(Adds statements from AstraZeneca, MHRA)
By Pushkala Aripaka and Ludwig Burger
June 11 (Reuters) - Europe's drug regulator on Friday
identified another very 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 (CLS) 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 giving a second
AstraZeneca shot to people with that clotting condition, known
as thrombosis with thrombocytopenia syndrome (TTS).
The committee reviewed six validated cases of CLS in people,
mostly women, who had received Vaxzevria, including one death.
Three had a history of the condition.
More than 78 million Vaxzevria doses have been administered
in the European Union, Liechtenstein, Iceland & Norway and
Britain.
In a statement, AstraZeneca pointed to the extreme rarity of
CLS cases, at less than 1 in 10 million vaccinated individuals.
"We are working actively, in collaboration with regulatory
authorities, on risk minimization measures... that includes
information to those being vaccinated...information to drive
early diagnosis and intervention, and appropriate treatment,"
the company said.
Britain’s regulator, the MHRA said it was considering
precautionary advice for people with a history of CLS but does
not see a causal link with the vaccine.
Two of eight reports of capillary leak syndrome following
AstraZeneca vaccination in the UK were in people with a history
of the condition, and 40 million doses of the vaccine had been
given, it said.
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 acknowledged 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)