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Created with Canva Dreamlab † Following the FDA’s refusal to review Moderna’s investigational mRNA flu vaccine last week, Commissioner Marty Makary faced questions from the U.S. president about the agency’s handling of vaccines. It’s a clear signal that the tension long brewing at the drug regulator has now gone all the way to the top. FDA Commissioner Marty Makary was summoned to the White House two days after the agency refused to review Moderna’s investigational mRNA-based flu vaccine, adding fuel to a fire that has been smoldering at the FDA’s most senior levels since late last year. Like most wildfires, the one currently engulfing the FDA appears to be spreading, from the agency’s lower rungs all the way up to President Donald Trump. Last week, the president “expressed frustration” to Makary over how the agency is handling vaccine issues, Politico reported on Wednesday, citing two people privy to details about the meeting. This, of course, followed the bigfooting of David Kaslow, review director at the FDA’s Office of Vaccines Research, regarding Moderna’s application by Center for Biologics Evaluation and Research (CBER) director Vinay Prasad. Kaslow went as far as to write an internal memo arguing against Prasad’s decision to not even review the application, according to reporting by STAT News . Following Makary’s discussion with Trump, a Type A meeting between Moderna and the FDA was quickly scheduled, which “gave [the FDA] a public way to save face,” Politico reported, citing one of its anonymous sources. The end result was an amended filing , which the FDA accepted on Wednesday. The agency promised a decision on the shot, called mRNA-1010, by August 5. This turn of events solidified a hunch that’s grown as I’ve closely covered Health Secretary Robert F. Kennedy Jr.’s Department of Health and Human Services. It’s now become abundantly clear that much of the FDA controversy revolves around one person: Vinay Prasad. FDA Moderna’s Outright Flu Refusal Just the Latest Case of Crossed FDA Signals The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is part of a larger communications crisis unfolding at the agency over the past nine months that has also ensnarled Sarepta, Capricor, uniQure and many more. February 13, 2026 · 6 min read · Heather McKenzie Prasad Involvement ‘Perplexing’ Prasad has been the subject of scrutiny since being named CBER director in May 2025. Jama Pitman, strategic advisor at psychedelic research organization Rose Hill Life Sciences, referred to Prasad’s “colored history with the agency,” despite his relatively short time at the FDA. “He’s been there, he’s not been there, he’s come back,” Pitman reminisced. In June 2025, Prasad reportedly butted heads with Nicole Verdun, the former director of the office that reviews cell and gene therapies, over an application for Capricor Therapeutics’ Duchenne muscular dystrophy (DMD) cardiomyopathy gene therapy. This situation allegedly led to Verdun’s ouster later that month. The next month, Prasad left the FDA following the agency’s controversial handling of Sarepta Therapeutics’ DMD gene therapy Elevidys following multiple deaths linked to the underlying viral vector platform. Ten days later, he was back “at the FDA’s request,” HHS spokesperson Andrew Nixon told STAT News at the time. Prasad’s departure was at the behest of the White House, Politico reported upon his reinstatement, but Makary was a driving force, as he had been in his hire. The two regulators have a long history of publishing articles together, which they continue to do at the FDA. Agency staff reacted to the decision with “incredulousness,” one FDA insider told Politico . Three months later, Prasad was back in the headlines yet again following the drama-filled resignation of former CDER Director George Tidmarsh in early November. Tidmarsh told The New York Times he found the agency to be a toxic work environment—a situation he attributed to Prasad. Fast forward to today and the spotlight on Prasad has not dimmed, nor has it gotten any rosier. He shocked the biopharma industry by personally signing Moderna’s refuse-to-file (RTF) letter, stepping over the deputy regulator who normally would have handled the file. Peter Pitts, president and co-founder of the Center for Medicine in the Public Interest, told me that in the case of Moderna’s RTF, Prasad was “both naive and dangerous, because he’s really impacting the ability for this country to protect itself against very dangerous viruses. Vaccines Moderna’s mRNA Tech Could Boost Flu Shot Efficacy. Americans Will Have To Wait After the FDA’s decision to reject a review of Moderna’s mRNA-1010 flu shot, executives explain what Americans will miss out on as other nations embrace the technology. February 16, 2026 · 3 min read · Annalee Armstrong “It’s almost as though he had a temper tantrum and took all the toys off the table and said, ‘I’m going to handle this, because I know what I’m doing, and you guys are all idiots,” Pitts, former associate commissioner for external relations at the FDA, continued. Then, in the midst of the FDA’s double-reversal on Moderna, The Wall Street Journal reported that the CBER director is the subject of a number of internal complaints. These include “sexual harassment, retaliation against subordinates and verbally berating staff,” WSJ wrote, citing unnamed sources familiar with the matter. The second two allegations are not difficult to believe. In November, Prasad sent a memo to FDA staffers claiming that COVID-19 vaccines were responsible for the deaths of “at least” 10 children. In that same memo, he made it clear that anyone who disagrees with his “core principles”—such as keeping the debate private within the FDA—was free to resign. Prasad also recently made a surprise appearance in the review of a drug application with CBER’s sister agency, where he doesn’t hold jurisdiction, rejecting Disc Medicine’s bitopertin despite that application having gone through CDER. Prasad had previously expressed skepticism in December about the efficacy of the rare disease drug. “This is becoming a thing now with him. It’s a little perplexing,” Pitman said. “I don’t know what he’s trying to do, quite frankly, because it’s not a good look for the agency; it’s not a good look for him.” Leading members of Congress have also grown frustrated with “unnecessary bottlenecks” in the FDA’s operations. On Wednesday, Sen. Bill Cassidy (R-LA), chairman of the Senate’s Health, Education, Labor and Pensions Committee, published a report in which he said the FDA’s review processes can be a “black box.” Pitts called on Makary to “intercede.” “[Prasad] single-handedly is setting back President Trump’s healthcare agenda and leaving the United States at great risk for having increasingly high rates of nonvaccinated men, women and children,” Pitts said. “This guy needs to be fired.” An Ongoing Saga Turmoil at the top of FDA is nothing new under Health Secretary Kennedy. Senior Trump administration officials have taken issue with Makary’s management style, according to reporting from The Wall Street Journal in November, to the point where Kennedy even considered limiting Makary’s role, bringing someone else on to lead the FDA while the surgical oncologist remained as a figurehead. FDA insiders and analysts saw agency stalwart Richard Pazdur’s appointment as CDER director in November 2025 as a stabilizing force for the turbulent agency. But Pazdur’s acceptance of the role allegedly hinged on Prasad. Makary courted Pazdur diligently, spending hours at the oncologist’s house, attempting to assure him that he would have autonomy and independence from the CBER director, Endpoints News reported in November. A few weeks after Pazdur agreed to step up, however, he announced his retirement. “I was thrilled when Rick Pazdur came up for CDER,” said Pitman, who previously served as chief development officer at Deciphera Pharmaceuticals. “That lasted literally a month.” FDA Makary Got His Man in Pazdur—But Can He Last as CDER Director? A week into his tenure as head of the FDA’s Center for Drug Evaluation and Research, experts agree that Rick Pazdur is the “ideal fit” to stabilize the agency. And, according to one ex-FDA official, if his CBER counterpart Vinay Prasad tries to supersede Pazdur’s authority, “there will be hell to pay.” November 18, 2025 · 6 min read · Heather McKenzie Pazdur this month went on record that he left after being pressured to support the agency’s move to reduce the number of pivotal trials required for a drug application. “All of a sudden, I was given a press release with a quotation by myself written in it, and asked to just agree to it,” Pazdur told WSJ on February 13. While previous FDA heads have refrained from getting involved with drug reviews, things have changed under Makary, Pazdur continued. Under his leadership, “this wall between the commissioner’s office and the review staff has been breached.” An HHS spokesperson defended Makary in a statement to WSJ . Makary “leads the agency with a profound sense of urgency in delivering cures to the American people,” they said, adding that regulatory verdicts under the commissioner have “represented the recommendation of each primary review team of career scientists.” But after a 12-month span that has seen five different leaders at CDER and three at the CDC , repeated demands for Kennedy’s removal from office, calls from Congress for FDA reform and midterm elections rapidly approaching, it’s time to ask the question: Are any of these senior HHS officials safe? .responsive-container { display: flex; flex-wrap: wrap; border: 1px solid #ededed; font-family: Helvetica, Arial, Sans-Serif; padding: 20px 20px 10px 20px; } .column-left { flex: 1; max-width: 45%; padding: 20px 20px 10px 20px; } .column-right { flex: 2; padding: 20px 20px 10px 20px; } @media (max-width: 768px) { .column-left, .column-right { max-width: 100%; flex: 100%; padding: 10px 0; } } Subscribe to ClinicaSpace! 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iStock, Tatyana Kim The Advisory Committee on Immunization Practices was supposed to convene next week, but that meeting has been pushed back as the CDC is once again leaderless and FDA’s double-reversal on Moderna’s flu shot highlights continued uncertainty in the vaccine space. A scheduled meeting of the vaccines advisory group for the CDC has been pushed back to next month amid continued instability to the agency’s leadership and mounting controversy surrounding the country’s immunization policies. A spokesperson for the Department of Health and Human Services confirmed the delay in a statement to Fierce Pharma , noting that the agency “will not hold the ACIP [Advisory Committee on Immunization Practices] meeting later this month.” The panel had originally been set to convene from Feb. 26 to 27 . Bloomberg News broke the news Thursday , citing an unnamed source familiar with the matter, who said the meeting was now set for mid-March. The HHS spokesperson did not confirm the rescheduled date, telling Fierce , “Further information will be shared as available.” News of the delay comes just days after HHS Deputy Secretary Jim O’Neill, who had also been acting as a temporary director for the CDC, left the agency . Jay Bhattacharya, head of the National Institutes of Health, has since been named as acting director of the CDC. It also comes amid vaccine drama at the FDA, which this week agreed to review Moderna’s application for its mRNA-based flu vaccine, after last week issuing a surprise refuse-to-file (RTF) letter . FDA Moderna’s Outright Flu Refusal Just the Latest Case of Crossed FDA Signals The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is part of a larger communications crisis unfolding at the agency over the past nine months that has also ensnarled Sarepta, Capricor, uniQure and many more. February 13, 2026 · 6 min read · Heather McKenzie Uncertainty has hung low over the vaccine space since longtime vaccine skeptic Robert F. Kennedy Jr. was confirmed as HHS Secretary just over one year ago, with the ACIP itself serving as a major source of controversy. Kennedy emptied the panel in June last year, claiming that the previous members were acting “as a rubber stamp for industry profit-taking agendas.” The ACIP has since been restacked , with many of its new members sharing Kennedy’s anti-vaccine views. Vaccines ACIP Day 2 Reveals Confusion, ‘Lack of Knowledge,’ on Revamped Committee After a tension-packed two days that saw recommended changes to the MMRV vaccine schedule and COVID-19 vaccine access, as well as a delayed hepatitis B vaccine vote, policy experts expressed concern with the reconstituted committee’s dearth of previous experience and understanding of their role. September 19, 2025 · 5 min read · Dan Samorodnitsky These views have informed the panel’s immunization recommendations. In December last year, for instance, the ACIP recommended delaying infant hepatitis B vaccination to two months after birth. This change, which will only apply to infants who were born to mothers negative for the virus, upends medical practice that has been in place for nearly three decades. The CDC soon adopted these recommendations. Last month, the CDC took an even more drastic action against the childhood vaccination schedule, removing recommendations for six of the 17 shots that had been previously given to kids to protect them from several diseases. The removed vaccines include those for flu, COVID-19 and rotavirus. Many experts have spoken out against these changes to vaccine policy. The American Academy of Pediatrics has even sued Kennedy, the HHS and other health leaders, alleging that their actions expose “vulnerable populations to serious illness with potentially irreversible long-term effects,” according to the July 2025 lawsuit . The case persists after a judge last month denied HHS’ motion to junk the complaint.