A vaccine study championed by Health Secretary Robert F. Kennedy Jr. has collapsed after a global outcry over plans to give only half of 14,000 newborn participants a hepatitis B vaccine at birth.
The World Health Organization deemed the proposed trial in Guinea-Bissau “unethical,” even after researchers revised its safeguards, Rolling Stone reported Thursday.
“Critics feared Kennedy would use the study to help support his efforts to end the hepatitis B vaccine birth dose in the United States, despite being proven safe and effective for decades,” according to the magazine.
The backlash included congressional demands for answers, resignations from a Danish ethics board and comparisons from public health experts to the Tuskegee study, which withheld syphilis treatment from Black men.
Researcher Frederick Schaltz-Buchholzer announced Wednesday that the trial would “not proceed” after failing to secure the “necessary government approval” from Guinea-Bissau authorities.
Medical ethicists raised serious concerns from the beginning, noting that the study stood out “as both ethically and scientifically compromised,” Rolling Stone reported Thursday.
“My worry was, they were using the study and the infants in Guinea-Bissau, for their own ends,” Seema Shah, bioethicist at the Lurie Children’s Hospital, told the outlet.
“If you’re not looking at the benefit of preventing hepatitis B, you’re looking for one half of the story and omitting the other half,” she added.
The now-scrapped trial, which was to be funded by the Trump administration’s Centers for Disease Control and Prevention, never received a full review by the CDC’s ethics board, according to the report.
But the Danish researchers still defended the study, saying they conceived it independently of Kennedy and would expand vaccine access before Guinea-Bissau introduces a routine birth dose in 2028.
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