EMA highlights latest safety data providing reassurance about use of mRNA vaccines during pregnancy

News Category: Regulatory news

Date: 18/01/2022

The European Medicines Agency’s COVID-19 task force (ETF)* has today highlighted the growing evidence indicating that mRNA COVID-19 vaccines do not cause pregnancy complications for expectant mothers and their babies. Vaccination remains a major pillar of the response to COVID-19, particularly as variants of the virus continue to spread in EU/EEA countries.

The task force undertook a detailed review of several studies involving around 65,000 pregnancies at different stages. The review did not find any sign of an increased risk of pregnancy complications, miscarriages, preterm births or adverse effects in the unborn babies following mRNA COVID-19 vaccination. Despite some limitations in the data, the results appear consistent across studies looking at these outcomes.

Studies also showed that COVID-19 vaccines are as effective at reducing the risk of hospitalisation and deaths in pregnant people as they are in non-pregnant people. The most common side effects of the vaccines in pregnant people also match those in the overall vaccinated population.

Given that so far pregnancy has been associated with a higher risk of severe COVID-19 particularly in the second and third trimesters, people who are pregnant or might become pregnant in the near future are encouraged to get vaccinated in line with national recommendations.

Further information can be found on the EMA’s website.

In Ireland, the HSE has published information and advice on its website:

Pregnant, breastfeeding and fertility: deciding on COVID-19 vaccination

Pregnancy and getting a COVID-19 vaccine

The HSE’s National Immunisation Office (NIO) has also created COVID-19 vaccine information videos for pregnant women in a range of languages which can be viewed on the HSE’s YouTube channel.

*The role of the EMA pandemic task force, of which the HPRA is a member, is to assist EU Member States and the European Commission to take quick and coordinated regulatory action on the development, authorisation and safety monitoring of treatments and vaccines intended for the treatment and prevention of COVID-19.

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