There are no studies proving the safety and efficacy of hepatitis B vaccines at birth, 30 days, or 12 years of age

Therefore they must be removed entirely from the CDC childhood vaccine schedule

Dec 03, 2025

I. Junk science clinical trials as the basis for FDA licensure of hepatitis B vaccines in the U.S.

The Advisory Committee on Immunization Practices (ACIP) will discuss hepatitis B vaccines at their meeting on December 4 and 5. In this article I will lay out the case for removing hepatitis B vaccines from the CDC childhood schedule altogether.

As the Informed Consent Action Network has demonstrated, the hepatitis B vaccines Recombivax and Engerix — injected into the vast majority of American children at birth, one month, and six months of age — never should have been licensed by the FDA in the first place.

The clinical trials for Recombivax and Engerix:

did not include a proper saline placebo control group;
were too small to detect uncommon adverse events; and
were too short to detect the majority of harms (the Recombivax trials monitored safety for just five days, the Engerix trials monitored solicited adverse events for just four days).

II. Hepatitis B vaccines are associated with autism

The real world data that are available on the safety of hepatitis B vaccines are horrifying. When autism rates in the U.S. exploded in the 1990s, the CDC looked into the possible role of vaccines. They assigned one of their senior scientists, Thomas Verstraeten, at the Epidemic Intelligence Service, to do the analysis. At the time, hepatitis B vaccines had mercury (thimerosal) in them. Dr. Verstraeten found that children in the highest exposure group had an 11.35x increased relative risk of autism.

Source: SafeMinds.

Then, because the CDC works for the pharmaceutical industry, Dr. Verstraeten did four additional rounds of data manipulation, that were not scientifically warranted, to try to make the signal go away. We have Dr. Verstraeten’s emails and the five different rounds of analysis because SafeMinds did a FOIA request to get all of Dr. Verstraeten’s communication about the study (see SafeMinds Powerpoint presentation here). The corrupted data were used in the final published paper and the original findings were covered up.

The CDC had this information in 1999 and has lied about it for 26 years (which I mentioned in my recent Senate testimony). In 2001, Dr. Verstraeten was scheduled to present his findings to the Institute of Medicine but he quit on the morning of the presentation to go work for vaccine manufacturer GlaxoSmithKline in Belgium (see Evidence of Harm).

Mercury was eventually taken out of hepatitis B vaccines however aluminum adjuvants remain. CDC/ACIP subsequently added several more aluminum containing vaccines to the childhood schedule. What we see in the autism prevalence data after the removal of mercury, together with the increase in total aluminum in the schedule, is that autism rates keep rising (owing to the increased aluminum) but the proportion of severe autism cases as a percentage of the total declined somewhat (owing to the removal of thimerosal which is even more toxic than aluminum).

III. Hepatitis B vaccines have killed an astonishing number of children in the U.S.

I asked the warrior mamas at OpenVAERS (who are doing the work that the CDC should be doing) to calculate the total number of deaths from hepatitis B vaccines from 1990 to the present. The results that came back show that hepatitis B vaccines are a crime against humanity.

Hepatitis B is a component in many combination vaccines including Twinrix, Pediarix, and Vaxelis. When one looks at VAERS reports in the U.S. for all vaccines containing a hepatitis B component there are 1,348 deaths of children and 82,980 total reports of harm across all ages.

Just looking at Recombivax and Engerix, U.S. reports, there are 643 deaths of children and 52,281 total reports of harm across all ages.

Remember that VAERS reports are a significant undercount of harms. The Lazarus and Klompas study for HHS in 2011 estimated that VAERS undercounts actual harms by a factor of 100x. More recent scholarship by Steve Kirsch, Mathew Crawford, and Jessica Rose in 2021 calculated a VAERS Under-Reporting Factor of 41x.

A similar estimate by VAERS Analysis (necessarily anonymous because whistleblowers are hunted by Pharma) in 2021 shows an Under-Reporting Factor of 44.64x for deaths. If that Under-Reporting Factor is correct, then an estimated 60,175 children have been killed by all vaccines with a hepatitis B component over the last 35 years in the U.S.; of that total, an estimated 28,704 children have been killed by Recombivax and Engerix in the U.S. over that same time period.

OpenVAERS also calculated the “days to death post vaccine” for all VAERS reports of death associated with hepatitis B containing vaccines and for Recombivax and Engerix. There we have a causal smoking gun as the largest numbers of deaths are on the day of vaccination or one or two days after.

IV. Conclusion: hepatitis B vaccines must be removed entirely from the CDC childhood schedule

The members of the ACIP are under tremendous pressure from the Pharmaceutical Industrial Complex to simply delay the timing of hepatitis B vaccines to day 30 or to 12 years of age. However, the fact remains that there are no data proving the safety and efficacy of hepatitis B vaccines on day 1, day 30, or 12 years of age.

If one wants to return to “Gold Standard Science” one must conduct proper double-blind randomized controlled trials, with an inert saline placebo in the control group, a large enough sample size (at least 60,000) to detect rare events, and long enough post vaccination monitoring (10 years) to capture non-specific effects.

No “Gold Standard” hepatitis B vaccine safety and efficacy studies in pediatric populations exist right now and so hepatitis B vaccines must be removed altogether from the CDC childhood schedule.

Hepatitis B vaccines were developed for IV drug addicts and prostitutes because those are the high risk groups. If hepatitis B vaccines are to be used at all, they should be properly tested and returned to that original purpose and that intended market. If prison guards want to get them as well because they are dealing with a high risk population that’s fine. Also, the benefits of hepatitis B vaccination appear to outweigh the risks for children born to mothers who are hepatitis B positive (and we know exactly who those children are because all pregnant women are tested for hepatitis B in the hospital prior to giving birth). However, the idea of administering hepatitis B vaccines to nearly the entire childhood population is self-evident madness.

Here’s the whole story in a one-page infographic created by OpenVAERS. Please share it with your networks because the lives of thousands of children and the fate of the Republic is on the line.