HPV vaccines would only be well-marketed products, inducing unacceptable sexual behavior and causing serious adverse effects. Gardasil® contains aluminum salts and Cervarix® the ASO5-adjuvant. To stimulate the immune response immunoenhancers are included in the adjuvant formulation. We want to give an overview of long term safety of the ASO4-adjuvanted vaccine.
Literature.
In the timeframe around immunization implementation, the number of reported concurrent autoimmune diseases will increase. Therefore, their prevalence needs to be monitored in advance. New onset of chronic diseases (NOCDs, mainly asthma, urticaria and hypersensitivity): 1.7% in the HPV16/18 group and 1.7% in the control group. The frequency did not differ between the groups during all follow-up periods. [1] New onset of autoimmune diseases (NOADs, mainly thyroid-related): 0.4% in the HPV16/18 group and 0.3% in the control group. The frequency did not differ between the groups during all follow-up periods.[1] Pregnancy: The percentage of spontaneous abortion in those exposed to vaccination within 60 day before pregnancy was 15.1% vs. 9.5% in a control group [2]. In an animal study, where the vaccine was administered to parental female rats, there was no negative effect on their clinical condition, bodyweight, food consumption. Their pregnancy-rates and embryo fetal growth were unaffected. The survival and development of the offspring was equal to the control animals (injection with saline). Transfer of antibodies to fetuses and pups occured in utero and during lactation, respectively . The concentration of antibodies in the rat fetuses was around 20% of that found in the vaccinated dams. [3] Deaths: In 2014, on 57 580 subjects, 63 deaths were administered: 25 in recipients, 20 in controls and 18 in blinded groups. Common causes were suicide, malignancy, infections and road accidents. [4] Solicited symptoms: Injection site symptoms and some general symptoms were more common in the vaccine group than in control groups [2] Most common unsolicited symptoms were events to be expected in the study population.
The HPV-16/18 ASO4-adjuvanted vaccine is safe. Point of attention might be not to get pregnant shorter than 60 days after administration.
[1] Safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine for cervical cancer prevention: a pooled analysis of 11 clinical trials. Descamps D, et al. Hum Vaccin 2009. [2] Strategies for continuous evaluation of the benefit-risk profile of HPV-16/18-AS04-adjuvanted vaccine. Angelo MG, et al. Expert Rev Vaccines 2014. [3] Evaluation of the intramuscular administration of Cervarix™ vaccine on fertility, pre- and post-natal development in rats. Segal L, et al. Reprod Toxicol 2011 [4] Pooled analysis of large and long-term safety data from the human papillomavirus-16/18-AS04-adjuvanted vaccine clinical trial programme. Angelo MG, et al. Pharmacoepidemiol Drug Saf 2014