MILAN (AP) — The head of a Swiss pharmaceutical company said Wednesday that hopes behind a deal with Russia to produce the Sputnik V vaccine in Italy are to sell it to EU countries, if regulators approve the jab.
“That is not the goal, it is a wish,’’ Adienne founder and president Antonio Francesco Di Naro told The Associated Press on Wednesday.
The first agreement to make the Sputnik V in any EU country was signed Tuesdayby Swiss-based Adienne Pharma & Biotech and the Russian Direct Investment Fund. Production is slated for Adienne’s plant near Milan, but Di Naro said the announcement that Adienne would produce 10 million doses this year, launching in July, was incorrect.
Adienne is in the process of acquiring the Russian technology, and will then start producing batches of vaccine that must be vetted by the Italian Medicines Agency before approval is granted for commercial production.
“This procedure requires months, or even more, because this is a biological product,” Di Naro said. “I cannot say when we will begin the production for the commercial batch.”
Eventual production levels will depend on market needs once production begins.
Adienne would need additional authorization from the European Medicines Agency, or EMA, before it can sell or distribute the vaccine throughout the EU. But the company could sell the vaccine it produced to non-EU countries as long as it obtains Italian regulatory approval, Di Naro said.
The EMA started a rolling review of the vaccine last week.
Di Naro said Adienne is being commissioned to produce the vaccine, but that it would be up to its Russian partners to negotiate eventual sales deals.
The Italian-Russian Chamber of commerce had put Adienne in touch with the Russian Direct Investment Fund for the vaccine’s production. investment fund.
Di Naro said Adienne has the necessary expertise needed to get the highest yield out of production, and that he doesn’t anticipate any problems scaling up production.
“We need to try to solve this problem of the very, very short availability of this kind of product on the market,” he said.