Meghan Laverty1, Natasha Crowcroft2,3, Shelly Bolotin3,4, Steven Hawken1,2,5,6, Kumanan Wilson1,2,5, Gayatri Amirthalingam7, Anne Biringer3,8, Jocelynn Cook9, Vinita Dubey3,10, Romina Fakhraei5,6, Scott A Halperin11, Frances Jamieson3,8, Jeffrey C Kwong2,3,4,12, Manish Sadarangani13,14, Ewa Sucha2, Mark C Walker1,5,15, Deshayne B Fell16,2,6. 1. University of Ottawa, Ottawa, Ontario, Canada. 2. ICES, Ontario, Canada. 3. University of Toronto, Toronto, Ontario, Canada. 4. Public Health Ontario, Toronto, Ontario, Canada. 5. Ottawa Hospital Research Institute, Ottawa, Ontario, Canada. 6. Children's Hospital of Eastern Ontario Research Institute, Ottawa, Ontario, Canada. 7. Public Health England, London, United Kingdom. 8. Mount Sinai Hospital, Toronto, Ontario, Canada. 9. Society of Obstetricians and Gynaecologists of Canada, Ottawa, Ontario, Canada. 10. Toronto Public Health, Ottawa, Ontario, Canada. 11. Canadian Center for Vaccinology, Dalhousie University and the IWK Health Centre, Halifax, Nova Scotia, Canada. 12. University Health Network, Toronto, Ontario, Canada. 13. Vaccine Evaluation Center, BC Children's Hospital Research Institute, Vancouver, British Columbia, Canada. 14. Department of Pediatrics, University of British Columbia, Vancouver, British Columbia, Canada; and. 15. The Ottawa Hospital, Ottawa, Ontario, Canada. 16. University of Ottawa, Ottawa, Ontario, Canada; dfell@cheo.on.ca.
Abstract
BACKGROUND AND OBJECTIVES: Maternal immunization with tetanus, diphtheria, and acellular pertussis vaccine (Tdap) is routinely recommended in many countries as a strategy to protect young infants against severe pertussis infection; few studies have assessed whether prenatal exposure to the vaccine is associated with any longer-term adverse health effects in children. We evaluated the long-term safety of exposure to Tdap vaccination during pregnancy. METHODS: Population-based retrospective cohort study conducted in Ontario, Canada using multiple linked province-wide health administrative databases. All live births between April 2012 and March 2017 were included, and children were followed for up to 6 years to ascertain study outcomes. Children exposed to prenatal Tdap were propensity score matched to unexposed children at a 1:5 ratio. Tdap vaccination during pregnancy was ascertained by using vaccine-specific fee codes. Immune-related (infectious diseases, asthma) and nonimmune-related (neoplasm, sensory disorders) outcomes and a nonspecific morbidity outcome (urgent or inpatient health service use) were evaluated from birth to end of follow-up. RESULTS: Of 625 643 live births, 12 045 (1.9%) were exposed to Tdap in utero. There were no significant increased risks of adverse childhood outcomes and prenatal Tdap exposure; however, we observed inverse associations (adjusted incidence rate ratio [95% confidence interval]) with upper respiratory infections (0.94 [0.90-0.99]), gastrointestinal infections (0.85 [0.79-0.91]), and urgent and inpatient health service use (0.93 [0.91-0.96]). CONCLUSIONS: Exposure to Tdap vaccination in pregnancy was not associated with any increased risk of adverse health outcomes in early childhood, supporting the long-term safety of Tdap administration in pregnancy.
BACKGROUND AND OBJECTIVES: Maternal immunization with tetanus, diphtheria, and acellular pertussis vaccine (Tdap) is routinely recommended in many countries as a strategy to protect young infants against severe pertussis infection; few studies have assessed whether prenatal exposure to the vaccine is associated with any longer-term adverse health effects in children. We evaluated the long-term safety of exposure to Tdap vaccination during pregnancy. METHODS: Population-based retrospective cohort study conducted in Ontario, Canada using multiple linked province-wide health administrative databases. All live births between April 2012 and March 2017 were included, and children were followed for up to 6 years to ascertain study outcomes. Children exposed to prenatal Tdap were propensity score matched to unexposed children at a 1:5 ratio. Tdap vaccination during pregnancy was ascertained by using vaccine-specific fee codes. Immune-related (infectious diseases, asthma) and nonimmune-related (neoplasm, sensory disorders) outcomes and a nonspecific morbidity outcome (urgent or inpatient health service use) were evaluated from birth to end of follow-up. RESULTS: Of 625 643 live births, 12 045 (1.9%) were exposed to Tdap in utero. There were no significant increased risks of adverse childhood outcomes and prenatal Tdap exposure; however, we observed inverse associations (adjusted incidence rate ratio [95% confidence interval]) with upper respiratory infections (0.94 [0.90-0.99]), gastrointestinal infections (0.85 [0.79-0.91]), and urgent and inpatient health service use (0.93 [0.91-0.96]). CONCLUSIONS: Exposure to Tdap vaccination in pregnancy was not associated with any increased risk of adverse health outcomes in early childhood, supporting the long-term safety of Tdap administration in pregnancy.