Guinea-Bissau rejects US-funded newborn hepatitis B vaccine trial after outcry

Government formally blocks Danish-led study; police later seize vaccines from Bandim Health offices

By LineZotpaper
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Guinea-Bissau's government has formally rejected a US-funded clinical trial of the newborn hepatitis B vaccine that was to be run by Danish researchers, following an international outcry over the study. Judicial police also raided the offices of a local health research group and seized vaccines.

Government officials in Guinea-Bissau have formally refused to allow a clinical trial examining alleged nonspecific harms from the newborn dose of the hepatitis B vaccine, a dose that is recommended globally for all newborns and has been used safely and effectively for decades.

The trial was to be run by Danish researchers and funded by the US. Christine Stabell Benn of the Bandim Health Project and the University of Southern Denmark, one of the study's lead researchers, said in an email that Guinea-Bissau's Council of Ministers "formally reaffirmed its non-acceptance of the study on 16 October."

The formal rejection came to light after news earlier in the week that judicial police in Guinea-Bissau had raided Bandim Health's offices and seized vaccines. Stabell Benn noted that the police search took place after the trial had been rejected.

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Analysis

Why This Matters

  • The decision blocks a US-funded research project that had already drawn international criticism for proposing to study a vaccine that is globally recommended and long established as safe.
  • The police raid on a respected research office raises questions about the treatment of researchers in Guinea-Bissau and the future of health research in the country.
  • The episode could affect trust in immunization programs in a region where vaccine confidence is a sensitive issue.

Background

The hepatitis B vaccine is given to newborns worldwide and has been part of routine infant immunization for decades. The proposed trial aimed to investigate alleged nonspecific effects of the vaccine. The researchers involved say the study was formally rejected by Guinea-Bissau's Council of Ministers, and that the police action came only after that rejection. The international outcry referenced in reports suggests the study had become controversial before the government's decision.

Key Perspectives

Guinea-Bissau authorities: The Council of Ministers formally reaffirmed its non-acceptance of the study, and judicial police later seized vaccines from Bandim Health's offices. The government's reasoning is not detailed in the available reporting.

The researchers: Christine Stabell Benn of the Bandim Health Project and the University of Southern Denmark confirmed the rejection and pointed out that the police search came only after the trial had already been refused.

Critics and observers: The reported international outcry indicates concern about the trial's premise, given the vaccine's long safety record and global recommendation for newborns.

What to Watch

  • Whether the police raid leads to formal charges against the research group or the return of the seized vaccines.
  • Any further statements from Guinea-Bissau officials explaining the rejection and the police action.
  • The impact on other vaccine research projects run by Bandim Health and international partners in the country.

Sources

Checked

9 claims in this story checked against 1 source: 9 supported.

Show each claim
  1. SupportedGuinea-Bissau rejected a US-funded newborn hepatitis B vaccine trial after international outcry.Ars Technica - All content: “Government officials in Guinea-Bissau have formally rejected a clinical trial that would be run by Danish researchers and funded by the US to look for alleged nonspecific harms from the newborn dose of the hepatitis B vaccine.”
  2. SupportedThe study was to be run by Danish researchers.Ars Technica - All content: “a clinical trial that would be run by Danish researchers”
  3. SupportedThe study was funded by the US.Ars Technica - All content: “a clinical trial that would be run by Danish researchers and funded by the US”
  4. SupportedJudicial police raided Bandim Health's offices and seized vaccines after the trial was rejected.Ars Technica - All content: “The revelation that the study was formally rejected last week comes after news on Monday that judicial police in Guinea-Bissau raided Bandim Health's offices and seized vaccines . Stabell Benn highlighted that the police search came after the trial was rejected.”
  5. SupportedThe trial was intended to look for alleged nonspecific harms from the newborn hepatitis B vaccine dose.Ars Technica - All content: “to look for alleged nonspecific harms from the newborn dose of the hepatitis B vaccine.”
  6. SupportedThe vaccine dose is recommended globally for all newborns.Ars Technica - All content: “The vaccine dose is currently recommended globally for all newborns”
  7. SupportedThe vaccine dose has been used safely and effectively for decades.Ars Technica - All content: “has been used safely and effectively for decades.”
  8. SupportedChristine Stabell Benn said Guinea-Bissau's Council of Ministers “formally reaffirmed its non-acceptance of the study on 16 October.”Ars Technica - All content: “In an email to Ars Technica, one of the trial's lead researchers, Christine Stabell Benn of Bandim Health Project and the University of Southern Denmark, said that Guinea-Bissau's Council of Ministers "formally reaffirmed its non-acceptance of the study on 16 October."”
  9. SupportedNews of the formal rejection emerged after reports earlier in the week of the police raid.Ars Technica - All content: “The revelation that the study was formally rejected last week comes after news on Monday that judicial police in Guinea-Bissau raided Bandim Health's offices and seized vaccines .”

Zotpaper

Written by June Katz on the Science desk. Claims checked by Ines Fairley, verification. Read for legal risk by Marcus Hale, legal. Edited by Angus Burke, chief sub. Plate by Ollie Flash, picture desk.

2 sources9 of 9 claims matched to a sourcefirst published
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