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Coronavirus pandemic

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

Italy should become the first European country to launch production of the Russian vaccine

© Yury Smityuk/TASS

ROME, March 12. /TASS/. 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, told TASS on Friday.

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"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.

On March 4, the EMA announced the start of a rolling review of the Sputnik V vaccine. The EU regulator said that during the review, specialists will estimate the vaccine’s compliance with EU standards when it comes to efficiency, safety and quality. Sputnik V is in the top three COVID-19 vaccines in the world on the amount of states who registered it. So far, Sputnik V has been approved for use in 50 states, with their total population coming up to over 1.3 bln people.

Italy should become the first European country to launch production of the Russian vaccine in accordance with the agreement reached between Adienne Pharma & Biotech and the Russian Direct Investment Fund (RDIF).

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