Published: 17 November 2021
Safety Information
Monitoring communication
COVID-19 vaccination in pregnancy: no safety concerns with Comirnaty (Pfizer COVID-19 vaccine)
17 November 2021
Medsafe and the COVID-19 Vaccine Independent Safety Monitoring Board (CV-ISMB) have completed a review of the available safety information on vaccination with Comirnaty during pregnancy. No safety concerns have been found when Comirnaty is administered during pregnancy.
Additional information
Regulator actions
Reporting
Additional information
Medsafe and the CV-ISMB have completed a review of the safety of vaccination with Comirnaty during pregnancy and no safety concerns were identified.
SARS-CoV-2 infection during pregnancy is associated with increased risk of severe COVID-19 disease and death.1,2 Pregnant women with COVID-19 disease are three times more likely to require treatment in an intensive care unit compared with non-pregnant women.3 Infants of mothers with COVID-19 disease are at increased risk of preterm birth and are more likely to require neonatal intensive care.4
In NZ more than 2,800 people have been vaccinated and completed their pregnancy and the Centre for Adverse Reactions Monitoring (CARM) has received 17 reports of miscarriage in people who were vaccinated with Comirnaty, up to 27 October 2021. In general, around 10 to 20 percent of clinically recognised pregnancies result in miscarriage5 and there are more than 2,500 cases of miscarriage requiring hospital treatment each year in New Zealand. The number of reports received by CARM (17) is lower than the expected rate.
The CV-ISMB reviewed the 17 cases alongside the medical literature and considered that there is no evidence to suggest an increased risk of miscarriage after vaccination. The CV-ISMB emphasised the considerable risks to both mother and child of COVID-19 disease in pregnancy and considered that the available safety information supports routine vaccination of pregnant people with Comirnaty (Pfizer COVID-19 vaccine).
More information
Ministry of Health advice on COVID-19 vaccination and pregnancy
Fact sheet from The Immunisation Advocacy Centre
Statement from the Royal Australian and New Zealand College of Obstetricians and Gynaecologists
Search for consumer medicine information and data sheets
Regulator actions
Medsafe continues to monitor the safety of Comirnaty when administered during pregnancy.
Reporting
Consumers and healthcare professionals are encouraged to report suspected adverse reactions to medicines to the Centre for Adverse Reactions Monitoring (CARM).
References
- Kotlar B, Gerson E, Petrillo S, et al. 2021. The impact of the COVID-19 pandemic on maternal and perinatal health: a scoping review. Reprod Health 18(1): 10. DOI: 10.1186/s12978-021-01070-6 (accessed 9 November 2021).
- Lokken EM, Huebner EM, Taylor GG, et al. 2021. Disease severity, pregnancy outcomes, and maternal deaths among pregnant patients with severe acute respiratory syndrome coronavirus 2 infection in Washington State. Am J Obstet Gynecol 225(1): 77.e1–77.e14. DOI: 10.1016/j.ajog.2020.12.1221 (accessed 9 November 2021).
- Zambrano LD, Ellington S, Strid P, et al. 2020. Update: characteristics of symptomatic women of reproductive age with laboratory-confirmed SARS-CoV-2 infection by pregnancy status - United States, January 22–October 3, 2020. MMWR Morb Mortal Wkly Rep 69(44): 1641–7. DOI: 10.15585/mmwr.mm6944e3 (accessed 9 November 2021).
- Allotey J, Stallings E, Bonet M, et al. 2020. Clinical manifestations, risk factors, and maternal and perinatal outcomes of coronavirus disease 2019 in pregnancy: living systematic review and meta-analysis. BMJ 370: m3320. DOI: 10.1136/bmj.m3320 (accessed 9 November 2021).
- Ministry of Health. 2017. Miscarriage and stillbirth 30 May 2017. URL: health.govt.nz/your-health/pregnancy-and-kids/services-and-support-during-pregnancy/miscarriage-and-stillbirth (accessed 9 November 2021).
