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US-backed hepatitis B vaccine trial in Guinea-Bissau newborns will not go ahead

A CDC-funded trial that would have withheld the hepatitis B birth dose from some newborns in Guinea-Bissau will not proceed, one of its Danish researchers said Wednesday, citing a lack of government approval [3].

What's new
  1. Ars Technica and DW África are now reporting this
  2. New headline Was: “Controversial US-backed vaccine trial in African newborns halted”
  3. Our desk filed its story

A planned hepatitis B vaccine trial in newborns in Guinea-Bissau will not go ahead, Danish researcher Frederik Schaltz-Buchholzer said Wednesday, Oct. 21, in a LinkedIn post reported by The Guardian, which said the team had not received government approval3.

The study, run by the Danish-led Bandim Health Project, was awarded a $1.6 million grant by the U.S. Centers for Disease Control and Prevention in December1. It would have enrolled about 14,000 newborns in two groups to examine the effects of not giving the vaccine at birth2.

International health experts called the design unethical because some babies would go without a birth dose in a country with high rates of hepatitis B, an infection that can cause lifelong liver disease1. Plans were paused in January amid that criticism1.

Guinea-Bissau's health minister, Quinhin Nantote, said last week that the government had not authorized the trial1,2, and told DW África it was cancelled2. On Monday, Oct. 19, judicial police searched the project's offices in Bissau and seized a batch of hepatitis B vaccines; police said the seizure did not by itself indicate any problem with the vaccines1.

Nantote said the country intends to introduce a universal hepatitis B birth dose, possibly in 2027, ahead of an earlier 2028 target2.

Sources

  1. Ars TechnicaCops raid office of RFK Jr. allies planning “unethical” vaccine trial on babies
  2. DW ÁfricaGoverno guineense nega ter autorizado estudo sobre hepatite B
  3. The GuardianControversial US-backed vaccine trial in African newborns halted

How it’s being reported

3 sources