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Sputnik V doses produced in Italy to hit the market no earlier than late 2021

12 March 2021 13:23 (UTC +04:00)

Doses of the Russian Sputnik V vaccine produced at the Adienne Pharma & Biotech plant in northern Italy will be available on the market no earlier than late 2021, Antonio Francesco Di Naro, President of Adienne Pharma & Biotech company with the headquarters in Lugano, said on Friday, APA reports citing TASS.

"We began the technological exchanges 15 days ago, we will finish this process in a couple of months, then we will hold test launches, and in July, we will produce a not-for-sale batch for assessment, then in September-October, we will produce a batch for registration, collect the data that we will then send to the Italian Medicines Agency, and for its part, it should inspect our production. The company will not produce batches for sale until late 2021," he informed.

He explained that even if the European Medicines Agency (EMA) approves the vaccine, his company’s product will need to pass additional inspections to be certified for sale in Europe. The company is oriented at the European market, so it intends to carry out all the necessary procedures.

Di Naro added that personnel training does not require significant investment. "Perhaps, we will add a few personnel, because we have our own production, we have been dealing with the production of biological products for a long time" he added, noting that the preliminary production volume is estimated at 10 mln doses.