Russia’s Sputnik Covid vaccine may never be approved in EU, says Italian PM

Russia's Sputnik Covid vaccine may never be approved in EU, says Italian PM
Mario Draghi arrives on the second day of an EU summit in Brussels on June 25th. Photo: Aris Oikonomou/POOL AFP
Russia's Sputnik V Covid-19 vaccine may never be approved by the European Union, Italian Prime Minister Mario Draghi said on Friday, as he also cast doubts on the effectiveness of China's Sinovac jab.

“Sputnik… has not yet managed to obtain and perhaps will never have the approval of EMA (the European Medicines Agency),” Draghi said in Brussels.

In his comments, Draghi said there was a need for a “strengthening and maybe also a reform of EMA” to avoid a repeat of recent “considerable confusion” on vaccines.

He referred to a “certain discrepancy in pronouncements” over the safety of Covid-19 vaccines between EMA and national medicine bodies.

READ ALSO: Italy approves ‘mix and match’ vaccinations for under-60s as regions issue varying rules on AstraZeneca

The EMA had been expected to conclude its review of the Russian jab and issue a decision in May or June. However, approval was delayed because the makers missed a June 10 deadline to submit data, Reuters reported.

Meanwhile, “the Chinese vaccine, which never applied (for EMA approval) has shown to be inadequate, look at the experience in Chile,” he added.

Chile has relied heavily on the Chinese Sinovac jab for its immunisation campaign, but health authorities in the country have questioned how effective it is against new virus strains, and are also now considering adding a third dose to boost protection.

READ ALSO: San Marino offers tourists Sputnik vaccine for €50

Draghi was speaking at the end of a two-day European Union summit, in which he said leaders had a general discussion on the state of play of coronavirus.

“The pandemic is not over, we are not yet out of it,” the Italian leader said, pointing to the spread of the more transmissible Delta variant in Britain.

In Italy too, outbreaks of the more transmissible variant have been detected, the country’s health authorities confirmed on Friday.


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