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LONDON, March 22 (Reuters) - AstraZeneca expects the EU drug
regulator to give approval for a factory in the Netherlands that
is at the centre of a row between Britain and the European Union
over COVID-19 vaccine supplies later this month or in early
April, a senior executive said on Monday.
The status of the Leiden-based plant, which is run by
sub-contractor Halix and is helping to make the AstraZeneca
shot, is closely watched as it is listed as a supplier of
vaccines in both the contracts that AstraZeneca has
signed with Britain and with the European Union.
"We are well on track in order to get the approval by EMA
(European Medicines Agency) in the course of March, beginning of
April, and this is exactly according to our plan," said Ruud
Dobber, executive vice president of the BioPharmaceuticals
business on a briefing.
Executives would not be drawn on when Britain's drug
watchdog may give the nod to accept Halix-produced shots.
After falling far behind post-Brexit Britain and the United
States in rolling out vaccines, the EU's leaders are set to
discuss imposing a ban on vaccine exports to Britain at a summit
on Thursday.
Without regulatory approval, vaccines produced at Halix
cannot be used in either the EU or Britain.
Astra executives said the site would play a relatively small
role in supplies to the EU, which mostly relied on production
from a Belgium site and another one in the United States.
On the briefing, Mene Pangalos, head of BioPharmaceuticals
R&D, said one batch of Halix-produced shots had been sent to
Britain ahead of approval from the Medicines and Healthcare
products Regulatory Agency (MHRA).
Dobber said the U.S. authorities are "very excited" by its
interim analysis of data from its U.S. clinical trial, which
shows the vaccine is 79% effective in preventing symptomatic
COVID-19.
But it is up to the U.S. government to decide how they are
distributed, he said.
Asked if there was any indication how the shots that will be
supplied to the U.S. government under its supply contract may be
used, he said he would be "very surprised" if they were not
deployed to vaccinate Americans.
He said the company can supply 50 million doses to the
United States in the first month after approval and 15-20
million doses on average after that.
(Reporting by Kate Kelland in London, Ludwig Burger in
Frankfurt and Pushkala Aripaka in Bangaluru;
Writing by Josephine Mason, editing by Louise Heavens and
Barbara Lewis)
