* Says possible link to myocarditis and pericarditis
* Says cases occurred more in younger adult men
* Also advices against J&J shot for those with rare blood
disorder
(Adds detail on cases, background)
By Pushkala Aripaka
July 9 (Reuters) - Europe's drug regulator has found a
possible link between very rare heart inflammation and COVID-19
vaccines from Pfizer-BioNTech and Moderna
, it said on Friday, stressing that the benefits of the
shots outweighed any risks.
The conditions, myocarditis and pericarditis, must be listed
as side-effects of the two mRNA vaccines, the safety committee
of the European Medicines Agency (EMA) said, adding that such
cases primarily occurred within 14 days of inoculation.
It said cases occurred more often after the second dose and
in younger adult men. This is in line with U.S. findings last
month.
Symptoms from the conditions include breathlessness,
palpitations and chest pain.
EMA's safety panel also advised that people with a history
of the rare blood disorder capillary leak syndrome (CLS), must
not be vaccinated with Johnson & Johnson's shot.
While the regulator cautioned healthcare professionals and
people to be on the lookout for post-vaccine symptoms, it said
it was continuously monitoring the safety of approved vaccines
as they are rolled out more widely.
"EMA confirms that the benefits of all authorised COVID-19
vaccines continue to outweigh their risks," it said.
EMA in total reviewed more than 300 cases of myocarditis and
pericarditis in the European Union, Iceland, Norway and
Liechtenstein - together referred to as the European Economic
Area (EEA).
Most cases occurred with Pfizer's vaccine, called Comirnaty,
the watchdog said.
SIDE-EFFECTS
Roughly 177 million doses of Comirnaty had been given in the
EEA as of May 31, compared to 20 million doses of Moderna's
Spikevax vaccine, EMA said.
The cases of myocarditis and pericarditis were "generally
mild," and individuals "tend to recover within a short time
following standard treatment and rest," Pfizer said in a
statement.
EMA had also been looking into such cases with J&J and
AstraZeneca vaccines, but on Friday said it had not
found any causal relationship so far and had asked for more data
from the drugmakers.
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.
EMA in June asked CLS to be added as a side-effect of
AstraZeneca's shot, Vaxzevria.
The regulator then too said people who had previously
sustained the condition, in which fluids leak from the smallest
blood vessels causing swelling and a drop in blood pressure,
should not receive the shot.
For J&J, EMA reviewed three cases of CLS which occurred
within two days of vaccination.
The developments could put pressure on vaccination plans in
Europe and on the U.S. company after millions of doses of the
vaccine were banned for EU use over safety concerns following a
contamination incident in the United States.
J&J did not immediately respond to a request for comment.
(Reporting by Pushkala Aripaka in Bengaluru; additional
reporting by Trisha Roy; Editing by Arun Koyyur, Nick Macfie,
Kirsten Donovan)