Covid: 19 vaccine batch Austria has halted use of went to 17 countries
09/03/2021 10:06
VIENNA, March 9 (Reuters) - Austria was one of 17 European
countries to receive doses from a batch of AstraZeneca's
COVID-19 vaccine that Austrian authorities have stopped using
while investigating a death and an illness following their use,
a senior health official said on Tuesday.
A 49-year-old nurse in Zwettl, a town northwest of Vienna,
died as a result of severe coagulation disorders after receiving
the vaccine. Another nurse from Zwettl who is 35 and received a
dose from the same batch, ABV 5300, developed a pulmonary
embolism and is recovering. urn:newsml:reuters.com:*:nL1N2L5070
"We informed all European colleagues in the European network
as this batch, which amounted to roughly a million doses in
total, was sent to 17 European countries," Christa
Wirthumer-Hoche, the head of Austrian public health agency AGES'
medicines market supervisory body, told a news conference.
The European Medicines Agency's Pharmacovigilance Risk
Assessment Committee (PRAC), which monitors the safety of
medicines, discussed the case on Monday, said Wirthumer-Hoche,
who also heads EMA's management board.
She did not identify the countries or say what steps, if
any, they had taken. AstraZeneca AZN.L has said it is in
contact with Austrian authorities and will fully support the
investigation.
The Anglo-Swedish company has said all batches are subject
to strict and rigorous quality controls and that there have been
"no confirmed serious adverse events associated with the
vaccine".
An autopsy of the nurse is being carried out and
Wirthumer-Hoche said she expected the results next week.
European Union regulators at the end of January approved the
product, saying it was effective and safe to use, while the
World Health Organization in mid-February listed it for
emergency use.
Adverse reactions seen in trials were short-lived for the
most part and blood clotting problems were not reported.
A safety assessment by Germany's vaccine regulator of more
than 360,000 people who received the AstraZeneca vaccine last
month concluded that adverse reactions were in line with the
safety profile described in clinical trials.
(Reporting by Francois Murphy, Editing by Timothy Heritage)
((francois.murphy@thomsonreuters.com))