RESUMO
In Veneto Region, HPV vaccine has been actively offered to 12 year-old females since 2008, and to 12 year-old males since 2015. The study aims to analyze the safety profile of HPV4v and HPV9v vaccines and perform a case-by-case review of conditions of interest. Spontaneous reports related to HPV uploaded to the database of the Regional Pharmacovigilance Center between 2008-2022 were included. HPV vaccine doses administered until April 2022 in the Veneto Region were considered to calculate the reporting rate (RR). Potential "safety concerns" examined as conditions of interest were included through Standardized MedDRA or preferred terms searching queries. The level of diagnostic certainty was evaluated as per the Brighton Collaboration case definition criteria. A total of 637 reports and 1316 Adverse Events Following Immunizations (AEFI) were retrieved: 469 for HPV4v (73.6 %) and 168 for HPV9v (26.4 %). Serious reports were 71 (11.1 %): 49 (10.4 %) for HPV4v and 22 (13.1 %) for HPV9v. The RR for serious events between 2008-2022 was 6.9/100,000 administered doses, with no differences by vaccine type. Females and adults showed higher overall RR compared to males and to children and adolescents (p < 0.001), this result was confirmed by stratifying analysis by vaccine type. One case of Guillain Barré syndrome, anaphylactic shock, thrombocytopenia, Henoch Schoenlein purpura and four generalized seizures were reviewed. Vaccinovigilance data from the Veneto Region reaffirm a good safety profile for HPV vaccination and found no vaccine-related unexpected events. Such a detailed analysis may assist healthcare providers to advocate properly for HPV vaccination.
RESUMO
OBJECTIVES: to investigate vaccine uptake among pregnant women during the 2nd and 3rd trimester of pregnancy. To describe the factors influencing vaccine uptake during pregnancy, comparing sociodemographic and clinical characteristics of pregnant women who were vaccinated during the 2nd or 3rd trimester with those who were not vaccinated, despite having the indication for vaccination. DESIGN: observational study with a cross-sectional approach and prevalence estimation in the population of women who gave birth in the study period, through record linkages between the ministry information flow Birth assistance certificate, the Regional vaccination register and the Italian flow for SARS-CoV-2 infections. SETTING AND PARTICIPANTS: the study included all the 4,772 pregnant women living in Trentino (north-east Italy), who were in the 2nd or 3rd trimester of pregnancy between the 5th May 2021 and the 28th February 2022 and who delivered in Trentino. MAIN OUTCOME MEASURES: vaccine uptake among pregnant women during the 2nd and 3rd trimester of pregnancy. Results: 33.3% of pregnant women got vaccinated with at least one dose of vaccine during the 2nd or 3rd trimester of pregnancy. Independent factors associated with vaccine uptake in the 2nd or 3rd trimester were the mother's citizenship, educational level, occupational status and age. CONCLUSIONS: the proportion of women who received at least one dose of COVID-19 vaccine during pregnancy was low. The results are important to start efficient actions to promote vaccination in pregnant women, particularly in the most vulnerable ones (unemployed, foreigners and with a low educational level), who appear to be less vaccinated frequently.