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The National Institutes of Health (NIH) is funding research at Nashville, Tennessee’s Meharry Medical College on how to increase uptake of the human papillomavirus (HPV) vaccine among underserved adolescents whose parents are “vaccine-hesitant,” documents obtained by Children’s Health Defense (CHD) via a Freedom of Information Act (FOIA) request revealed.
The NIH awarded a $519,399, four-year grant in 2019 to Jennifer Cunningham-Erves, Ph.D., MPH, associate professor of internal medicine, to develop “tailored health communication messaging” to target vaccine-hesitant parents by testing out an intervention in a trial at a local clinic serving primarily African-American families and Medicaid recipients.
It is one of nearly 50 grants identified by CHD in June — totaling more than $40 million — awarded by the U.S. Department of Health and Human Services (HHS) to universities, healthcare systems and public health departments to increase HPV vaccine uptake among adolescents.
It is the second grant CHD identified that targets primarily Black families. As previously reported, FOIA documents revealed HHS awarded a $600,000, three-year grant to a Rutgers University researcher to develop “culturally tailored” follow-up text messages to Black vaccine-hesitant parents after their provider recommended the HPV vaccine for their children.
The grant awarded to Erves funds a project that develops a smartphone-based tool to send to parents before they see a provider that identifies the reasons behind their hesitancy and offers counterarguments tailored to their concerns.
Both grants fit into a broader research program across the various HHS institutions, including the NIH, to dedicate hundreds of millions of dollars toward creating strategies specifically tailored to increase vaccine uptake in general among vaccine-hesitant communities of color.
And they are in line with a national push to provide substantial grant funding to increase HPV vaccination rates by raising awareness and combating “misinformation.”
For example, Rep. Kathy Castor (D-Fla.) is promoting a federal bill, the PREVENT HPV Cancers Act of 2023, that would authorize $5 million annually through 2028 for an HPV vaccine awareness campaign.
The campaign would fund “tailored messaging” toward males, LGBTQ people, Black and Hispanic women, and rural communities.
Overcoming ‘vaccine hesitancy’ with a smartphone
Erves, an early career researcher, is designing a pilot clinical trial through research mentored by experts in HPV vaccine hesitancy and health equity.
Listed as mentors to Erves on the grant include Dr. Consuelo Wilkins of Vanderbilt University Medical Center, Pamela Hull, Ph.D., of Vanderbilt University Medical Center and Amanda Dempsey, M.D., Ph.D., MPH.
Dempsey was a professor of pediatrics at the University of Colorado at the time the grant application was filed, but the research project’s HPVVaxFacts website lists her as Regional Medical Scientific Director at Merck, the maker of the Gardasil HPV vaccine.
Dempsey also serves on advisory boards for Merck, Pfizer, and Sanofi Pasteur. She authored one of the seminal articles in the field of HPV vaccine hesitancy, finding that generic educational materials had little impact on vaccine-hesitant parents and giving rise to research like Erves’ on “tailored” interventions.
The pilot aims to develop a smartphone-based tool that sends text messages to parents designed to overcome their hesitancy about HPV vaccines — hesitancy the researchers said is linked to “vaccine concerns (i.e. safety and side effects), misinformation, lack of knowledge, and concerns of transmission through sexual activity.”
The goal is to test the tool in a large-scale clinical trial.
Researchers will draft a pre-visit text to parents who in the past refused HPV vaccination for their children. Parents can click on a link in the text that will lead them to a webpage where they can take a quiz that gauges their attitudes and beliefs about the HPV vaccine.
By categorizing the responses, researchers can define the types of hesitancy parents have and then respond with messages specifically tailored to change their minds.
The messages use the child and parents’ names to personalize the materials and match the materials — including images — to the parents’ ethnicity and race.
For example, parents whose quiz responses indicate they are concerned about whether the vaccine is effective might receive this message:
“The HPV vaccine is highly effective in protecting against 93% of cancers caused by HPV. It is most effective when given before age 13.”
Those concerned with serious adverse impacts might receive this message:
“The HPV vaccine is very safe. Vaccines, like any medications, can have side effects. Many people who get the HPV vaccine have no side effects. Some people report mild side effects like a sore arm, fever, nausea, or fever. Serious reactions are very rare.”
The parents also receive links to “reliable” websites and suggested questions they can ask their doctor.
Researchers identify vaccine-hesitant parents by examining the health records of children ages 11-18 and identifying those whose parents refused vaccination for their children within the previous two years.
Parents are paid $30 for their participation in the pilot. They are interviewed and surveyed at various points in the process, so the quiz design can be measured for effectiveness and amended based on their responses. Providers receive $50.
The study includes approximately 45 parents and physicians, nurse practitioners and physician assistants at Meharry Medical College.
‘Fact checking’ the study’s premise and the text message claims
The move to focus resources on communities of color and poor and underserved communities that have higher rates of HPV-associated cancers is based on the claim that the HPV vaccine will reduce these cancer rates significantly.
For example, this research proposal states:
“Human papillomavirus (HPV) causes 31,500 new cancer cases yearly (i.e., cervical, oropharyngeal, anal, vaginal, vulvar, and penile). … Up to 93% of these cancer cases could be prevented with HPV vaccination. … Improving HPV vaccination among adolescents is an urgent public health priority to prevent and reduce disparities in HPV-associated cancers.”
And the proposed quiz response to parents concerned about efficacy repeats that same claim.
But the data cited don’t support the claim. Erves provides two citations — one is a Centers for Disease Control and Prevention webpage that doesn’t even mention the HPV vaccine.
The second is an article published in F1000Research that explicitly states, “It is too early to show clinical disease or population-based disease reduction for cervical cancer.”
And yet, the NIH funded the research to propagate this same unsubstantiated claim.
The F1000 article also says, “Although some studies have shown detectable neutralizing antibodies 10 years after vaccination, there are not yet any data about antibody persistence beyond that.”
That statement throws the proposed quiz’s second assertion — that the vaccine is most effective when given prior to age 13 — into question.
Other NIH-funded grants CHD examined made similar claims. For example, the research proposal funded at Rutgers to increase HPV vaccine among Black adolescents begins with the claim that “vaccination against HPV can prevent multiple kinds of cancer that disproportionately affect Black and Hispanic populations.”
That proposal treats the assertion as so “common sense” that it doesn’t provide any citation for the claim.
However, studying HPV vaccine efficacy for eliminating cervical cancer is challenging due to the extended time — 23.5 years on average — between infection and the development of cancer, lack of adequate informed consent, and the complex relationship between HPV infection and cervical cancer.
According to James Lyons-Weiler, Ph.D., president and CEO of the Institute for Pure and Applied Knowledge, studies claiming the vaccine reduces cervical cancer are misleading for a number of reasons.
For example, some research has shown that because the HPV vaccine targets only specific HPV strains, it has led to an increase in more lethal types of HPV, replacing the less lethal types targeted by vaccination.
Lyons-Weiler also pointed to other research, published in the Journal of the Royal Society of Medicine, showing that Phase 2 and Phase 3 efficacy trials themselves have been rife with methodological problems that undermine efficacy claims.
That research also points out that none of the trials were designed to detect the vaccine’s effectiveness against cervical cancer. And most trials tested HPV outcomes for people much older than children ages 9-13, when vaccination is typically offered.
Research shows that in all countries that performed smear screening, the pre-vaccination period from 1989 to 2007 was marked by a significant decrease in the incidence of cervical cancer. And that since vaccination began, that trend has reversed.
The second sample intervention made by the quiz repeats Merck’s marketing claims that the HPV vaccine is “safe,” and there are very few serious side effects.
In fact, many recipients have experienced serious side effects. But the number of adverse events remains unknown, in part because Merck refused to make the data it has collected on Gardasil injuries in its proprietary Adverse Event Reporting and Review System available to researchers or the public.
In April, a North Carolina district court ordered Merck to turn over all of its Gardasil adverse events databases to plaintiffs suing the pharmaceutical giant for injuries allegedly caused by the HPV vaccine.
Some of the signature impacts observed following HPV vaccination include permanently disabling autoimmune and neurological conditions such as postural orthostatic tachycardia syndrome, or POTS, fibromyalgia and myalgic encephalomyelitis/chronic fatigue syndrome.
There have been thousands of reports of adverse events worldwide, peer-reviewed scientific literature from the U.S., Australia, Denmark, Sweden, France and Japan, and statistics published by public health agencies in each of these countries that demonstrate associations between HPV vaccination and autoimmune conditions.
