Published by Med Check: the Informed Prescriber, Japan
Editor in Chief, Rokuro Hama, MD Chairperson of NPO Japan Institute of Pharmacovigilance; Deputy Editors, Deputy Editors, Y. Kimoto, MD and N Tanida, MD
Plain Language summary:
Two products of HPV vaccines (Cervarix and Gardasil) are marketed in Japan since 2010. More than 3 million girls were inoculated with HPV vaccines until the cancelation of recommendation by Japanese Ministry of Health, Labor and Welfare (MHLW) in May 2013.
Incidence of serious adverse reactions to Cervarix was 800 among 2.6 million girls inoculated (one in 3000 before withdrawal of the recommendation), while the incidence increased to 3.2% per year after the retraction, using the latest data (3,200 cases per 100,000 person years or one in 30 per year). This is similar to the frequency of serious adverse events within 1.2 years after the first vaccination (annual rate of 2.8%) reported in a well-controlled clinical study of Cervarix. In this study, annual incidence of serious reactions, autoimmune diseases and death after 3.4 years comparing with those during 1.2-3.4 years was estimated 4 %, 0.63% and more than one per thousand. These incidence rates might also occur in Japan.
The epidemiologic surveys that Japanese MHLW used as evidence of safety have serious flaws in their methodologies. One study confuses incidence (newly occurred disease among certain population within a certain period of time) with prevalence (a proportion of persons having a disease among certain population at a certain point of time). The other two have serious bias known as the “healthy vaccinee effects”. Those vaccinated are usually healthier than those non-vaccinated, because the latter group avoids vaccines due to their health problems.
While there is no evidence yet that HPV vaccine decreases mortality from cervical cancer, if we assume that the vaccine could cut the cervical cancer mortality by half, the expected maximum benefit would be 2.0 less deaths per 100,000 person-years. Hence, the harm experienced is overwhelmingly greater than the expected maximum benefit.
We strongly recommend avoiding HPV vaccine.
Read Harm of HPV vaccine: Latest information and examination of epidemiological studies here. Begins on page 9.