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* UK reports five cases of blood clots due to vaccines
* 11 million people have had AstraZeneca's vaccine in UK
* Medical regulator cautions on 4-day headache or bruising
* Benefits of the shot far outweigh possible risks, it says
(Adds quotes, detail)
By Alistair Smout
LONDON, March 18 (Reuters) - Britain's medicines regulator
said there had been five cases of a rare type of blood clot in
the brain among 11 million given AstraZeneca's COVID-19 vaccine
but said that it found the benefits of the shot far outweigh any
possible risks.
Concerns about reports of blood clots, along with low
platelet levels, have led to some European countries including
Germany to pause the rollout of the shot while the cases are
investigated.
However, Britain's Medicines and Healthcare products
Regulatory Agency (MHRA) said that use of the vaccine should
continue while five reports were investigated, and one official
said that the rollout would likely continue even if a link was
proved.
"There is no evidence that blood clots in veins is occurring
more than would be expected in the absence of vaccination, for
either vaccine," said June Raine, MHRA Chief Executive,
referring to AstraZeneca and Pfizer shots.
Raine said there had been a very small number of reports of
an extremely rare form of blood clot in the cerebral veins
(sinus vein thrombosis, or CSVT) occurring together with lowered
platelets soon after vaccination.
"Given the extremely rare rate of occurrence of these CSVT
events among the 11 million people vaccinated (with
AstraZeneca), and as a link to the vaccine is unproven, the
benefits of the vaccine in preventing COVID-19, with its
associated risk of hospitalisation and death, continue to
outweigh the risks of potential side effects," she said.
Still, the MHRA said anyone with a headache that lasts for
more than four days after vaccination, or bruising beyond the
site of vaccination after a few days, should seek medical
attention.
The MHRA said there was an ongoing review into "five UK
reports of a very rare and specific type of blood clot in the
cerebral veins (sinus vein thrombosis) occurring together with
lowered platelets (thrombocytopenia)."
Munir Pirmohamed, Chair of the Commission on Human
Medicines, in a statement suggested that even if a link between
the clots and the vaccine was established, it likely wouldn't
halt Britain's rollout.
"If we feel that there's causal link then we may need to
update the product information, but overall, I don't think that
would necessitate pause to any kind of vaccination programme,"
he told reporters in a briefing.
The European Medicines Agency is investigating reports of 30
cases of unusual blood disorders out of 5 million people who got
the AstraZeneca vaccine in the EU.
The EMA's focus and primary concern is on cases of blood
clots in the head, a rare condition that's difficult to treat
called cerebral venous thrombosis (CVT). It is expected to
announce its findings later on Thursday.
(Reporting by Alistair Smout, Guy Faulconbridge, Kate Holton;
Editing by Nick Macfie)
