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(Adds EU comment)
By Francesco Guarascio
BRUSSELS, March 13 (Reuters) - AstraZeneca's new aim
to supply 30 million doses of its COVID-19 vaccine to the
European Union by the end of 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, which confirmed an earlier report from
Reuters, is not guaranteed as it depends on a vaccine factory in
Leiden run by subcontractor Halix getting the regulatory
approval, the internal document dated March 10 showed.
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.
A spokesman for the European Commission said on Saturday the
EU executive was in talks with the company to make sure it did
all it could to honour its commitments. He did not comment on
Halix approval.
Asked about possible sanctions, he said: "What matters is
that we ensure the delivery of a sufficient number of doses in
line with the company's earlier commitments. We are looking at
all options to make this happen."
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.
SECOND-QUARTER CUTS
The European Medicines Agency (EMA) said 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, or on its production and stockpiling
capacity. Halix declined to comment on its regulatory approval.
The Halix plant in Leiden 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 between April and June,
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 drug 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 and Mike Harrison)
