AstraZeneca vaccine gets EU green-light amid delivery row
The European Commission has pre-ordered 300 million doses of the cheap and easy-to-use drug, with an option to buy 100 million more.
The European Union's drug regulator endorsed pharmaceutical company AstraZeneca's Covid-19 vaccine for all adults on Friday, against the backdrop of an ongoing scrap over major delivery delays.
"We now have three vaccines that have been developed and approved for use against a disease that one year ago we did not know," European Medicines Agency director Emer Cooke said.
"None of them is perfect" or a "magic wand," Cooke told reporters from a press conference in Amsterdam, but together they offer tools and options in the fight against the deadly respiratory disease.
The European Commission has pre-ordered 300 million doses of the cheap and easy-to-use drug, which requires two shots for inoculation, with an option to buy 100 million more.
The EU executive must give the final go-ahead for the drug, but this is considered a formality. It can then join shots developed by US-German venture Pfizer-BioNTech and US firm Moderna on the EU market.
EMA has recommended the drug for conditional market authorization for all those 18 or older, despite limited data available for over-55s.
While the clinical trials demonstrate around 60% efficacy overall, there are not yet enough results from that age group to conclude how well the vaccine works for them, the agency said in a press release.
"However, protection is expected, given that an immune response is seen in this age group and based on experience with other vaccines," EMA said.
Only for younger people?
There had been speculation the EMA might only endorse the drug's use for younger people after Germany announced such an approach on Thursday.
AstraZeneca's vaccine, developed at the University of Oxford, is already approved for use in Britain, India, South Africa, Brazil, Morocco and Bahrain, among others.
The jab has two significant advantages over the other vaccines already green-lighted by the EU, despite being less effective.
First, it can be shipped at normal fridge temperature rather than needing to be deep-frozen. Second, each dose costs only a fraction of the price.
The EU still has to contend with significantly smaller than expected initial deliveries from AstraZeneca, around 40% of the agreed sum - 31 million doses by the end of March rather than 80 million.
AstraZeneca announced major hold-ups at an EU production site last week, to the consternation of the commission and member states.
European Commission President Ursula von der Leyen urged AstraZeneca to deliver on its commitments to the bloc in comments to German radio early Friday. "What I demand is transparency and planning certainty," von der Leyen told the Deutschlandfunk broadcaster.
"The contract is crystal clear," she said.
The pharmaceutical firm has argued that it is only contractually bound to make its "best effort" amid an unprecedented push to scale up production to meet the huge current demand.
Moderna, Pfizer
Fellow producers Moderna and Pfizer-BioNTech have also been affected by delays, albeit much less sizeable and more temporary.
While von der Leyen agreed that teething problems were to be expected due to the fact that vaccines were being developed in such a short space of time, she called for an explanation for AstraZeneca's difficulties so that both sides could find solutions.
A series of crisis talks have failed to resolve the dispute so far.
The commission published a heavily redacted version of the contract on Friday, in an apparent bid to pressure the company.
However, due to an apparent technical glitch, parts of the contract, including the estimated purchase cost - 870 million euros (1.1 billion dollars) - were temporarily visible online, though not the delivery timetable.
The error was quickly rectified, and a new version of the document uploaded.
The stakes in the row are high: The EU executive branch wants 70% of the bloc's 450 million population vaccinated by summer.
But a few weeks into the campaign, the 27 countries have mustered an average 2% vaccination rate, compared to 50% in Israel and 12% in neighbouring Britain.
On top of delivery hiccups, a slower approval process, a lack of preparedness to roll out the jabs and also tardy order placement are being blamed for the EU's foot-dragging.
The commission also created on Friday an EU "transparency register" on exports of Covid-19 shots outside the bloc until the end of March.
As of Saturday, this will allow blockades on exports of vaccines made in the bloc that the EU feels it is legally entitled to by its agreements with pharmaceutical firms.