ROMA (Sputnik) – The European Medicines Agency (EMA) will send a group of experts to Russia in April to inspect clinical trials and the production of the Sputnik V coronavirus vaccine, the head of the agency’s health threats and vaccines strategy, Marco Cavaleri, said live on the air during a broadcast by Italy’s Rai 3 radio station on Monday.
The statement came after a source familiar with the negotiations between the Sputnik V developer and EMA said last week that the bloc could approve the Russian vaccine in the second half of May.
“We are conducting a cyclic check of [Sputnik V], so we will review all the data as soon as it is collected in order to authorize it faster. In April, we will conduct an inspection of both [vaccine’s] production and clinical trials in Russia. Then we will try to estimate by what time we will have all the data necessary for the approval of this vaccine,” Cavaleri said.
The official added that the EMA was also inspecting the data regarding Germany’s CureVac vaccine and the one developed by US Novavax.
Russia’s Sputnik V has already been approved for use in 54 countries.
Over the weekend, Nicola Zingaretti, the president of Italy’s Lazio region said that the Lazzaro Spallanzani National Institute for Infectious Diseases was going to start trials of the vaccine. The institute chief said that Rome would send two inspectors to visit vaccine production sites in Russia.