mRNA Vaccine Safety Data Offers Pregnant Women Reassurances

The European Medicines Agency (EMA) COVID-19 task force highlighted growing evidence on January 18, 2022, indicating that mRNA COVID-19 vaccines do not cause pregnancy complications for expectant mothers and their babies. 

The task force undertook a detailed review of several clinical 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 on unborn babies following mRNA COVID-19 vaccination.

The most common side effects of mRNA vaccines in pregnant women also match those in the overall vaccinated population. However, these side effects are usually mild or moderate and improve within a few days of vaccination.

Most of the information for this EMA review came from mRNA vaccines (Comirnaty and Spikevax).

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 authorization but are obtained afterward.

Furthermore, the review of real-world evidence suggests that the benefits of receiving mRNA COVID-19 vaccines during pregnancy outweigh any possible risks for expectant mothers and unborn babies.

The EMA confirmed the human medicines committee would consider the latest data from the manufacturers of mRNA COVID-19 vaccines during pregnancy to update the recommendations in the product information for the vaccines where applicable.

In addition to COVID-19 and influenza vaccinations, the U.S. CDC suggests women get the Tdap vaccine to protect their baby against whooping cough, which can have similar symptoms to COVID-19.

The CDC recommends all pregnant women receive a Tdap vaccine during each pregnancy.

In addition, everyone who is around the baby should be up to date with their whooping cough vaccine.