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Covid19 / EMA: Vaccines in pregnant women are just as effective in reducing the risk of hospitalization and death as in non-pregnant women

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Covid19 / EMA: Vaccines in pregnant women are just as effective in reducing the risk of hospitalization and death as in non-pregnant women

Vaccination remains a key pillar against COVID-19, especially as variants of the virus continue to spread to EU / EEA countries. The EMA Working Group on COVID-19 (ETF) points to growing evidence that mRNA vaccines against 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 COVID-19. Despite some data limitations, the results are consistent in studies examining these outcomes.

Studies have also shown that vaccines against COVID-19 in pregnant women are 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.

Given that pregnancy has so far been associated with a higher risk of serious COVID-19 disease, especially in the second and third trimesters, women who become pregnant or may become pregnant in the near future are encouraged to be vaccinated according to national recommendations.

Most of the information so far concerns mRNA vaccines (Comirnaty and Spikevax). The EMA will also review relevant data for other licensed COVID-19 vaccines 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 COVID-19 vaccine have shown no adverse effects on pregnancy or postnatal development. A review of the facts suggests that the benefits of mRNA vaccination against COVID-19 during pregnancy outweigh the potential risks to expectant mothers and unborn babies.

The EMA Commission for Human Use (CHMP) will review the latest data from mRNA vaccine manufacturers on COVID-19 during pregnancy to update recommendations on vaccine product information, where applicable. is applicable.

Vaccine safety monitoring

According to the EU COVID-19 vaccine safety monitoring plan, 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 been vaccinated against COVID-19, some side effects may continue to occur as more and more people become involved 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.

Source: politis.com.cy

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