Safety of influenza vaccination during pregnancy: a systematic review
Objective We conducted a systematic review to evaluate associations between influenza vaccination during pregnancy and adverse birth outcomes and maternal non-obstetric serious adverse events (SAEs), taking into consideration confounding and temporal biases.Methods Electronic databases (Ovid MEDLINE...
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BMJ Publishing Group
2023-09-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/13/9/e066182.full |
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| author | Brian Hutton David Moher Danielle B Rice Claire Butler Andrea C Tricco Becky Skidmore Candyce Hamel Chantelle Garritty Paul A Khan Marco Ghassemi Charlene Soobiah Leila Esmaeilisaraji Dianna M Wolfe Deshayne Fell Mona Hersi Nadera Ahmadzai Alan Michaud Angela Sinilaite |
| author_facet | Brian Hutton David Moher Danielle B Rice Claire Butler Andrea C Tricco Becky Skidmore Candyce Hamel Chantelle Garritty Paul A Khan Marco Ghassemi Charlene Soobiah Leila Esmaeilisaraji Dianna M Wolfe Deshayne Fell Mona Hersi Nadera Ahmadzai Alan Michaud Angela Sinilaite |
| author_sort | Brian Hutton |
| collection | DOAJ |
| description | Objective We conducted a systematic review to evaluate associations between influenza vaccination during pregnancy and adverse birth outcomes and maternal non-obstetric serious adverse events (SAEs), taking into consideration confounding and temporal biases.Methods Electronic databases (Ovid MEDLINE ALL, Embase Classic+Embase and the Cochrane Central Register of Controlled Trials) were searched to June 2021 for observational studies assessing associations between influenza vaccination during pregnancy and maternal non-obstetric SAEs and adverse birth outcomes, including preterm birth, spontaneous abortion, stillbirth, small-for-gestational-age birth and congenital anomalies. Studies of live attenuated vaccines, single-arm cohort studies and abstract-only publications were excluded. Records were screened using a liberal accelerated approach initially, followed by a dual independent approach for full-text screening, data extraction and risk of bias assessment. Pairwise meta-analyses were conducted, where two or more studies met methodological criteria for inclusion. The Grading of Recommendations, Assessment, Development and Evaluation approach was used to assess evidence certainty.Results Of 9443 records screened, 63 studies were included. Twenty-nine studies (24 cohort and 5 case–control) evaluated seasonal influenza vaccination (trivalent and/or quadrivalent) versus no vaccination and were the focus of our prioritised syntheses; 34 studies of pandemic vaccines (2009 A/H1N1 and others), combinations of pandemic and seasonal vaccines, and seasonal versus seasonal vaccines were also reviewed. Control for confounding and temporal biases was inconsistent across studies, limiting pooling of data. Meta-analyses for preterm birth, spontaneous abortion and small-for-gestational-age birth demonstrated no significant associations with seasonal influenza vaccination. Immortal time bias was observed in a sensitivity analysis of meta-analysing risk-based preterm birth data. In descriptive summaries for stillbirth, congenital anomalies and maternal non-obstetric SAEs, no significant association with increased risk was found in any studies. All evidence was of very low certainty.Conclusions Evidence of very low certainty suggests that seasonal influenza vaccination during pregnancy is not associated with adverse birth outcomes or maternal non-obstetric SAEs. Appropriate control of confounding and temporal biases in future studies would improve the evidence base. |
| format | Article |
| id | doaj-art-94e6cd8ef4fc4dc089a90734cb991db6 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2023-09-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-94e6cd8ef4fc4dc089a90734cb991db62025-02-08T23:35:10ZengBMJ Publishing GroupBMJ Open2044-60552023-09-0113910.1136/bmjopen-2022-066182Safety of influenza vaccination during pregnancy: a systematic reviewBrian Hutton0David Moher1Danielle B Rice2Claire Butler3Andrea C Tricco4Becky Skidmore5Candyce Hamel6Chantelle Garritty7Paul A Khan8Marco Ghassemi9Charlene Soobiah10Leila Esmaeilisaraji11Dianna M Wolfe12Deshayne Fell13Mona Hersi14Nadera Ahmadzai15Alan Michaud16Angela Sinilaite17Clinical Epidemiology Program, the Ottawa Hospital Research Institute, Ottawa, ON, CanadaClinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, CanadaDepartment of Psychology, McGill University, Montreal, Quebec, CanadaClinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, CanadaDalla Lana School of Public Health and Li Ka Shing Knowledge Institute, University of Toronto and St. Michael`s Hospital, Unity Health, Toronto, Ontario, Canada6 Independent Information Specialist Consultant, Ottawa, Ontario, Canadaadjunct professor and senior epidemiologistClinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, CanadaLi Ka Shing Knowledge Institute, St Michael`s Hospital, Toronto, Ontario, CanadaLi Ka Shing Knowledge Institute, St Michael`s Hospital, Toronto, Ontario, CanadaInstitute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, CanadaClinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, CanadaClinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, CanadaSchool of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario, CanadaCentre for Immunization Programs, Infectious Diseases & Vaccination Programs Branch, Public Health Agency of Canada, Ottawa, Ontario, CanadaClinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, CanadaClinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, CanadaCentre for Immunization Readiness, Public Health Agency of Canada, Ottawa, Ontario, CanadaObjective We conducted a systematic review to evaluate associations between influenza vaccination during pregnancy and adverse birth outcomes and maternal non-obstetric serious adverse events (SAEs), taking into consideration confounding and temporal biases.Methods Electronic databases (Ovid MEDLINE ALL, Embase Classic+Embase and the Cochrane Central Register of Controlled Trials) were searched to June 2021 for observational studies assessing associations between influenza vaccination during pregnancy and maternal non-obstetric SAEs and adverse birth outcomes, including preterm birth, spontaneous abortion, stillbirth, small-for-gestational-age birth and congenital anomalies. Studies of live attenuated vaccines, single-arm cohort studies and abstract-only publications were excluded. Records were screened using a liberal accelerated approach initially, followed by a dual independent approach for full-text screening, data extraction and risk of bias assessment. Pairwise meta-analyses were conducted, where two or more studies met methodological criteria for inclusion. The Grading of Recommendations, Assessment, Development and Evaluation approach was used to assess evidence certainty.Results Of 9443 records screened, 63 studies were included. Twenty-nine studies (24 cohort and 5 case–control) evaluated seasonal influenza vaccination (trivalent and/or quadrivalent) versus no vaccination and were the focus of our prioritised syntheses; 34 studies of pandemic vaccines (2009 A/H1N1 and others), combinations of pandemic and seasonal vaccines, and seasonal versus seasonal vaccines were also reviewed. Control for confounding and temporal biases was inconsistent across studies, limiting pooling of data. Meta-analyses for preterm birth, spontaneous abortion and small-for-gestational-age birth demonstrated no significant associations with seasonal influenza vaccination. Immortal time bias was observed in a sensitivity analysis of meta-analysing risk-based preterm birth data. In descriptive summaries for stillbirth, congenital anomalies and maternal non-obstetric SAEs, no significant association with increased risk was found in any studies. All evidence was of very low certainty.Conclusions Evidence of very low certainty suggests that seasonal influenza vaccination during pregnancy is not associated with adverse birth outcomes or maternal non-obstetric SAEs. Appropriate control of confounding and temporal biases in future studies would improve the evidence base.https://bmjopen.bmj.com/content/13/9/e066182.full |
| spellingShingle | Brian Hutton David Moher Danielle B Rice Claire Butler Andrea C Tricco Becky Skidmore Candyce Hamel Chantelle Garritty Paul A Khan Marco Ghassemi Charlene Soobiah Leila Esmaeilisaraji Dianna M Wolfe Deshayne Fell Mona Hersi Nadera Ahmadzai Alan Michaud Angela Sinilaite Safety of influenza vaccination during pregnancy: a systematic review BMJ Open |
| title | Safety of influenza vaccination during pregnancy: a systematic review |
| title_full | Safety of influenza vaccination during pregnancy: a systematic review |
| title_fullStr | Safety of influenza vaccination during pregnancy: a systematic review |
| title_full_unstemmed | Safety of influenza vaccination during pregnancy: a systematic review |
| title_short | Safety of influenza vaccination during pregnancy: a systematic review |
| title_sort | safety of influenza vaccination during pregnancy a systematic review |
| url | https://bmjopen.bmj.com/content/13/9/e066182.full |
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