Strides Pharma starts making Sputnik COVID vaccine in India

Strides Pharma Science Ltd said its mega vaccine plant in Bangalore is ready and has started commercially producing Russian COVID vaccine Sputnik Light.

“As previously committed, the company is on track to commercialize this vaccine for Global markets in Q4FY22,” it added.

Strides Pharma unit Stelis was the third pharma manufacturer in India to sign up to produce Sputnik vaccine, in March of this year. The agreement followed similar deal between Russian Direct Investment Fund (RDIF) and Gland Pharma as well as Hetero Biopharma.

The Russian agency then went on to ink several such agreements with manufacturers such as Dr Reddy’s and Panacea Biotech.

The Russians were looking towards Indian pharma companies to provide the much-needed scale in the manufacturing of Sputnik V, which is being sold in dozens of countries across the world.

The initial plan was to start India production by August of this year, and for the country to supply 65-70% of the total Sputnik vaccines produced in the world.

However, it is not clear whether and how many of RDIF’s other partners in India have started production on a commercial scale.

The deal with Stelis envisages production of around 200 mn doses per year from a new plant put up by Strides in Bangalore.

Due to the nature of the emergency, Strides Pharma put up the new facility in a record time of just 200 days.

The government of India too has been supportive and had the unit inspected by the Central Drugs Standard Control Organization (CDSCO) and given an initial Export No Objection Certificate (NOC).

The NOC is for export up to 50 million doses of the Sputnik Light vaccine produced in the Bangalore plant.

Even though the Sputnik vaccine was supposed to be a third alternative in India’s vaccine armament, the shot has taken its own time in coming to the market.

The majority of adults in India have already been inoculated with either AstraZeneca’s COVID vaccine or the home-grown Covaxin from Bharat Biotech.

Meanwhile, plans to sell imported Sputnik vaccine did not achieve the scale that many industry observers expected.

It now remains to be seen if the Sputnik Light — a single dose variant — will be able to capture a substantial share of the market as India ponders the question of whether to go for booster doses or not.

The vaccine, developed by Moscow-based Gamaleya Research Institute of Epidemiology and Microbiology, is based on the traditional adenovirus technology. In this technology, scientists engineer adenovirus — a common virus that causes diseases such as the cold — to express the spike protein of SARS-CoV-2, the virus that causes COVID-19.

This vector virus, when injected into the body, leads to an immune reaction from the host.

RDIF has claimed that Sputnik Light is more effective against the new Omicron variant of SARS-CoV-2, since it generates an immune reaction in the body that goes beyond mere antibodies. Last week, the Gamaleya Institute claimed Sputnik V “the best virus neutralisation results against omicron in comparison with other vaccines”.

However, another study conducted by University of Washington and Swiss drugmaker Humabs Biomed SA claimed serum from those who had been injected with the vaccine showed “no neutralising activity against omicron”.

Almost all the vaccines developed so far have failed against Omicron, as the virus has a very different looking spike protein compared to its ancestors. Vaccine makers have incorporated the spike protein from the original SARS-CoV-2 virus when making their vaccines.

Meanwhile, Strides’ Bangalore plant is has been created in such a way that it can produce vaccines “several vaccine formats”, according to the company, besides being one of the largest viral vector manufacturing sites with a bespoke design for producing the Russian Sputnik Vaccine.

“In its current state, the site can offer flexible technologies to manufacture lentivirus, adenovirus and retrovirus products and vaccines, along with adherent and suspension-based processes,” Strides Pharma said.

The Bangalore plant is equipped with a 40,000L Drug Substance bioreactor capacity at a 2,000L scale, using Single-Use Bioreactor technology.

It can produce up to 720 million doses in a year.