A now-halted plan to run a hepatitis B vaccine trial involving thousands of newborns in Guinea-Bissau has been criticized by the World Health Organization as 'unethical'.
The US-funded study had sought to give one set of babies the vaccine at birth, while another would have had the shot delayed until six weeks of age.
The WHO said it had 'significant concerns' about the plan, and described the birth-dose vaccine as 'an effective and essential public health intervention, with a proven record'.
The US health department, headed by Robert F Kennedy Jr, who has questioned the effects of vaccines, had sought to use the trial to answer questions about the jab's broader health effects.
The WHO said on Friday that its concerns regarded the study's scientific justification, ethical safeguards and consistency with established standards for research involving humans. It stressed that the jab had been used for more than three decades in more than 115 countries.
The WHO argued that trials giving one group a placebo or not treating them were only acceptable when no proven treatment existed, something that was not the case with the hepatitis B birth dose vaccine. The organization recommends that all newborns receive the hepatitis B vaccine within 24 hours of birth, as infection at birth is the most common way of having a lifelong infection.
In Guinea-Bissau, the dose is currently given at six weeks, though authorities plan to introduce the birth dose nationwide by 2028 to align with global standards, something the WHO said it would help accelerate. A total of 14,000 babies in the West African country were due to be involved in the study funded by the US and led by Danish researchers.
However, public outrage at the project prompted the Guinea-Bissau government to suspend it last month. Critics questioned why babies in the African country were being proposed for the trial, especially in light of a recent recommendation halting the recommendation for newborns in the US to receive the hepatitis B vaccine.
The former health minister of Guinea-Bissau, Magda Robalo, voiced strong opposition to the trial, stating, 'Guinea-Bissauans are not guinea pigs.' With more than 12% of the country's adult population estimated to possess chronic Hepatitis B, the WHO highlights the critical importance of administering the vaccine at birth to prevent transmission.
The US-funded study had sought to give one set of babies the vaccine at birth, while another would have had the shot delayed until six weeks of age.
The WHO said it had 'significant concerns' about the plan, and described the birth-dose vaccine as 'an effective and essential public health intervention, with a proven record'.
The US health department, headed by Robert F Kennedy Jr, who has questioned the effects of vaccines, had sought to use the trial to answer questions about the jab's broader health effects.
The WHO said on Friday that its concerns regarded the study's scientific justification, ethical safeguards and consistency with established standards for research involving humans. It stressed that the jab had been used for more than three decades in more than 115 countries.
The WHO argued that trials giving one group a placebo or not treating them were only acceptable when no proven treatment existed, something that was not the case with the hepatitis B birth dose vaccine. The organization recommends that all newborns receive the hepatitis B vaccine within 24 hours of birth, as infection at birth is the most common way of having a lifelong infection.
In Guinea-Bissau, the dose is currently given at six weeks, though authorities plan to introduce the birth dose nationwide by 2028 to align with global standards, something the WHO said it would help accelerate. A total of 14,000 babies in the West African country were due to be involved in the study funded by the US and led by Danish researchers.
However, public outrage at the project prompted the Guinea-Bissau government to suspend it last month. Critics questioned why babies in the African country were being proposed for the trial, especially in light of a recent recommendation halting the recommendation for newborns in the US to receive the hepatitis B vaccine.
The former health minister of Guinea-Bissau, Magda Robalo, voiced strong opposition to the trial, stating, 'Guinea-Bissauans are not guinea pigs.' With more than 12% of the country's adult population estimated to possess chronic Hepatitis B, the WHO highlights the critical importance of administering the vaccine at birth to prevent transmission.
