Abstract
Influenza immunization is recommended in pregnancy to prevent severe infections in pregnant women and newborns, yet vaccine uptake remains low. Studies suggest that cautionary language in vaccine product monographs regarding safety and use in pregnancy affects health care providers' perceptions of vaccine safety and how they counsel pregnant women. To conduct a qualitative analysis of health care provider perceptions of the safety of inactivated influenza vaccines and their recommendations for use in pregnancy based on product monograph language statements. Health care providers were recruited at two international health conferences and from teaching programs in Ethiopia, Ghana, Uganda, and Laos during September and October 2015. After reading the product monograph excerpts for three licensed inactivated influenza vaccines, participants completed a ten-item online survey with quantitative and qualitative components that captured perceptions of vaccine safety. Health care providers identified a lack of trust in manufacturers' and product monograph information. They perceived product monograph language as ambiguous and not "up-to-date" with current evidence. Health care providers wanted product monograph language that clearly conveyed evidence for the risks and benefits of the vaccine in an understandable manner. This study suggests that adopting best practices in the wording of product monographs would help to support evidence-based use of vaccines in pregnant women.
Highlights
Seasonal influenza is associated with an increased risk of hospitalization during pregnancy and in infants younger than six months of age [1,2]
Sixty-one respondents provided comments about product monograph information, of which eight (14%) comments were from Canadians and 44 (72%) comments were from respondents in low- and middle-income countries
Some respondents expressed a view that product monograph content is restricted by vaccine manufacturers who are “protecting themselves against litigation”
Summary
Seasonal influenza is associated with an increased risk of hospitalization during pregnancy and in infants younger than six months of age [1,2]. The Canadian National Advisory Committee on Immunization (NACI) and World Health Organization (WHO) recommend influenza immunization during pregnancy to reduce the risk of severe infection in pregnancy and early infancy [1,3]. The safety of influenza immunization in pregnancy has been demonstrated in numerous studies and summarized in several systematic reviews [3,4,5,6]. Based on systematic reviews, including a review by the WHO Global Advisory Committee on Vaccine Safety [3], inactivated influenza vaccines (IIVs) demonstrated no increased risk of adverse outcomes, such as spontaneous abortion, stillbirth or congenital anomalies. Vaccine uptake among pregnant women remains low [7,8]. Influenza immunization is recommended in pregnancy to prevent severe infections in pregnant women and newborns, yet vaccine uptake remains low. Studies suggest that cautionary language in vaccine product monographs regarding safety and use in pregnancy affects health care providers’ perceptions of vaccine safety and how they counsel pregnant women
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