The CDC’s Advisory Committee on Immunization Practices (also called ACIP or ACIP), it voted 8-3 to recommend shared decision-making for the hepatitis B birth dose in infants born to mothers testing negative for the virus. According to their recommendation, if skipped, vaccination would start no earlier than 2 months of age, while high-risk babies still get it immediately. President Trump praised the move for promoting parental choice, and directed the US Department of HHS, led by Health Secretary RFK Jr, ALSO to review the US’s childhood vaccine schedules against global standards. As you would expect, this move drew a number of critics who claim that this move could increase rare perinatal infections after decades of alleged progress. We ought to zoom in on the Hepatitis B vaccine, juxtaposing this with previous discussions where we’ve addressed this vaccine as a secondary or tertiary consideration, part of a broader discussion on developments regarding vaccine policy.

HOW HEPATITIS B VACCINE WAS ADDED TO THE VACCINE SCHEDULE

And now onto our main discussion, regarding “The War Against Pharmaceutical Evil: and Zeroing In on the Hepatitis B Vaccine”. Now, when you investigate the historical origins or perspective regarding a particular subject matter, you discover so much that clarifies or demystifies the present, and this certainly applies when we consider the history of how the hepatitis b vaccine was added to the vaccine schedule.

In essence, the post-1989 vaccines (which are vaccines that came after the childhood Vaccine Injury Act, which gave a protection from liability to vaccine manufacturers), and even include the Hepatitis B vaccine – these were primarily driven more by pharmaceutical profits than public health imperatives. As such, the entrance of the Hepatitis B vaccine into the vaccine schedule is a story of regulatory capture, where Merck pharmaceutical’s commercial struggles prompted the CDC to mandate universal infant dosing, while sidelining medical rationale. 

In more detail, the saga begins in the mid-20th century, rooted in the quest to combat a stealthy liver virus. Hepatitis B, identified in the 1960s by Dr Baruch Blumberg spreads primarily through blood, or other bodily fluids—via sexual contact, shared needles, or perinatal transmission from mother to child. And unlike acute hepatitis A, Hepatitis B can become chronic, silently scarring the liver and raising risks for cirrhosis and cancer. Dr Blumberg and colleague Irving Millman created the first vaccine prototype in the 1970s, using heat-treated surface antigens from infected human plasma. It was this risky approach, harvested from high-risk donors like intravenous drug users and men who have sexual relations with other men, that then yielded Merck’s Heptavax-B vaccine, which was licensed by the FDA in 1981. 

Now, what this tells us is that this Hepatitis B vaccine was primarily developed for those high risk populations. This is further evidenced by the fact that in June 1982, the Advisory Committee on Immunization Practices (ACIP)—which we established earlier is the CDC’s vaccine advisory arm – it then issued its first recommendations, targeting (again) high-risk adults: and this then included healthcare workers, injection drug users, sexually active gay and bisexual men, multiple sexual partners, and household contacts of carriers. 

Yet, uptake of the vaccine collapsed. By 1989, only about 2.5 million doses had been administered, mostly to healthcare workers—who accounted for just 5% of cases. And the reason is that high-risk groups evaded vaccination largely due to stigma – which was a fairly foreseeable issue, in that high risk persons were made into a specific category in society (although factually accurate) but that is a very concerning this in a world with a historical backdrop provided by the discourse surrounding eugenics and the discourse that led to the Nuremberg Laws, both of which constantly warn us that so-called medical interventions for a specific category of people are to raise suspicion. In any case, as the high risk groups were not taking the vaccine, Merck told regulators in the US that (quote): “Nobody is buying it”. Even official records (by the way) confirm this impasse: where despite aggressive promotion, adult immunization rates hovered below 10% in targeted cohorts. 

Then, enter the recombinant era, which was claimed to be a safer pivot. Concerns over plasma-derived vaccines’ potential for blood-borne contaminants like HIV influenced this recombinant era. As such, in 1986, Merck’s Recombivax HB and SmithKline’s Engerix-B debuted as genetically engineered versions, which were said to use yeast cells to produce surface proteins. HOWEVER, these new hepatitis B vaccines did NOT salvage the sales issue for pharmaceutical companies – in other words, people were still not interested. Well, here’s where this history matters for our discussion: Robert Kennedy Jr, highlighted Merck Pharmaceutical’s efforts to change their sale’s misfortunes. He states that Merck lobbied the FDA and CDC, prompting a seismic shift. The outcome was that the CDC then began to recommend the Hepatitis B vaccine for children, through a 1991 ACIP decision.

And so, Merck pharmaceuticals had essentially corrupted the regulatory process to secure a profit streak. From the beginning, they had a defined target market (of people who genuinely were at risk of hepatitis B infection, and included homosexual men, injection drug users and healthcare providers, as the hepatitis B spreads primarily through blood, or other bodily fluids. But, since this group was categorised, it formed a stigma which dismayed them from taking the vaccine. Their answer was not a focus on preventive or alternative, non-vaccine remedial efforts; no, their answer to the lack of uptake on their Hepatitis B vaccine – by the targeted high risk group – was to make infants (who do not have the same exposure to Hepatitis B as that high risk group) to take the vaccine as default customers at birth – and this is despite the fact that a mother is tested for Hepatitis B before giving birth. [PAUSE] And so, no one can convince me that pharmaceutical corporations exist to help people – not with historical files like this.

Now, there was also a 1986 clinical trial that was used to justify the insertion of the Hepatitis B vaccine into the vaccine schedule. The clinical trial involved 147 infants with safety monitoring 5 days after each dose, BUT no saline placebo.

WHAT IS STATED AS THE JUSTIFICATION FOR THE GIVING THE HEPATITIS VACCINE TO NEWBORNS

Now that we’ve established the historical context on how the hepatitis B vaccine got into the vaccine schedule, let’s contrast that with what is stated to be the justification for giving infants (who are not even born to mothers with Hepatitis B) the vaccine, and we’re hearing this from Dr Sallie Permar, who is the Chairman of the Department of Paediatrics at Weill Cornell Medicine.

So, the primary justification from Dr Sallie Permar is that infants can get Hepatitis B from the mom, or through the screening process. At the very core of her justification is the claim that the hepatitis B vaccine provides infants with the necessary protection from this potential infection from the mother and screening process. Let’s directly address her remarks, and to do this, I’d like to bring in a question that was asked by Attorney Aaron Siri in his testimony to the ACIP on the 5th of December, as the Hepatitis B vaccine was being discussed. He asked, in essence: Why do we need the 1986 act if vaccines are so safe and effective? Why does a product need immunity if it doesn’t cause harm? Why do products that have been on the market for decades, like the hepatitis B vaccine, still need immunity?

Now this enquiry is crucial. The vaccine schedule correlates with a surge in chronic childhood illnesses from under 10% in the 1980s to over 40% today. There clearly is an inadequacy of pre-licensure safety testing. No routine childhood vaccine has been licensed based on randomised, double-blind, placebo-controlled trials using inert substances like saline. Instead, controls often consisted of other vaccines or adjuvants, confounding results. For instance, the Hepatitis B vaccines Recombivax HB and Engerix-B—administered to newborns despite low perinatal risk in the US—lack placebo arms in trials involving just 122 and 128 children, respectively, with follow-up limited to 4-5 days.

Similarly, DTaP formulations like Infanrix used prior DTP vaccines as controls, ignoring a 2014 review linking whole-cell DTP to increased mortality in girls. PCV13 (or Prevnar) trials, enrolling fewer than 5,000 infants, monitored adverse events for only 30-60 days, far short of the six-year pediatric follow-up deemed essential to capture developmental impacts. These studies, he noted, are chronically underpowered—lacking statistical strength to detect rare events like anaphylaxis or Guillain-Barré syndrome—and fail ethical standards, as withholding placebos from children is justified only by proven safety, creating a circular logic.

Meanwhile, vaccines OFTEN fail to confer durable, transmission-blocking protection. Acellular pertussis components in the DTaP vaccine, for example, target serum antibodies but neglect mucosal immunity, allowing asymptomatic colonisation and sustained outbreaks despite 90 percent plus coverage. Similarly, pertussis inter-epidemic intervals remain unchanged since the 1990s switch to acellular formulations, undermining herd immunity claims. Also, the inactivated polio vaccine is said to prevent paralysis but not gut infection, which enables fecal-oral spread. Even the live-attenuated varicella vaccine wanes over time, with breakthrough cases fueling community transmission.

So, it appears that while a case for potential infection of infants exists, there is not a strong case for giving the Hepatitis vaccine to infants because the Hepatitis B vaccines lack placebo arms in trials that prove their efficacy and safety. Additionally, vaccines OFTEN fail to confer durable, transmission-blocking protection anyways, and without placebo trials, there is no evidence that the Hepatitis B vaccine provides durable protection.

THE INCONSISTENCIES FROM CRITICS OF THE ACIP VOTE

Now, as alluded to earlier, there have been some critics to the ACIP recommendation against the Hepatitis B vaccine being given at birth, and president Trump calling for a revaluation of the childhood vaccination schedule. One of them is Senator Bill Cassidy. So, he noted in a tweet, that (quote): “As a liver doctor who has treated patients with hepatitis B for decades, this change to the vaccine schedule is a mistake. The hepatitis B vaccine is safe and effective. The birth dose is a recommendation, NOT a mandate.”

Well, this would sound like the words of a genuinely concerned physician, except they are quite contradictory to his earlier remarks, in which Senator Cassidy said if a mother’s Hepatitis B status is definitively known then the vaccine “can be safely delayed”, which is exactly what ACIP voted for. SO, why is he now outraged?

QUESTION EVERYTHING: IT IS CRUCIAL TO HAVE A FUNDAMENTALIST APPROACH TO VACCINES

Understanding that many people think of health not as a partisan matter, but a question that speaks primarily to their wellbeing and that of their family, I would ask that if you aren’t a Trump supporter, kindly put aside for a moment the fact that these changes are happening through the Trump administration, and through the Trump-appointed Secretary RFK Jr, and the RFK Jr appointed ACIP. Kindly consider the substance of what they are saying, and the track-record of their accuracy on these matters. And here’s why I allude to this.

What should matter is the consequence of these decisions on your wellbeing; and that of your family. Of course it matters who is making them, but if the tendency is to assume that anything from the Trump administration is erroneous, then pivot and consider the message. This is crucial because when it comes to health it is important to question EVERYTHING, and have a fundamentalist approach, where you do not rely on existent medical literature, and even enquire about modern changes.

THE HEPATITIS B VACCINE VOTE SHOWS WHY IT WAS KEY TO CHANGE PERSONNEL IN ACIP

Then, finally, for our discussion, part of the reason we are having this discussion is because on the 5th of December, the CDC’s ACIP confirmed, through a vote, that the Hepatitis B vaccine is not required at birth for newborns. In terms of the vote, what emerged is that “For infants born to Hepatitis B Surface Antigen-negative women: ACIP recommends individual-based decision- making, in consultation with a health care provider, for parents deciding when or if to give the HBV vaccine, including the birth dose. (A] Parents and health care providers should consider vaccine benefits, vaccine risks, and infection risks. For those not receiving the HBV birth dose, it is suggested that the initial dose is administered no earlier than 2 months of age.” 

This reveals why the change in the personnel in ACIP was necessary. The ACIP used to have financial conflicts of interest and rubber stamp almost all vaccines for consideration. In contrast with the RFK Jr appointed new ACIP, we see a far more vaccine critical approach. For instance, you’d recall that there was a bombshell admission from within the ACIP committee that exposed a foundational flaw in vaccine safety science. During a discussion on MMRV and Hepatitis B vaccines, committee member Dr Retsef Levi pointedly questioned the confident “safe and effective” declarations made in the absence of gold-standard evidence.

Now, Dr Retsef Levi’s statement cuts to the core of a decade-long demand from transparency advocates: which is a demand for an answer to the question on why none of the vaccines on the CDC’s routine schedule have been licensed based on placebo-controlled trials using an inert saline placebo. This revelation is now forcing a public defense of this practice. A recent PBS article quotes experts arguing that placebo trials are apparently “unethical” once a vaccine exists, as the so-called “standard of care” is the older vaccine. Let’s directly respond to this. Simply, the problem with this is that this logic creates an unsolvable circular problem, where new vaccines are only tested against older vaccines, and NOT a true placebo, which then means that the original safety benchmark for the first vaccine in a class of vaccines is never established against a neutral control. As a result, the entire schedule rests on a pyramid of relative comparisons, with no absolute baseline for safety. And yet, this is what they are propping up as the gold standard of vaccine safety science – just relative comparisons to previous vaccines, which probably also had inherent flaws, as taught to us by the history of the smallpox vaccine. In any case, that is the response to the claim made in the PBS article, arguing that placebo trials are apparently “unethical” once a vaccine exists.

Millions of newborns receive the hepatitis B vaccine on their first day of life, a practice long justified by public health authorities despite the vaccine not undergoing pre-licensure testing against a true saline placebo in infants. For babies born to mothers who test negative for the virus, the individual risk of infection is extremely low, as perinatal transmission is the primary concern only when the mother is infected. Now, if doctors bound by the Hippocratic oath of “first, do no harm” and public officials tasked with safeguarding citizens have prioritised pharmaceutical interests over rigorous, ethical scrutiny, then administering this vaccine to healthy newborns raises profound questions about true medical necessity versus institutional routine.

I say this because the Nuremberg Code emerged from the ashes of horrific medical experiments to ensure that no one—especially the vulnerable—could be subjected to unconsented or inadequately tested interventions under the guise of “public health.” Injecting a newborn with a product whose long-term safety in this population relies on post-marketing data rather than gold-standard placebo trials, particularly when personal risk is minimal, challenges the ethical boundaries the world vowed never to cross again.

Therefore, it is incredibly important that parents retain the right to decline. Anything less is tyranny dressed up as care. Additionally, we need to see more accountability in the medical and pharmaceutical industries: we should see manufacturers AND regulators conduct proper, transparent safety studies with inert placebos. Additionally, regulators in particular should also hold accountable those who have compromised ethical standards.

Written By Lindokuhle Mabaso