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July 9 (Reuters) - Europe's drug regulator has found a
possible link between very rare heart inflammation and COVID-19
vaccines from Pfizer and Moderna, it said on
Friday, stressing that the benefits of the shots outweighed any
risks.
Heart conditions myocarditis and pericarditis must be listed
as possible 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
vaccination.
It added that the conditions occurred more often after the
second dose and in younger adult men. This is in line with U.S.
findings last month.
The EMA reviewed more than 300 cases of myocarditis and
pericarditis overall in the European Union, plus Iceland, Norway
and Liechtenstein. Most of the cases occurred after inoculation
with Pfizer's vaccine, called Comirnaty, it said.
Pfizer's vaccine has been used more widely in the EU than
Moderna's.
Pfizer said in a statement that the cases were "generally
mild" and individuals "tend to recover within a short time
following standard treatment and rest". Its German partner,
BioNTech, was not immediately available for comment.
The EMA had also been looking into such cases with Johnson &
Johnson and AstraZeneca vaccines, but on Friday
said it had not found any causal relationship so far.
Symptoms from the conditions include breathlessness,
palpitations and chest pain.
"EMA confirms that the benefits of all authorised COVID-19
vaccines continue to outweigh their risks," it said.
The EMA's safety panel also advised that people who have a
history of a rare blood disorder called capillary leak syndrome
(CLS) must not be vaccinated with J&J's single-shot vaccine,
after reviewing three cases which occurred within two days of
vaccination.
J&J did not immediately respond to a request for comment.
The watchdog in June asked CLS to be added as a side-effect
of AstraZeneca's shot, Vaxzevria.
The EMA 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.
Both AstraZeneca and J&J vaccines use different versions of
a cold virus to deliver instructions for making coronavirus
proteins produce an immune response.
(Reporting by Pushkala Aripaka and Trisha Roy in Bengaluru;
Editing by Arun Koyyur and Nick Macfie)
