Hep B vaccine safety studies don't exist
And yet the vaccine is given to millions of infants every day
WASHINGTON, District of Columbia—It’s my personal opinion that the addition of the Hepatitis B vaccine in 1991 to the CDC’s immunization schedule is the single biggest contributor to the autism epidemic given the vaccine’s high aluminum content, toxicity, and the fact that it’s often given on Day 1 of life. To make things worse, it’s a nearly useless vaccine, unless you are in the tiny minority of babies who have a mother with Hepatitis B.
When I say that “safety studies don’t exist” for the vaccine, what I really mean is that the safety studies that were done for the two different brands of Hepatitis B vaccine—Engerix-B and Recombivax HB—were so pathetic in terms of the duration of post-injection safety review as to render them utterly useless. Most people don’t believe me when I explain this to them, which is why I’m going to share the package inserts with the two vaccines with you right now.
Engerix-B
Here’s the entire package insert from the FDA’s website. Here’s the remarkable admission of the study’s post-injection duration:
Four days. If the baby dies on day 5? Not part of the study.
Recombivax HB
Here’s the entire package insert from the FDA’s website. Here’s the detail of the study’s post-injection duration:
Five days. Suffer a seizure on Day 6? Not reported.
ICAN understood the insanity
The nonprofit ICAN understood how crazy this was, in a blog post they explained it:
In 2017, a supporter of ICAN told us that the clinical trials the FDA relied upon to license these vaccines only reviewed safety for a few days after injection. ICAN found this claim incredible. It assumed the claim was likely false.
It seemed improbable because Congress mandated that the FDA only license drugs which have been proven to be “safe and effective” in a clinical trial, and five days of post-injection safety data would be patently insufficient to demonstrate safety. This is why drugs, such as Enbrel, Lipitor, Belviq, and Botox, typically given to adults, had safety review periods of 6.6 years, 4.8 years, 2 years, and 51 weeks respectively, and each was tested against a placebo control group. The FDA even states that the clinical trial relied upon for licensure is typically “1 to 4 years” in duration.
If anything, the safety review period in a clinical trial for a vaccine given to babies and toddlers should be longer since autoimmune, neurological, and developmental disorders will often not be diagnosed until after babies are at least a few years old. Indeed, a 2019 review of 306 pediatric studies, authored by researchers at the FDA and Duke University, explained that, compared to licensing a drug for adults, “data on drug efficacy and safety in children may require an additional 6 years.”
Putting this all together, it seemed like science fiction to claim the Hepatitis B vaccines were licensed by the FDA based on only a few days of post-injection safety data. That was, until ICAN reviewed the package inserts for Engerix-B and Recombivax HB issued by their manufacturers and approved by the FDA. To ICAN’s amazement, the package inserts stated that safety in these clinical trials was only reviewed for a few days post-injection into babies.
ICAN’s FDA letter
Eight long years ago, ICAN sent a letter to the FDA demanding that it “list and provide the safety data relied upon when recommending babies receive the Hepatitis B vaccine on the first day of life.”
The FDA’s response is unlikely to reassure any new parents:
Interpretation: the studies done for Energix-B (4 days post-injection) and Recombivax HB (5-days post-injection) are all they have. That’s it. Every baby could’ve died a week later or developed autism a year later and it wouldn't be in the study…
Blue ribbon bench science?
RFK Jr. often talks about returning the FDA to “blue ribbon bench science.”
When it comes to vaccines, they have miles to go, the “safety studies” done to approve what may be the single most neurologically devastating vaccine on the childhood schedule has no safety science behind it. If you’d like to read a master class in taking down the FDA’s shoddy system, read the letter ICAN sent to them after their weak response above. Here’s a small excerpt:
In our opening letter, we asked that HHS identify the clinical trial data showing that the safety of pediatric vaccines was carefully studied prior to licensing and injecting them into millions of American children.9 In response, HHS did not cite any such data. Instead, HHS merely made conclusory assertions regarding pediatric vaccine clinical trials that contradict HHS’s published documents.
Let’s hope sanity returns soon to the FDA and to the childhood schedule.
About the author
J.B. Handley is the proud father of a child with Autism. He spent his career in the private equity industry and received his undergraduate degree with honors from Stanford University. His first book, How to End the Autism Epidemic, was published in September 2018. The book has sold more than 75,000 copies, was an NPD Bookscan and Publisher’s Weekly Bestseller, broke the Top 40 on Amazon, and has more than 1,000 Five-star reviews. Mr. Handley and his nonspeaking son are also the authors of Underestimated: An Autism Miracle and co-produced the film SPELLERS, available now on YouTube.
I have two vaccine related experiences that are relevant to the Hep B shot. About thirty years ago, when I was in my last year of medical training doing a fellowship, the institution I was at decided that all residents and fellows had to get MMR boosters. We all got our shots. Then, for some unexplained reason, they decided to draw our blood and see who had measurable antibody titers to the shots. I was told that I did not generate antibodies, so I had to get another shot. I got it. They drew antibody titers again, and again they said I had none. The nurse was approaching me with another MMR booster, and I said "Stop. Obviously I am not making the particular antibody that you are measuring. My body is likely making antibodies to a different part of the virus that you are not measuring. Are you just going to keep mindlessly injecting me forever?" The nurse angrily grunted "Are you refusing?" I said "Of course I'm refusing." She left and I was never questioned on the issue again. However, this episode raised my awareness and skepticism towards the entire vaccine operation. I did not really investigate further at this point. Fast forward five years later at the birth of my first child, when the nurse came running up with two syringes barely a few minutes after birth. I asked "What are those?" She said Vitamin K and Hepatitis B. Incredulous, I said "Hepatitis B? Hepatitis B is endemic in China and Mexico, not the US. And neither my wife or newborn child are intravenous drug users. Why on earth are you injecting Hep B vax?" She, just like that first nurse, very angrily barked "Are you refusing?" I said" you can give the Vitamin K but not the Hep B." (Incidentally, based on more study, I should have refused both.) Now many years later, and a lot more reading, particular the works of individuals like JB Handley, I realize that our system has devolved into a corrupt cesspool of power, profit, propaganda, regulatory capture, virtue signalling, self-delusion, coersion, public shaming, fear, and very little health.
Gut issues, skin issues, sensory over- and under-sensitivity, apraxia, autism. Kids who suffer harms from hep b injections appear to be "born that way," when, in fact, their parents never knew them without their injuries that began on day one outside the womb, or for younger kids, even before that because of the relatively recent practice of vaccinating pregnant women.