Guinea-Bissau still debating controversial US hepatitis B vaccine trial

Guinea-Bissau is still considering a controversial hepatitis B vaccine trial funded by the U.S. Centers for Disease Control and Prevention. “We didn't have sufficient evidence from our ethics committee, and that is the difficulty we had in taking any decision,” said Dr. Armando Sifna, the director-general of public health from Guinea-Bissau, said through a translator during a press briefing on Thursday. “We have not yet held a meeting for the approval at the level of the country.” The U.S. CDC awarded, without competition, Bandim Health Project at the University of Southern Denmark a $1.6 million, five-year grant to study the “health effects” of hepatitis B vaccinations on newborns in Guinea-Bissau, with half the babies vaccinated at birth and the others reportedly not vaccinated for it. Guinea-Bissau has a 19% hepatitis B prevalence rate. Dr. Jeremy Faust, an assistant professor at Harvard Medical School, reported that the trial protocol noted the study would examine mortality rates, as well as examine neurodevelopment disorders and eczema. This trial has raised ethical concerns from researchers who question why a vaccine that has already proven to be safe and efficacious, and has been recommended to be given at birth, is undergoing these trials, where some children won’t receive the lifesaving vaccine, among other concerns. There are also questions around whether it’s a good use of taxpayer funds. “Hepatitis B can be prevented with a safe and effective vaccine. The vaccine is usually given soon after birth with boosters a few weeks later. It offers nearly 100% protection against the virus,” according to the World Health Organization. While Guinea-Bissau currently gives hepatitis B doses at six weeks, it was slated to roll them out at birth in 2027. But during the press conference, Sifna noted that the introduction of hepatitis vaccines for newborns “has been planned for 2028.” The U.S. CDC is run by Secretary of Health and Human Services Robert F. Kennedy Jr., who is a known vaccine skeptic. Last June, he said the U.S. would cut funding to Gavi, the Vaccine Alliance, and criticized Gavi’s provision of another widely used vaccine — the DTP immunization, which protects against three infectious diseases that primarily kill children, including diphtheria, neonatal tetanus, and pertussis. In December, the U.S. CDC ended its recommendation for U.S. newborns to receive hepatitis B vaccines. "We are restoring the balance of informed consent to parents whose newborns face little risk of contracting hepatitis B,” said Acting Director of the CDC and Deputy Secretary of Health and Human Services Jim O'Neill. RFK Jr. has also tasked CDC with abandoning its position that vaccines don't cause autism despite extensive scientific evidence showing no link. The New York Times reported that "critics say he is cherry-picking facts and seeking studies to confirm his own predetermined conclusion." There had been conflicting information around whether the Guinea-Bissau trial would move forward. Africa CDC’s Dr. Yap Boum said last week that “our information is that the study has been canceled.” Following this, the publication Futurism reported on Tuesday that the U.S. Health and Human Services press office said that “the trial will proceed as planned.” Africa CDC’s Dr. Jean Kaseya clarified during the press conference on Thursday that it is up to a country’s internal regulatory authorizations and ethical approvals, and political clearances, to approve a trial. “It's not Africa CDC that will say: This clinical trial will take place or not,” he said. “It's not a foreign country that will come and say: This one will take place. It's the sovereignty of the country.” Guinea-Bissau needs to first have in-depth technical recommendations on the study following a review before making a final decision, Sifna said. “We need to respect our internal structures,” he said.