A healthcare worker prepares hepatitis B vaccine.

Nicholas Cahova/Xinhua News Agency/via Getty Images

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Nicholas Cahova/Xinhua News Agency/via Getty Images

The past week has seen a whirlwind of back-and-forth over U.S.-funded medical research trials.

While many public health experts have likened the study to the infamous Tuskegee experiment and called it unethical and unnecessary, the Trump administration has promoted it as a rare opportunity to study the vaccine’s potential negative effects.

The randomized controlled trial, funded in part by $1.6 million from the U.S. Centers for Disease Control and Prevention, will study the general health effects of the hepatitis B vaccine given at birth in the West African country of Guinea-Bissau.

Despite being a relatively small study in a relatively remote location, it has garnered a lot of attention and rumors. There have been conflicting reports that the trial has already begun, has been canceled, or is proceeding as scheduled.

At a press conference this morning, Guinea-Bissau’s Minister of Public Health, Quinhin Nantote, finally spoke out, saying the study would be halted pending an investigation.

“We have decided to suspend or even cancel the above studies,” Nantote said in Portuguese through an interpreter. He said the local ethics committee that approved the study did not have the “necessary technical resources” or the necessary coordination with other health authorities in the country. The country experienced a military coup last November, and many senior officials were replaced in the process.

Nantote said the ethics review “resulted in misinformation, weak social communication channels and a lack of international communication, leading to an inappropriate interpretation of the national health policy regarding vaccination and health research.” He added: “We do not yet have sufficient coordination to make a final decision on that study.”

The African Union’s health agency, the Africa CDC, said it was sending a team to Guinea-Bissau to help evaluate the study there. The final authority rests with local governments.

“It’s not a foreign country that says it’s going to be held. It’s a country’s sovereignty,” said Dr. Gene Kaseya, director of the Africa CDC.

Immediately after Thursday’s press conference, a U.S. Department of Health and Human Services official, who requested anonymity, sent NPR contradictory emails to Nantote and Casaya, insisting that the study had not been stopped.

Let’s take a look at why this trial attracted so much attention.

The study comes as U.S. vaccine policy changes.

For over 30 years, hepatitis B Vaccination of all newborns is standard in the United States. That too Recommendations of the World Health Organization.

This vaccine helps prevent infants from contracting the hepatitis B virus from their mothers during birth. This virus attacks the liver and can cause cirrhosis, liver cancer, and death after several years. There is no known cure.

However, on December 5th, CDC advisors voted to overturn US policy.

Vaccine skeptics and health secretary Robert F. Kennedy Jr.’s hand-picked advisers were concerned that the vaccines would cause some harm. But outside medical groups say there are a number of concerns. the study This indicates that it is safe and that the infection rate of childhood hepatitis B virus is low. reduced by 99% Since 1991, CDC reported In 2020, only 10 children in the United States became infected with hepatitis B due to exposure at birth.

Less than two weeks after the vote, A document has appeared The CDC detailed that it will fund a study investigating hepatitis B vaccines in Guinea-Bissau, where nearly 1 in 5 adults are infected with the hepatitis B virus. This rate is much higher than in other parts of sub-Saharan Africa, where the prevalence is only about 6%, according to the Africa CDC.

basics of study

Guinea-Bissau is not currently vaccinating newborns with hepatitis B vaccine in accordance with WHO recommendations, but plans to start doing so in 2028, according to Guinea-Bissau’s Nantote news agency.

Danish researchers say: their website They hope to study 14,500 newborns during this “unique opportunity” before birth vaccinations begin. Half of newborns will receive the hepatitis B vaccine at birth, and the other half will receive it later as part of other routine immunizations at 6, 10, and 14 weeks of age.

The idea is not to test whether the hepatitis B vaccine is effective against hepatitis B. Instead, researchers are looking for other health effects of the vaccine. Do vaccinated newborns develop other serious illnesses within the first few weeks of life? Do they develop eczema during the first two years of life? Or do neurological differences appear before the age of five?

Ethics: Unethical and unnecessary?

Shortly after the study surfaced, doctors and medical ethicists called for it to be halted.

”[The Guinea-Bissau study] It’s extremely unethical, cruel and frankly dishonest.” Dr. Paul Offitdirector of the Center for Vaccine Education at Children’s Hospital of Philadelphia and a former member of the CDC’s Advisory Committee on Immunization Practices.

He is one of many doctors to compare this study to the infamous study. tuskegee experimentThe system began in the 1930s and denied treatment to poor African Americans with syphilis for decades so researchers could observe how the disease progressed. As a result, more than 100 people died.

“A group of 7,000 people who were not vaccinated until they were six weeks old are now being exposed to substandard health care, which is paid for by American tax dollars,” Offit said, noting that because the prevalence of the hepatitis B virus in the population is so high, many of these young people could be infected by their mothers before six weeks of age.

Dr. Bogma TitanjiThe infectious disease physician at Emory University agrees with the Tuskegee analogy and worries that this study could be “the first trigger for subsequent community mistrust of medical interventions and vaccines.” She says mistrust can last for decades and even be passed down from generation to generation.

Researchers involved in the study countered that currently, newborns in Guinea-Bissau are not vaccinated at birth.

“Newborns in Guinea-Bissau will not receive fewer vaccinations because of this study,” they wrote. their websitedefend their research. They predict that “vaccination rates will increase,” explaining that “investigational vaccination teams will operate 24/7, including weekends and holidays. This is expected to increase timely vaccination rates compared to routine services.” The researchers did not respond to multiple NPR requests for comment about ethical issues or whether the study was halted.

Some bioethicists say there’s a more fundamental problem. “The first important consideration in making research ethical is that it must answer valuable questions,” says Christine Grady, former chief of bioethics at the National Institutes of Health Clinical Center. “In this case, I think that’s probably the biggest problem with this study,” she said, noting that vaccines have long been known to be safe and effective.

The researchers claim on their website that the results “contribute to the global scientific understanding of how vaccination affects the overall health of children” and that “this is an important trial that has the potential to influence future vaccine policy locally and globally.”

Politics: Uncompetitive and questionable researchers

Another major point of contention is who is conducting the investigation and how it was selected.

The Danish researchers leading the charge, including Dr. Christine Stavel Benn, are highly controversial. They are affiliated with the University of Southern Denmark and lead the Bandim Health Project, which has been conducting research in Guinea-Bissau for decades.

Although Stabel-Benn’s team’s research has been published in reputable scientific journals, their statistical work has been questioned. For example, in last month’s diary, vaccinean external biostatistician evaluated the research from Bandim Health. They found that the group “systematically overinterprets the results of randomized trials,” meaning that the conclusions are exaggerated and often not supported by the data. If there was “appropriate statistical processing”. According to some people, press release Attached to the article.

“I was surprised by some very strong claims,” he explains. Henrik StöblingProfessor of Pharmacy and Statistics at Aarhus University, Denmark, is the paper’s first author. “But when you look at the randomized trials, which is the main result I found, they didn’t show statistical significance.”

Stabell Benn’s team objected to this conclusion and demanded that the journal retract its review. Your request is under consideration.

Still, RFK Jr. is a fan of Stabel Benn’s team.

He cited a widely criticized study on vaccine safety by Stubbel-Ben et al. Withdrawn more than $1 billion Contributed to funding the Gavi Vaccine Alliance in the United States. That money would have helped fund childhood immunizations in many low-resource settings. Anti-vaccine group RFK Jr. serves as president protect children’s health – Also quote Danish researchers.

Outside vaccine experts have raised other concerns that the CDC awarded the $1.6 million without going through an open and competitive process.

that is the initiative Angela RasmussenA University of Saskatchewan virologist is concerned that the Bandim Health Project was hand-picked by RFK Jr.’s team to conduct research. That’s because they are known to raise safety concerns about vaccines long considered safe.

”[The thing] people really need to know [is] “Behind all this is nepotism and bad science,” she says, “babies can develop chronic diseases and die.”

In a statement to NPR, the U.S. Department of Health defended the study, saying it is proceeding as planned and protocols are being finalized. In their statement, they said the study “represents the world’s first, and perhaps only, opportunity to test the overall health effects.” [the hepatitis B vaccine at birth]. ”