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The agency’s COVID-19 task force says latest data shows use of COVID-19 mRNA vaccines during pregnancy is safe.
On January 18, 2022, the European Medicines Agency (EMA) stated that its COVID-19 task force reviewed several studies involving approximately 65,000 pregnancies and did not find any sign of increased risk of complications, miscarriages, preterm births, or adverse events after vaccination with mRNA vaccines. “Despite some limitations in the data, the results appear consistent across studies looking at these outcomes,” the agency stated in a press release.
According to EMA, the studies also showed the vaccines reduce the risk of hospitalization and death in pregnant people as well as non-pregnant people, and side effects related to the mRNA vaccines in pregnant people matched those of non-pregnant people. “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,” EMA stated in the release.
Because clinical trials do not usually include pregnant people, according to EMA, data on the use of the vaccines are obtained after authorization. The agency will review the latest data on these vaccines administered during pregnancy and will update product information as necessary. “In line with the EU’s safety monitoring plan for COVID-19 vaccines, those vaccines are closely monitored, and relevant new information emerging is continuously collected and promptly reviewed. Although very large numbers of people have already received COVID-19 vaccines, certain side effects may still emerge as more and more people are included in vaccination programmes. EMA’s safety committee, PRAC will continue to monitor safety in pregnancy,” the agency stated.