Research Team Led by Prof. Ju-Young Shin (School of Pharmacy) Demonstrates Stability of Human Papillomavirus Vaccination for female adolescents

- Identifies that there is no significant increase in risk in the vaccinated groups compared to unvaccinated groups
- Published the paper in British Medical Journal, one of the world’s four major medical journals

[Image 1] From the left – Prof. Ju-Young Shin, Researcher Dong-Won Yoon (first author), Ph.D Hye-Sung Lee (co-author)

A research team led by Prof. Ju-Young Shin (School of Pharmacy) announced that they demonstrated stability of human papillomavirus vaccination (HPV) for female adolescents.

Since its development, HPV has been introduced as national vaccination in more than 120 countries around the world and has been widely used. Through many researches from various countries, its stability has been proved and the World Health Organization recommends two vaccinations every six months.

Since June 2016, the Korea Disease Control and Prevention Agency has also introduced a two-dose schedule of bivalent or quadrivalent HPV for adolescent girls aged 12-13 years as part of its national immunization programme. Despite the extensive use of the HPV worldwide, safety concerns about HPV have not diminished, and concerns about vaccine related serious adverse events have undermined public confidence about immunization. A survey among Korean parents who did not want their children to receive HPV indicated that 73.5% were reluctant because of concerns about serious adverse events. To alleviate these concerns, good quality evidence on the safety of the vaccine in the Korean population is needed. Because most studies have focused on Western populations, information on the safety profile of HPV in Asian populations is insufficient.

In response, with the support of GFID, the research team received vaccination registration data from the Korea Disease Control and Prevention Agency as part of its project to study vaccine adverse events and develop safety and efficacy quality assessment technologies. With the given data and the customized data from the National Health Insurance Service, the team conducted research on stability of HPV.

Unlike previous studies, the research team adopted two complementary research designs: cohort study and self-controlled risk interval to assess the association between HPV and the predefined serious adverse events separately. In addition, the team presents the mean days (interquartile range) to disease diagnosis after each dose of HPV. Outcomes were 33 serious adverse events, including endocrine, gastrointestinal, cardiovascular, musculoskeletal, haematological, dermatological, and neurological diseases. As a result, it was confirmed that there was no significant association for serious adverse events in vaccinated group compared to the unvaccinated group.

Prof. Shin said, “This study proves the safety of HPV and mitigate public concerns. Through the result of this study, it seems that it would be used as basis for safety vaccination at actual clinical sites. It is also expected to play an important role in improving public health by reducing the burden of disease on cervical cancer.”

Researcher Yoon and Ph.D. Lee said, “It is significant that it is possible to generate evidence for safe vaccination by proving the safety of cervical cancer vaccines for population group in Korea. With the current introduction of the novel coronavirus infection (COVID-19) vaccine, the same methodology can be applied to assess the association between COVID-19 vaccination and adverse events.

This paper was published in British Medical Journal (Impact Factor=30.31, JCR Ranking Top 2.7%), one of the world’s four major medical journals, on January 29 (Fri) online.

※ Title: Association between human papillomavirus vaccination and serious adverse events in South Korean adolescent girls: nationwide cohort study
※ URL: https://www.bmj.com/content/372/bmj.m4931