ACIP to Review Hepatitis B Shots, as FDA Insert Admits Aluminum and No Cancer Testing—While Science Reveals Hidden Plasmids, SV40 Risks, and Genome Integration Threats
Are recipients being exposed to genome integration risks without informed consent?
The FDA’s own package insert for GlaxoSmithKline’s Hepatitis B vaccine Engerix-B reveals a disturbing pattern: aluminum adjuvants, plasmid DNA manufacturing secrets, admitted serious adverse events, and a total lack of long-term safety testing for cancer or genetic damage.
The revelation comes as the Advisory Committee on Immunization Practices (ACIP) is set to meet September 18-19 to discuss and possibly vote on a number of childhood and adult vaccines. The ACIP meeting will focus on COVID-19 vaccines, the Hep B vaccine, the Measles, Mumps, Rubella, Varicella (MMRV) vaccine, and the Respiratory Syncytial Virus (RSV) vaccine.
The Engerix-B hepatitis vaccine is produced using genetically engineered yeast carrying undisclosed plasmids, yet the complete plasmid sequence is never made public. That means recipients have no way of knowing what other genetic elements are involved—such as bacterial origins of replication or antibiotic resistance genes. Since plasmids are integration-competent DNA molecules, any contamination in the final vaccine raises the possibility of foreign DNA integrating into the human genome.
On top of this, the recombinant hepatitis B surface antigen undergoes a gain-of-function change: in yeast, it acquires the ability to self-assemble into virus-like particles (VLPs)—a property it does not have in nature. This engineered characteristic makes the protein hyper-immunogenic but represents yet another undisclosed layer of genetic manipulation.
Meanwhile, the insert itself lists grave warnings: apnea in premature infants, fainting with seizure-like activity, life-threatening anaphylaxis, diminished efficacy in the elderly and immunocompromised, and diagnostic confusion caused by vaccine-derived antigen lingering in the blood. Postmarketing surveillance reports include devastating neurological, autoimmune, cardiac, respiratory, blood, liver, and skin disorders. And yet, the FDA-approved label admits that Engerix-B has never been evaluated for carcinogenicity, mutagenicity, or impairment of male fertility.
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Undisclosed Plasmid Sequences & Informed Consent Gap
Plasmid secrecy:
The hepatitis B vaccine is made using plasmids that insert the surface antigen gene into genetically engineered yeast. Yet the complete plasmid sequence profile is not disclosed in the FDA insert and has never been made public, leaving doctors and patients blind to the full genetic elements involved in manufacturing.
Human genome integration risk:
Plasmids are integration-competent DNA molecules (here, here). If residual plasmid DNA contaminates the final vaccine dose, it carries the potential to insert into human DNA. Without disclosure of the full plasmid composition—including bacterial origins, promoters, and resistance markers—recipients cannot assess what foreign genetic material might integrate into their genome.
Informed consent problem:
The lack of a full plasmid map removes the ability for independent verification and denies patients true informed consent, since they are not told exactly what DNA constructs are involved in producing the vaccine they are receiving.
Dr. Richard Bartlett, a thirty-year Texas emergency room physician, warned:
“The revelation that DNA plasmids are used in the mass production of the hepatitis B vaccine raises a critical safety question: is there plasmid contamination in the final product? We already know this occurred with the COVID-19 mRNA shots, where plasmid contamination was found at levels 627 times higher than the FDA’s regulatory safety limit of 10 ng per dose. This is why the expertise of MIT-trained scientist Dr. Kevin McKernan is urgently needed. If his analysis shows that hepatitis B vaccines are likewise adulterated with plasmids, it would represent a blatant violation of patient rights and a purposeful denial of informed consent.”
Plasmid Antibiotic Resistance & Contamination Risks
Antibiotic resistance genes:
Plasmids used in recombinant protein production typically contain antibiotic resistance markers (such as ampicillin resistance) to allow selection in bacteria. This is standard for yeast–bacterial shuttle vectors used since the 1980s.
Contamination risks:
If residual plasmid DNA contaminates the final vaccine, it could include antibiotic resistance genes or other bacterial sequences. The implications are alarming: such DNA could, in theory, integrate into the human genome or contribute to the spread of resistance, yet the public is not warned about this possibility.
SV40 Promoter Concerns in Plasmid Design
Historical use of SV40:
Early hepatitis B DNA vaccine plasmids often carried SV40 promoter or enhancer sequences to drive strong gene expression in mammalian systems. The problem is that SV40 elements have long been associated (here, here) with the risk of promoting tumors.
Engerix-B plasmid secrecy:
The full plasmid map for Engerix-B has never been disclosed. While yeast expression systems typically use yeast promoters (such as ADH1 or PGK), the lack of transparency means the public cannot know whether any SV40 sequences remain in the backbone. This secrecy leaves an open question: are recipients being injected with trace SV40 regulatory DNA, and if so, what are the long-term consequences?
Unresolved safety gap:
Even if the manufacturer insists SV40 is not in the final vaccine, the absence of published plasmid blueprints means there is no independent verification. Given the historical record, it cannot be ruled out that SV40 or other viral elements were used at some stage of plasmid design. Without transparency, patients are denied the ability to make a fully informed decision.
Gain-of-Function Antigen Engineering
Self-assembling particles:
In nature, the hepatitis B surface antigen (HBsAg) is just an envelope protein embedded in the viral shell. On its own, it does not form stable structures. But when expressed in yeast, the recombinant HBsAg acquires a new function—the ability to autonomously self-assemble into virus-like particles (VLPs).
Amplified immunogenicity:
These engineered particles are highly repetitive and strongly immunogenic, provoking antibody responses far beyond what the wild-type surface protein could achieve in isolation. This gain of function is not disclosed to patients and represents yet another layer of genetic manipulation behind the vaccine.
Warnings & Precautions
According to the Engerix-B FDA insert:
Infants under 2,000 grams (4.4 lbs): Vaccination should be deferred unless the mother is hepatitis B–positive. Low-birthweight infants respond poorly and require an extra dose later.
Apnea in premature infants: The insert admits that apnea (temporary cessation of breathing) has been observed in some premature infants after intramuscular vaccination.
Syncope with neurological signs: Fainting is acknowledged as a risk, sometimes accompanied by visual disturbances, tingling, or seizure-like tonic-clonic movements.
Anaphylaxis: Life-threatening allergic reactions are possible, requiring immediate access to epinephrine.
Effectiveness limitations: The vaccine may fail in individuals who already had an unrecognized hepatitis B infection or in those who fail to develop protective antibody titers.
Adverse Reactions Documented in Clinical Trials
Common (≥10%): Injection-site soreness (22%), fatigue (14%).
1–10%: Headache, dizziness, fever, swelling, redness, or hardening at the injection site.
<1%: Upper respiratory infections, lymphadenopathy, hypotension, agitation, tingling, vomiting, diarrhea, rash, hives, muscle pain, chills, influenza-like symptoms, malaise, and weakness.
Serious Postmarketing Adverse Events
After widespread use, the following conditions have been reported and are documented in the FDA’s own label:
Neurological disorders: Encephalitis, encephalopathy, seizures, Guillain-Barré syndrome, Bell’s palsy, optic neuritis, transverse myelitis, and paralysis.
Autoimmune and hypersensitivity reactions: Serum sickness-like syndromes, arthritis, vasculitis, and severe skin disorders including erythema multiforme, Stevens-Johnson syndrome, and lichen planus.
Cardiac and vascular events: Palpitations, tachycardia, and vasculitis.
Respiratory issues: Apnea and asthma-like bronchospasm.
Blood disorders: Thrombocytopenia (dangerously low platelet count).
Eye and ear conditions: Visual disturbances, keratitis, tinnitus, and vertigo.
Liver effects: Abnormal liver function tests.
Ingredients
Antigen: Recombinant hepatitis B surface antigen (HBsAg) manufactured in genetically engineered yeast (Saccharomyces cerevisiae), with up to 5% residual yeast protein.
Adjuvant (aluminum): Each pediatric dose (0.5 mL) contains 0.25 mg of aluminum as aluminum hydroxide. Each adult dose (1 mL) contains 0.5 mg.
Excipients: Sodium chloride and phosphate buffers.
This means every injection delivers aluminum—a neurotoxic (here, here, here) metal—directly into muscle tissue, where it can persist and accumulate.
Built-In Limitations & Effectiveness Gaps
The vaccine can fail outright if given to someone already infected without knowing it, or if antibody levels never reach protective thresholds, according to the insert.
Older adults—especially those over 60—are less likely to mount a protective immune response.
Immunocompromised individuals also respond poorly.
Laboratory confusion: The insert admits that vaccine-derived hepatitis B surface antigen can circulate in blood for up to 28 days after vaccination, potentially confounding diagnostic tests.
Administration Caveats
Subcutaneous injections: Only permitted if there’s a bleeding risk. The insert admits this route produces lower antibody responses and more local reactions/nodules.
Premature infants: Breathing pauses (apnea) may follow intramuscular vaccination, so the timing of doses must be weighed carefully.
Infants <2,000 g with HBsAg-negative mothers: Vaccination should be delayed; if given at birth, the first dose doesn’t count and must be followed by three more doses (total of four).
Contraindications & Safety Gaps
Contraindicated in anyone with a prior severe allergic reaction to yeast or any hepatitis B vaccine.
No long-term safety testing: The insert explicitly states that Engerix-B has never been evaluated for carcinogenic (cancer-causing) or mutagenic (DNA-altering) potential, nor for impairment of male fertility.
Bottom Line
The hepatitis B vaccine Engerix-B is far from the clean, safe, and transparent product it is marketed to be.
It is built on plasmid DNA whose full genetic profile is withheld, eliminating true informed consent.
Those plasmids might contain antibiotic resistance and SV40 genes, raising contamination and genome-integration risks.
The antigen itself is the product of gain-of-function engineering, creating self-assembling particles foreign to nature.
Every dose delivers aluminum, a known neurotoxin, into the body.
The FDA’s own insert lists serious adverse events including seizures, Guillain-Barré syndrome, encephalitis, paralysis, autoimmune reactions, and fatal skin conditions.
It admits the vaccine may not work in certain groups and can even interfere with lab tests.
Perhaps most alarming of all, no long-term testing for cancer-causing or DNA-mutating potential has ever been done.
Taken together, the disclosures paint a picture of a product riddled with risks, built on undisclosed genetic technology, and lacking the most basic long-term safety assurances.
The Engerix-B insert itself—when read closely—shows why this vaccine should be viewed with extreme caution.
As ACIP meets this week to review the Hepatitis B vaccine, the real question is whether these documented dangers and undisclosed risks will even be considered—or quietly swept aside once again.
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Are all these depopulating injections (called vaccines) formulated with mRNA? This seems mRNA is the most effective method of condemning ('vax') recipients to DEATH or, if they're really lucky, to a dramatically shortened Life Expectancy, rife with ill-health, and immediately susceptible to a myriad of new diseases and illnesses to try and cope with.
Corrupt 'vax investors' are running for the exits?
FDA, CDC, NIH, etc, must immediately suspend manufacturing and distribution of all mRNA injectable SV40 jabs which include enormous amounts of contaminants (CANCER-INDUCING SV40 crap) (per dose). They must all be corrupted to allow this mass-murder to continue unquestioned.
Alternatively, disband the FDA, CDC, HIH, etc,.
We now wonder if the Pfizer's, Moderna's, etc, deadly SV40 formula is deliberately poisonous - in order to dramatically reduce the world's population?
No more ‘Experimental Jabs’ until quality and safety is independently proven by honest, uninfluenced laboratories, and then independently proven consistently and reliably adjudicated over a period exceeding 30 days!
Repeal the insane PREP Act because this encourages the corrupt vax makers to continue without consequence.
LIABILITY to be mandated before another poisonous mRNA injection into an unsuspecting human.
Unjabbed Mick (UK). We live longer!
The hits just keep coming. Thank you again for delivering them. Those Who Do Not Wish Us Well will only be taken down through death by a thousand cuts.