AstraZeneca's new aim of supplying 30 million doses of its Covid-19 vaccine to the EU by the end March hinges on the EU's drug regulator approving supplies from a factory in the Netherlands, an internal document showed.
The Anglo-Swedish drugmaker said yesterday it would try to deliver 30 million doses to the EU by the end of March.
That is 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 10 March 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 25 March and has pencilled in deliveries of nearly 10 million doses for the following week.
The European Medicines Agency 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 said 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 yesterday, 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 it was 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.
Taoiseach holds talks with AstraZeneca boss
At a meeting with the company last night, the Taoiseach expressed frustration at the failure of AstraZeneca to meet delivery schedules for vaccinations.
Micheál Martin held what was described as "lengthy, positive" virtual discussions with the CEO of the pharmaceutical firm, Pascal Soriot.
A spokesperson for the Taoiseach said he made clear Ireland's disappointment and frustrations at the failure to meet earlier delivery schedules.
Despite setbacks elsewhere, US President Joe Biden has worked to offer hope to his country, which has battled the largest outbreak in the world.
He vowed a return to some kind of normality by 4 July, marking the national holiday as his target for "independence" from the virus.
WHO insists AstraZeneca Covid-19 vaccine is safe
The World Health Organization said there was no reason to stop using AstraZeneca's Covid-19 jab after several countries suspended roll out over blood clot fears, while the hard-hit Us exceeded 100 million doses of vaccine administered to its people.
The WHO, which said its vaccines advisory committee was examining the safety data coming in, stressed yesterday that no causal link has been established between the AstraZeneca vaccine and clotting.
"Yes, we should continue using the AstraZeneca vaccine," WHO spokeswoman Margaret Harris said, stressing that any concerns over safety must be investigated.
The Britain-based AstraZeneca insisted its jab was safe, adding there is "no evidence" of higher blood clot risks.
Despite hopes that vaccines will pave the way to a return to normality, hard-hit Italy announced tough new restrictions in much of the country, with Prime Minister Mario Draghi warning the country faced "a new wave" of infections.
One year after it became the first European country to face a major outbreak, Italy is again struggling with the rapid spread of Covid-19, this time fuelled by new, more contagious variants.
Schools, restaurants, shops and museums were ordered to close across most regions of Italy, including Rome and Milan from next week.
Disneyland Paris, one of Europe's biggest tourist attractions, said it will not be able to reopen as planned on 2 April as infections remain stubbornly high in France.
The shadow cast over the AstraZeneca jab is adding to the European Union's problems distributing vaccines.
Denmark, Norway and Iceland paused use of the drugmaker's shot as a precaution after isolated reports of recipients developing blood clots.
Italy and Austria have banned the use of jabs from separate batches of AstraZeneca, and Thailand and Bulgaria said this week they would delay rollout.
India will carry out a deeper review of post-vaccination side effects from the AstraZeneca shot next week although no cases of blood clots have been reported so far, the Hindustan Times daily reported, quoting officials.
"The review is taking place as a matter of abundant precaution," NK Arora from the Indian covid task force told the paper.
In Spain, at least five regions said they had suspended use of AstraZeneca vaccines from the suspect batch banned by Austria as a precautionary measure.
But several other countries, including Australia, said they would continue their roll-outs as they had found no reason to alter course.
Canada also said there was no evidence the jab causes adverse reactions.