By Brenda Baletti, Ph.D.

Consultants paid by Merck and the Gates Foundation are publicly advocating to administer HPV vaccines to children as young as 12-24 months — an age group in which the vaccine has never been tested and for which no safety data exist.

Mark Kane and Eduardo Franco laid out the campaign to extend HPV vaccination to toddlers in an opinion piece published in Clinical Infectious Diseases — an official journal of the Infectious Diseases Society of America (IDSA).

Merck, a “Silver” level industry partner, donates tens of thousands of dollars annually to the IDSA foundation.

The push to vaccinate younger children comes as Merck — maker of Gardasil, the only HPV vaccine marketed in the U.S. — partners with major universities to run clinical trials of its HPV vaccine in children ages 4-8 in the U.S. and Gambia.

Merck’s Gardasil vaccine is designed to protect against human papillomavirus (HPV), a sexually transmitted disease. In the U.S., the drug is approved for children starting at age 9 — well before children are sexually active.

Conflicts of interest ‘so thick’ they obscure the science

In the conflict-of-interest statement at the end of the IDSA op-ed, Franco disclosed that he is a vaccine consultant who also holds a patent on a cervical cancer test.

Kane reported no conflicts of interest. However, that claim omits these significant financial and professional credentials:

• Kane is the former director of the Bill & Melinda Gates Children’s Vaccine Program.
• Kane worked at the Gates-affiliated PATH organization.
• Kane was a consultant for Merck.
• Kane sat on the Merck Global Advisory Board for HPV.

“The conflicts are so thick it’s impossible to tell if this is a serious immunization policy suggestion, or a fact-pattern of Merck publishing Merck recommendations to use more Merck products,” said Karl Jablonowski, Ph.D., senior research scientist for Children’s Health Defense (CHD).

Franco and Kane argue that vaccination of adolescents has been hampered by bad publicity about side effects, and that school-based mandates are less effective in low-income countries where not all children attend school.

Their solution: Give the shots to infants and toddlers when vaccination rates tend to be higher, and bundle them with other routine childhood vaccines to reduce cost.

Jablonowski noted that HPV vaccines have been linked to a wide range of serious adverse events, including death. “Unsafe HPV vaccinations for 12-month-olds is unthinkable,” he said, “unless you’re an agent of Merck.”

Trials in children ages 4-8 already underway — with no safety controls

Merck is funding and running clinical trials for Gardasil on children ages 4-8 at Boston Medical Center. The trials involve 150 children who receive two doses of Gardasil over 12 months.

Healthy children ages 4-8 who receive care at a community health center associated with Boston Medical Center are eligible to participate.

Recruitment ads for the study highlighted that participation is compensated — parents receive $400 in “study cards” — usable like credit cards — for enrolling their children. Children receive their first dose of the shot as soon as they enroll.

The Boston Medical Center Health System primarily targets “historically underserved,” typically low-income, communities.

Critics who spoke with The Defender raised concerns that:

• The trial targets low-income families.
• The trial doesn’t include an unvaccinated control group.
• The study design fails to investigate vaccine safety.
• The trial monitors only one side effect — injection-site swelling — observed on a single day, three days after injection.

Because children so young have no exposure to HPV, the trial is not even measuring whether the vaccine prevents infection — it only determines if the children produce antibodies to the HPV strains covered by the vaccine.

If antibody levels in 4- to 8-year-olds are comparable to those in older children who get the shot, researchers said that would justify proceeding to a larger Phase 2 study among a larger group of young children.

The lead investigator listed on the government’s clinical trials registry, Dr. Elisha M. Wachman, did not respond to a request for comment.

Trial design ‘completely useless’ for evaluating safety

Lucija Tomljenović, Ph.D., author of more than a dozen peer-reviewed papers on the HPV vaccine, called the Boston Medical Center trial “completely useless for any meaningful evaluation of HPV vaccine safety.”

She said safety should be a key focus of all vaccine studies. The U.S. Food and Drug Administration’s Center for Biologics Evaluation and Research has stated that because vaccines are given primarily to large numbers of healthy people — often healthy infants and children — “significant emphasis” must be placed on their safety.

“Yet the focus of essentially all vaccine clinical trials is immunogenicity and efficacy, not safety,” Tomljenović said.

She said the safety bar should be set even higher for HPV vaccines because they target a disease that poses no immediate threat to healthy children and is preventable through other means, such as routine Pap screening.

The trial’s three-day adverse event window is particularly problematic, she said. Many of the most serious adverse events linked to HPV vaccines — including autoimmune conditions — take weeks or months to manifest. A three-day observation window can’t detect them.

“This is rather reckless in my opinion,” she said. “The trial assumes safety in an age group in which the vaccine has never been tested.”

Long list of adverse events being ignored

The adverse events Tomljenović said Merck is overlooking are documented in published case reports and adverse event reporting systems. They include: cardiac arrhythmias, acute hemorrhagic encephalomyelitis, autonomic nervous system disorders, chronic fatigue syndrome, premature ovarian failure and permanent disability.

Other studies have identified similar adverse events.

The National Vaccine Injury Compensation Program has recognized serious adverse events linked to Gardasil. In one case, a federal judge awarded compensation to the family of Christina Tarsell, a young woman who died following Gardasil vaccination.

CHD Chief Scientific Officer Brian Hooker said that in addition to the many reports of autoimmune issues following the HPV shot, “exposure to the untested HPV shot aluminum salt adjuvant is cause for sufficient concern to utterly dismiss any such study for this very vulnerable population of individuals.”

Last year, documents revealed that Merck’s Gardasil vaccine contains an additional adjuvant that was not disclosed to recipients and did not have regulatory approval.

The Boston Medical Center trial is not actively monitoring any of Gardasil’s known adverse events.

Parallel study in Gambia — by a Gates-connected researcher

A larger, parallel trial has been running in Gambia, West Africa, since 2019.

The study involves 1,720 female participants across three age groups: 4-8, 9-14, and 15-26. It is led by Ed Clarke, Ph.D., who has also conducted research funded by the Gates Foundation. The study is sponsored in part by the Wellcome Trust, with Merck as a collaborator.

Similar to the U.S. trial, the Gambia study is primarily focused on antibody production, not safety outcomes.

Adverse events that researchers explicitly ask patients about — injection-site swelling, headaches, and other similar symptoms — are tracked for only six days after vaccination. Adverse reactions reported by participants, even though they weren’t asked about the reactions in advance, are recorded for 28 days, and serious unexpected events are reported over three years.

Preliminary results from the Gambia study have been published. Researchers reported a strong immune response in the 4- to 8-year-old cohort, particularly after the second dose. The researchers said their study is the first to report this finding and that it merits further study.

Gardasil sales down 40% globally

Meanwhile, Gardasil sales have been in freefall: down 40% globally between 2024 and 2025, driven in part by a collapse in demand in China, then down another 22% in the first quarter of 2026, with notable declines in Japan and the U.S.

At the same time, an international campaign — funded largely by the Gates Foundation — is underway to vaccinate 86 million girls in low- and middle-income countries against HPV.

The American Academy of Pediatrics, which since 2023 has recommended Gardasil for 9-year-olds, has acknowledged that earlier administration provides no direct benefit to individual children.

The rationale for starting younger is that it increases overall vaccine uptake — a population-level metric, not a medical one.

Related articles in The Defender

• Gates-Funded Plan to Vaccinate 86 Million Girls Against HPV Will ‘Unleash Mass Casualty Event,’ Critic Says
• Merck Knew Gardasil Contained Unapproved Ingredient but Didn’t Tell Public
• Gardasil’s Long Shadow of Autoimmunity Confirmed — Again — by New Study
• Merck Used Highly Potent Aluminum in Gardasil HPV Vaccine Trials Without Informing Participants

The post Consultants Push HPV Vaccines for Infants, as Merck Tests Gardasil in Kids as Young as 4 appeared first on Children’s Health Defense.

 

IPAK-EDU is grateful to The Defender as this piece was originally published there and is included in this news feed with mutual agreement. Read More