EMA recommends expansion of Moderna and Pfizer side effects list

The EU regulator recommends adding another one to the existing list of “side effects” from anti-covid vaccines with Moderna and Pfizer vaccines.

We are talking about possible heavy menstrual bleeding, it says in a committee statement European Medicines Agency (EMA). The report notes that some women complained during clinical trials of heavy bleeding, which was characterized by an increase in duration and / or volume, which was reflected in the quality of life.

As noted in the statement, all cases were reported after the first and second booster doses. Most of the changes in the female body were temporary. Attention is drawn to the fact that changes in the menstrual cycle do not affect reproduction and fertility. In conclusion, the EMA notes:

“After reviewing the data, the committee concluded that there is at least a reasonable likelihood that heavy menstrual bleeding is associated with these vaccines and therefore recommended that the product information be updated.”

Moderna said they are aware of these changes, but do not yet see a causal relationship with the drug. Pfizer and BioNTech do not comment on the situation.

Experts remind that vaccination against COVID-19 significantly reduces the risk of complications from the disease. Also, mRNA vaccines are safe for pregnant women.



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