The European Medicines Agency (EMA), the European Union’s pharmaceutical regulator, on Friday recommended adding heavy menstrual bleeding to the list of side effects of mRNA vaccines against COVID-19, Reuters reported.
The measure targets two Covid vaccines developed by Moderna and Pfizer in partnership with BioNTech.
EMA states that reports of heavy periods characterized by increased volume/duration of bleeding affecting quality of life have been observed in clinical trials, in real-world cases and in the literature.
The cases, most of which were not serious and only temporary, were reported after the first, second and booster doses of the Comirnaty and Spikevax vaccines developed by Pfizer/BioNTech and Moderna, respectively.
The regulator has now concluded that there is at least a “reasonable possibility” that heavy menstrual bleeding is causally linked to these vaccines.
MRNA vaccines do not affect fertility in any way
Pfizer, BioNTech and Moderna have not yet commented on the EMA decision.
The European regulator also stated that there is no evidence that menstrual disorders affect reproductive functions and fertility.
The EMA also notes that mRNA vaccines do not cause complications during pregnancy in either mothers or infants, and that they are as effective in preventing hospitalizations and deaths related to COVID-19 as in the general population.
On Friday, the European Agency reiterated that all evidence continues to show that the benefits of these vaccines far outweigh the potential risks.
Source: Hot News RU
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