.
While both Pfizer and Moderna harnessed the technology during Operation Warp Speed, they have forged different relationships with Trump and his second administration. While Moderna is focused on mRNA, Pfizer has a range of drugs and products, and was the first to reach a deal with Trump on drug pricing that got a splashy Oval Office announcement, during which Trump and Pfizer CEO Albert Bourla lauded each other and spoke of their friendship. Trump even praised Bourla for his leadership during COVID.
Other vaccine makers with diverse products have reached similar agreements with the administration, receiving perks such as relief from tariffs or priority reviews from the FDA in exchange for pricing and manufacturing pledges. Separately, though, Bourla said in January that he still worries about the “antivaccine” posture of Kennedy and others in the administration.
Moderna, lacking other products to reach such pricing deals, has not had the same access to Trump and, in some ways, has taken a less congenial approach.
At the annual J.P. Morgan Healthcare Conference in San Francisco in January, Moderna’s chairman, Noubar Afeyan, said in multiple interviews that the administration’s antipathy to mRNA vaccines and recommendations of fewer childhood vaccines is an assault on science.
“The politicization of [science] is dangerous because it can go to the heart of what underlies the medical enterprise,” said Afeyan.
Dr. Peter Hotez, director of the Center for Vaccine Development at Texas Children’s Hospital, said the FDA’s original refusal to accept Moderna’s application for the new flu vaccine was undoubtedly political and represented an egregious case of the government “moving the goal posts in the middle of the process.”
“The question is whose politics were they?” said Hotez, citing Kennedy, FDA Commissioner Marty Makary, and Prasad.
“None of the three have expertise in vaccine science, so, yes, there was politics,” Hotez said. “For the FDA to maintain its integrity, it really had no choice but to walk it back.”
Marin Wolf of the Globe staff contributed to this report.
Tal Kopan can be reached at tal.kopan@globe.com. Follow her @talkopan. Jonathan Saltzman can be reached at jonathan.saltzman@globe.com.