EU, Italy block AstraZeneca shipment to Australia – Further export blocks considered sources

BRUSSELS / ROME (Reuters) – The European Union is planning to extend its export authorisation scheme for COVID-19 vaccines to the end of June, two EU sources told Reuters on Thursday, as a shipment of AstraZeneca shots from the EU to Australia was blocked. 

Extending controls could reignite tensions with countries who rely on shots made in the EU.

The European Commission and Italy have blocked a shipment of AstraZeneca’s coronavirus vaccine destined for Australia after the drug manufacturer failed to meet its EU contract commitments, two sources said on Thursday. The sources said AstraZeneca had requested permission from the Italian government to export some 250,000 doses from its Anagni plant, near Rome.

The Italian government refused and the European Commission supported its decision, the sources said. An EU source in Brussels said national authorities had the final say in such matters.

There was no immediate comment from AstraZeneca. The move came just days after Prime Minister Mario Draghi, who took office last month, told fellow EU leaders that the bloc needed to speed up vaccinations and crack down on pharma companies that failed to deliver on promised supplies.

EU countries started inoculations at the end of December, but are moving at a far slower pace than other nations, including Israel and ex-EU member Britain. Officials have blamed the slow progress in part on supply problems with key manufacturer.

Meanwhile, the European Medicines Agency has begun an in-depth review of Russia’s Sputnik V coronavirus vaccine, putting it on course to be the first non-Western jab used across the 27-nation EU.

Russia, which has pushed for a speedy approval, said it was ready to provide jabs for 50 million Europeans as soon as the shot gets the green light from the Amsterdam-based regulator.

“EMA has started a rolling review of Sputnik V, a Covid-19 vaccine developed by Russia’s Gamaleya National Centre of Epidemiology and Microbiology,” the EMA said in a statement.

The watchdog said its decision was based on clinical studies and lab tests which “indicate that Sputnik V triggers the production of antibodies and immune cells that target the SARS-CoV-2 coronavirus and may help protect against Covid-19.”

“EMA will assess Sputnik V’s compliance with the usual EU standards for effectiveness, safety and quality,” it added.

The timeline for possible approval should “take less time than normal” due to the work already done during the rolling review, it said.

Several EU member states, including Germany and Spain, have said they would be interested in Sputnik V if it was approved.

Concerns were initially raised about Sputnik after a fast-track procedure that saw it approved for use in Russia last August and deployed in December ahead of large-scale clinical trials.

But the Lancet medical journal published results in February showing Sputnik V to be 91.6% effective, based on third-phase trials with more than 20,000 volunteers.

Hungary has broken ranks and become the first EU country to approve and order the vaccine, while the Czech Republic and Slovakia have also ordered Sputnik stocks.

The three approved for use in the bloc so far are the Pfizer-BioNTech jab, Moderna’s shot, and the vaccine developed by AstraZeneca with Oxford University.

US-based Johnson & Johnson has also applied for authorisation while Novavax and CureVac are under rolling review.

The EMA is set to give its decision on Johnson & Johnson’s single-shot vaccine on 11 March.

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