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. Issue 48 (27th November 2015)

• Record Type: Journal Article
• Authors: Baril, Laurence; Rosillon, Dominique; Willame, Corinne; Angelo, Maria Genalin; Zima, Julia; van den Bosch, Judith H.; Van Staa, Tjeerd; Boggon, Rachael; Bunge, Eveline M.; Hernandez-Diaz, Sonia; Chambers, Christina D.
• Is Part Of: Vaccine. Volume 33:Issue 48(2015)
• Page Start: 6884
• Page End: 6891
• Publication Date: 2015-11-27
• Subjects: Spontaneous abortion -- Human papillomavirus vaccine -- Pregnancy -- Safety -- Vaccine -- Mathematical model; Vaccines -- Periodicals; 615.372
• DOI: 10.1016/j.vaccine.2015.07.024
• Languages: English
• ISSNs: 0264-410X

Abstract

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