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When the Centers for Disease Control and Prevention (CDC) last week reduced the number of recommended routine childhood vaccines, the agency left the controversial human papillomavirus (HPV) vaccine on the schedule.
However, the CDC now advises a single dose of the HPV vaccine, instead of the previous two-dose regimen.
The new schedule recommends children receive a single dose of the HPV vaccine at age 11. The previous schedule recommended two doses of the vaccine for children ages 9-14 and three doses for teens and adults, ages 15 and up.
Merck’s Gardasil 9, intended to protect against 9 HPV strains, is the only HPV vaccine distributed in the U.S.
In making the new recommendations, the U.S. Department of Health and Human Services (HHS) cited a growing global consensus that one shot is effective at protecting against HPV.
“Recent scientific research shows that vaccination with one dose of the HPV vaccine is as or nearly as effective as two doses,” HHS Press Secretary Emily G. Hilliard told The Defender in an email. “Australia, Canada, Ireland, Spain and the United Kingdom have already changed their recommendation to one dose.”
In 2022, the World Health Organization (WHO) also changed its recommendation, stating that “a single-dose Human Papillomavirus (HPV) vaccine delivers solid protection against HPV.” The WHO changed its recommendations from three doses to a one or two-dose schedule for girls and women ages 9 and up.
Some mainstream public health advocates said the CDC lacked scientific support for its decision to drop the recommendation from two doses to only one.
However, the change aligns with moves already being considered by the CDC before U.S. Health Secretary Robert F. Kennedy Jr. took office. The previous members of the CDC’s Advisory Committee on Immunization Practices had already begun considering changing the recommendation to a single dose.
Some experts who spoke with The Defender supported the change, arguing that one dose was about as effective as more doses and that it would be safer. However, experts in HPV vaccine injury criticized the decision to keep the shot on the schedule.
Dr. Diane Harper, a former Gardasil researcher for Merck and former critic of the vaccine, said that “the one dose HPV vaccination for adolescents 15 and younger is the most appropriate medical care possible.” She said that it is simpler to recommend one shot, because follow-up appointments are not needed.
Harper, now with the University of Michigan’s Department of Family Medicine, has in the past advocated for a single dose, believing it would lead to fewer vaccine injuries.
“Safety is even better as there is only one dose,” she said. “As with any medication, the fewer the doses, the lower the potential for any side effects.” However, she emphasized that the vaccine does not reduce the need for regular cervical cancer screenings.
Vaccine researcher James Lyons-Weiler, Ph.D., said the new recommendation was “a major win” for families whose children are susceptible to injury from the HPV vaccine. He said the change made sense given the lack of evidence of increased efficacy from additional doses.
‘Just one dose … contains 500 micrograms of aluminum nanoparticles’
Some experts told The Defender that even one shot of the HPV vaccine offers so little benefit and poses such serious risks that the shot shouldn’t be on the schedule at all.
“Frankly I am very disappointed with the CDC’s decision,” said Lucija Tomljenovic, Ph.D., author of several articles on the HPV vaccine.
Tomljenovic also wrote an expert report detailing how Merck manipulated data during the Gardasil approval process. The report was part of the expert testimony prepared for a lawsuit against Merck.
“They [the HPV vaccines] are demonstrably neither safer nor more effective than Pap screening combined with routine procedures for the removal of pre-cancerous lesions in the cervix, nor can they improve the diagnosis of serious cervical cancer outcomes,” Tomljenovic said.
Dr. Sin Hang Lee, a pathologist, agreed with Tomljenovic. In 2011, Lee discovered high levels of HPV DNA fragments in Gardasil vials from several countries. The fragments were linked to autoimmune disorders from the shot.
Lee said that given the HPV vaccines’ poor safety profile and lack of evidence that they reduce cervical cancer, combined with the documented “fraudulent manipulation” in the clinical trials, “the HPV vaccines should be taken off the market.”
Children’s Health Defense Chief Scientific Officer Brian Hooker said he didn’t know of any valid study showing a reduction in cervical cancer in the U.S. since the introduction of the HPV vaccine.
“We also know that the shot can lead to a higher incidence of cervical cancer in individuals already infected with HPV, yet there is no testing for HPV prior to giving the vaccine,” he said.
Hooker added:
“I believe that the HPV shot should be taken off of the CDC schedule completely. Limiting the schedule to one HPV shot will indeed save lives and reduce associated injuries. However, just one dose of the vaccine contains 500 micrograms of aluminum nanoparticles which become the payload for macrophages to deliver this neurotoxin to the brain. This needs to be considered in light of any yet-to-be-affirmed benefit of HPV vaccination.”
MarketWatch reported that the CDC’s new recommendation could result in Merck losing up to $630 million in Gardasil revenue this year. Merck did not respond to The Defender’s request for comment on the change.
Gardasil trials never demonstrated cancer prevention
Tomljenovic said the HPV vaccines were approved on the basis that they prevent cervical cancer, which was never demonstrated in the clinical trials.
Lee added that the trials used surrogate endpoints, rather than testing for cervical cancer reduction.
“The clinical trials were based on using reversible surrogate or proxy cell changes as the endpoints for cancer prevention efficacy evaluation,” Lee said. “The FDA approval of Gardasil being a cancer prevention vaccine was based on manipulation of the clinical trial data, a potential fraud.”
The clinical trials, called FUTURE I and II, included participants from outside the U.S., and data from countries with much higher rates of cervical cancer than in the U.S., where regular screening had already reduced cancer incidence to low levels.
The trials also didn’t test for cervical cancer, according to Lee. Instead, they tested for CIN3 lesions, which are mild and not likely to progress to cancer. CIN3 lesions often resolve on their own.
“The practice of selecting a specific, potentially non-representative group of subjects to ensure a desired outcome in clinical trials is a form of selection bias, a fraudulent manipulation,” Lee said.
Tomljenovic also noted that the annual incidence of cervical cancer in the Western world is extremely low. She said the HPV vaccines can’t reduce the incidence further. That’s because Gardasil 9 doesn’t protect against all 14 strains of HPV, and because for the vaccine to provide any overall benefit, virtually all children would need to be vaccinated and the vaccine would have to have 100% efficacy.
“This is an extremely unrealistic scenario,” she said.
Since the clinical trials, “The epidemiological data purportedly showing cervical cancer prevention following HPV vaccination is still limited and fraught with methodological biases and hence uncertain,” Tomljenovic said.
She said that to further reduce cervical cancer, it would be better to target other risk factors for the disease and promote regular pap smears. Other risk factors include the use of oral contraceptives, smoking and the presence of other sexually transmitted infections.
First dose causes most HPV vaccine injuries, expert says
Tomljenovic said that reducing the number of doses from two or three to only one will “for sure” prevent some adverse events.
“It ought to be a matter of common sense reasoning that for vaccines with uncertain/unproven benefits designed to prevent a disease that is already safely and very efficaciously preventable by Pap screening, the risk to those vaccinated should be ZERO,” if a vaccine is recommended, she said.
But that’s far from being the case, she said. National and international vaccine safety surveillance databases show a disproportionately higher reporting of adverse events related to HPV vaccines in comparison to all other vaccines, Tomljenovic said.
“They also show a remarkable consistency in the type of adverse events that are disproportionately reported — with serious disabling systemic, neurological and autoimmune manifestations showing the highest safety signals.
Tomljenovic’s analysis of Gardasil adverse events in the Vaccine Adverse Event Reporting System or VAERS database since the vaccine hit the market in 2006 shows that most adverse events are associated with the first dose.
Lee said his research showed that HPV vaccines contain undisclosed ingredients designed to strongly stimulate the immune system. Gardasil uses components that activate a specific immune receptor (TLR9) that is part of the body’s first-line immune defense.
When this immune stimulator is injected, it can trigger inflammation and cause the body to release a chemical called TNF-alpha. TNF-alpha is a factor in inflammation and, at high or inappropriate levels, can suppress heart function. It is linked to autoimmune diseases, he said.
Hundreds of cases have been filed against Merck in state and federal court alleging the drugmaker failed to adequately warn people about serious side effects of its Gardasil HPV vaccine. Last year, a federal judge ruled in Merck’s favor, but plaintiffs are planning an appeal.
Related articles in The Defender- ‘Stunning Admission’: Widely Used HPV Vaccine Linked to 4 Autoimmune Disorders
- HPV Vaccine May Cause Increase in Cancer-Causing Strains, Study Shows — But Media Puts Misleading Spin on Study’s Findings
- Gates-Funded Plan to Vaccinate 86 Million Girls Against HPV Will ‘Unleash Mass Casualty Event,’ Critic Says
- HPV Vaccine Increases Risk of Autonomic Dysfunction and Menstrual Irregularities in Young Women
- CDC Relied on Cherry-picked Data to Claim No Link Between Merck’s Gardasil Vaccine and POTS
