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By Francesco Guarascio
BRUSSELS, March 13 (Reuters) - AstraZeneca's new aim
of supplying 30 million doses of its COVID-19 vaccine to the
European Union by the end March hinges on the bloc's drug
regulator approving supplies from a factory in the Netherlands,
an internal document showed.
The Anglo-Swedish drugmaker said on Friday it would try to
deliver 30 million doses to the EU by the end of March, down
from a contractual obligation of 90 million and a previous
pledge made last month to deliver 40 million doses.
The new lower target for March deliveries, which confirmed
an earlier report from Reuters, depends on the regulatory
approval of a vaccine factory in Leiden run by subcontractor
Halix, the internal document dated March 10 showed.
EU leaders have come under fire for rolling out vaccines at
a far slower pace than neighbouring Britain due to a longer
approval and purchasing process as well as repeated delays in
supplies from AstraZeneca and other drugmakers.
AstraZeneca said in the document seen by Reuters that it is
assuming the Halix factory will get the green light on March 25
and has pencilled in deliveries of nearly 10 million doses for
the following week.
The European Medicines Agency (EMA) confirmed in a statement
that the Halix factory had not yet been approved and declined to
comment on when any authorisation might be granted.
An EU official close to EMA's decision-making told Reuters
that a decision "might perhaps" come at the end of March.
It was unclear whether any delay in the plant's approval
would also affect AstraZeneca's vaccine supplies to the EU in
the second quarter.
A spokesman for AstraZeneca declined to comment on the
factory's approval status nor on its production and stockpiling
capacity. Halix declined to comment on its regulatory approval.
The Halix plant is one of four mentioned as manufacturers of
vaccines for the EU in AstraZeneca's supply contract with
Brussels signed in August.
However, only one in Belgium has been used to supply the
bloc so far, EU officials have said, noting that two plants in
Britain have not exported vaccines to the EU.
In its statement on Friday, AstraZeneca also said it "aims"
to deliver 70 million doses to the EU in the April-June period,
despite contractual obligations for 180 million shots.
It said export restrictions had prevented it from boosting
supplies to the EU from its global network to make up for
production problems in the EU supply chain.
Shortly after Reuters reported in February that the company
had told the EU it could deliver less than 90 million doses in
the second quarter, AstraZeneca said it was still committed to
meeting the 180 million supply target.
Overall, the company is now aiming to ship only 100 million
vaccines to the EU by the end of June, instead of the 300
million foreseen in the contract.
(Reporting by Francesco Guarascio @fraguarascio in Brussels;
Additional reporting by Toby Sterling in Amsterdam; Editing by
David Clarke)
