EU regulator recommends adding heavy periods to side effects of mRNA COVID shots - Reuters

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Oct 28 (Reuters) - A European Medicines Agency (EMA) committee on Friday recommended adding heavy menstrual bleeding as a side effect of mRNA COVID-19 vaccines made by Moderna (MRNA.O), as well as partners Pfizer (PFE.N) and BioNTech (22UAy.DE).

Reports of heavy periods - bleeding characterised by increased volume and/or duration that interferes with the quality of life - have been observed during clinical trials, from cases in the real world and in medical literature, the EMA said.

The cases - which have mostly been non-serious and temporary in nature - have been reported after the first, second and booster doses of Pfizer-BioNTech's Comirnaty and Moderna's Spikevax, it added.

The regulator has now concluded that there is at least a "reasonable possibility" that heavy menstrual bleeding is causally associated with these vaccines.

Menstrual disorders can occur due to a range of reasons, including underlying medical conditions as well as stress and tiredness. Health authorities have highlighted that cases have also been reported following COVID-19 infection.

Reporting by Bhanvi Satija in Bengaluru and Natalie Grover in London; Editing by Shailesh Kuber and Louise Heavens

Our Standards: The Thomson Reuters Trust Principles.

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EU regulator recommends adding heavy periods to side effects of mRNA COVID shots - Reuters
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