mRNA COVID-19 vaccines safe for pregnant women, finds EMA review

According to the European Medicines Agency (EMA)’s COVID-19 task force (ETF), a growing body of evidence suggests that messenger RNA (mRNA) COVID-19 vaccines do not cause pregnancy complications for expectant mothers and their babies. 

The ETF undertook a detailed review of several studies involving around 65,000 pregnancies at different stages and 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 EMA stated the results appear consistent across studies looking at these outcomes.

The studies also highlighted 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. In addition, the most common side effects in pregnant people are the same as those in the overall vaccinated population. These symptoms, including pain at the injection site, tiredness, headache, redness and swelling at the site of injection, muscle pain and chills, are usually mild or moderate and improve within a few days of vaccination.

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

Most of the information so far has come from the mRNA vaccines Comirnaty (Pfizer and BioNTech’s vaccine) and Spikevax (previously COVID-19 Vaccine Moderna). EMA stated that it will review data for other authorised COVID-19 vaccines as they become available.

Initial clinical trials do not generally include pregnant people. As a result, data on the use of vaccines as any other medicines during pregnancy, are not usually available at the time of the authorisation but are obtained afterwards. Animal studies with the COVID-19 vaccines did not show any harmful effects in pregnancy or post-natal development. The review of real-world evidence suggests that the benefits of receiving mRNA COVID-19 vaccines during pregnancy outweighs any possible risks for expectant mothers and unborn babies.

EMA’s Committee for Medicinal Products for Human Use (CHMP) will consider the latest data from the manufacturers of mRNA COVID-19 vaccines during pregnancy with a view to updating the recommendations in the product information for the vaccines where applicable.