WASHINGTON (AP) 鈥� Shortly before he was , the nation鈥檚 says he refused to grant Health Secretary team unrestricted access to a tightly held vaccine safety database, fearing that the information might be manipulated or even deleted.
In an interview with The Associated Press, former Food and Drug Administration vaccine chief Dr. Peter Marks discussed his efforts to 鈥渕ake nice鈥� with and address his about vaccine safety, including by developing a 鈥渧accine transparency action plan.鈥�
Marks agreed to give Kennedy's associates the ability to read thousands of reports of potential vaccine-related issues sent to the government's , or VAERS. But he would not allow them to directly edit the data.
鈥淲hy wouldn鈥檛 we? Because frankly we don鈥檛 trust (them),鈥� he said, using a profanity. 鈥淭hey鈥檇 write over it or erase the whole database.鈥�
Marks spoke to the AP on Sunday, after officials in Texas confirmed the nation's second this year. Marks attributed the death to the tepid response from the U.S. Department of Health and Human Services, which again encouraged the measles, mumps and rubella vaccine on Sunday but has also promoted claims about vitamin A supplements.
During his Senate confirmation hearings, ." But since taking office, he鈥檚 promised to 鈥渋nvestigate鈥� children鈥檚 shots, and agencies under his watch have terminated vaccine-related research, canceled meetings of vaccine advisers and are poised to reinvestigate ties between vaccines and autism 鈥� a link debunked long ago.
Since being sworn in, 鈥淢r. Kennedy has increased the pace by which he intends to minimize the use of vaccines in this country,鈥� Marks said.
An HHS spokesperson said Kennedy has advocated for vaccination multiple times since becoming health secretary and pointed to a Sunday in which he called the vaccine 鈥渢he most effective way to prevent the spread of measles.鈥� But hours later, Kennedy also praised 鈥渆xtraordinary healers鈥� in the Mennonite community who he said were using a drug combination to treat measles. Neither of the drugs has been shown to directly treat the disease, which is a viral infection.
Marks is highly regarded by former FDA leaders and biotech industry executives, but his time at the agency was not without controversy. During the COVID-19 pandemic he was alternately criticized for being 鈥� under Trump鈥� and 鈥� under Biden鈥� to authorize new vaccines and boosters.
Marks says he 鈥渢ried everything鈥� to work with Kennedy. At the center of that effort was a plan to increase publicly available information about vaccine ingredients, safety and side effects.
Marks and his team had hoped to kick off the initiative with a two-day public 鈥渓istening session,鈥� followed by an expert report written by an independent organization, such as the National Academies of Sciences.
Overhauling the VAERS system
The centerpiece of the effort would be a vast overhaul of the VAERS system, maintained by the FDA and Centers for Disease Control and Prevention.
FDA and CDC scientists monitor the database for 鈥減ossible signals鈥� of emerging problems with vaccines. But analyzing the data requires both medical and statistical expertise, because anyone can submit unverified reports of side effects, injuries and death. The public-facing website warns that the data is unverified and may be incomplete or inaccurate. have long been central to and messaging.
Marks notes that government scientists spend hours adjudicating each report of serious injury or death, often by tracking down death certificates and interviewing health providers. It鈥檚 not unusual for investigators to find reports of deaths that were caused by something totally unrelated to a vaccine, like a car crash, or that a death occurred months after vaccination in someone with a serious illness.
Much of that detail is redacted for legal reasons. But Marks said his office was committed to making much more information available.
鈥淭his is a legitimate thing that I actually was willing to compromise on,鈥� Marks said 鈥淲e need to make VAERS more transparent so that people can understand that we actually do the work on the backend.鈥�
Details of Marks' plan were confirmed by a second person with direct knowledge of the matter, who spoke on condition of anonymity because they did not have permission to speak publicly about internal agency matters.
The proposal was sent to FDA鈥檚 acting commissioner, Trump appointee Dr. Sara Brenner, in mid-February, but Marks and his team did not hear back.
By mid-March, Marks' office was fielding multiple requests from Trump administration staffers seeking full access to the VAERS database. In responding to the requests, Marks and his staff emphasized the sensitive nature of the data, which includes confidential personal, medical and corporate information.
The HHS spokesperson said that it would make 鈥減erfect sense鈥� for staffers working for Kennedy to seek access to the VAERS database to do their own analysis.
Marks says Kennedy is 鈥榳alled off鈥� from FDA
Marks said he never spoke directly with Kennedy, whom he described as 鈥渨alled off鈥� from FDA officials.
On the day he was forced out of his post, Marks said he was summoned to a meeting at HHS headquarters.
Two senior HHS officials greeted him and recalled Marks' work during the COVID-19 pandemic; he had coined the name and developed the concept for 鈥淥peration Warp Speed,鈥� which rapidly accelerated the development of vaccines and therapies to treat the virus.
After an awkward silence, Marks said, one of the officials told him: 鈥淟ook, he wants you gone.鈥� According to Marks, it was an obvious reference to Kennedy.
鈥淚t was pretty clear that either I was going to resign, or they were going to fire me,鈥� Marks said.
He submitted his resignation later that day, citing Kennedy鈥檚 support for 鈥渕isinformation and lies" about vaccines.
The HHS spokesperson said Kennedy is 鈥渋nstalling scientists committed to reversing the chronic disease crisis,鈥� and that Marks was a 鈥渞ubber stamp鈥� for the drug industry.
This week, Kennedy is making stops across the southwestern U.S. as part of a 鈥淢ake America Healthy Again鈥� tour focused on fluoridation, food dyes and other issues.
Marks said Kennedy should be working to get more children vaccinated to stop the outbreak.
鈥淚 consider these needless and senseless deaths,鈥� Marks said. 鈥淭hese kids should get vaccinated. That鈥檚 how you prevent people from dying of measles.鈥�
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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute鈥檚 Science and Educational Media Group and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.
Matthew Perrone, The Associated Press
