Risk of spontaneous abortion and other pregnancy outcomes in 15–25 year old women exposed to human papillomavirus-16/18 AS04-adjuvanted vaccine in the United Kingdom

• DOI: 10.1016/j.vaccine.2015.07.024
• Publication Date: 2015-07-20T23:28:23Z
• Authors: Laurence Baril; Dominique Rosillon; Corinne Willame; Maria Genalin Angelo; Julia Zima; Judith H. van den...; Tjeerd Van Staa; Rachael Boggon; Eveline M. Bunge; Sonia Hernandez-Diaz; Christina D. Cham...
• Keywords: Adult; Adolescent; Aluminum Hydroxide; Human papillomavirus vaccine; Risk Assessment; Young Adult; 03 medical and health sciences; Mathematical model; 0302 clinical medicine; Pregnancy; Immunology and Microbiology(all); Humans; Papillomavirus Vaccines; Spontaneous abortion; Public Health, Environmental and Occupational Health; Pregnancy Outcome; veterinary(all); United Kingdom; 3. Good health; Abortion, Spontaneous; Infectious Diseases; Lipid A; Molecular Medicine; Female; Safety; Vaccine

We assessed the risk of spontaneous abortion (SA) after inadvertent exposure to HPV-16/18-vaccine during pregnancy using an observational cohort design. The study population included women aged 15–25 years registered with Clinical Practice Research Datalink General OnLine Database in United Kingdom (UK), who received at least one dose between 1st September 2008 and 30th June 2011. Exposed had first day gestation 30 days before 45 (90 for extended period) any dose. Non-exposed 120 days–18 months last SA defined as foetal loss weeks 1 23 (UK definition). frequency was 11.6% (among 207 exposed) 9.0% (632 non-exposed), women: hazard ratio (HR) adjusted age 1.30 (95% confidence interval: 0.79–2.12). Sensitivity analysis per number doses administered (−30 +45-day showed a HR 1.11 (0.64–1.91) 18/178 period versus 2.55 (1.09–5.93) 6/29 two within 4–5 period. proportion pre-term/full-term/postterm deliveries, small/large gestational infants, birth defects not significantly different exposed non-exposed women. Results were consistent (United States) definition 1–19 and/or There no evidence increased other adverse outcomes young inadvertently HPV-16/18-vaccinated around gestation. Nevertheless, are pregnant or trying become advised postpone vaccination until completion pregnancy.