US-funded hepatitis B vaccine trial on newborns in Guinea-Bissau canceled
A US-funded trial of the hepatitis B vaccine in newborns in Guinea-Bissau will not go ahead, the Guardian, Ars Technica and The Hill reported. The lead researcher said the government did not approve it. Experts had called the trial unethical because half the babies would not get the shot.
A US-funded trial of the hepatitis B vaccine in newborns in Guinea-Bissau will not go ahead, according to the Guardian, Ars Technica and The Hill.
It was "now clear" that the study "will not move forward in Guinea-Bissau," the lead researcher, Frederik Schaltz-Buchholzer, wrote on LinkedIn, the Guardian reported. "We were not given the necessary governmental approval," he wrote.
Christine Stabell Benn, another lead researcher, wrote to Ars Technica that the country's Council of Ministers "formally reaffirmed its non-acceptance of the study on 16 October." On Monday, police searched the offices of the Bandim Health Project and took its vaccines, the Guardian and Ars Technica reported.
The CDC agreed to give $1.6 million to the Danish researchers, the Guardian, Ars Technica and The Hill reported. The Guardian said private groups would add another $1.6 million.
The plan was to give the vaccine at birth to only half of the babies in the trial, The Hill reported. The Hill said the trial would have enrolled 14,000 newborns. Many experts called that unethical, the outlets reported. Nearly 1 in 5 people in Guinea-Bissau have hepatitis B, The Hill said. The country does not now give the shot at birth but plans to start by 2028.
"The solution is clear here: take the money and vaccinate as many kids as you can," said Paul Offit, a vaccine expert at the Children's Hospital of Philadelphia, according to the Guardian. The World Health Organization says all babies should get a first dose as soon as possible after birth, the Guardian reported.
Stabell Benn said her team regrets the decision but respects the government's authority, Ars Technica reported.
On Thursday, top Democrats on a House committee asked the CDC for answers about the funding, The Hill reported. They asked for a briefing by November 6. "This proposed study harms children, and CDC should not have approved using American taxpayer dollars to fund it," they wrote, according to The Hill.
What we know: The trial will not go ahead after Guinea-Bissau refused to approve it.
What we don't: What will happen to the CDC money set aside for it.
Where outlets agree The Guardian, Ars Technica and The Hill report that the Guinea-Bissau hepatitis B vaccine trial will not go ahead and that the CDC agreed to put $1.6 million toward it.
Where they differ The cited reports agree on the key facts so far.