Vaccination remains a key pillar against COVID-19, especially as variants of the virus continue to spread in EU/EEA countries. The EMA Working Group on COVID-19 (ETF) highlights the growing evidence suggesting that mRNA vaccines against COVID-19 do not cause pregnancy complications for expectant mothers and their babies.
The working group conducted a detailed review of several studies involving approximately 65,000 pregnancies at different stages. The review found no increased risk of pregnancy complications, miscarriage, preterm delivery or adverse events in unborn babies following vaccination with mRNA technology vaccines against COVID-19. Despite some limitations in the data, the results are consistent across studies examining these outcomes.
Studies have also shown that COVID-19 vaccines in pregnant women are as effective in reducing the risk of hospitalization and death as in non-pregnant women. The most common side effects of vaccines in pregnant women are also consistent with those of the overall 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 severe COVID-19 infection, particularly in the second and third trimester, women who are pregnant or are likely to become pregnant in the near future are encouraged to be vaccinated according to national recommendations.
Most information so far relates to the mRNA vaccines (Comirnaty and Spikevax). The EMA will also review relevant data on other licensed COVID-19 vaccines as they become available.
Initial clinical trials do not generally include pregnant women. As a result, data on the use of the vaccines, as for any other drug during pregnancy, are usually not available at the time of licensing, but are obtained retrospectively. Animal studies with COVID-19 vaccines have shown no adverse effects on pregnancy or postnatal development. The review of the evidence suggests that the benefits of receiving mRNA technology vaccines against COVID-19 during pregnancy outweigh the potential risks to expectant mothers and unborn babies.
The EMA Committee for Medicinal Products for Human Use (CHMP) will review the most recent data from manufacturers of mRNA vaccines against COVID-19 disease during pregnancy with a view to updating the recommendations in the product information for vaccines, where applicable.
Vaccine safety monitoring
In accordance with the EU safety monitoring plan for COVID-19 vaccines, these vaccines are closely monitored and relevant new information arising is continuously collected and evaluated in a timely manner. Although a very large number of people have already received COVID-19 vaccines, some side effects may continue to occur as more and more people are included in the vaccination programmes. The EMA's safety committee, PRAC will continue to monitor safety during pregnancy.
Companies are required to provide regular updates and conduct studies to monitor the safety and effectiveness of their vaccines as they are used by the public. The authorities shall also conduct additional studies to monitor the safety and efficacy of vaccines, including their use during pregnancy.
These measures allow regulators to quickly assess data from a range of different sources and, if necessary, take appropriate regulatory action to protect public health.
(AF)
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