Wan-Ting Huang1, Fa-Wei Tang2, Shu-Er Yang3, Yi-Chien Chih4, Jen-Hsiang Chuang5. 1. Taiwan Centers for Disease Control, 6 Linsen S. Road, Taipei 10050, Taiwan. Electronic address: huangwt@ntu.edu.tw. 2. Taiwan Centers for Disease Control, 6 Linsen S. Road, Taipei 10050, Taiwan. Electronic address: pluto0507@hotmail.com. 3. Taiwan Centers for Disease Control, 6 Linsen S. Road, Taipei 10050, Taiwan. Electronic address: shuer@cdc.gov.tw. 4. Taiwan Centers for Disease Control, 6 Linsen S. Road, Taipei 10050, Taiwan. Electronic address: chih@cdc.gov.tw. 5. 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.
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.
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: Lakshmi Panagiotakopoulos; Natalie L McCarthy; Naomi K Tepper; Elyse O Kharbanda; Heather S Lipkind; Gabriela Vazquez-Benitez; David L McClure; Victoria Greenberg; Darios Getahun; Jason M Glanz; Allison L Naleway; Nicola P Klein; Jennifer C Nelson; Eric S Weintraub Journal: Obstet Gynecol Date: 2020-12 Impact factor: 7.623
Authors: Malini DeSilva; Flor M Munoz; Mark Mcmillan; Alison Tse Kawai; Helen Marshall; Kristine K Macartney; Jyoti Joshi; Martina Oneko; Annette Elliott Rose; Helen Dolk; Francesco Trotta; Hans Spiegel; Sylvie Tomczyk; Anju Shrestha; Sonali Kochhar; Elyse O Kharbanda Journal: Vaccine Date: 2016-07-18 Impact factor: 3.641
Authors: Jonas F Ludvigsson; Peter Ström; Cecilia Lundholm; Sven Cnattingius; Anders Ekbom; Åke Örtqvist; Nils Feltelius; Fredrik Granath; Olof Stephansson Journal: BMJ Date: 2015-11-16
Authors: Elizabeth P Schlaudecker; Flor M Munoz; Azucena Bardají; Nansi S Boghossian; Asma Khalil; Hatem Mousa; Mirjana Nesin; Muhammad Imran Nisar; Vitali Pool; Hans M L Spiegel; Milagritos D Tapia; Sonali Kochhar; Steven Black Journal: Vaccine Date: 2017-12-04 Impact factor: 3.641
Authors: Malini DeSilva; Flor M Munoz; Erick Sell; Helen Marshall; Alison Tse Kawai; Alisa Kachikis; Paul Heath; Nicola P Klein; James M Oleske; Fyezah Jehan; Hans Spiegel; Mirjana Nesin; Beckie N Tagbo; Anju Shrestha; Clare L Cutland; Linda O Eckert; Sonali Kochhar; Azucena Bardají Journal: Vaccine Date: 2017-12-04 Impact factor: 3.641
Authors: Lisa A Grohskopf; Leslie Z Sokolow; Karen R Broder; Emmanuel B Walter; Alicia M Fry; Daniel B Jernigan Journal: MMWR Recomm Rep Date: 2018-08-24