* EMA reviews AstraZeneca shot for Guillain-Barre syndrome
* Rare nerve syndrome also linked some vaccinations in past
* EMA assessing heart inflammation with Pfizer, Moderna
shots
* Studies into possible links to rare blood clots ongoing
(Adds BioNTech, Pfizer statement)
May 7 (Reuters) - Europe's medicines regulator is reviewing
reports of a rare nerve-degenerating disorder in people who
received AstraZeneca's COVID-19 shots, raising fresh
questions about potential side-effects of the vaccine.
As part of a regular review of safety reports for the
vaccine, Vaxzevria, the safety committee of the European
Medicines Agency (EMA), is analysing data provided by
AstraZeneca on cases of Guillain-Barre syndrome (GBS), it said
on Friday, without specifying the number of cases.
The Anglo-Swedish drugmaker did not immediately respond to a
request for comment.
The move comes after the EMA found last month that COVID-19
vaccines from both AstraZeneca and Johnson & Johnson may
have caused very rare blood clotting cases.
While the regulator has said the benefits of AstraZeneca's
cheap and easily transportable vaccine in fighting the deadly
pandemic outweigh any risks, several European countries have
limited use to older age groups or suspended use altogether.
The EMA has also backed J&J's vaccine, which is based on a
similar technology to AstraZeneca's.
The regulator said GBS was identified as a possible adverse
event that needed to be specifically monitored during the
vaccine's conditional approval process, adding it had requested
more detailed data on the cases from AstraZeneca.
RARE CONDITION
GBS is a rare neurological condition in which the body's
immune system attacks the protective coating on nerve fibres.
Most cases follow a bacterial or viral infection.
The condition has been linked in the past to vaccinations -
most notably to a vaccination campaign during a swine flu
outbreak in the United States in 1976, and decades later to the
vaccine used during the 2009 H1N1 flu pandemic.
However, researchers have found the chances of developing
GBS after vaccination are extremely small.
On Friday, the EMA also said it was looking into reports of
heart inflammation with Pfizer-BioNTech's
vaccine and Moderna's shot. It said there was no
indication at present that these cases were due to the vaccines.
Both the Pfizer-BioNTech and Moderna vaccines use new mRNA
technology to build immunity.
Last week, the U.S. Centers for Disease Control and
Prevention said it had not found a link between heart
inflammation and COVID-19 vaccines.
Pfizer and BioNTech said in a joint statement they would
support the EMA's review and that they also saw no indication of
a causal link after more than 450 million doses had been
administered globally.
Myocarditis was not observed at a higher rate than would be
expected in the general population, they added.
Moderna did not immediately respond to a request for
comment.
(Reporting by Pushkala Aripaka and Yadarisa Shabong in
Bengaluru, Ludwig Burger in Frankfurt and Kate Kelland in
London; Editing by Gareth Jones and Mark Potter)
Astrazeneca (AZN)
