SEOUL (Reuters) – South Korean biotech company GL Rapha expects to receive government approval from Russia this month to export Sputnik Light coronavirus vaccines, its chairman said, paving the way for the first overseas production of the shot to address a supply bottleneck to alleviate.
The Russian Direct Investment Fund (RDIF), which markets Sputnik V and the single-dose version Sputnik Light abroad, plans to produce around 700 million cans abroad this year.
Production started slowly, however, and growing domestic demand limited supply from Russia, which disrupted the global rollout plan of both shots and allowed competing vaccine manufacturers to fill the void in several markets.
“Everything is as good as ready and we are continuing to produce the vaccine while we wait for Russia to validate our production process,” said GL Chairman Whang Jae-gan in an interview.
He said RDIF, the Russian sovereign wealth fund, has informed the company that approval is expected later this month and is preparing a joint ceremony to celebrate the first overseas vaccine production and delivery.
RDIF declined to comment.
GL, which oversees the entire production of the vaccine from the active ingredient to the packaging at its plant in Chuncheon, east of Seoul, already has at least 10 million doses of Sputnik Light in stock, which are ready for dispatch until approval.
It comes more than a year after the two sides first began collaborative talks, which accelerated after the technology transfer from Russian developer Gamaleya Research Institute in October, underscoring the intricate process facing global efforts to rapidly increase vaccine supplies .
“We had to act decisively and decided to use all of our resources,” said Whang, adding that confidential clinical data was presented to him before a deal was made.
He said the company has stopped all other drug production and has stepped up efforts to expand and generate synergies.
In April, only six months after the technology transfer, GL sent out a validation batch for Sputnik V, and around the same time the RDIF asked the company to produce Sputnik Light at the same time. GL is now waiting for Good Manufacturing Practice (GMP) approval from Russia for its production facility.
The company has grown production well beyond its original goal of 650 million doses per year through its consortia that include botox maker Jetema Corp, CKD BiO Corp, Hankook Korus Pharm, and Boryung Biopharma, a vaccine maker owned by Boryung Pharm said Whang.
He didn’t want to go into the exact capacity.
While the RDIF will decide which nations will get the vaccine first, it will likely be sent to various countries that have reported delays, Whang said.
Production is slated to accelerate elsewhere as well, with the Serum Institute of India planning to start producing test batches this month.
Six Indian companies have already signed contracts for the annual production of around 1 billion cans of Sputnik V.
Reporting by Sangmi Cha; Additional reporting by Anton Zverev in Moscow; Editing by Miyoung Kim & Shri Navratnam