Risks and safety of pandemic H1N1 influenza vaccine in pregnancy: exposure prevalence, preterm delivery, and specific birth defects

Abstract

We estimated exposure prevalence and studied potential risks for preterm delivery (PTD) and specific birth defects associated with exposure to the unadjuvanted pH1N1-containing vaccines in the 2009-2010 and 2010-2011 influenza seasons. We used data from 4 regional centers in the United States collected as part of the Slone Epidemiology Center's Birth Defects Study. For PTD, propensity score-adjusted time-varying hazard ratios (HRs) and 95% confidence intervals (CIs) were estimated for exposure anytime in pregnancy and for each trimester. For 41 specific major birth defects, propensity score-adjusted odds ratios (ORs) and 95% confidence intervals (CIs) were estimated. Among 4191 subjects, there were 3104 mothers of malformed (cases) and 1087 mothers of nonmalformed (controls). Exposure prevalences among controls were 47% for the 2009-2010 season and 38% for the 2010-2011 season; prevalence varied by geographic region. Results for PTD differed between the two seasons, with risks above and below the null for the 2009-2010 and 2010-2011 seasons, respectively. For 41 specific birth defects, most adjusted ORs were close to 1.0. Three defects had adjusted ORs>2.0 and four had risks<0.5; however, 95% CIs for these were wide.

Conclusions: Among women exposed to pH1N1 vaccine, we found a decreased risk for PTD in the 2010-2011 season; risk was increased in 2009-2010, particularly following exposure in the first trimester, though the decrease in gestational length was less than 2 days. For specific major defects, we found no meaningful evidence of increased risk for specific congenital malformations following pH1N1 influenza vaccinations in the 2009-2010 and 2010-2011 seasons.

Keywords: Birth defects; Pandemic H1N1 vaccine; Pregnancy; Preterm delivery.