Gardasil for Infants Peer Review

In her 2016 article “Gardasil, considered the most dangerous vaccine on the market,
may soon be pushed for infants”, Vicki Batts expresses her concerns about using a vaccine,
Gardasil, to prevent human papillomavirus (HPV) in infants. She claims that this vaccine,
approved by the FDA in 2006, is the most dangerous vaccine available, and that there is no
relationship between HPV and the development of cervical cancer. She postulates, based on a
2013 study conducted by McCormack and colleagues, that there is no way to prevent cervical
cancers related to HPV infection because the karyotypes analyzed in the study were unique and
independent of viral manipulation. Thus, there is no need for a prophylactic vaccine to prevent
carcinomagenesis of cervical cancers. She also claims that some people had even died
following vaccination with Gardasil. However, there were not any clinical trials conducted with
the intent that the vaccine could be used in infants during the time period that she stated, there
is a clear explanation of how HPV can cause cervical cancer development, and there is no
evidence to support the claim that vaccination with Gardasil directly caused reproductive
adverse events or death in some patients.
There are 40 types of HPV that can infect the stratified squamous epithelium that are
found in the anogenital region of the body, 12 are which are known to cause cancer [1]. The two
serotypes that are associated with being responsible for causing various cancers are 16 and 18
[1]. Many of these cancers are preventable upon receiving a vaccine. Gardasil is the most used
vaccine to prevent HPV, but has been a point of debate since its release in 2006 [2]. This
vaccine is safe and highly efficacious in preventing cancer, making it an invaluable resource as
HPV prevalence continues to rise [2, 3].
Batts’ claim that there was a clinical trial to expand the indication for Gardasil to infants
is not substantiated from searching several clinical trial databases, including Merck’s.
Nonetheless, if there was a clinical trial planned for this purpose, it would need to be in
accordance with the National Institute of Health’s (NIH) guidelines for regulating the involvement
of children in research. These requirements are enacted to protect the autonomy of children in a
research setting and promote ethical use of adolescent subjects in this environment [4]. If a
clinical trial were going to be conducted for Gardasil use in infants, it would have to align with
these rigorous requirements, and by doing so, would be overseen so that no infants were put in
harm’s way.
Cervical cancer is the third most common type of cancer in women in the United states,
surpassed only by skin cancer and breast cancer [5]. HPV has been related to 99.7% of cases
of cervical cancer across the world, with HPV 16 and HPV 18 genotypes being the primary
contributors to carcinomagenesis [5-8]. HPV infections begin with the invasion of viral material
into the basal layer of stratified squamous epithelium, which is found in many parts of the body,
including the reproductive tract [5, 7, 8]. E proteins are responsible for the transcription and
replication of viral HPV cells, and many are conserved across different genotypes of the virus
[7]. E5, E6, and E7 proteins are primary initiators of the development of cervical cancer, but
many other factors contribute to the proliferation and survival of carcinogenic HPV cells in the
body [5, 7]. These proteins utilize the MAPK-ERK, Wnt, Notch, and PI3K/AKT pathways to
control malignant cell transformations in the body [7]. Each of these pathways have unique roles
in carcinomagenesis that is directly related to their activation by E proteins introduced to the
system by HPV.
There are very few incidences of severe adverse events associated with HPV
vaccination relative to how many immunizations are given. By July of 2008, at least 26 million
doses of quadrivalent HPV vaccines had been administered [9]. In Australia, there were 1,012
reports of adverse events following immunization of 3.7 million people [9]. Within this group, 103
reports were of severe adverse events, with 8 cases reporting a confirmed anaphylactic
response [9]. Therefore, the incidence of an anaphylactic response is about 0.2 cases per
100,000 doses of HPV vaccine, a lower rate than many other vaccines that are given to children
and adolescents. In the United States, the Vaccine Adverse Event Reporting System (VAERS)
can be used to report any adverse events that may occur after receiving a vaccination. It
categorizes death, life-threatening illness, disability, and hospitalization as adverse events [9].
There were 7,802 reports of adverse events, with less than 7% being considered serious,
following the administration of more than 12 million HPV vaccinations. There were 15 deaths
reported to be a result of HPV vaccination, but after investigation, researchers concluded that
none of them were a direct result of such immunizations. Another common concern is the
development of Guillain-Barre syndrome (GBS) following vaccination [9]. There were 31 reports
of people developing GBS after receiving the HPV vaccine [9]. Of these reports, 19 were
investigated further and 10 of them were confirmed [9]. However, 5 people had received the
quadrivalent meningococcal conjugate vaccine that is known to cause symptoms of GBS [9].
Many of the adverse events associated with HPV vaccination are mild and subside shortly after
receiving the vaccine, and severe adverse events associated with the HPV vaccine are
extremely rare.
To conclude her article, Batts referred to “leading HPV researcher” Dr. Dianne Harper’s
statement that adverse events from receiving Gardasil were as serious and as common as
deaths related to cervical cancer each year. Harper’s insights may not be so credible, however.
While Harper was associated with the development of Gardasil, she was never so involved in
the research that she was listed as a contributing author to any publications. She has become
the face of the movement to remove Gardasil from the market, as her words are often twisted by
biased, “anti-vaxxers”, such as Batts herself.
Overall, Batts had little evidence to support her claims about the dangers of receiving a
vaccine for HPV. Moreover, her worries about the vaccine being used in infants are
unsubstantiated due to the fact that there was no such clinical trial that intended to do so. HPV
vaccines are safe, and it is recommended that children receive them starting at 9 years of age.
While some severe adverse events are associated with HPV vaccination, they are incredibly
rare, and do not outweigh the benefits that the vaccine provides to a majority of the population
that receives it.
 Bibliography
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