Dear CHIFA colleagues,
Under the Trump Administration and Health Secretary R F Kennedy, the United States Centers for Disease Control has had major funding cuts, dismissal and resignation of experienced senior staff, and eerosion of scientific independence [https://jamanetwork.com/journals/jama-health-forum/fullarticle/2840162]. Just two weeks ago it ordered researchers to retract papers that included forbidden terms such as “gender, transgender, pregnant person, pregnant people, LGBT, transsexual, non-binary, nonbinary, assigned male at birth, assigned female at birth, biologically male, biologically female” [https://climate.law.columbia.edu/content/cdc-orders-retraction-or-pause-.... The CDC advisory panel has been replaced by RFK appointees who recently dropped the universal recommendation that US children should get vaccinated for hepatitis B at birth [https://www.pbs.org/newshour/show/rfk-appointed-cdc-panel-drops-hepatiti.... The latest development is that the CDC has approved a grant of US$1.6 million for a highly controversial hepatitis B trial in Guinea-Bissau, whereby half of babies would not receive the vaccine at birth. There has been a furore in the medical community and Guinea-Bissau have decided to suspend the study for now.
Below is a statement from WHO. While other parties are guided by unfounded opinion and ideology, WHO continues to be a beacon of evidence-informed policy and ethics.
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Friday, 13 February 2026
Statement on the planned hepatitis B birth dose vaccine trial in Guinea-Bissau
https://www.who.int/news/item/13-02-2026-statement-on-the-planned-hepati...
The World Health Organization (WHO) underscores that the hepatitis B birth dose vaccine is an effective, and essential public health intervention, with a proven record. It prevents life threatening liver disease by stopping mother to child transmission at birth. It has been used for over three decades, with more than 115 countries including it in their national schedules. Protecting newborns with a timely birth dose not only provides individual benefit but is also central to national and global elimination efforts.
In response to recent questions from the media, WHO would like to state the following:
WHO is aware of the proposed randomized controlled trial (RCT) on the hepatitis B birth dose vaccine in Guinea Bissau. Based on questions raised in publicly available information and consultation with relevant experts, WHO has significant concerns regarding the study’s scientific justification, ethical safeguards, and overall alignment with established principles for research involving human participants.
Why withholding the vaccine is unethical
• Proven benefit, foreseeable harm: The hepatitis B birth dose vaccine is known to have a proven safety record across decades of use and is effective in preventing 70–95% of cases of mother to child transmission. A study which provides the hepatitis B birth dose vaccine, a proven lifesaving intervention, but withholds it from some study participants exposes newborns to serious and potentially irreversible harm, including chronic infection, cirrhosis, and liver cancer.
• No scientific necessity for a no treatment arm: Placebo or no treatment vaccine trials are only acceptable when no proven intervention exists or when such a design is indispensable to answer a critical question of efficacy or safety. Neither condition appears to be met based on publicly available descriptions of the study.
• Insufficient scientific justification: Publicly available descriptions indicate that the protocol does not question the established efficacy and impact of the birth dose; instead, it posits hypothetical safety outcomes without sufficient credible evidence of a safety signal that would warrant exposing participants to risk.
• Biased and low utility design: As described publicly, the single blind, no treatment controlled design raises a significant likelihood of substantial risk of bias, limiting interpretability of the study results and their policy relevance.
• Exploiting scarcity is not ethical: Resource constraints cannot be used to justify withholding proven care in a research study involving people. Ethical obligations require minimizing risk and ensuring a prospect of benefit for participants. From what is publicly described, the protocol does not appear to ensure even a minimum level of harm reduction and benefit to the study participants (e.g. screening pregnant women and vaccinating newborns exposed to hepatitis B).
In its current form, and based on publicly available information, the trial is inconsistent with established ethical and scientific principles.
WHO is aware that Guinea-Bissau has suspended the study pending further technical reviews. WHO stands ready to support Guinea Bissau as it considers its way forward and in accelerating the introduction of the birth dose and strengthening implementation through:
• birth dose delivery within 24 hours (including strategies for home and facility births);
• antenatal screening for hepatitis B surface antigen (HBsAg), linkage to care, and neonatal prophylaxis;
• cold chain, last mile logistics, and midwife/HCW training; and
• monitoring of timeliness and coverage, pharmacovigilance, and data use for continuous improvement.
WHO remains committed to working with national authorities, researchers, and partners to ensure that all newborns – in Guinea Bissau and worldwide – receive timely, evidence based protection against hepatitis B, and that research conducted in this area meets the highest ethical and scientific standards.
Editor’s note
Hepatitis B causes hundreds of thousands of deaths globally each year. Transmission at birth is the most common route to lifelong infection; ~90% of newborns infected during childbirth become chronic carriers at high risk of cirrhosis and liver cancer.
In Guinea Bissau, >12% of adults are estimated to be living with chronic hepatitis B (2022), and infection in children under five (~2% in 2020) is far above the global target (≤0.1%). Guinea Bissau formally decided in 2024 to add the hepatitis B birth dose to its national schedule, with introduction planned by 2028. This policy decision affirms the vaccine’s value and further underscores the ethical imperative not to deny newborns timely protection.
Media contact:
mediainquiries@who.int
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HIFA profile: Neil Pakenham-Walsh is coordinator of HIFA (Healthcare Information For All), a global health community that brings all stakeholders together around the shared goal of universal access to reliable healthcare information. HIFA has 20,000 members in 180 countries, interacting in four languages and representing all parts of the global evidence ecosystem. HIFA is administered by Global Healthcare Information Network, a UK-based nonprofit in official relations with the World Health Organization. Email: neil@hifa.org