End-of-study safety results from a community-randomized controlled trial in Finland comparing the efficacy of two vaccination methods utilising the AS04-adjuvanted human papillomavirus (HPV)-16/18 vaccine are presented in this paper. The overall vaccination cohort comprised 32,175 adolescents aged 12–15 years old at the time of immunisation, with 14,837 receiving the AS04-HPV-16/18 vaccine and 17,338 receiving the hepatitis-B virus vaccine. The AS04-HPV-16/18 vaccination has an acceptable safety profile based on spontaneous reporting of severe adverse events (SAEs) and monitoring utilising national health registries.
During the research period, the occurrences of reported SAEs thought to be probably related to vaccination were 39.1 and 39.8, respectively, in the HPV and control groups. Ulcerative colitis, insulin-dependent diabetes mellitus, Crohn’s disease, celiac disease, and juvenile idiopathic arthritis were the most often reported new-onset autoimmune disorders. The majority of the 1,344 recorded pregnancies ended in intentional termination, the birth of a live child, or spontaneous abortion. There were no serious, recorded congenital abnormalities found. NOAD incidence rates and pregnancy outcomes were fairly balanced among groups. In the population-based heal, no particular safety signs were discovered.
Reference: https://www.tandfonline.com/doi/full/10.1080/21645515.2019.1692557
