Merck Didn’t Tell Public Gardasil Contained Unapproved Ingredient
Documents reveal that Merck was aware of an additional adjuvant in its Gardasil HPV vaccine that was not disclosed to recipients and did not have regulatory approval
The documents came to light as a result of a lawsuit filed against Merck. Children’s Health Defense is supporting the lawsuit.
An ongoing lawsuit against Merck, accusing the company of misrepresenting the safety of its Gardasil vaccine, has uncovered damning evidence of corporate deception.
Court documents reveal that Merck was fully aware of an additional adjuvant in Gardasil that was not disclosed to recipients and did not have regulatory approval.
This revelation raises profound legal and ethical concerns regarding the informed consent of the millions who received Gardasil without full knowledge of its composition.
The undisclosed adjuvant
Adjuvants are substances added to vaccines purportedly to enhance the immune response.
In Gardasil, the aluminum-based adjuvant (AAHS) is added to help the immune system recognize the L1 protein found on human papillomavirus (HPV) strains.
These L1 proteins self-assemble into virus-like particles (VLPs), which, when combined with AAHS, constitute the approved vaccine formulation.
However, it has been demonstrated that Gardasil also contains billions of fragments of HPV L1 DNA — which originate from the synthetic DNA plasmid used in manufacturing.
Here’s the kicker
The HPV L1 DNA fragments act as a second adjuvant — which has not been approved — and make Gardasil far more immunogenic than if the fragments were not present.
Merck was aware of this and failed to publicly disclose it.
In fact, court documents reveal that Merck took deliberate steps to preserve and retain these HPV DNA fragments in the final vaccine formulation.
Processing Gardasil
During the first part of the manufacturing process, yeast cells containing synthetic DNA plasmids are used to produce L1 proteins, which then assemble into VLPs.
This mixture is then filtered to remove larger yeast genomes, in order to retain the VLPs.
But Merck’s own patent reveals that a 0.65-micron filter was used — a size sufficient to capture larger yeast nuclear DNA but too large to trap the much smaller VLPs and HPV L1 DNA. This is akin to mosquitoes slipping through a chain-link fence, while larger debris is caught.
Next, is the “disassembly-reassembly step” designed to further purify the VLPs. It removes any sequestered HPV L1 DNA.
However, the explosive discovery in Merck’s documents, shown below, is that in Gardasil 4 — the version targeting HPV types 6, 11, 16 and 18 — the VLPs containing HPV 18 DNA are omitted from this step (see red arrow).
As a result, HPV 18 VLPs retain their spherical structure, protecting and preserving the HPV 18 L1 DNA. This ensures that it remains in the final aqueous product (FAP).
Once the aluminum adjuvant is added to the FAP, all three components — VLPs, viral DNA and AAHS — aggregate into stable precipitates (as shown).
Locked into this precipitate, the HPV L1 DNA is resistant to enzyme breakdown and shielded from the body’s natural defenses against foreign DNA.
Immune consequences of HPV DNA
Dr. Sin Hang Lee, a pathologist and expert in molecular diagnostics, has noted in court filings that while the combination of VLPs and AAHS triggers an antibody response, it does not generate a strong cellular immune response.
However, the presence of HPV L1 DNA fragments activates Toll-like receptor 9 (TLR9), significantly amplifying immune activity.
In fact, Gardasil is known to stimulate the immune response over 50 times greater than a natural infection.
Such excessive and prolonged immune activation can lead to a loss of “immune tolerance,” meaning the immune system fails to recognize its own tissue as benign, potentially resulting in autoimmune conditions.
In some individuals, the resulting inflammatory cascade has been implicated in postural orthostatic tachycardia syndrome (POTS) and, in rare cases, fatal outcomes.
Escaping regulatory approval
The vaccine industry has long known that synthetic DNA can enhance adjuvant activity.
In 2022, Kaur and colleagues noted that “in some cases, adjuvants are purposely in-built into the vaccine antigen to enhance immunogenicity.”
For instance, CpG oligodeoxynucleotides (CpG ODNs) — synthetic DNA molecules — are approved by the U.S. Food and Drug Administration (FDA) as adjuvants in vaccines like Heplisav-B (for hepatitis B) and Cyfendus (for anthrax).
Yet, no regulatory agency worldwide has approved HPV L1 DNA as an adjuvant.
Not only did Merck fail to seek approval, but the company also actively concealed its presence.
Merck’s efforts to conceal the second adjuvant
Internal emails submitted in court expose Merck’s efforts to suppress critical information.
In 2018, independent researcher Stephen Tunley directly asked CSL Behring Seqirus, the Australian manufacturer of Gardasil, whether the HPV DNA fragments were used to stimulate TLR9 and enhance the immune response.
CSL’s medical manager, Dr. Debra Bourke, initially drafted an email acknowledging that HPV DNA could act as a TLR9 agonist, boosting the immune response, although she denied the vaccine contained any viral DNA.
When Merck’s legal team reviewed the draft, they ordered CSL to remove all references to DNA and TLR9 activation.
Barbara Kuter (referred to as “Barb” in the email), who was an executive director at Merck, instructed Bourke to “delete the last 2 paragraphs” and advised that further inquiries be handled via phone, rather than written documentation.
The final email sent to Tunley was stripped of all substantive information, merely referring him to generic FDA and European Medicines Agency statements online.
Misleading product label and lack of informed consent
Even today, product information for Gardasil distributed by CSL Seqirus, Australian and European regulators, continue to mislead the public.
The European package insert of Gardasil explicitly states that “VLPs contain no viral DNA” — a false claim refuted by Lee as far back as 2011.
Failing to disclose the presence of an unapproved secondary adjuvant violates transparency and informed consent. Millions worldwide have received this vaccine without full knowledge of its contents or its potential immunological effects.
This is not just an ethical failure; it may also constitute a legal violation. Patients had the right to be informed about the secondary adjuvant and its associated risks before vaccination.
Despite repeated requests for comment, professor Ian Frazer, co-inventor of the HPV vaccine and 2006 Australian of the Year, has not responded to inquiries regarding this issue.
The road ahead
As this high-stakes litigation unfolds, it highlights the urgent need for stronger regulatory oversight and corporate accountability. Governments and public health agencies continue to promote Gardasil, even as evidence of deception mounts.
The trial, held in a Los Angeles court last week, has now been adjourned until September, leaving critical questions unanswered and many awaiting a resolution that will determine whether justice for the vaccine-injured will be served.
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