GlaxoSmithKline’s HPV vaccine, Cervarix™ wasn’t approved for marketing in Canada until Feb 2010. In April 2012 it was added to BC’s taxpayer funded vaccines as a one time catch up for 18-21 yr old females, ie those teens/young adults who were too old to be eligible for the BC schoolgirl Gardasil HPV vaccine program when it was introduced. Like Gardasil, it contains genetically engineered “virus-like particles” manufactured from HPVs 16 and 18 which are said to cause cervical cancer; Unlike Gardasil, it doesn’t contain the “virus-like particles” manufactured from HPVs 6 and 11, said to cause genital warts.
Whereas Gardasil contains only one adjuvant, aluminum hydroxyphosphate sulphate, Cervarix is formulated with the proprietary adjuvant system AS04 which contains both an aluminum adjuvant and the oil-in-water adjuvant, MPL. Supposedly, this novel system will make Cervarix better able to prevent cervical cancer than Gardasil, but only a very long time will tell. For reasons discussed in our article highlighting Gardasil, it’s possible that neither vaccine will reduce the incidence of cervical cancer and either might even increase it.
The Cervarix™ monograph warns, “Vaccination should not be undertaken in women who are pregnant and vaccinees should be advised to take adequate precautions to avoid pregnancy for 2 months following vaccination.” It also admits, “Cervical cancers begin as asymptomatic precancerous lesions and usually develop gradually over many years.” This reminds us that, for those concerned about acquiring cervical cancer, regular Pap tests can detect signs of cancer early enough that the disease can be prevented.
During clinical trials of Cervarix, 91.8% of 10-25 yr old participants suffered pain at the injection site within seven days of receiving Cervarix; 55% experienced fatigue within that same time frame. The trials showed little difference in rates of serious adverse events between participants vaccinated with Cervarix and “controls” vaccinated with Hepatitis A vaccine or aluminum hydroxide adjuvant (which is not surprising considering the riskiness of the so-called “controls”).
Of the deaths which occurred during the trials, those which occurred more frequently in participants injected with Cervarix than in those injected with a “control” were due to neoplasm (new abnormal growth, in this case obviously malignant), autoimmune disease, infectious disease and cardiovascular disorders. Perhaps conveniently for GlaxoSmithKline, whether or not vaccination with Cervarix triggered these diseases was not determined. Overall, rates of potential new onset autoimmune diseases were similar in both the Cervarix-injected and control-injected participants. However, the Cervarix™ monograph states that, “the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice”.
A study published in 2011 discusses HPV vaccine adverse events which have been observed and reported in many countries. It reports, “In the Netherlands, the reported rate of serious ADRs [adverse reactions] from Cervarix per 100,000 doses administered is nearly 4-fold higher than the age-standardized death rate from cervical cancer.” The authors suggest that, given “the uncertain benefits” of the vaccine, we should be concerned about this high rate of ADRs. They note that, “for any of the two HPV vaccines, the reported rate of ADRs per 100,000 doses administered is very similar across different countries”. They also inform that, “the total number of ADRs reported for Cervarix appears to be 24-104 times higher than that reported for any other vaccine in the U.K. immunization schedule.”
An example of a UK ADR is the case of Ashleigh Cave who, nine months after a Cervarix vaccination, was still in hospital unable to stand unaided and without bladder control at the age of thirteen. Ashleigh’s horrific adverse event is just one of several in UK school girls which are discussed in detail online.