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Safety of inactivated monovalent pandemic (H1N1) 2009 vaccination during pregnancy: a population-based study in Taiwan.
Vaccine. 2014 Nov 12; 32(48):6463-8.V

Abstract

BACKGROUND

Pregnant women were prioritized for H1N1 vaccination during the 2009-2010 pandemic. Safety concerns exist with vaccinating pregnant women, particularly in their first trimesters.

METHODS

We linked computerized data on H1N1 vaccination, National Health Insurance, and Taiwan Birth Registry and identified events of spontaneous abortions (SABs) and all singleton births that occurred/delivered during November 1, 2009-September 30, 2010. The observation period for each case of SAB (6-19 weeks gestation) was divided into period at risk (1-28 days after vaccination) and control periods (the remaining person-days until SAB). The self-controlled case series method for truncated observational periods assessed the incidence rate ratio (IRR) of SAB during the 1-28 days compared with those in the control period. The case-control design matched each case of adverse fetal outcomes to up to 10 controls on fetal sex and year/month of pregnancy onset, and calculated matched odds ratio (OR) on H1N1 vaccination at <14 or ≥14 weeks gestation.

RESULTS

Sixty-five women with SAB had received H1N1 vaccination at 6-19 weeks gestation. The IRR of SAB for the risk period 1-28 days was 1.03 (95% confidence interval [CI] 0.55-1.93). Among the 147,294 live births and 1354 stillbirths, maternal H1N1 vaccine receipt at <14 weeks gestation was associated with significantly reduced likelihood of small for gestational age (SGA) birth (OR 0.72, 95% CI 0.61-0.84) and birth defect (OR 0.46, 95% CI 0.22-1.00), whereas receipt at ≥14 weeks gestation was associated with significantly reduced likelihood of stillbirth (OR 0.63, 95% CI 0.46-0.86), prematurity (OR 0.90, 95% CI 0.83-0.97), low birth weight (OR 0.81, 95% CI 0.74-0.88), and SGA birth (OR 0.90, 95% CI 0.84-0.97).

CONCLUSIONS

H1N1 vaccination during pregnancy did not increase risk of SAB or adverse fetal outcomes.

Authors+Show Affiliations

Taiwan Centers for Disease Control, 6 Linsen S. Road, Taipei 10050, Taiwan. Electronic address: huangwt@ntu.edu.tw.Taiwan Centers for Disease Control, 6 Linsen S. Road, Taipei 10050, Taiwan. Electronic address: pluto0507@hotmail.com.Taiwan Centers for Disease Control, 6 Linsen S. Road, Taipei 10050, Taiwan. Electronic address: shuer@cdc.gov.tw.Taiwan Centers for Disease Control, 6 Linsen S. Road, Taipei 10050, Taiwan. Electronic address: chih@cdc.gov.tw.Taiwan Centers for Disease Control, 6 Linsen S. Road, Taipei 10050, Taiwan; Institute of Biomedical Informatics & Institute of Public Health, National Yang-Ming University, 155 Section 2, Linong Street, Taipei 11221, Taiwan. Electronic address: jhchuang@cdc.gov.tw.

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

25285884

Citation

Huang, Wan-Ting, et al. "Safety of Inactivated Monovalent Pandemic (H1N1) 2009 Vaccination During Pregnancy: a Population-based Study in Taiwan." Vaccine, vol. 32, no. 48, 2014, pp. 6463-8.
Huang WT, Tang FW, Yang SE, et al. Safety of inactivated monovalent pandemic (H1N1) 2009 vaccination during pregnancy: a population-based study in Taiwan. Vaccine. 2014;32(48):6463-8.
Huang, W. T., Tang, F. W., Yang, S. E., Chih, Y. C., & Chuang, J. H. (2014). Safety of inactivated monovalent pandemic (H1N1) 2009 vaccination during pregnancy: a population-based study in Taiwan. Vaccine, 32(48), 6463-8. https://doi.org/10.1016/j.vaccine.2014.09.054
Huang WT, et al. Safety of Inactivated Monovalent Pandemic (H1N1) 2009 Vaccination During Pregnancy: a Population-based Study in Taiwan. Vaccine. 2014 Nov 12;32(48):6463-8. PubMed PMID: 25285884.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety of inactivated monovalent pandemic (H1N1) 2009 vaccination during pregnancy: a population-based study in Taiwan. AU - Huang,Wan-Ting, AU - Tang,Fa-Wei, AU - Yang,Shu-Er, AU - Chih,Yi-Chien, AU - Chuang,Jen-Hsiang, Y1 - 2014/10/05/ PY - 2014/08/04/received PY - 2014/09/19/revised PY - 2014/09/20/accepted PY - 2014/10/7/entrez PY - 2014/10/7/pubmed PY - 2015/6/16/medline KW - H1N1 virus KW - MF59 adjuvant KW - Pregnancy KW - Taiwan KW - Vaccine safety SP - 6463 EP - 8 JF - Vaccine JO - Vaccine VL - 32 IS - 48 N2 - BACKGROUND: Pregnant women were prioritized for H1N1 vaccination during the 2009-2010 pandemic. Safety concerns exist with vaccinating pregnant women, particularly in their first trimesters. METHODS: We linked computerized data on H1N1 vaccination, National Health Insurance, and Taiwan Birth Registry and identified events of spontaneous abortions (SABs) and all singleton births that occurred/delivered during November 1, 2009-September 30, 2010. The observation period for each case of SAB (6-19 weeks gestation) was divided into period at risk (1-28 days after vaccination) and control periods (the remaining person-days until SAB). The self-controlled case series method for truncated observational periods assessed the incidence rate ratio (IRR) of SAB during the 1-28 days compared with those in the control period. The case-control design matched each case of adverse fetal outcomes to up to 10 controls on fetal sex and year/month of pregnancy onset, and calculated matched odds ratio (OR) on H1N1 vaccination at <14 or ≥14 weeks gestation. RESULTS: Sixty-five women with SAB had received H1N1 vaccination at 6-19 weeks gestation. The IRR of SAB for the risk period 1-28 days was 1.03 (95% confidence interval [CI] 0.55-1.93). Among the 147,294 live births and 1354 stillbirths, maternal H1N1 vaccine receipt at <14 weeks gestation was associated with significantly reduced likelihood of small for gestational age (SGA) birth (OR 0.72, 95% CI 0.61-0.84) and birth defect (OR 0.46, 95% CI 0.22-1.00), whereas receipt at ≥14 weeks gestation was associated with significantly reduced likelihood of stillbirth (OR 0.63, 95% CI 0.46-0.86), prematurity (OR 0.90, 95% CI 0.83-0.97), low birth weight (OR 0.81, 95% CI 0.74-0.88), and SGA birth (OR 0.90, 95% CI 0.84-0.97). CONCLUSIONS: H1N1 vaccination during pregnancy did not increase risk of SAB or adverse fetal outcomes. SN - 1873-2518 UR - https://www.unboundmedicine.com/medline/citation/25285884/Safety_of_inactivated_monovalent_pandemic__H1N1__2009_vaccination_during_pregnancy:_a_population_based_study_in_Taiwan_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0264-410X(14)01322-X DB - PRIME DP - Unbound Medicine ER -