• Katherine Donegan, Bridget King, and Phil Bryan.
• Vigilance and Risk Management of Medicines, Medicines and Healthcare products Regulatory Agency, London SW1W 9SZ, UK katherine.donegan@mhra.gsi.gov.uk.
• BMJ. 2014 Jan 1;349:g4219.

ObjectiveTo examine the safety of pertussis vaccination in pregnancy.DesignObservational cohort study.SettingThe UK Clinical Practice Research Datalink.Participants20,074 pregnant women with a median age of 30 who received the pertussis vaccine and a matched historical unvaccinated control group.Main Outcome MeasureAdverse events identified from clinical diagnoses during pregnancy, with additional data from the matched child record identified through mother-child linkage. The primary event of interest was stillbirth (intrauterine death after 24 weeks' gestation).ResultsThere was no evidence of an increased risk of stillbirth in the 14 days immediately after vaccination (incidence rate ratio 0.69, 95% confidence interval 0.23 to 1.62) or later in pregnancy (0.85, 0.44 to 1.61) compared with historical national rates. Compared with a matched historical cohort of unvaccinated pregnant women, there was no evidence that vaccination accelerated the time to delivery (hazard ratio 1.00, 0.97 to 1.02). Furthermore, there was no evidence of an increased risk of stillbirth, maternal or neonatal death, pre-eclampsia or eclampsia, haemorrhage, fetal distress, uterine rupture, placenta or vasa praevia, caesarean delivery, low birth weight, or neonatal renal failure, all serious events that can occur naturally in pregnancy.ConclusionIn women given pertussis vaccination in the third trimester, there is no evidence of an increased risk of any of an extensive predefined list of adverse events related to pregnancy. In particular, there was no evidence of an increased risk of stillbirth. Given the recent increases in the rate of pertussis infection and morbidity and mortality in neonates, these early data provide initial evidence for evaluating the safety of the vaccine in pregnancy for health professionals and the public and can help to inform vaccination policy making.© Donegan et al 2014.

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