Melody Schreiber
The Guardian
January 15, 2026
Summary
The controversial US-funded study on hepatitis B vaccines among newborns in Guinea-Bissau has been halted, according to Yap Boum, a senior official at the Africa Centres for Disease Control and Prevention.
The $1.6 million study, funded under the purview of Robert F. Kennedy Jr., drew widespread criticism over ethical questions about withholding vaccines proven to prevent hepatitis B in a country with very high disease burden.
The trial design would have randomly assigned 14,000 newborns to either receive or not receive the vaccine at birth, effectively denying 7,000 children access to a life-saving vaccine based on a coin flip.
About 18% of adults and 11% of children under age one in Guinea-Bissau have hepatitis B, and children who catch the virus when very young are much more likely to develop long-term effects including liver cirrhosis, cancer and death.
Africa CDC officials said the study was cancelled due to critical ethical concerns about how it was designed, though Guinea-Bissau officials indicated conversations continue about potentially redesigning the trial to meet ethical standards. The Danish researchers conducting the trial have not responded to inquiries about the cancellation. Critics, including infectious diseases physician Paul Offit, compared the trial to the Tuskegee experiment and called its cancellation a victory for research ethics.
Quotes
"It's of importance for Africa CDC to have evidence that can be translated in policy, but this has to be done within the norm. So we are glad that at this point the study is being cancelled."
"The way the study was designed was a big challenge."
"The good guys won. This administration did not see people in Africa as valuable. You can't treat children like this, you can't treat people like this. We were able to stand up for them. We were able to convince people about the fact that this was unethical."
"The institutions are getting stronger."
"A win for advocacy and upholding the ethics of research."
"Take the $1.6m and vaccinate as many children as you can at birth."
"Projects like the Danish study basically exploit the scarcity of a proven beneficial vaccine in a context where that vaccine is needed. You are not solving the problem. You're actually being part of the problem."
(Continuation of comment)
ReplyDeleteI believe the Hepatitis B vaccine was the first virus vaccine that was not attenuated, but was instead a sub component of the hepatitis b virus. Maurice Hilleman and his team developed this design and shepherded it through the FDA and many other national control authorities. It was a revolutionary new type of vaccine in 1977 when it was first used. I know about this because I happened to work with Hillelman's group as it was going though the production of the first standard batches of the then new HBV vaccine. There’s a good explanation of this product and Maurice’s work in Wikipedia.
For info, the Covid vaccine by Pfizer and Moderna were the next big evolution in virus vaccine design, these focused on one key element of the covid virus, the so called ’spike protein.’ So this was the most targeted viral vaccine type developed to date.
Back to the trial that’s being held up in Guinea Bissau, first, Hep B vaccine as it’s called has been in broad use in Africa, Asia, Europe and the americas for decades now. When I finished at unicef we had managed to get the price of the vaccine down to 25 cents a dose. I remain a vaccine buyer at heart. The key to making vaccination ‘work’ for unicef and our partners was having good vaccines available in large quantities at prices our programs could afford. All the way back in the 1990’s when we began talking with manufacturers and the WHO about introducing Hep B vaccine, the key issue was the price. In the 1970’s it was launched in the USA for $50 dollars a dose. I still remember meetings with groups of manufacturers and explaining that we could only afford a 25 cent HBV. Af first there were howls of derision and laughter, that we in unicef were nuts, and that we would never see the day of that vaccine at those kinds of prices. It took a while, but the early 2000’s we began to have 25 cent HBV from high quality large suppliers. One of the marvelous parts of the Unicef/WHO HBV introduction was there were never serious side reactions. That’s the key to the so-called sub unit design, the vaccine did not contain other proteins or preservatives that caused side effects.
Finally, how did we handle stories like this in the media? We, unicef, had an excellent ongoing relationship with the WHO vaccine/biological quality team in Geneva. This small group in Geneva was in turn also in strong relationship with the best national control laboratories in the world. Basically, Unicef’s policy was not to comment on technical or quality concerns from the media; we would refer them on the record to the correct counterpart in WHO. This team would then respond, generally with the support of a national control lab like the MRC in England, on all the quality and technical issues. When needed we would send joint teams to investigate a serious claim.
Updating a field trial protocol before the study begins is not unusual and in the US there is a public website and database where any one can locate any human trial that is in proposal form, or any study that is underway, and most of the recent studies that are completed. It is very transparent. That showed be the case here. As the protocol is modified the research team is required to explain what changes were proposed, whether they were approved and then the current status of the study. I’d expect this study will have a similar public availability.
Hope this helps, thanks, John
I went to the Guardian and below copied the complete item they published, its a bit different.
ReplyDeleteI have a few comments;
Perhaps most important, this article is leaping into an already blazing bonfire of outrage in the US public health community. I would be careful about xunicef publishing any thing on this as it’s now a battle between the RFK administration and the most highly respected public health voices in the US. Paul Offit being chief among these.
My opinions. First I’m a former supply guy who bought a lot of vaccines and sat in a too many WHO meetings with well qualified epidemiologists and immunologists. My opinions have no credibility with the voices being quoted here.
Nevertheless, first it is not unusual for a study protocol to be stopped before the study in the field begins. Clinical trials on humans are required to have a variety of expert review panels, each of then comment on the study design before the field trial begins. I sat on one of these panels for a trial in the Gambia many years ago, for a then new vaccine called HiB (Haemophilous Influenza type B). The ethical review panel will have distinguished clinical and lab experts as well as full time ethicists who guide the group in the tricky questions about what is or isn’t ethical in field trials. These discussions can get heated. Not because someone is unethical, but because sometimes what is the ethical lapse is difficult to see or misunderstood. It appears in this proposed trial someone had not addressed the issue of the control group not receiving a later immunization after the trial period ends.There is no discussion here of the trials duration, will the immunized babies be followed up for six months? One year or two years? I doubt that they willl be followed up for longer than that time frame. However, Hepatitis the disease, is one of those that usually doesn’t present until much later, ie. Middle age in the USA population. This question of when to end the followup period in the study is a big one, it involves usually a lot of the study’s budget, and the desire by the study sponsors to come to a conclusion and publish the results. It also involves logistics and credibility of the study. The longer the study must follow up with the two groups, the active and the control, the more each test group will shrink, So, in this case, each group starts off as 7,000 newborns. If after the passage of a year, that same group becomes only 4,000 returning infants for followup blood work and interviews with the mother, that loss of subjects starts to influence the credibility of the study results. If the last followup is in two years, the test populations may be very dispersed and then the data will become less credible. There is also the issue of finding the folks in the test and paying the staff and testing costs for this follow-up. In the pharmaceutical world, this part of what are called phase three studies is the most expensive and difficult to complete. Ministries of Public Health are at a disadvantage on these followup rounds due to lack of funding and marketing skills. $1.6 million budget for a field study this large in Africa is a very small budget.
The article mentions this product as an attenuated vaccine. Hep B is not an attenuated vaccine, it is a viral sub unit type of vaccine. At the time of its introduction, it was the first commercially used subunit type of vaccine. In terms of the vaccine's stafety profile, this is a big difference. An attenuated vaccine is a weak form of a live virus. The Measles Rubella and Mumps combination vaccine is an example of an attenuated live virus vaccine. A weakened/ attenuated form of measles is used to immunize the child. It is still a form of Measle virus, and is still “live”, but the great advance of the MMR attenuated vaccines was that they would not induce the full blown measles disease.
(Comment truncated due its length)
The study is back on. Again, I would treat anything about this story as controversial
ReplyDeletehttps://www.scientificamerican.com/article/a-controversial-u-s-study-of-hepatitis-b-vaccines-will-continue-in-africa/
Here’s a copy of the “preprint” report on a related vaccine study. This one also involves vaccines that have been in use for many decades. This may also come out in something like the Guardian as proving something or claiming something negative about vaccine use. Randomized Clinical Trials of the type in use today were generally not used (actually not invented yet) for the first field reviews of the vaccines mentioned. These vaccines predated the RCT style of testing. Preprints are not peer reviewed before publication, which is also still controversial.
ReplyDeletehttps://www.medrxiv.org/content/10.64898/2025.12.31.25343212v1