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* 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
(Adding details throughout)
By Pushkala Aripaka, Anthony Deutsch and John Miller
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 review of the cases prompted a pause in the rollout of
the vaccine in Europe and the United States last week, the
latest blow to efforts to tackle the pandemic, which has killed
more than 3.1 million and infected 142.1 million worldwide.
While the regulator said it considers the vaccine safe, it
was up to the EU member states to decide how to use it, taking a
similar stance to that with AstraZeneca.
"I have to stress again (the cases) are very rare and in the
vast majority of cases these vaccines are going to prevent death
and hospitalisation from COVID-19," EMA executive Director Emer
Cooke said in a briefing.
"We have to balance the benefits of the vaccine with the
risks."
Several nations have suspended or limited the use of
AstraZeneca's vaccine over possible blood clots. (https://bit.ly/3xckNFu)
The EMA examined eight cases of clotting that occurred in
U.S. adults under 60 years, mostly women, within three weeks of
vaccination with J&J's single shot.
If treated early, health care professionals can help people
in their recovery and avoid further complications, Sabine
Straus, chair of EMA's safety committee, told the briefing.
EXTREMELY RARE CLOTTING
With both the AstraZeneca and J&J vaccines, the reports
involve extremely rare clotting, mainly a type of blood clot
called cerebral venous sinus thrombosis (CVST), which was seen
in combination with low levels of blood platelets, called
thrombocytopenia.
J&J has said it is working closely with regulators and noted
that no clear causal relationship had been established between
the clotting cases and its shot.
The EU 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.
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 blood clots after receiving it.
The cases were reported out of more than 7 million doses
administered in the United States as of April 13, the EMA said.
U.S. authorities will meet on Friday to discuss whether to
resume using the vaccine.
J&J, which recorded $100 million in COVID-19 vaccine sales,
has delayed rolling out the vaccine to Europe, but said on
Tuesday it was 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.
(Additional reporting by John Miller in Zurich, Ludwig Burger
in Frankfrut, Julie Steenhuysen in Chicago; Writing by Josephine
Mason; Editing by Gareth Jones)
