May 24, 2022

Messenger RNA vaccines against Covid-19 do not lead to “increased risk of complications during pregnancy”, reassures the European Medicines Agency

A working group of the European regulator has examined several studies devoted to the question, carried out with some 65,000 women, before communicating its conclusions.

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Studies of pregnant women have found that the two Covid-19 vaccines from Pfizer and Moderna, made with messenger RNA technology, pose no risk to mothers or babies, said (in English) the European Medicines Agency (EMA), Tuesday 18 January. To reach these conclusions, the EMA working group carried out a “extensive review of several studies” – the bibliography cites a dozen.

Research involving some 65,000 women has shown “increasing evidence” that the injections of the Pfizer and Moderna vaccines did not cause complications during the pregnancy, thus affirms the European regulator. “The review did not identify any signs of an increased risk of complications during pregnancy, miscarriage, premature birth or adverse effects in unborn babies following vaccination with the Covid mRNA vaccine”, the statement said.

Vaccinations have also provided increased protection against hospitalizations and death, especially in late pregnancy. “The review (…) suggests that the benefits of mRNA Covid vaccines during pregnancy outweigh any possible risks to pregnant women and unborn babies”, underlined the EMA. Pregnancy itself had been associated with a higher risk of developing a severe form of the disease during the second and third trimesters, so expectant mothers should get the shot.

The first ones clinical tests generally do not include pregnant women. Consequently, data on the use of vaccines, like any other medicine during pregnancy, are generally not available at the time of authorization but obtained afterwards, by studying the effects in real life. EMA said it will now review data from other licensed vaccines “as they become available”.