tetano
Editor, Senior Moderator
Pharmacoepidemiol Drug Saf
. 2022 Apr 2.
doi: 10.1002/pds.5435. Online ahead of print.
Influenza vaccination during pregnancy and risk of selected major structural non-cardiac birth defects, National Birth Defects Prevention Study 2006-2011
Kristin Palmsten[SUP] 1 [/SUP], Jonathan Suhl[SUP] 2 [/SUP], Kristin M Conway[SUP] 2 [/SUP], Elyse O Kharbanda[SUP] 1 [/SUP], Elizabeth C Ailes[SUP] 3 [/SUP], Janet D Cragan[SUP] 3 4 [/SUP], Eirini Nestoridi[SUP] 5 [/SUP], Eleni A Papadopoulos[SUP] 6 [/SUP], Stephen M Kerr[SUP] 7 [/SUP], Sean G Young[SUP] 8 9 [/SUP], Frank DeStefano[SUP] 10 [/SUP], Paul A Romitti[SUP] 2 [/SUP], National Birth Defects Prevention Study
Affiliations
Abstract
Purpose: To assess associations between influenza vaccination during etiologically-relevant windows and selected major structural non-cardiac birth defects.
Study design: We analyzed data from the National Birth Defects Prevention Study, a multisite, population-based case-control study, for 8233 case children diagnosed with a birth defect and 4937 control children without a birth defect with delivery dates during 2006-2011. For all analyses except for neural tube defects (NTDs), we classified mothers who reported influenza vaccination one month before through the third pregnancy month as exposed; the exposure window for NTDs was one month before through the first pregnancy month. For defects with five or more exposed case children, we used logistic regression to estimate propensity score-adjusted odds ratios (aORs) and 95% confidence intervals (CIs), adjusting for estimated delivery year and season; maternal age; race/ethnicity; plurality; smoking and alcohol use; low folate intake; and, for NTDs, folate antagonist medications.
Results: There were 334 (4.1%) case and 197 (4.0%) control mothers who reported influenza vaccination from one month before through the third pregnancy month. Adjusted ORs ranged from 0.53 for omphalocele to 1.74 for duodenal atresia/stenosis. Most aORs (11 of 19) were ≤1 and all adjusted CIs included the null. The unadjusted CIs for two defects, hypospadias and craniosynostosis, excluded the null. These estimates were attenuated upon covariate adjustment (hypospadias aOR: 1.25 (95% CI 0.89, 1.76); craniosynostosis aOR: 1.23 (95% CI: 0.88, 1.74)).
Conclusions: Results for several non-cardiac major birth defects add to the existing evidence supporting the safety of inactivated influenza vaccination during pregnancy. Under-reporting of vaccination may have biased estimates downward. This article is protected by copyright. All rights reserved.
. 2022 Apr 2.
doi: 10.1002/pds.5435. Online ahead of print.
Influenza vaccination during pregnancy and risk of selected major structural non-cardiac birth defects, National Birth Defects Prevention Study 2006-2011
Kristin Palmsten[SUP] 1 [/SUP], Jonathan Suhl[SUP] 2 [/SUP], Kristin M Conway[SUP] 2 [/SUP], Elyse O Kharbanda[SUP] 1 [/SUP], Elizabeth C Ailes[SUP] 3 [/SUP], Janet D Cragan[SUP] 3 4 [/SUP], Eirini Nestoridi[SUP] 5 [/SUP], Eleni A Papadopoulos[SUP] 6 [/SUP], Stephen M Kerr[SUP] 7 [/SUP], Sean G Young[SUP] 8 9 [/SUP], Frank DeStefano[SUP] 10 [/SUP], Paul A Romitti[SUP] 2 [/SUP], National Birth Defects Prevention Study
Affiliations
- PMID: 35366035
- DOI: 10.1002/pds.5435
Abstract
Purpose: To assess associations between influenza vaccination during etiologically-relevant windows and selected major structural non-cardiac birth defects.
Study design: We analyzed data from the National Birth Defects Prevention Study, a multisite, population-based case-control study, for 8233 case children diagnosed with a birth defect and 4937 control children without a birth defect with delivery dates during 2006-2011. For all analyses except for neural tube defects (NTDs), we classified mothers who reported influenza vaccination one month before through the third pregnancy month as exposed; the exposure window for NTDs was one month before through the first pregnancy month. For defects with five or more exposed case children, we used logistic regression to estimate propensity score-adjusted odds ratios (aORs) and 95% confidence intervals (CIs), adjusting for estimated delivery year and season; maternal age; race/ethnicity; plurality; smoking and alcohol use; low folate intake; and, for NTDs, folate antagonist medications.
Results: There were 334 (4.1%) case and 197 (4.0%) control mothers who reported influenza vaccination from one month before through the third pregnancy month. Adjusted ORs ranged from 0.53 for omphalocele to 1.74 for duodenal atresia/stenosis. Most aORs (11 of 19) were ≤1 and all adjusted CIs included the null. The unadjusted CIs for two defects, hypospadias and craniosynostosis, excluded the null. These estimates were attenuated upon covariate adjustment (hypospadias aOR: 1.25 (95% CI 0.89, 1.76); craniosynostosis aOR: 1.23 (95% CI: 0.88, 1.74)).
Conclusions: Results for several non-cardiac major birth defects add to the existing evidence supporting the safety of inactivated influenza vaccination during pregnancy. Under-reporting of vaccination may have biased estimates downward. This article is protected by copyright. All rights reserved.