(Adds J&J statement in sixth paragraph)
By Pushkala Aripaka
Aug 6 (Reuters) - No causal link between COVID-19 vaccines
and menstrual disorders has been found so far, Europe's drugs
regulator said on Friday, separately recommending that three
new conditions be added as possible side-effects of J&J's
coronavirus shot.
The European Medicines Agency said its safety committee had
studied cases of menstrual disorders reported after vaccination,
adding it had requested more data from vaccine developers to
assess the issue.
Menstrual disorders can occur for various reasons, from
stress and tiredness to underlying medical conditions such as
fibroids and endometriosis.
Separately, the EMA on Friday recommended that immune
thrombocytopenia, or low blood platelets, dizziness, and
tinnitus, or ringing in the ear, be added to the labels of
J&J's single-shot vaccine as potential adverse reactions.
The EU agency stressed that benefits of J&J's vaccine still
outweighed any risks, adding that it had analysed 1,183 cases of
dizziness and more than 100 cases of tinnitus to reach its
conclusion.
"We strongly support raising awareness of the signs and
symptoms of rare events to ensure they can be quickly identified
and effectively treated," U.S.-based J&J said in a statement,
adding that data on adverse reactions is periodically shared
with regulators.
The EMA last month listed a rare nerve-degenerating
disorder, Guillain-Barré syndrome (GBS), as a possible rare
side-effect from the J&J shot. The company has also struggled
with supply in the European Union.
The EMA has also added GBS as a possible side-effect of
AstraZeneca's COVID-19 vaccine, and said on Friday it
was still monitoring such reports.
Both J&J and AstraZeneca vaccines use similar technology but
with different versions of a cold virus to deliver
immunity-building instructions to the body.
(Reporting by Pushkala Aripaka and Yadarisa Shabong in
Bengaluru
Editing by Shounak Dasgupta and Frances Kerry)