Vaccination remains a key pillar against the disease COVID-19, in particular as virus variants continue to spread to EU / EEA countries. The EMA Working Group on Disease COVID-19 (ETF) points to growing evidence that mRNA vaccines against the disease COVID-19 do not cause pregnancy complications for expectant mothers and their babies.
The working group carried out a detailed review of several studies involving approximately 65.000 pregnancies at different stages. The review did not show an increased risk of pregnancy complications, miscarriages, premature births or adverse reactions in unborn babies after vaccination with mRNA technology vaccines against the disease. COVID-19. Despite some data limitations, the results are consistent in studies examining these outcomes.
Studies have also shown that vaccines against the disease COVID-19 in pregnant women is just as effective in reducing the risk of hospitalization and death as in non-pregnant women. The most common side effects of the vaccine in pregnant women are also consistent with those in the general vaccinated population and include injection site pain, fatigue, headache, redness and swelling at the injection site, muscle pain and chills. These effects are usually mild or moderate and improve within a few days after vaccination.
Since pregnancy has so far been associated with a higher risk of serious disease with COVID-19, especially in the second and third trimesters, women who become pregnant or may become pregnant in the near future are encouraged to be vaccinated in accordance with national recommendations.
Most of the information so far concerns mRNA vaccines (Comirnaty and Spikevax). The EMA will also review relevant data for other licensed vaccines for the disease COVID-19 as soon as they become available.
Initial clinical trials generally do not involve pregnant women. As a result, data on the use of vaccines, as with any other medicine during pregnancy, are not usually available at the time of licensing, but are retrospectively obtained. Animal studies with vaccines COVID-19 showed no adverse effects on pregnancy or postpartum development. A review of the facts suggests that the benefits of receiving mRNA vaccines against the disease COVID-19 during pregnancy outweigh the potential risks to expectant mothers and unborn babies.
EMA Commission for Human Use (CHMP) to review latest data from mRNA vaccine manufacturers COVID-19 during pregnancy, with the aim of updating the recommendations in the vaccine product information, where applicable.
Vaccine safety monitoring
According to the vaccine safety monitoring plan COVID-19 EU vaccines, these vaccines are closely monitored and the relevant up-to-date information is continuously collected and evaluated in a timely manner. Although a very large number of people have already received vaccines against the disease COVID-19, some side effects may continue to occur as more and more people are included in vaccination programs. The EMA Safety Committee, PRAC will continue to monitor safety during pregnancy.
Companies are required to provide regular updates and conduct surveys to monitor the safety and effectiveness of their vaccines as they are used by the public. Authorities are also conducting additional studies to monitor the safety and effectiveness of vaccines, including their use during pregnancy.
These measures allow regulators to quickly evaluate data from a variety of sources and take appropriate regulatory measures to protect public health, if necessary.