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The CDC’s Universal Infant HepB Vaccination Recommendation Is Unsupported by Safety Data

There are no randomized placebo-controlled trials supporting the safety of the CDC's recommendation for universal infant HepB vaccination.

Dec 19, 2025 | 0 comments

GSK's Engerix-B HepB vaccine (Photo by Whispyhistory/Licensed under CC BY-SA 4.0)

The hepatitis B (HepB) vaccine is making headlines lately because of the recommendation of the CDC’s Advisory Committee on Immunization Practices (ACIP) to delay the first dose of this aluminum-containing injection until after the age of two months.

That provoked outrage among the faithful adherents to the vaccine religion.

What the pro-pharma crowd won’t tell you is that when the US Centers for Disease Control and Prevention (CDC) in 1991 issued its recommendation that all newborn babies receive a three-dose series of the HepB vaccine starting on the day of birth, it was based on zero safety data from randomized, placebo-controlled trials.

I detail that in my freely downloadable e-book The New York Times vs. Robert F. Kennedy, Jr.: How the Mainstream Media Spread Vaccine Misinformation. You can read the relevant excerpt in my post “How the New York Times Lies about HepB Vaccine Safety”.

I’ve also written about this in a detailed article I wrote for Children’s Health Defense (CHD) that provides the disturbing true answer to the question “Why Does the CDC Recommend Hepatitis B Vaccination for Infants?”

(And just so you don’t have to wait in suspense, the answer is because they couldn’t achieve their target vaccination rate among adults at risk of the disease, i.e., sexually promiscuous individuals and intravenous drug users, so they figured that to achieve that policy goal they’d just indiscriminately vaccinate everyone at birth.)

As I note in that CHD article, infants whose mothers are not carriers are at very low risk from the virus, and routine screening is done during pregnancy to determine the risk.

Hence the recommendation puts most infants at unnecessary risk of harm from the vaccine.

Here’s a four-minute summary version of my CHD article: “How CDC’s HepB Vaccine Recommendation Endangers Children’s Health”.

On social media, I have often observed the absence of placebo-controlled trial data to support the CDC’s recommendation.

That observation has been predictably met by pro-pharma shills who vainly attempt to deny the truth of my statement by claiming that the CDC’s recommendation is evidence-based and safety-proven—including by randomized controlled trials.

Yet, none of my challengers to date have ever been able to produce any randomized controlled trial examining the safety of injecting infants with this aluminum-containing vaccine.

I posit that their inabiity to produce such a study is indicative that it doesn’t exist.

Another instance of such an exchange occurred today on X, where Dr. Jake Scott objected to the Department of Health and Human Services (HHS), headed by Robert F. Kennedry, Jr., issuing a grant to the University of Southern Denmark to run a randomized controlled trial in Guinea-Bissau to determine “the optimal timing and delivery” of HepB vaccine in infants and to assess the vaccine’s effects “on early-life mortality, morbidity, and long-term developmental outcomes.”

Scott objects to the idea of determing the vaccine’s effect on all-cause mortality on the grounds we already know that “the birth dose works” and causes “no serious adverse events”.

But that is the fallacy of begging the question. It is an expression of faith that ignores the fact that aluminum-adjuvanted vaccines in general, including the HepB vaccine, are associated with an increased rate of childhood mortality, particularly among females.

To support his belief that the practice of injecting all newborns is “safe” and has benefits far outweighing any possible harms, Scott cites a paper published on December 2 by the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota.

It’s touted as an “independent review” of the vaccine’s safety and effectiveness and claims that studies—including “randomized trials”—show that “the hepatitits B vaccine is safe regardless of vaccine timing.”

But that is a brazen lie.

Not one of the randomized controlled trials cited as proof of safety included a placebo control group.

Every single one was a vaccinated versus vaccinated comparison that cannot possibly have shown that this shot is “safe” to inject into infants regardless of individual risk.

You can easily confirm this for yourself by quickly reviewing Table 3 of the paper.

Dr. Jake Scott, incidentally, is heavily featured in my December 8 article “Scientific Data Show Unvaccinated Children Are Healthier”, about how the dismissals of a rare vaccinated versus unvaccinated study out of Henry Ford Health finding vaccines to be strongly associated with an increased risk of chronic disease illuminates the cognitive dissonance and sheer hypocrisy of public vaccine policy apologists.

Oh, and don’t believe the claim that a large Danish study recently proved that aluminum-containing vaccines are harmless. I debunk that nonsense in my article “How the Danish Study on Aluminum in Vaccines Was Designed to Find No Harm”.

Scott is among a number of pro-pharma shills who regularly appear in my X feed even though I don’t follow them. Another is a guy named Drew Comments, who has over 43,000 followers and describes himself as a “science communicator”.

Reposting Scott’s complaint, Comments remarked,

Instead of using 40 years of strong data showing safety, they will instead purposefully leave Black infants unprotected from HepB virus just to see what happens.

Somehow, I doubt Drew Comment would similarly condemn a malaria vaccine study funded by the World Health Organization (WHO) that experimented on African children without informed consent.

I absolutely welcome him to prove me wrong about that.

More directly to the point, his “40 years” claim was a repetition of Scott’s remark that “We have 40 years of randomized trials…” supporting the safety of the CDC’s universal infant vaccination recommendation.

That’s the same claim Scott vainly tried to support by citing the CIDRAP paper that in fact shows that no randomized placebo-controlled trials have been done.

When I saw Comments’ post in my feed, I reposted it with the comment:

The CDC’s 1991 recommendation for universal infant HepB vaccination (34 yrs ago) was based on no safety data from randomized placebo controlled trials. None. That’s never changed. Don’t let the pharma shills and vaccine religion adherents gaslight you.

To which Comments replied, “You was sayin?”, with a prior post of his challenging a statement that he attributes to Dr. Mary Talley Bowden that “They studied Hepatitis B for 5 days.”

One problem with Drew Comments’ argument is that Dr. Bowden is right.

The package insert for Merck’s Recombivax B vaccine states that clinical studies included a mere 147 children, with an unspecified number of infants along with kids up to age 10, who “were monitored for 5 days after each dose.”

Again, you can verify that fact for yourself simply by reading the package insert. See Section 6.1. I just quoted it verbatim.

The other HepB vaccine used in infants is GSK’s Engerix-B, which cites thirty-six clinical studies including a total of 5,071 “healthy adults and children”, again with an unspecified number of newborns, who were “monitored for 4 days”.

Again, don’t take my word for it. Read the insert and see for yourself.

But Comments attempts to falsely characterize Bowden’s statement as false with the remark,

Reality: Original HepB vax clinical trial shows data for 15 months

First HepB vax trial in kids followed them for ten (10) years. An entire decade. 12 month follow-up strongest efficacy predictor

To support his claim that the original clinical trial for the HepB vaccine had a follow-up of 15 months, Comments completely ignores what the manufacturers themselves say right in their own package inserts, which absolutely confirm the truth of what Bowden said.

(And Bowden was being generous, in terms of follow-up period, by referencing Merck’s package insert.)

In a vain attempt to prove her wrong, Comments instead cites a 1982 study titled “The Prevention of Hepatitis B with Vaccine: Report of the Centers for Disease Control Multi-Center Efficacy Trial Among Homosexual Men”.

Okay, so, if you are a reasonably intelligent person capable of independent thought, you ought to be able to immediately identify the problem with citing that trial as evidence supporting the CDC’s recommendation for universal vaccination of infants.

Clearly, there is a relevant distinction between newborn babies and adult men.

It also matters that the HepB vaccine studied in that trial was a completely different vaccine from those injected routinely into infants today.

That 1982 study happens to be the same randomized controlled trial that the New York Times was implicitly relying on as the basis for its claim that Robert F. Kennedy, Jr. is wrong to say that the CDC’s recommendation is unsupported by data from randomized, placebo-controlled trials.

So, you can see how deceptive the public vaccine apologists are.

Drew Comments next attempts to prove Bowden wrong by citing a study from Taiwan titled “Hepatitis B Vaccination in High-Risk Infants: 10-Year Follow-Up”.

And, again, if you are a reasonably intelligent person capable of independent thought, you ought to be able to immediately identify Comments’ logical fallacy just from the title of that study.

Clearly, a study among high-risk infants—meaning those born to carrier mothers—cannot possibly support the claim that it is “safe” to universally vaccinate all infants regardless of individual risk.

Also, a study that only measured vaccine efficacy cannot possibly support the claim that the CDC’s reccomendation is “safe”.

A study from a country whose schedule is different from the CDC’s cannot possibly support the claim that the CDC’s is “safe”.

And a study that looked at efficacy of an older vaccine manufactured by a completely different process cannot possibly support the claim that the shots injected into children in the US today—which are made by genetically engineering yeast cells to produce a single viral protein—is “safe”.

Since Drew Comments was being such a smart-ass with his reply to my observation that the CDC’s universal infant HepB vaccine recommendation is unsupported by data from randomized, placebo-controlled trials, I responded in turn with the following post:

You do understand the difference between an infant and a gay man, right
@sjs856?

And you understand the difference between a prelicensure randomized placebo-controlled trial and a postmarketing observational study?

And you understand the difference between a study designed to determine EFFICACY and a study designed to determine SAFETY?

And you understand that the plasma-derived study is a totally different HepB vaccine than the recombinant vax injected into infants in the US?

You smart-ass pro-pharma shills really make me sick with your incessant attempts to gaslight and deceive the public about vaccine safety.

But THANK YOU for helping to prove my point that the CDC’s recommendation for universal HepB vaccination of infants is based on NO SAFETY DATA FROM RANDOMIZED PLACEBO-CONTROLLED TRIALS.

If you are on X and share my opposition to shameless liars who try to defend criminal government policies resulting in the systematic violation of the fundamental human right to informed consent, kindly help get the truth out by sharing my X post and the link to this article.

Also please also share your thoughts in the comments below, and if you aren’t already getting my newsletters, sign up here and get my free e-book exposing how the mainstream media spread vaccine misinformation.

Now you know. Others don’t. Share the knowledge.

About the Author

About the Author

I am an independent researcher, journalist, and author dedicated to exposing mainstream propaganda that serves to manufacture consent for criminal government policies.

I write about critically important issues including US foreign policy, economic policy, and so-called "public health" policies.

My books include Obstacle to Peace: The US Role in the Israeli-Palestinian Conflict, Ron Paul vs. Paul Krugman: Austrian vs. Keynesian Economics in the Financial Crisis, and The War on Informed Consent.

To learn more about my mission and core values, visit my About page.

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