(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, as well as partners Pfizer and BioNTech.
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)
