Panacea Biotec Ltd on Monday announced that it had signed an agreement with Russian Direct Investment Fund (RDIF) for manufacturing 100 million doses of Sputnik V vaccine per year.
“Panacea Biotec will produce Sputnik V in its internationally accredited facilities· complying to strict GMP standards and prequalified by WHO," Panacea Biotec managing director Rajesh Jain said in a statement.
Premium 
Premium Mint had on 11 February reported that the company was in advanced talks with RDIF to manufacture the Sputnik V vaccine, and that final contours of the deal were being worked out.
The covid-19 vaccine is among those with the highest efficacy to be available in India. A study published in The Lancet in February showed that the vaccine was 91.6% efficacious in preventing covid-19.
The Delhi-based company is the first experienced vaccine manufacturer in India with whom RDIF has a manufacturing agreement.
Before this, it has signed agreements with four companies—Hetero Biopharma, Gland Pharma, Stelis Biotech and Virchow Biotech—to manufacture 750 million doses of the vaccine in total. However, the pacts include repurposing of biological drug manufacturing facilities, or in Gland Pharma’s case use of a newly installed vaccine producing plant, to make Sputnik V.
Production of Sputnik V at Panacea Biotec sites will help facilitate global supply of Sputnik V to international partners of RDIF, the two companies said in the statement. RDIF is the global commercialisation partner of the original developer of the vaccine—Moscow’s Gamaleya Research Institute of Epidemiology and Microbiology.
Apart from the manufacturing pacts, Dr Reddy’s Laboratories is also in a partnership with RDIF, in which the Indian firm will conduct clinical trials and also distribute the vaccine in the country depending on its securing an authorization.
Premium Premium 
Premium Premium The vaccine is currently waiting a recommendation for emergency authorisation from a subject expert committee of the Central Drugs Standard Control Organization, following which it will go for a nod from the Drugs Controller General of India V.G. Somani, who heads CDSCO.
On Thursday, the SEC deferred its decision on whether to recommend the Russian Sputnik V vaccine for emergency use, and instead asked applicant Dr Reddy’s Laboratories for more data.
The SEC asked the Hyderabad-based drugmaker to submit the fact sheet for the vaccine along with details on stability, as a variant of the vaccine needs to be stored at a temperature of -18 degree Celsius.
While the liquid form requires a storage temperature of -18 degree Celsius, the freeze-dried form can be stored at 2-8 degree Celsius. The Sputnik V vaccine involves two shots using two different human adenovirus vectors that transport the spike protein gene of the novel coronavirus to the cells. The jabs are given three weeks apart.
Click here to read the Mint ePaperMint is now on Telegram. Join Mint channel in your Telegram and stay updated with the latest business news.
