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A follow-up comparative safety analysis of pandemic H1N1 vaccination during pregnancy and risk of infant birth defects among U.S. military mothers.
Vaccine. 2018 05 11; 36(20):2855-2860.V

Abstract

OBJECTIVE

To update a previous assessment of birth defects among infants born to active duty U.S. military mothers who received the 2009-2010 pandemic H1N1 vaccine, in comparison to the 2008-2009 seasonal influenza vaccine, during pregnancy. Here, we updated the previous comparative analyses with a more refined definition for birth defects using an additional year of follow-up data from both inpatient and outpatient medical encounters.

METHODS

The study population included 15,510 live born infants born to active duty mothers vaccinated during pregnancy with either the 2009-2010 pandemic H1N1 vaccine (n = 9033) or the 2008-2009 seasonal influenza vaccine (n = 6477). Birth defect cases were defined as those infants who received a birth defect diagnosis on one inpatient record or two outpatient records on different days within the first year of life. Multivariable logistic regression models were conducted to estimate the odds ratios (ORs) and 95% confidence intervals (CIs) for the association between birth defects and maternal vaccination during pregnancy with pandemic H1N1 vaccine versus seasonal influenza vaccine.

RESULTS

Infants born to mothers vaccinated during pregnancy with the pandemic H1N1 vaccine, versus the seasonal influenza vaccine, were not at increased odds of birth defects in univariable (OR: 1.13, 95% CI: 0.95-1.34) or multivariable (OR: 1.14, 95% CI: 0.96-1.35) models. Findings were not significant when further limited to first trimester exposure. Multivariable models were adjusted for infant sex and plurality; maternal age, race/ethnicity, marital status, service branch, military rank, and occupation; timing of vaccination; and receipt of vaccination(s) not routinely recommended during pregnancy.

CONCLUSION

Comparable to our previous analyses assessing birth defects diagnosed at birth, no significant association was found between the pandemic H1N1 vaccination during pregnancy and birth defects, versus the seasonal influenza vaccine. These findings are reassuring and provide additional support for H1N1-containing seasonal influenza vaccination during pregnancy.

Authors+Show Affiliations

The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc., 6720A Rockledge Drive, Suite 100, Bethesda, MD 20817, United States. Electronic address: avamarie.s.conlin.ctr@mail.mil.The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc., 6720A Rockledge Drive, Suite 100, Bethesda, MD 20817, United States.The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc., 6720A Rockledge Drive, Suite 100, Bethesda, MD 20817, United States.The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc., 6720A Rockledge Drive, Suite 100, Bethesda, MD 20817, United States.The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc., 6720A Rockledge Drive, Suite 100, Bethesda, MD 20817, United States.Naval Health Research Center, 140 Sylvester Road, San Diego, CA 92106, United States.Naval Health Research Center, 140 Sylvester Road, San Diego, CA 92106, United States.

Pub Type(s)

Comparative Study
Journal Article
Research Support, U.S. Gov't, Non-P.H.S.

Language

eng

PubMed ID

29625766

Citation

Conlin, Ava Marie S., et al. "A Follow-up Comparative Safety Analysis of Pandemic H1N1 Vaccination During Pregnancy and Risk of Infant Birth Defects Among U.S. Military Mothers." Vaccine, vol. 36, no. 20, 2018, pp. 2855-2860.
Conlin AMS, Bukowinski AT, Levine JA, et al. A follow-up comparative safety analysis of pandemic H1N1 vaccination during pregnancy and risk of infant birth defects among U.S. military mothers. Vaccine. 2018;36(20):2855-2860.
Conlin, A. M. S., Bukowinski, A. T., Levine, J. A., Khodr, Z. G., Kaur, N., Farrish, S. C., & Sevick, C. J. (2018). A follow-up comparative safety analysis of pandemic H1N1 vaccination during pregnancy and risk of infant birth defects among U.S. military mothers. Vaccine, 36(20), 2855-2860. https://doi.org/10.1016/j.vaccine.2018.03.061
Conlin AMS, et al. A Follow-up Comparative Safety Analysis of Pandemic H1N1 Vaccination During Pregnancy and Risk of Infant Birth Defects Among U.S. Military Mothers. Vaccine. 2018 05 11;36(20):2855-2860. PubMed PMID: 29625766.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A follow-up comparative safety analysis of pandemic H1N1 vaccination during pregnancy and risk of infant birth defects among U.S. military mothers. AU - Conlin,Ava Marie S, AU - Bukowinski,Anna T, AU - Levine,Jordan A, AU - Khodr,Zeina G, AU - Kaur,Navjot, AU - Farrish,Susan C, AU - Sevick,Carter J, Y1 - 2018/04/03/ PY - 2018/01/19/received PY - 2018/03/21/revised PY - 2018/03/22/accepted PY - 2018/4/8/pubmed PY - 2018/9/19/medline PY - 2018/4/8/entrez KW - Congenital abnormalities KW - Influenza vaccine KW - Maternal exposure KW - Military personnel KW - Pregnancy KW - Prenatal exposure delayed effects SP - 2855 EP - 2860 JF - Vaccine JO - Vaccine VL - 36 IS - 20 N2 - OBJECTIVE: To update a previous assessment of birth defects among infants born to active duty U.S. military mothers who received the 2009-2010 pandemic H1N1 vaccine, in comparison to the 2008-2009 seasonal influenza vaccine, during pregnancy. Here, we updated the previous comparative analyses with a more refined definition for birth defects using an additional year of follow-up data from both inpatient and outpatient medical encounters. METHODS: The study population included 15,510 live born infants born to active duty mothers vaccinated during pregnancy with either the 2009-2010 pandemic H1N1 vaccine (n = 9033) or the 2008-2009 seasonal influenza vaccine (n = 6477). Birth defect cases were defined as those infants who received a birth defect diagnosis on one inpatient record or two outpatient records on different days within the first year of life. Multivariable logistic regression models were conducted to estimate the odds ratios (ORs) and 95% confidence intervals (CIs) for the association between birth defects and maternal vaccination during pregnancy with pandemic H1N1 vaccine versus seasonal influenza vaccine. RESULTS: Infants born to mothers vaccinated during pregnancy with the pandemic H1N1 vaccine, versus the seasonal influenza vaccine, were not at increased odds of birth defects in univariable (OR: 1.13, 95% CI: 0.95-1.34) or multivariable (OR: 1.14, 95% CI: 0.96-1.35) models. Findings were not significant when further limited to first trimester exposure. Multivariable models were adjusted for infant sex and plurality; maternal age, race/ethnicity, marital status, service branch, military rank, and occupation; timing of vaccination; and receipt of vaccination(s) not routinely recommended during pregnancy. CONCLUSION: Comparable to our previous analyses assessing birth defects diagnosed at birth, no significant association was found between the pandemic H1N1 vaccination during pregnancy and birth defects, versus the seasonal influenza vaccine. These findings are reassuring and provide additional support for H1N1-containing seasonal influenza vaccination during pregnancy. SN - 1873-2518 UR - https://www.unboundmedicine.com/medline/citation/29625766/A_follow_up_comparative_safety_analysis_of_pandemic_H1N1_vaccination_during_pregnancy_and_risk_of_infant_birth_defects_among_U_S__military_mothers_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0264-410X(18)30417-1 DB - PRIME DP - Unbound Medicine ER -