AstraZeneca has provided insufficient clarification at a meeting on Monday to its decision to slow down supplies of Covid-19 vaccines to the European Union, the EU's health commissioner has said.
Stella Kyriakides said that another meeting with the company would be held later on Monday.
She also said in a video statement that in future manufacturers of Covid-19 vaccines will have to register their planned exports outside the bloc.
The European Union has urged AstraZeneca to find ways to swiftly deliver vaccines after the company announced a large cut in supplies of its Covid-19 shot to the bloc, as news emerged the drugmaker also faced supply problems elsewhere.
AstraZeneca, which developed its shot with Oxford University, told the EU on Friday it could not meet agreed supply targets up to the end of March, with an EU official involved in the talks telling Reuters that meant a 60 per cent cut to 31 million doses.
“We expect the company to find solutions and to exploit all possible flexibilities to deliver swiftly,” an EU Commission spokesman said, adding the head of the EU executive Ursula von der Leyen had a call earlier on Monday with AstraZeneca's chief Pascal Soriot to remind him of the firm's commitments.
Global supply shock
A spokesman for AstraZeneca said Soriot told von der Leyen the company was doing everything it could to bring its vaccine to millions of Europeans as soon as possible.
News emerged on Monday that the company faces wider supply problems.
Australia's health minister Greg Hunt told reporters AstraZeneca had advised the country it had experienced “a significant supply shock”, which would cut supplies in March below what was agreed. He did not provide figures.
Thailand's health minister Anutin Charnvirakul said AstraZeneca would be supplying 150,000 doses instead of the 200,000 planned, and far less than the one million shots the country had initially requested.
AstraZeneca declined to comment on global supply issues.
The senior EU official said the bloc had a contractual right to check the company's books to assess production and deliveries, a move that could imply the EU fears doses being diverted from Europe to other buyers outside the bloc.
'Flimsy justification'
AstraZeneca has received an upfront payment of €336 million from the EU, another official told Reuters when the 27-nation bloc sealed a supply deal with the company in August for at least 300 million doses – the first signed by the EU to secure Covid-19 shots.
Under advance purchase deals sealed during the pandemic, the EU makes down-payments to companies to secure doses, with the money expected to be mostly used to expand production capacity.
“Initial volumes will be lower than originally anticipated due to reduced yields at a manufacturing site within our European supply chain,” AstraZeneca said on Friday.
The site is a viral vectors factory in Belgium run by the drugmaker's partner Novasep.
Viral vectors are produced in genetically modified living cells that have to be nurtured in bioreactors. The complex procedure requires fine-tuning of various inputs and variables to arrive at consistently high yields.
“The flimsy justification that there are difficulties in the EU supply chain but not elsewhere does not hold water, as it is of course no problem to get the vaccine from the UK to the continent,” said EU lawmaker Peter Liese, who is from the same party as German chancellor Angela Merkel.
Penalties
The EU called a meeting with AstraZeneca after Friday's announcement to seek further clarification. The meeting started at 11.30pm Irish time on Monday.
The EU official involved in the talks with AstraZeneca said expectations were not high for the meeting, in which the company was be asked to better explain the delays.
Earlier in January, Pfizer, which is currently the largest supplier of Covid-19 vaccines to the EU, announced delays of nearly a month to its shipments, but hours later revised this to say the delays would last only a week.
EU contracts with vaccine makers are confidential, but the EU official involved in the talks did not rule out penalties for AstraZeneca, given the large revision to its commitments. However, the source did not elaborate on what could trigger the penalties. “We are not there yet,” the official added.
“AstraZeneca has been contractually obligated to produce since as early as October and they are apparently delivering to other parts of the world, including the UK without delay,” Liese said.
AstraZeneca's vaccine is expected to be approved for use in the EU on January 29th, with first deliveries expected from February 15th.
