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The National Institutes of Health (NIH) is funding research on how to boost the uptake of the human papillomavirus (HPV) vaccine among fifth-grade boys and girls in South Africa, grant documents obtained by Children’s Health Defense (CHD) via a Freedom of Information Act request revealed.
The NIH awarded approximately $340,000 to principal investigators Dr. Ingrid Katz, a physician at Brigham and Women’s Hospital in Massachusetts, and Lisa Michelle Butler, Ph.D., an epidemiologist at the University of Connecticut.
The grant funds a project to develop and test school-based communication strategies targeting children and their parents at schools in the KwaZulu-Natal province in South Africa, to determine what types of communication are more likely to result in more children getting the HPV vaccine.
The funding covers a one-year pilot feasibility study in five schools to test strategies that the researchers will then refine and test on hundreds of children in a larger, “full-scale hybrid type 2 trial.”
The researchers hope the school-based communications strategies they develop will help increase child and adolescent HPV vaccination uptake in South Africa from the current rate of 37% of girls to the target rate of over 80% of all children ages 9-12.
They hope to later use the same strategy in other low- and middle-income countries to increase their rates as well.
“The HPV vaccines have not been independently evaluated for both safety and efficacy,” said Dr. Shankara Chetty, a general practitioner and natural scientist from KwaZulu-Natal. “As such, no amount of coercive marketing strategies will suffice to honestly inform the recipients in their decision to consent.”
“Seeing that minors are being targeted, it is imperative that the guardians of these minors are given all the current information and, more importantly, made aware of the lack of information on safety and efficacy to make an informed choice,” Chetty said. “This cannot be done by the industry profiting from its rollout.”
Part of $40 million grant initiative to promote HPV shots
CHD in June 2023 identified nearly 50 grants awarded by the U.S. Department of Health and Human Services (HHS) and its sub-agencies, including the NIH. The grants, totaling more than $40 million, went to universities, healthcare systems and public health departments to use behavioral psychology strategies to increase HPV vaccine uptake among adolescents.
This is the first grant CHD identified that uses those same methods to target children in Africa.
The research fits into a broader program across HHS institutions that includes hundreds of millions of dollars in grant funding to develop and test strategies to increase the uptake of all vaccines among vaccine-hesitant low-income communities and communities of color using “culturally tailored” messaging in the name of “health equity.”
It is also in line with a push to provide substantial grant funding to increase HPV vaccination rates by “raising awareness” and combating “misinformation.”
In addition to satisfying HHS’ goals, the South Africa project responds to a global program laid out in 2020 by the World Health Organization’s (WHO) World Health Assembly to eradicate cervical cancer as a public health problem worldwide, largely through HPV vaccination.
Bill & Melinda Gates Foundation-backed Gavi, the Vaccine Alliance, last year announced it would invest more than $600 million to reach its goal of vaccinating 86 million girls against HPV in low- and middle-income countries by 2025, largely through national vaccination campaigns.
That announcement coincided with Gavi-supported national vaccination campaigns in Indonesia, Nigeria, Bangladesh, Zambia, Sierra Leone and Eritrea over the past two years.
South Africa was one of the earlier African countries to launch a national school-based vaccination campaign targeted at girls age 9 or older in fourth grade in public schools.
Katz and Butler reported in their grant application that the campaign was initially “successful” but rates have since plummeted, particularly during and after the COVID-19 pandemic.
Merck, which makes the Gardasil HPV vaccine, said it will donate vaccines for the new study. Merck is one of Gavi’s key partners in distributing vaccines in low- and middle-income countries worldwide.
Shabnam Palesa Mohamed, executive director of CHD Africa, told The Defender she was disappointed to see South African researchers collaborating on the project.
She said:
“It is difficult to understand why UKZN [University of KwaZulu-Natal] researchers don’t see this manipulative experiment on children as racist and dehumanizing. The pharmaceutical industry has a horrendous track record in Africa, where pharmacovigilance is weak or non-existent, largely due to pharma funding scientists, regulatory authorities and departments of health. UKZN is no exception. Its funders include the Bill and Melinda Gates Foundation.
“I am reminded of behavioral scientists who helped the U.K. government manipulate the public [during the COVID-19 pandemic] and later said we have been systematically ‘stunned by the weaponization of behavioral psychology’ throughout the pandemic.”
South Africa project ‘smacks of pharmaceutical imperialism’
Under the $340,000 grant awarded to Katz and Butler, principal investigators will collaborate with a team of psychologists, an education specialist, an epidemiologist and a biomedical engineer from U.S. universities and the UKZN, along with the local department of health and elementary schools in an urban setting in the KwaZulu-Natal province.
The name of the city and schools where the project will be implemented were redacted from the FOIA documents provided to CHD.
Researchers will specifically target “diverse populations” and integrate “the voices of individuals living in low-resource settings” as they try to understand why children don’t take the HPV vaccine and in particular why those numbers declined after the COVID-19 pandemic.
“Health equity is at the core of our research,” they wrote.
However, Mohamed said, “Manipulating children and families from underprivileged backgrounds is the essence of medical colonialism.”
She added:
“Not for the first time, there will be no proper informed consent with these children or their families, and there will be no compensation for harms or death caused.
“The role of the controversial NIH in behavioral manipulation — the same NIH that did not expose the WHO facilitating fertility experiments on Kenyan girls and women — smacks of pharmaceutical imperialism.”
The researchers hypothesize declining HPV vaccination rates may be linked to COVID-19-related program interruptions, “increased medical mistrust, and vaccine hesitancy related to misinformation spread on social media,” which they seek to correct.
They are expanding the HPV vaccine target population to include boys and children in private schools who were not initially included in South Africa’s national school-based vaccination program.
Currently, GSK’s bivalent Cervarix vaccine is administered at no charge by school nurses in public schools on two designated days per year. Boys and private school children must pay for the shot.
The HPV vaccine has not previously been made widely available to boys in the country, and most low- and middle-income national vaccination campaigns target girls only.
However, since the U.S. Food and Drug Administration in 2009 expanded the license for use in males ages 9-26 for the prevention of genital warts, and in 2011 the CDC’s Advisory Committee on Immunization Practices recommended it for routine use in boys, vaccination campaigns, at least in the U.S. and Europe, have also targeted boys.
The WHO noted that market sustainability for the drug will require also targeting boys.
To develop the communication materials for testing, researchers held initial meetings with school principals and teachers, nurses and parents of boys and girls enrolled in public and private schools in the study area. They reported respondents expressed a desire to “center community knowledge.”
Respondents also indicated they wanted to make the vaccine program “inclusive” of boys and private school children and to have access to “culturally tailored education materials” to address persistent misunderstandings about vaccination — a set of goals that mirrors those of all other NIH-funded HPV uptake research programs in the U.S.
The pilot project will convene a “Stakeholder Working Group” with representatives from government, civil society, academia and those with legal, financial or ethical stakes in the HPV vaccination program. The group will meet periodically to discuss the research.
The researchers also plan to survey and interview children, families, teachers and school nurses about their ideas and behaviors related to the vaccine.
Based on information gathered in those meetings, they will develop a “multi-level communication strategy” for schools that includes promotional curricular material aimed at children and informational brochures to be distributed to parents.
They also will develop a “conversation map” strategy for teachers and nurses fluent in Zulu that they can use as a tool to “facilitate dialogue” around “misinformation” and vaccine efficacy.
Jive Media Africa will produce “entertaining” curricular materials. The company was selected based on its work producing COVID-19 materials for schools.
The study’s success will be measured by how many children get vaccinated two months, six months and 12 months after the intervention and whether they get an initial dose or the full two-dose series. It also will measure whether the research subjects’ knowledge, ideas and beliefs about the HPV vaccine change.
The project targets fifth-graders and their parents, the researchers wrote, because research has found low coverage in South Africa is primarily due to lack of parental consent. It also targets those who might be able to influence the parents, such as teachers and nurses.
The five-school randomized controlled pilot study funded by the grant will target 200 parents and children and 16 teachers and nurses.
In the Phase 2 trial, a 10-school randomized study will aim for about 1,500 participants.
Parents and students will be recruited in the selected schools through a letter sent home with the fifth-graders asking them to consent to participate in surveys and to share their children’s immunization records. People interviewed will provide verbal consent to be interviewed.
After the pilot study, researchers will refine their materials and launch the Phase 2 randomized control trial in more schools.
The Phase 2 trial is scheduled to begin in January 2025, according to the U.S. government clinical trials website. It is unclear whether funding has already been secured for the Phase 2 trial.
Justification: cervical cancer eradication
According to Gavi, nearly 80-90% percent of the approximately 300,000 deaths per year from cervical cancer — the fourth most common cancer among women — occur in low- and middle-income countries and the majority occur in sub-Saharan Africa.
The higher rates of cancer in low- and middle-income countries are largely attributed to low screening coverage for cervical cancer and limited treatment options in the region, although actual numbers vary widely from country to country.
The HPV virus has been associated with cervical cancer, although the vast majority of HPV infections clear on their own.
There are more than 150 strains of HPV. High-risk HPV types can cause cervical cell abnormalities that are precursors to cancer, although HPV infection is not the sole risk factor for cervical cancer.
Regular pap screening has been found to reduce the incidence and mortality of cervical cancer among women by at least 80%.
However, according to Gavi, “Cervical cancer is almost entirely vaccine-preventable, which means that alongside screening for early detection, rolling out the HPV vaccine is critical to preventing infections.”
The grant documents use this same language although they are less equivocal, stating that cervical cancer is “entirely preventable” with the HPV vaccine. This is despite the fact that the vaccines have not been tested for cancer prevention, only for their ability to suppress target strains of HPV.
Between 2007 and 2012, several low- and middle-income countries conducted small-scale HPV vaccine demonstration projects with vaccines provided by Merck’s now-discontinued Gardasil Access Program or by the Bill & Melinda Gates Foundation through the PATH initiative.
In 2012, Gavi began supporting national HPV vaccine introductions in low- and middle-income countries and it continues to do so today.
A total of 122 WHO member states have added the HPV vaccine to their routine immunization schedules.
However, according to research published in Preventative Medicine, vaccine uptake is highly uneven and researchers argue more “effective communication strategies” are needed.
When South Africa’s program launched in 2012, 86.6% of age-eligible girls were vaccinated in the first year. But by 2019 the numbers were down to 69% and in 2021 they were down to 37%.
HPV vaccine dangers remain unaddressed by project proponents
The Gardasil vaccine has been linked to myriad adverse events worldwide. 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.
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, demonstrate plausible associations between HPV vaccination and autoimmune conditions.
According to an article in the British Journal of Clinical Pharmacology, most low- to middle-income countries have very low reporting rates for adverse events associated with vaccines or other pharmaceutical products, so it is difficult to track injuries related to previous vaccine rollouts.
