* Opinion on conditional authorisation expected by Jan. 29
* EMA studying additional information provided by
AstraZeneca
* EMA began rolling review of vaccine in Oct
(Adds details on deliveries, bullets, context)
By Pushkala Aripaka
Jan 12 (Reuters) - Europe's drugs regulator will review the
COVID-19 vaccine developed by AstraZeneca and Oxford
University this month under an accelerated timeline, the
watchdog said on Tuesday.
The 27-member European Union is trying to speed up
vaccinations after a slow start and as supply shortages oblige
authorities to consider measures, such as extending the time
between first and second shots.
The European Medicines Agency (EMA) said on Tuesday it had
received an application from the British drugmaker and could
issue an opinion on a conditional marketing authorisation by
Jan. 29 at a meeting of its human medicines committee (CHMP). (https://bit.ly/2XuWmm3)
If endorsed by the EMA and formally approved by the European
Commission, the vaccine would become the third against the new
coronavirus available on the continent, after Pfizer-BioNTech's
and Moderna's.
Pressure for a decision has increased following the
discovery of more contagious variants of the novel coronavirus.
AstraZeneca has said its vaccine should be effective against
the variant prevalent in Britain, although trials have yet to
confirm that.
While cheaper and easier to distribute than rivals, the
AstraZeneca/Oxford vaccine has been troubled by doubts over its
most effective dosage.
Britain in December became the first to approve the vaccine
and other countries, including Argentina, El Salvador and India,
have since given approval.
The EMA said on Tuesday that during its rolling review of
the vaccine, which it began in October, it had assessed data
from ongoing trials in Brazil, Britain and South Africa.
It is also studying additional information AstraZeneca
provided at the CHMP's request.
EU conditional marketing authorisation allows a treatment to
be sold for a year before all necessary data on its efficacy and
side-effects are available.
The EU last year agreed to buy up to 400 million doses of
the AstaZeneca shot and hopes to receive a first delivery two
weeks after authorisation.
"They are thinking of two deliveries a month, but this is
all in the making. They need to discuss this with member
states," EU top vaccine negotiator Sandra Gallina told an EU
Parliament hearing.
(Reporting by Pushkala Aripaka in Bengaluru and Francesco
Guarascio in Brussels; Editing by Saumyadeb Chakrabarty and
Barbara Lewis)
Astrazeneca (AZN)
