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Safety of the 2010-11, 2011-12, 2012-13, and 2013-14 seasonal influenza vaccines in pregnancy: Birth defects, spontaneous abortion, preterm delivery, and small for gestational age infants, a study from the cohort arm of VAMPSS.
Vaccine. 2016 08 17; 34(37):4443-9.V

Abstract

INTRODUCTION

There is a need for pregnancy safety information overall and for each seasonal formulation of the influenza vaccine.

METHODS

As part of the cohort arm of the Vaccines and Medications in Pregnancy Surveillance System, vaccine-exposed and unexposed women in the U.S. or Canada were recruited during pregnancy in the 2010-2014 vaccine seasons and followed to pregnancy outcome. For the four seasons combined, crude and adjusted relative risks (RRs) were estimated with 95% confidence intervals (CIs) for major birth defects overall and infants small for gestational age. Crude and adjusted hazard ratios (HRs) were estimated with 95% CIs for spontaneous abortion and preterm delivery. Specific influenza season subanalyses were also conducted.

RESULTS

Of 1730 women, 1263 were exposed to an influenza vaccine and 467 were unexposed to any influenza vaccine. Among pregnancies with first-trimester exposure excluding lost-to-follow-up, 26/457 (5.7%) resulted in an infant with a major birth defect compared to 13/427 (3.0%) in the unexposed (RR 1.87, 95% CI 0.97, 3.59). No specific pattern of defects was evident in the vaccine-exposed cohort. The overall risk of spontaneous abortion was not elevated (HR 1.09, 95% CI 0.49, 2.40). Adjusted HRs for preterm delivery approximated 1.0 (adjusted HR 1.23, 95% CI 0.75, 2.02). RRs for small for gestational age infants on weight, length and head circumference ranged from 1.19 to 1.49 with all CIs including 1. Season-by-season analyses resulted in variation by season; however, estimates were based on small numbers.

CONCLUSIONS

Combining the 2010-2014 influenza seasons, we found a moderately elevated RR for major birth defects overall, but no evidence of a specific pattern; 95% CIs included 1, and this finding could be due to chance. In the combined seasons, we found no meaningful evidence of an increased risk for spontaneous abortion or preterm delivery following exposure to the seasonal influenza vaccine.

Authors+Show Affiliations

Department of Pediatrics, University of California San Diego, La Jolla, CA, United States; Department of Family Medicine and Public Health, University of California San Diego, La Jolla, CA, United States; Vaccines and Medications in Pregnancy Surveillance System, United States. Electronic address: chchambers@ucsd.edu.Department of Pediatrics, University of California San Diego, La Jolla, CA, United States.Department of Family Medicine and Public Health, University of California San Diego, La Jolla, CA, United States; Department of Mathematics, University of California San Diego, La Jolla, CA, United States.Department of Pediatrics, University of California San Diego, La Jolla, CA, United States.Slone Epidemiology Center at Boston University, Boston, MA, United States; Vaccines and Medications in Pregnancy Surveillance System, United States.Slone Epidemiology Center at Boston University, Boston, MA, United States; Vaccines and Medications in Pregnancy Surveillance System, United States.American Academy of Asthma, Allergy & Immunology, Milwaukee, WI, United States; Vaccines and Medications in Pregnancy Surveillance System, United States.Department of Pediatrics, University of California San Diego, La Jolla, CA, United States; Vaccines and Medications in Pregnancy Surveillance System, United States.No affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

27449682

Citation

Chambers, Christina D., et al. "Safety of the 2010-11, 2011-12, 2012-13, and 2013-14 Seasonal Influenza Vaccines in Pregnancy: Birth Defects, Spontaneous Abortion, Preterm Delivery, and Small for Gestational Age Infants, a Study From the Cohort Arm of VAMPSS." Vaccine, vol. 34, no. 37, 2016, pp. 4443-9.
Chambers CD, Johnson DL, Xu R, et al. Safety of the 2010-11, 2011-12, 2012-13, and 2013-14 seasonal influenza vaccines in pregnancy: Birth defects, spontaneous abortion, preterm delivery, and small for gestational age infants, a study from the cohort arm of VAMPSS. Vaccine. 2016;34(37):4443-9.
Chambers, C. D., Johnson, D. L., Xu, R., Luo, Y. J., Louik, C., Mitchell, A. A., Schatz, M., & Jones, K. L. (2016). Safety of the 2010-11, 2011-12, 2012-13, and 2013-14 seasonal influenza vaccines in pregnancy: Birth defects, spontaneous abortion, preterm delivery, and small for gestational age infants, a study from the cohort arm of VAMPSS. Vaccine, 34(37), 4443-9. https://doi.org/10.1016/j.vaccine.2016.06.054
Chambers CD, et al. Safety of the 2010-11, 2011-12, 2012-13, and 2013-14 Seasonal Influenza Vaccines in Pregnancy: Birth Defects, Spontaneous Abortion, Preterm Delivery, and Small for Gestational Age Infants, a Study From the Cohort Arm of VAMPSS. Vaccine. 2016 08 17;34(37):4443-9. PubMed PMID: 27449682.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety of the 2010-11, 2011-12, 2012-13, and 2013-14 seasonal influenza vaccines in pregnancy: Birth defects, spontaneous abortion, preterm delivery, and small for gestational age infants, a study from the cohort arm of VAMPSS. AU - Chambers,Christina D, AU - Johnson,Diana L, AU - Xu,Ronghui, AU - Luo,Yunjun J, AU - Louik,Carol, AU - Mitchell,Allen A, AU - Schatz,Michael, AU - Jones,Kenneth L, AU - ,, Y1 - 2016/07/20/ PY - 2016/03/01/received PY - 2016/06/13/revised PY - 2016/06/16/accepted PY - 2016/7/25/entrez PY - 2016/7/28/pubmed PY - 2017/11/7/medline KW - Birth defects KW - Influenza vaccine KW - Pregnancy KW - Preterm delivery KW - Safety KW - Small for gestational age KW - Spontaneous abortion SP - 4443 EP - 9 JF - Vaccine JO - Vaccine VL - 34 IS - 37 N2 - INTRODUCTION: There is a need for pregnancy safety information overall and for each seasonal formulation of the influenza vaccine. METHODS: As part of the cohort arm of the Vaccines and Medications in Pregnancy Surveillance System, vaccine-exposed and unexposed women in the U.S. or Canada were recruited during pregnancy in the 2010-2014 vaccine seasons and followed to pregnancy outcome. For the four seasons combined, crude and adjusted relative risks (RRs) were estimated with 95% confidence intervals (CIs) for major birth defects overall and infants small for gestational age. Crude and adjusted hazard ratios (HRs) were estimated with 95% CIs for spontaneous abortion and preterm delivery. Specific influenza season subanalyses were also conducted. RESULTS: Of 1730 women, 1263 were exposed to an influenza vaccine and 467 were unexposed to any influenza vaccine. Among pregnancies with first-trimester exposure excluding lost-to-follow-up, 26/457 (5.7%) resulted in an infant with a major birth defect compared to 13/427 (3.0%) in the unexposed (RR 1.87, 95% CI 0.97, 3.59). No specific pattern of defects was evident in the vaccine-exposed cohort. The overall risk of spontaneous abortion was not elevated (HR 1.09, 95% CI 0.49, 2.40). Adjusted HRs for preterm delivery approximated 1.0 (adjusted HR 1.23, 95% CI 0.75, 2.02). RRs for small for gestational age infants on weight, length and head circumference ranged from 1.19 to 1.49 with all CIs including 1. Season-by-season analyses resulted in variation by season; however, estimates were based on small numbers. CONCLUSIONS: Combining the 2010-2014 influenza seasons, we found a moderately elevated RR for major birth defects overall, but no evidence of a specific pattern; 95% CIs included 1, and this finding could be due to chance. In the combined seasons, we found no meaningful evidence of an increased risk for spontaneous abortion or preterm delivery following exposure to the seasonal influenza vaccine. SN - 1873-2518 UR - https://www.unboundmedicine.com/medline/citation/27449682/Safety_of_the_2010_11_2011_12_2012_13_and_2013_14_seasonal_influenza_vaccines_in_pregnancy:_Birth_defects_spontaneous_abortion_preterm_delivery_and_small_for_gestational_age_infants_a_study_from_the_cohort_arm_of_VAMPSS_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0264-410X(16)30478-9 DB - PRIME DP - Unbound Medicine ER -