Writing in JAMA, four former governmental officials warn that the Trump administration’s involvement in delaying the approval of Novavax’s COVID-19 vaccine could indicate a politicization of the drug approval processes that could ‘imperil public health.’
A group of policy analysts and advocates, all former government officials, are sounding the alarm on the FDA’s actions surrounding the delay and ultimate approval of Novavax’s updated COVID-19 vaccine.
An unusual chain of events led up to the eventual approval of Novavax’s Nuvaxovid. The product was first approved under emergency use authorization (EUA) during the heat of the pandemic in July 2022. In June 2024, Novavax submitted a biologics license application for full approval for an updated version of Nuvaxovid for all individuals aged 12 or older, the same population for which it was authorized under the EUA.
But the FDA missed its target PDUFA date of April 1. At the time, the reasons for the miss were unclear, though later reporting indicated that agency’s principal deputy commissioner Sara Brenner intervened in the review. A few days later, Health and Human Services Secretary Robert F. Kennedy Jr. said the delay reflected HHS’ “shifting [its] priorities to multiple-antigen vaccines.”
An approval came in mid-May—six weeks after the target action date—but was restricted to individuals 65 or older, and those 12 through 64 years with health complications.
In an opinion piece in the Journal of the American Medical Association published June 9, four former government officials write that the drug approval process has become overtly political, using Nuvaxovid as a case study.
The authors list several ways in which the Novavax approval timeline and decision-making process deviated from FDA’s normal procedures. The most significant, they said, was Kennedy and Brenner’s weighing in on the decision.
“Under existing FDA policies, product approval decisions are delegated to the expert staff at the relevant center,” the authors wrote. Commissioners and political appointees do not get involved unless there’s disagreement among the scientific experts, they added.
“Our goal with the paper is to explain to the JAMA audience, and to the public, that the process by which the FDA makes decisions matters. There’s good reason that the FDA has these policies in place where typically these product specific decisions are made by career staff with relevant expertise,” Patricia Zettler, co-author and HHS deputy general counsel from 2023 to 2025, told BioSpace.
“From the start vaccines have been an area of interest for this HHS and FDA leadership team,” Zettler continued. “What we saw happen with Novavax would have been notable regardless of the drug. But it’s concerning that it is a vaccine, given that there’s all this action around vaccines that the science would not support.”
Peter Lurie, co-author and FDA associate commissioner from 2014 to 2017, concurred. “They strayed from the process in an area where the secretary has very specific ideas,” Lurie told BioSpace. “If it’s a harbinger of what’s to come in vaccines or elsewhere, the very integrity of the approval process is at stake.”
Lurie specifically raised concerns about Brenner’s involvement in the Novavax decision, adding that Kennedy at least had indirect involvement in terms of his consistent and vocal opposition to vaccines. “People know full well where he stands on vaccines.”
Administrators stepping into drug approval processes is uncommon even when it comes to contentious decisions. In 2016, for example, former FDA commissioner Robert Califf declined to overturn the approval of Sarepta’s Duchenne muscular dystrophy drug therapy eteplirsen, marketed as Exondys 51, despite Janet Woodcock, director of the Center for Drug Evaluation and Research at the time, overruling three reviewers’ objections.
In explaining his decision to not intervene, Califf wrote, “Given that I do not have technical expertise beyond those already involved in this decision . . . I defer to the judgement of the Center Director.”
The insertion of political actors into the drug regulation process isn’t a left/right matter, Zettler said. Their abstention is the bedrock upon which biomedical research depends, she explained. “The really quite impressive biomedical innovation we’ve had [in the U.S.] is in many ways dependent on the FDA operating as a relatively dependable science-based regulator.”
“We hope that the regulatory process for the Novavax BLA will not prove to be a precedent. If, however, the Novavax BLA represents a new normal process at the FDA, it portends potential trouble ahead for COVID-19 vaccines—and the nation’s ability to weather the upcoming respiratory season,” the JAMA authors—which also include Stephen Cha, counselor to the HHS secretary from 2021 to 2025, and Sarah Despres, a former counselor for public health and science to the HHS secretary from 2021 to 2025—wrote toward the end of their piece. “Beyond vaccines, infusing political considerations and political appointees into individual product decisions imperils public health and innovation.”
Four days later, these words appeared prescient. On June 13, KalVista Pharmaceuticals announced that the FDA had notified the company it would not meet its June 17 PDUFA date for a hereditary angioedema (HAE) drug. According to KalVista, the FDA cited a “heavy workload” and “limited resources” as reasons for the delay. But on June 24, Endpoints News reported, citing “multiple agency sources,” that FDA Commissioner Marty Makary was behind a request to reject the candidate. FDA scientists pushed back, according to the publication, raising legal concerns that such a move would be “arbitrary and capricious,” according to internal messages reviewed by Endpoints.
“We find reports of a push from leadership to issue a CRL for sebetralstat in HAE, without any specific reasons cited, to be bizarre/surprising given the strong data package submitted by [KalVista],” Stifel analysts wrote in a Wednesday note to investors, citing the Endpoints article.
Zettler concurred. “This is the kind of thing we warn about in our paper, and it’s quite troubling to see reports of it happening,” she told BioSpace in a follow-up email. Delegating work to scientific staff and keeping political appointees separate from drug approval decisions, Zettler continued, “help to prevent political interference, giving product developers confidence their applications will get a fair shake based on the scientific evidence.”
