A Disputed Plan for a Hepatitis B Vaccine Trial in Guinea-Bissau
A proposed trial for a Hepatitis B vaccine in Guinea-Bissau, involving thousands of newborn babies, has been suspended following criticism from the World Health Organization (WHO). The organization deemed the plan as "unethical" and expressed "significant concerns" about it.
The Details of the Controversial Plan
The halted trial, which was funded by the U.S., aimed to administer a Hepatitis B vaccine to a group of babies at birth, while delaying the vaccine for another group until they were six weeks old. The plan was intended to study the broader health impacts of the vaccine.
The WHO, however, argued against the trial, stating that the Hepatitis B vaccine at birth is a crucial public health measure with a proven track record. The organization emphasized that the vaccine has been used for over 30 years in more than 115 countries. They also expressed concerns about the potential scientific validity of the study, ethical considerations, and adherence to established research standards involving human subjects.
Risks and Implications
The WHO also highlighted the potential risks associated with the trial. By withholding a proven life-saving intervention from some babies, they argued, these newborns could be exposed to "potentially irreversible harm". Hepatitis B is prevalent in Guinea-Bissau, and the WHO states that vaccination at birth prevents mother-to-baby transmission of the virus in 70-95% of cases.
Trials that involve giving one group a placebo or withholding treatment are only deemed acceptable when there is no proven treatment available. This is not the case with the Hepatitis B vaccine. The WHO recommends that all newborns receive the vaccine within 24 hours of birth, as it is the most effective way to prevent lifelong infection. Currently, 90% of infected newborns become chronic carriers.
Public Outcry and the Suspension of the Trial
The proposed trial was supposed to involve 14,000 babies in Guinea-Bissau. However, public backlash led to the government suspending the trial. Critics questioned why babies in this African nation were chosen for the trial.
A few months ago, a panel of top advisors decided not to recommend that all newborns in the U.S. receive a Hepatitis B vaccine. The panel had been appointed by the U.S. Health Secretary, who is known to have questioned the effects of vaccines in the past. Despite this, he has stated that he and his children have been vaccinated and has denied being anti-vaccination.
Opposition from Local Health Leaders
Vocal opponents of the project in Guinea-Bissau include the country's former health minister, Magda Robalo. She expressed her disapproval of the trial, stating "Guinea-Bissauans are not guinea pigs."
Over 12% of the country's adult population has chronic Hepatitis B, according to WHO. Other smaller studies suggest that the number could be as high as one in five. Most people with the virus do not have any symptoms, or have very mild ones. However, some people can experience severe symptoms such as jaundice, dark urine, extreme fatigue, nausea, vomiting, and abdominal pain.
Currently, the Hepatitis B vaccine is administered to babies in Guinea-Bissau at six weeks of age. The government plans to introduce the birth dose nationwide by 2028 to align with global standards. The WHO has stated that it will assist in accelerating this process.