K A Top1,2, C Arkell3, J E Graham1,2, H Scott4, S A McNeil2,5, J Mannerfeldt6, N E MacDonald1,2. 1. Department of Pediatrics, Dalhousie University, Halifax, NS. 2. Canadian Center for Vaccinology, Dalhousie University, IWK Health Centre, Nova Scotia Health Authority, Halifax, NS. 3. School of Population and Public Health, University of British Columbia, Vancouver, BC. 4. Department of Obstetrics & Gynecology, Dalhousie University, Halifax, NS. 5. Department of Medicine, Dalhousie University, Halifax, NS. 6. Departments of Obstetrics & Gynecology and Family Medicine, University of Calgary, Calgary, AB.
Abstract
BACKGROUND: 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. OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.
BACKGROUND: 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. OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.
Authors: Karina A Top; Catherine Arkell; Heather Scott; Shelly A McNeil; Jaelene Mannerfeldt; Justin R Ortiz; Philipp Lambach; Noni E MacDonald Journal: Lancet Glob Health Date: 2016-10 Impact factor: 26.763
Authors: Deshayne B Fell; Eduardo Azziz-Baumgartner; Michael G Baker; Maneesh Batra; Julien Beauté; Philippe Beutels; Niranjan Bhat; Zulfiqar A Bhutta; Cheryl Cohen; Bremen De Mucio; Bradford D Gessner; Michael G Gravett; Mark A Katz; Marian Knight; Vernon J Lee; Mark Loeb; Johannes M Luteijn; Helen Marshall; Harish Nair; Kevin Pottie; Rehana A Salam; David A Savitz; Suzanne J Serruya; Becky Skidmore; Justin R Ortiz Journal: Vaccine Date: 2017-09-01 Impact factor: 3.641
Authors: Jannat Saini; Mallory K Ellingson; Richard H Beigi; Noni E MacDonald; Karina A Top; Sarah Carroll; Saad B Omer Journal: Hum Vaccin Immunother Date: 2021-07-08 Impact factor: 4.526