for-phone-onlyfor-tablet-portrait-upfor-tablet-landscape-upfor-desktop-upfor-wide-desktop-up

German plant aims to make up to 10 mln doses of Sputnik V vaccine monthly by year-end

* R-Pharm aims to launch production in Germany in Q4

* Targets initial output of 4-5 mln doses per month

* Russian vaccine is under rolling review by EU regulator

MOSCOW, April 9 (Reuters) - Russian pharmaceutical firm R-Pharm expects to produce up to 8-10 million doses monthly of the Sputnik V vaccine against COVID-19 at its plant in Bavaria, southern Germany, when operating at full capacity, its chief executive told Reuters.

Germany is gearing up to start bilateral negotiations with Russia to obtain supplies of the vaccine, Reuters reported on Wednesday, though a final decision would depend on approval of the shot by the European Medicines Agency (EMA).

The EMA is currently conducting a rolling review of Sputnik V, for which the applicant is R-Pharm Germany GmbH. An EMA team was due to visit Moscow this week as part of the review process.

R-Pharm chief executive Alexey Repik said plans to begin production at the company’s plant in the Bavarian town of Illertissen were moving ahead.

“I think we’ll start with 4-5 million complete doses (per month),” Repik said. A complete dose comprises both a first shot and a booster shot.

“At a maximum, we’ll reach around 8-10 million doses per month,” he said, adding this target was likely to be reached in the fourth quarter of 2021.

SEEKING APPROVAL

Whether or not the vaccine can be marketed widely in the European Union largely hinges on winning approval from the EMA, the bloc’s regulatory body, though two EU nations, Hungary and Slovakia, have already approved the shot independently for emergency use. Only Hungary has so far begun to administer it.

Pressed on whether production of Sputnik V depended on winning EMA approval, Repik said: “While we get production up and running, I’m sure we’ll resolve this.”

Germany and other EU countries are keen to widen the number of vaccines in use as they try to overcome big delays in their vaccination campaigns amid a deadly third wave of the pandemic.

Should the EMA approve Sputnik V, R-Pharm’s Bavarian plant could become a key manufacturer for the huge EU market.

Repik said the plant was currently working on expanding and automating its capacity for filling vials with the shots and packaging them. This would be followed by testing and validation in a process likely to take about five months.

“Production in Germany won’t start any earlier than the third or fourth quarter,” he said.

Repik’s R-Pharm is also gearing up production of Sputnik V doses in Russia across three sites, though the launch of large-scale production has suffered delays.

It remains unclear how long the EMA review will take. The agency will be assessing production lines, as well as looking into how trials were conducted.

The EU Observer newspaper said on Friday the EMA would also consider four cases of death following vaccinations in Russia, though none were linked to the shot itself.

Russian authorities say the cases involved people who died after contracting COVID-19 during the period between receiving the first shot and the booster, and said they had registered no deaths related to vaccination. (Writing by Polina Ivanova; Editing by Gareth Jones)

for-phone-onlyfor-tablet-portrait-upfor-tablet-landscape-upfor-desktop-upfor-wide-desktop-up