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“We are making every effort to start production in the summer,” Alexander Bikov, head of R-Pharm, told DPA, adding that the plant in Illertisen, Bavaria, is already equipped and will be able to produce millions of doses a month.
Sputnik V has not yet been approved by the European Medicines Agency (EMA) for use in the European Union (EU).
“We are awaiting EZA’s decision because it is the legal basis needed to start production,” Bikov said.
After approval, Sputnik V doses to EU countries will be available from Illertisen. EZA inspections in Russia are scheduled for April.
This month, EZA launched the Sputnik V accelerated assessment procedure, an important step towards the eventual approval of the first non-Western vaccine in the EU.
Hungary has already approved Sputnik V and started using the vaccine. The Czech Republic and Slovakia have also ordered doses of Sputnik V and state that they will not wait for EU approval.
Sputnik V was developed by the Russian Gamalay National Center for Epidemiology and Microbiology in Moscow.
The vaccine was initially viewed with skepticism abroad, as it was approved by Russia before extensive clinical trials were completed.
However, a study published in the medical journal The Lancet in February shows that the vaccine developed in Russia is 91.6% effective.
Sputnik V is approved in more than 50 countries and is distributed by the Russian Direct Investment Fund.
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