Public pressure is working. Hepatitis B vaccine trial in Guinea-Bissau suspended.

Plus, updates on a few stories we're tracking.

A flyer for Thursday’s press briefing.

I don’t say this often or lightly, but public pressure is working. On Thursday, Quinhin Nantote, the Minister of Public Health for the Guinea-Bissau Ministry of Health, announced that the controversial US-funded trial of the Hepatitis B birth dose has been suspended. Until then, the status of the trial had been somewhat unclear, although as I wrote here Monday, I had ascertained that the trial was not yet enrolling participants.

Now we know it’s far more than that. During a press conference on Thursday, the Guinea-Bissau official said that the study had not been approved by an in-country ethics board, despite an explicit claim to the contrary found in the trial’s protocol, which was first leaked here on Inside Medicine a week ago. (Read about the September and January protocols—where the claim appears—including expert critiques of the trial’s design.)

Text on the front page of the most recently dated protocol, from January 14, 2026, reads, “The study will be conducted in compliance with all stipulations of this protocol and the conditions of ethics committee approval which was provided by the Guinea-Bissau Committee of Ethics on November 5, 2025, approval number 036-CNES-INASA-2025.”

That was flatly contradicted at Thursday’s press briefing, when the official said, “We have no evidence of any meeting they held, we don’t even have minutes of a negotiated approval,” he said. “We believe that they did not hold a meeting, did not gather and did not address the issue.”

Who is ‘they,’ you ask? The previous government in Guinea-Bissau. The current leadership has only been in place since a November 25 coup d’état, So, the chain of information might not be pristine here.

Regardless, of who is correct, we can conclude that the protocol is anything but final. "We decided to suspend or even cancel the above mentioned study," Mr. Nantote said at the press event. That’s good. (In an email to The Futurist this week, I described the research plan by University of Southern Denmark researchers as “wretched.”)

The uncertainty itself signals a change in attitude on the ground. In recent days, the Danish researchers behind the trial had taken to the comments section of Substack to vigorously defend their research proposal. Their tone had been confident, which likely reflected the sense that the Secretary Kennedy’s CDC/HHS was wind in their sails. (They’ve also been carefully responding to emails from colleagues doing the same, but I do not have permission to share those emails.)

Indeed, until Thursday’s announcement, it seemed like the researchers might just try to railroad their way through and start the trial soon. Now it seems like they’ll, at a minimum, have to rethink things. That’s despite an HHS quote to The New York Times saying that the trial reflected the “highest scientific and ethical standards.” That’s incorrect, but more saliently, apparently not a conclusion that the Guinea-Bissau Ministry of Health has reached. At least, not its current leaders.

It’s a fascinating history in progress. I’d trace the momentum shift to last week. Public outrage erupted in the wake of several influential articles circulated online (in The Guardian, Rolling Stone, and here on Substack). Respected scientists had begun referring to the trial as a modern Tuskegee—a reference to the despicably unethical research carried out upon Black men by the US government in the mid-20th century. Shortly after those articles were published, rumors began flying that the January 14th protocol we’d published was not final.

Now, Africa CDC, the autonomous public health agency of the African Union, will send a team to Guinea-Bissau to help sort out whether the trial should occur. Ultimately, the choice belongs to local officials, the Director of Africa CDC said.

So. That’s where we are on this. I’ll conclude with a verbatim repeat of what I wrote about this on Tuesday’s Public Health Radar.

Bottom line: The goal should be to accelerate Guinea-Bissau’s planned rollout of the birth dose of the Hepatitis B vaccine in 2027. That is, rather than randomizing 14,500 newborns to receive the vaccine or not, we need to find a way to get 60,000 doses there now. Is that possible? Actually, it is. More on that when I learn it.

Stories I’m watching…

Some quick hits for you so we don’t get behind...

• The US has officially left the WHO, a year after President Trump announced that we would do so. Interestingly, during our Substack Live this week, we learned from Dr. Demetre Daskalakis that CDC experts in fact quietly participated in some WHO activities last year. Whether that will continue is unknown.

• Moderna announced new follow-up data on their mRNA skin cancer vaccine. The great news is that after five years (in conjunction with Merck’s drug Keytruda), the vaccine lowered the risk of melanoma recurrence or death by 49%. However, sometimes these outcomes don’t quite mean what they sound like, so we’ll need to see the data before we celebrate. That said, may I remind you that the Trump administration is not pursuing mRNA vaccine research because it believes that the public does not trust the platform. So sayeth NIH Director Dr. Jay Bhattacharya, anyway. He may not trust mRNA vaccines. But we trust the science—which is how it should be.

• The Trump administration celebrated its one-year anniversary by doing what it does best: canceling life-saving research. Then it did what it does second-best: reversing course under pressure. Billions of dollars in funding to the Substance Abuse and Mental Health Services Administration (SAMHSA) were slashed this week, before the outcry forced a swift reconsideration. According to Dr. Noam Ross (one of this week’s guests on Substack Live), here is what was nearly lost:

  “417 programs aimed to prevent suicide, 465 mentioned alcohol use, and 351 helped Americans living with HIV.
  - Another 218 grants helped Americans with depression, while 9 supported adults living with schizophrenia and their caregivers.
  - 573 grants focused on services in rural areas.
  - Over 300 grants supported law enforcement, who are often called on to help Americans in mental health crises.”

  This is why we have to keep speaking up. We should applaud the American Academy of Child & Adolescent Psychiatry for speaking out strongly on this.

MedPage Today round-up.

We’ve got three more key stories covered by MedPage Today for you, curated by our Enterprise & Investigations editor, Kristina Fiore.

• RFK Jr. Links His Vocal Issues to Flu Shots. Kennedy says he can’t “rule out” flu jabs as culprit in his spasmodic dysphonia. This guy is a true menace.

• Texas Probe Targets Pediatricians, Alleges Illegal Vaccination ‘Scheme’.

  Meanwhile, an anti-vaccine group filed a racketeering lawsuit against a top medical society.

• CMS Paying More for Medicare Advantage Patients Compared to Traditional Enrollees. Difference in spending attributed to “coding intensity” and “favorable selection.”

Reminder! Live Webinar on the new US dietary guidelines is today! Join us!

Lastly, don’t forget to join us today at 1:30 pm ET for a live webinar on the new dietary guidelines. We’re doing it on Zoom! Our guests are Jessica Knurick, PhD, RN, and Kevin Klatt, PhD, RD. Register for the webinar here! (We’ll post it online later as well.) For more information, click here.

That’s all for now! Thank you for reading! If you have information about any of the unfolding stories we are following, please email me or find me on Signal at InsideMedicine.88.