Concerns Arise Over CDC’s Fast-Tracked Grant for Hepatitis B Vaccine Study
In December, two political figures at the CDC embarked on a peculiar mission: they sought to find a department capable of handling a grant proposal from Danish researchers who are favorites of Health and Human Services Secretary Robert F. Kennedy Jr.
This unsolicited grant proposal aimed to conduct a randomized controlled trial in Guinea-Bissau, a country grappling with severe poverty. The study would investigate whether administering a birth dose of the hepatitis B vaccine, which has been deemed safe for years, might have adverse effects, including skin issues or developmental disorders.
According to seven current and former agency employees, the manner in which the proposal was processed raised significant concerns within the CDC, particularly regarding the protection of human subjects involved in research.
The grant was moving forward without the usual scientific scrutiny or competitive bidding process. It proposed giving only about half of the 14,000 infants enrolled a protective birth dose of the hepatitis B vaccine, despite the disease affecting one in five adults in that region, resulting in high transmission rates. Sources within the CDC noted that there was considerable pressure from the director’s office for the grant’s approval. “Our scientists wanted to have nothing to do with this,” one employee stated.
Some scientists were so uneasy about the proposal that they refused to even have it sent to their inboxes.
Documents recently obtained show that rather than being evaluated by a scientific authority within the CDC, the request was fast-tracked directly from the director’s office to the grant management team, a process that took only ten days, as opposed to the standard review period that can last over a year.
Once the $1.6 million grant was made public on December 18, many scientists globally criticized it as unethical. While U.S. health officials asserted publicly that the study would continue, the health secretary of Guinea-Bissau announced on January 22 that the trial would be paused to evaluate its ethical implications.
In response to inquiries regarding the ethics of the study, Ole Skøtt, dean of the health sciences faculty at the University of Southern Denmark, where the lead researchers are based, stated that new information regarding the study’s ethical approval would be investigated. Consequently, the project has been put on hold.
The study has faced growing backlash. On February 6, members of the House Energy and Commerce Committee demanded clarification regarding the study from then-acting CDC director Jim O’Neill. A week later, the World Health Organization expressed significant concerns about the study’s scientific basis, ethical standards, and compliance with essential research principles. In the midst of this discord, lead scientist Christine Stabell Benn defended the ethical basis of the study. She stated that the trial aligns with current national policies in Guinea-Bissau and has received the necessary approvals from the national ethics committee, arguing that it addresses a vital public health question.
However, reports indicate that the Guinea-Bissau ethics committee had not adhered to U.S. requirements for grant funding. It had an expired registration, and there weren’t enough active members on the committee. Moreover, the approval letter bore the name of an ethics committee president who had resigned years prior, without any permission to use his name for the letter.
Questions arise about how this seemingly small grant led to such an international ethics uproar. An investigation revealed that CDC appointees connected to Kennedy appeared to bypass essential scientific and ethical safeguards in a rush to support research that might back significant alterations to the U.S. vaccination schedule.
The future of the study remains uncertain. A report from Reuters mentioned that the Guinea-Bissau foreign minister indicated the study was permanently halted due to scientific concerns. However, Benn claimed they were still in discussions to ensure the research continues and mentioned that a revised study protocol would be submitted to the ethics committee.
An HHS spokesperson maintained that the proposal underwent proper review according to CDC protocols, although a former senior CDC official criticized the notion that rigorous scientific scrutiny was involved.
In light of controversies and allegations of dubious research practices connected to Benn and Aaby in the past, they refute claims of impropriety. They have actively pursued their critics via legal action and complaints to challenges made against their work.
As discussions unfolded about their intended research in Guinea-Bissau, communication with Kennedy’s aide revealed interest in further funding opportunities.
The research’s framework proposed examining potential unknown effects from hepatitis B vaccination while timing also played a role—Guinea-Bissau planned to introduce the vaccine at birth soon. Critics point out the ethical dilemma this poses, especially regarding participants not receiving the most effective intervention available.
Despite assurances from Benn that participants would not receive less than what is mandated by national policy, concerns linger regarding adherence to international ethical guidelines governing medical research.
Benn insists that her research aligns with local policies but also noted the ongoing debate among experts on how such clinical trials ought to be structured, indicating that reasonable differences do not equate to unethical practices.
In reaction to the proposal’s approval, critics like Dr. Benjamin Cowie express worries about the long-term implications for participating infants, suggesting that many could face chronic health issues, including liver cancer, as a direct result of not receiving timely vaccination.
In November, Guinea-Bissau’s ethics committee gave the study a green light, but doubts about the thoroughness of their review remain strong.
Subsequent communications revealed much turmoil within the CDC, as the agency had faced significant staffing changes and challenges, particularly with its leadership after a controversial reshuffling that included the firing of the previous director.
As the agency grappled with internal upheaval, the contentious grant initially bypassed all standard procedures, leaving employees apprehensive about the implications of such haste for public safety, particularly for a vulnerable population like infants.
Concerns about governance and adequate oversight also emerged in light of CDC’s expedited handling of the grant, signalling potentially troubling trends in its funding processes.
In early January, amid ongoing debates about vaccine policies, Kennedy announced a shift in CDC recommendations regarding vaccines, which coincided with funding efforts for the Guinea-Bissau study. Many in the medical community criticized this significant departure, raising alarms about the future health outcomes for infants in America.
Cowie foresees dire consequences from these changes in policy, predicting that some American children may suffer from chronic issues as a result.
Several experts, including Dr. Jake Scott, link the acceleration of the Guinea-Bissau study funding to a broader strategy to undermine confidence in vaccines as the CDC’s policies shift away from established vaccination schedules.
