ROME, June 16. / TASS /. Italy has launched the production of the first test batch of the Russian Sputnik V vaccine, the Swiss-Italian company Adienne Pharma & Biotech’s press service told TASS on Wednesday.
"We have launched the production of a test batch, which will be subjected to an internal review for safety and compliance," a spokesperson said. The work is being carried out in close contact with the drug’s developer, he noted. After the internal assessment, the company will produce a batch to submit all necessary documents to the competent sanitary authorities so that the jab can be approved for sale. Meanwhile, the company did not mention any specific date.
In late March, the Russian Direct Investment Fund agreed on launching the Sputnik V jab’s production at the Swiss-Italian company Adienne Pharma & Biotech. Earlier, the company’s CEO Antonio Di Naro told TASS that the vaccine would enter the market as early as in late 2021 after passing all the necessary certification procedures.
Russia’s Sputnik V jab has not been approved by the European Medicines Agency (EMA) yet. On March 4, the EMA launched the rolling review of the vaccine. Recently, the experts have completed an inspection of Russia’s production sites, and now some additional documents are underway. If no such permission for Sputnik V’s sales in Europe is issued, the batches produced in Italy can be sold to the countries where the drug is approved. There are more than 60 of them, the Swiss-Italian company said.