The Covid-19 working group of the European Medicines Agency (EMA) launched a detailed evaluation, which included a number of studies looking at a total of 65,000 pregnancies at different stages of pregnancy.
The assessment did not reveal any evidence of a complication of pregnancy, miscarriage, premature birth or an increased risk of adverse effects on the unborn child following vaccination with Covid-19 mRNA vaccines. Despite the lack of data, these results have been observed in several studies examining these outcomes.
These studies also show that Covid-19 vaccines are equally effective in reducing the risk of hospitalization in both pregnant and non-pregnant women.
The most common side effects with vaccines in pregnant women are the same as in the general population. These include pain at the injection site, tiredness, headache, redness and swelling at the injection site, muscle aches and chills. These side effects are usually mild to moderate and go away within a few days of vaccination.
Given that pregnancy has been associated with an increased risk of severe Covid-19, especially in the second and third trimesters, pregnant women and women who may become pregnant in the near future are encouraged to be vaccinated according to national guidelines.
Most information to date has been obtained on mRNA vaccines (Comirnaty and Spikevax). The ESA will also evaluate data on other registered Covid-19 vaccines as they become available.
Pregnant women are generally excluded from initial clinical trials. Therefore, data on the use of the vaccine as well as any other medicinal products during pregnancy are usually not available at the time of registration but will be available at a later date.
Animal studies with Covid-19 do not indicate any harmful effect with respect to pregnancy or postnatal development. An evaluation of the evidence from real practice shows that the benefits of receiving mRNA vaccines during pregnancy outweigh any potential risks to expectant mothers and unborn children.
The Committee for Medicinal Products for Human Use (CHMP) will review the latest information from the manufacturers of mRNA Covid-19 in order to assess the need for changes to the product information in the vaccine products, where applicable.
Monitoring the safety of vaccines
According to the EU Covid-19 Vaccine Surveillance Plan, these vaccines are closely monitored and up-to-date information is collected and evaluated on an ongoing basis. Although a very large number of people have already received Covid-19 vaccines, some new side effects may still be seen as more people are included in vaccination programs. The ESA Safety Committee PRAC will continue to monitor their safety during pregnancy.
Companies are required to provide regular updates and research to monitor the safety and effectiveness of their vaccines in the general population. The competent authorities shall also carry out further studies to monitor the safety and efficacy of the vaccines, including their use during pregnancy.
These measures allow regulators to timely assess data from a variety of sources and, if necessary, take the necessary regulatory action to protect public health.
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