* EMA assessed 8 cases of serious clots in the United States
* Says overall benefits outweigh any risks
* Cases occurred in adults under 60, most of them women
(Writes through with details, background)
April 20 (Reuters) - Europe's drug regulator has found a
possible link between Johnson & Johnson's COVID-19
vaccine and rare blood clotting issues in adults who received
doses in the United States, but backed its overall benefits
against any risks.
The European Medicines Agency (EMA) said on Tuesday its
safety committee had concluded that a warning about unusual
blood clots with low platelets must be added to the vaccine's
labels, just as it has also required of rival vaccine maker
AstraZeneca.
The findings are a blow to the European Union, which is
battling major hurdles to its immunisation campaign after
several nations suspended or limited the use of AstraZeneca's
vaccine over possible blood clots. (https://bit.ly/3xckNFu)
The EMA found that all instances of clotting had occurred in
adults under 60 years, mostly women, within three weeks of
vaccination with J&J's single shot.
It said all available evidence, including eight U.S. reports
of cases, had formed part of its assessment.
The watchdog also said that most clots had occurred in the
brain and abdomen, as was the case with AstraZeneca's
shot, Vaxzevria, which is also being studied for similar blood
clotting problems.
"One plausible explanation for the combination of blood
clots and low blood platelets is an immune response, leading to
a condition similar to one seen sometimes in patients treated
with heparin," the EMA said.
RARE BLOOD CLOTS
The U.S. health regulator last week recommended pausing the
use of the J&J single-dose shot after six women under the age of
50 developed rare blood clots after receiving it, in a fresh
setback to global efforts to tackle the pandemic.
The cases were reported out of more than 7 million doses
administered in the United States as of April 13, the EMA said.
J&J, which recorded $100 million in COVID-19 vaccine sales,
has delayed rolling out the vaccine to Europe, but is prepared
to resume the deployment. It has said it would aim to deliver 55
million doses to the EU, as contracted, by the end of June.
J&J's vaccine, developed by its Janssen unit, is one of four
COVID-19 vaccines authorised for use in Europe.
(Reporting by Pushkala Aripaka in Bengaluru
Editing by Gareth Jones)
Astrazeneca (AZN)