Adverse pregnancy outcome (APO) in 4vHPV vaccinated Armenian cohort
Vahe Ter-Minasyan1,*, Vadim Frolov2, Gagik Bazikyan1, Ara Drampyan1, Vahan Manvelyan1, Gayane Sahakyan, Hayk Melkumyan
¹National Institute of Health (Yerevan, Armenia)
²”Astghik” Medical Center (Yerevan, Armenia)
Abstract
Introduction. High coverage of HPV immunization among girls of target age population can significantly increase the efficiency of Cervical cancer (CC) prevention strategy and help the health system to achieve the target prevalence of 4 cases per 100 000 female population, indicated by WHO in 2020. Decreased prevalence of precancerous conditions and cancers verified by screening, finally resulting in decline of CC mortality rates are the most significant proofs of the vaccination importance as a CC primary prevention measure. We conducted a retrospective, observational cohort study using clinical data for to verify the influence of HPV vaccine (Gardasil, Merck&CO) on pregnancy outcome in women, vaccinated in RA since 2017 year in the limits of anti-HPV vaccination Program (included in National Vaccination Calendar).
Materials and Methods. For the study, we analyzed data contributed by 2 Maternity Hospitals of Yerevan. The clinical data of patients applied to the mentioned Medical Centers within 01.11.2019- 31.10.2023 were retrospectively observed. The data of all 51 women with distal exposure of anti HPV vaccine and all 28 women with pre-pregnancy exposure of anti HPV were engaged in current study. Vaccine exposure windows were considered distal (4vHPV vaccine administered from 22 to 6 weeks before last menstrual period [LMP]) and pre-pregnancy (4vHPV vaccine administered from 42 days before LMP). The control group was composed by randomly selected women aged 18 to 28 years, who have delivered in one of two mentioned above Maternity Hospitals in the same time frame and have never exposed anti HPV vaccine.
Results. The data obtained regarding the prevalence of complications of anti HPV vaccine exposure shown no significant difference in pregnancy complications’ prevalence indicators in patients with the distal and pre-pregnancy exposure of the vaccine. The distal and pre-pregnancy exposure to the quadrivalent anti HPV vaccine was not associated with reliably increased risks of adverse pregnancy outcomes.
Conclusion. The data obtained make us to conclude about non-affected prevalence of adverse pregnancy outcomes in HPV vaccinated cohort in RA. The study results can serve the background for additional confirmation of the safety of the HPV vaccine. The significant elevation of targeted cohort’s engagement will, in our opinion, be one of the most important milestones on the path to increasing the HPV control efficacy, while the negative impact on antepartal health indicators are not anticipated.
Keywords։ HPV, vaccination, papillomavirus, adverse pregnancy outcome, safety