(Adds background on capillary lead syndrome, heart
inflammation; BioNTech comment)
By Pushkala Aripaka and Ludwig Burger
June 11 (Reuters) - Europe's drug regulator on Friday
identified another rare blood condition as a potential side
effect of AstraZeneca's COVID-19 vaccine and said it was
looking into cases of heart inflammation after inoculation with
all coronavirus shots.
The European Medicines Agency's (EMA) safety committee said
that capillary leak syndrome must be added as a new side effect
to labelling on AstraZeneca's vaccine, known as Vaxzevria.
People who had previously sustained the condition, where
fluids leak from the smallest blood vessels causing swelling and
a drop in blood pressure, should not receive the shot, the EMA
added.
The regulator first began looking into these cases in April
and the recommendation adds to AstraZeneca's woes after its
vaccine was associated with very rare and potentially lethal
cases of blood clotting that come with a low platelet count.
Last month, the EMA had advised against using the second
AstraZeneca shot for people with that clotting condition, known
as thrombosis with thrombocytopenia syndrome (TTS).
The committee reviewed six validated cases of capillary leak
syndrome in people, mostly women, who had received Vaxzevria,
including one death. Three had had a history of the condition.
AstraZeneca declined to immediately comment.
More than 78 million Vaxzevria doses have been administered
in the European Union, Liechtenstein, Iceland & Norway and
Britain.
Britain’s regulator, the MHRA said on Thursday it had
received 8 reports of capillary leak syndrome in the context of
more than 40 million doses of the AstraZeneca vaccine given, and
currently does not see a causal link.
Separately, the EMA said it was continuing its probe into
cases of heart inflammation known as myocarditis and
pericarditis, primarily following inoculation with the
Pfizer/BioNTech and Moderna mRNA shots, but
also after the J&J and AstraZeneca vaccines.
U.S. health officials said on Thursday they had registered a
higher-than-expected number of heart inflammation cases in young
men who received a second dose of the mRNA shots, though a
causal relationship could not be established.
Israel’s Health Ministry said this month it had found a
likely link to the condition in young men who received the
Pfizer/BioNTech shot.
Both Pfizer and Moderna have acknowldged the observations
but said a causal association with their vaccines has not been
established.
BioNTech said adverse events, including myocarditis and
pericarditis, are being regularly and thoroughly reviewed by the
companies and regulatory authorities.
"More than 300 million doses of the Pfizer-BioNTech COVID-19
vaccine have been administered globally and the benefit risk
profile of our vaccine remains positive."
The United States and Israel have been months ahead of the
EU in vaccinating men below 30, who are particularly prone to
heart inflammation, giving them potentially more cases to
analyse.
(Reporting by Pushkala Aripaka in Bengaluru and Ludwig Burger
in Frankfurt; Editing by Arun Koyyur, Kirsten Donovan)
Astrazeneca (AZN)
