Sputnik V developers demand apology from European Medicines Agency official

Sputnik V developers demand apology from European Medicines Agency official

"Such comments are inappropriate and undermine credibility of EMA and its review process," the Sputnik V team said

Developers of Russia’s Sputnik V vaccine against the novel coronavirus have demanded an apology from Chair of the European Medicines Agency (EMA) Management Board Christa Wirthumer-Hoche for comparing the possibility of approving the emergency use of the vaccine with a ‘Russian roulette.’

"We demand a public apology from EMA’s Christa Wirthumer-Hoche for her negative comments on EU states directly approving Sputnik V. Her comments raise serious questions about possible political interference in the ongoing EMA review. Sputnik V is approved by 46 nations," reads a post on the vaccine’s official Twitter account.

"EMA did not allow such statements about any other vaccine. Such comments are inappropriate and undermine credibility of EMA and its review process. Vaccines and EMA should be above and beyond politics," it says.

In a broadcast by Austria’s ORF TV channel, Wirthumer-Hoche, who is also head of the Austrian Medicines and Medical Devices Agency, said the idea of approving Sputnik V for emergency use in the country, as was done in Hungary, was a "Russian roulette."

On March 4, the European Medicines Agency (EMA) announced that it began the procedure of a rolling review of the Russian Sputnik V vaccine. The EU regulator stated that during the review specialists will evaluate the compliance of the preparation with EU standards of efficacy, safety and quality. As Head of the Russian Direct Investment Fund (RDIF) Kirill Dmitriev noted, the approval by the EMA will allow to provide the Sputnik V vaccine to EU residents starting in June 2021.

Earlier, it was reported that a number of EU countries have already individually approved the use of the Sputnik V preparation without waiting for the EMA’s registration. Currently, the vaccine has been registered in Hungary and Slovakia.

Sputnik V ranks second among all vaccines against the coronavirus worldwide in terms of approvals received from state regulators. To date, Sputnik V has been registered by 46 countries with the total population of more than 1.1 bln people.

In early February 2020, The Lancet, a world-acclaimed medical journal, published the results of the third phase of Sputnik V clinical tests. The vaccine has proved to be among the world’s safest and most efficient. Thus, its efficacy is estimated at 91.6% and 91.8% among volunteers older than 60. A total of 98% of volunteers developed antibodies to the coronavirus.

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