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The Food and Drug Administration\u2019s top vaccine official, Dr. Peter Marks, resigned under pressure Friday and said that Health Secretary Robert F. Kennedy Jr.\u2019s aggressive stance on vaccines was irresponsible and posed a danger to the public.<\/p>\n
\u201cIt has become clear that truth and transparency are not desired by the secretary, but rather he wishes subservient confirmation of his misinformation and lies,\u201d Dr. Marks wrote<\/a> to Sara Brenner, the agency\u2019s acting commissioner. He reiterated the sentiments in an interview, saying: \u201cThis man doesn\u2019t care about the truth. He cares about what is making him followers.\u201d<\/p>\n Dr. Marks resigned after he was summoned to the Department of Health and Human Services Friday afternoon and told that he could either quit or be fired, according to a person familiar with the matter.<\/p>\n Dr. Marks led the agency\u2019s Center for Biologics Evaluation and Research, which authorized and monitored the safety of vaccines and a wide array of other treatments, including cell and gene therapies. He was viewed as a steady hand by many during the Covid pandemic but had come under criticism for being overly generous<\/a> to companies that sought approvals for therapies with mixed evidence<\/a> of a benefit.<\/p>\n<\/div>\n<\/div>\n His continued oversight of the F.D.A.\u2019s vaccine program clearly put him at odds with the new health secretary. Since Mr. Kennedy was sworn in on Feb. 13, he has issued a series of directives on vaccine policy that have signaled his willingness to unravel decades of vaccine safety policies. He has rattled people who fear he will use his powerful government authority to further his decades-long campaign of claiming that vaccines are singularly harmful, despite vast evidence of their role in saving millions of lives worldwide.<\/p>\n \u201cUndermining confidence in well-established vaccines that have met the high standards for quality, safety and effectiveness that have been in place for decades at F.D.A. is irresponsible, detrimental to public health, and a clear danger to our nation\u2019s health, safety and security,\u201d Dr. Marks wrote.<\/p>\n Mr. Kennedy has, for example, promoted the value<\/a> of vitamin A as a treatment during the major measles outbreak in Texas while downplaying the value of vaccines. He has installed an<\/a> analyst with deep ties to the anti-vaccine movement to work on a study examining the long-debunked theory that vaccines are linked to autism.<\/p>\n And on Thursday, Mr. Kennedy said on NewsNation that he planned to create a vaccine injury agency within the Centers for Disease Control and Prevention. He said the effort was a priority for him and would help bring \u201cgold-standard science\u201d to the federal government.<\/p>\n An H.H.S. spokesman said in a statement Friday night that Dr. Marks had no place at the F.D.A. if he was not committed to transparency.<\/p>\n<\/div>\n<\/div>\n In his letter, Dr. Marks mentioned the deadly toll of measles in light of Mr. Kennedy\u2019s tepid advice on the need for immunization during the outbreak among many unvaccinated people in Texas and other states.<\/p>\n Dr. Marks wrote that measles, \u201cwhich killed more than 100,000 unvaccinated children last year in Africa and Asia,\u201d because of complications, \u201chad been eliminated from our shores\u201d through the widespread availability of vaccines.<\/p>\n Dr. Marks added that he had been willing to address Mr. Kennedy\u2019s concerns about vaccine safety and transparency with public meetings and by working with the National Academies of Sciences, Engineering and Medicine, but was rebuffed.<\/p>\n \u201cI did everything I possibly could for this administration to work with them in an effort to restore confidence in vaccines,\u201d Dr. Marks said in the interview. \u201cIt became clear that\u2019s not what they wanted.\u201d<\/p>\n Leaving the F.D.A., Dr. Marks added, was a \u201cweight lifted from me, because I was in an environment where it was spiraling deeper and deeper into danger.\u201d<\/p>\n<\/div>\n<\/div>\n Ellen V. Sigal, founder of the advocacy group Friends of Cancer Research and a close ally of Dr. Marks\u2019s, said his \u201cleadership has been instrumental in driving medical innovation and ensuring that lifesaving treatments reach patients who need them most.\u201d His departure, she said, \u201cwill create a significant void.\u201d<\/p>\n Dr. Marks steered the F.D.A.\u2019s vaccine program during the tumultuous years of the coronavirus pandemic, guiding the agency and its outside advisers through a number of decisions about the kind of evidence needed to grant emergency authorization for the vaccines produced under the Trump administration\u2019s Operation Warp Speed initiative, which Dr. Marks helped start up.<\/p>\n In June 2022, he pleaded with a committee of outside experts to consider the danger the virus posed to children younger than 5; the panel voted later that day to recommend vaccines for that age group.<\/p>\n \u201cWe have to be careful that we don\u2019t become numb to the number of pediatric deaths because of the overwhelming number of older deaths here,\u201d Dr. Marks said at the time.<\/a><\/p>\n Dr. Peter Hotez, a vaccine expert from Baylor College of Medicine, said he had spoken with Dr. Marks regularly during the pandemic. \u201cHe was extraordinarily committed to using science to help the American people,\u201d he said. \u201cHe was one of the heroes of the pandemic, so I\u2019m sorry to see him go.\u201d<\/p>\n<\/div>\n<\/div>\n Dr. Marks was viewed skeptically by some at the F.D.A., including former members of his own vaccine team. The two most senior regulators in the agency\u2019s vaccine office resigned in 2021<\/a> in part because of a Biden administration effort to expedite the licensing<\/a> of Pfizer\u2019s coronavirus shot and the authorization of Covid booster shots.<\/p>\n While Mr. Kennedy has been pressing for more study of vaccine injuries, Dr. Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, said such research had already been a priority for decades.<\/p>\n \u201cI fear this is a way to emphasize vaccine injuries in a way that\u2019s completely disproportionate to what the real risk is,\u201d he said.<\/p>\n Dr. Marks clearly shared those concerns. In his letter, he expressed a desire that damage caused by the current administration be limited.<\/p>\n \u201cMy hope,\u201d he wrote, \u201cis that during the coming years, the unprecedented assault on scientific truth that has adversely impacted public health in our nation comes to an end so that the citizens of our country can fully benefit from the breadth of advances in medical science.\u201d<\/p>\n<\/div>\n<\/div>\n