Trial would deny vaccines to newborns

A hepatitis B study would withhold vaccines from half of fourteen thousand newborns in Guinea-Bissau for six weeks, tracking overall mortality and neurodevelopmental conditions instead of vaccine safety.

RFK Jr championed the controversial research

Robert F Kennedy Jr, secretary of the US Department of Health and Human Services and a longtime anti-vaccine activist, has championed the study, saying it shows vaccines can cause mass injuries.

Danish committee told of approval

Members of a Danish research ethics committee were informed that Guinea-Bissau officials had approved an updated study design, influencing some committee members' votes to proceed with the trial last week.

Guinea-Bissau denies giving approval

Health minister Quinhin Nantote said on Tuesday the ministry did not authorize the tests under the terms presented in publications. Officials were surprised to see media reports claiming the country had approved the study.

“The ministry did not authorize the tests under the terms presented in the publications currently in circulation.”

Researchers' past work questioned

The study is run by Danish researchers Peter Aaby and Christine Stabell Benn. Danish researcher Charlotte Strøm says their claims are highly misleading and they had no significant findings in twenty four out of twenty…

“When researchers operate like this and abandon proper methodological rigor, they literally decide on the results themselves, and that is not science.”

Study could not be done in Denmark

In Denmark, infants born to hepatitis B-negative parents do not receive the shot, there is widespread testing for the virus, low incidence, and a robust healthcare system that can track outcomes and provide timely medical…

Experts call trial deeply unethical

Researchers including BK Titanji at Emory University say the trial is completely unethical because a safe and effective vaccine has been available for decades and would be conducted on the most vulnerable population in a…

“It's completely unethical that this trial is even proposed.”

Cost of vaccinating all newborns

It would cost approximately thirteen thousand two hundred dollars to buy enough vaccines through Unicef and Gavi, the Vaccine Alliance, to immunize all newborns in Guinea-Bissau each year, researcher Colette Delawalla pointed out.

“This is not muddy water: we can use Black babies to further pseudoscience or we can save children's lives with a twenty-cent shot.”

US funding remains unclear

The US Centers for Disease Control and Prevention has set aside one point six million dollars for funding the trial this year, to be matched by private funding from the Pershing Square Foundation and the…

Danish committee members resigned

At least four members of the Danish ethics committee resigned after approval for the trial was fast-tracked. The committee's rules had to be changed because randomized controlled trials were outside its purview.

Guinea-Bissau sought independent review

Guinea-Bissau, which has a transitional military government following a coup in November, requested in January a team of experts from the Africa Centres for Disease Control and Prevention to help evaluate the study.

“It's not going to happen, period.”