Panel clears Sputnik, could soon be India’s 3rd shot against Covid-19 surge

An expert panel on Monday recommended emergency licensure for Sputnik V, the Russian-made vaccine against the novel coronavirus, The Indian Express has learnt.

This is a major development for India, which is struggling to increase supply of vaccines in its immunisation programme amidst a powerful second surge of Covid-19 infections.

Once green-lighted by the country’s top drug regulator, India can expect at least 200 million doses of the Sputnik V vaccine, as per an agreement between the Russian Direct Investment Fund (RDIF) and Hyderabad-based Dr Reddy’s Laboratories (DRL). Sputnik V will be the third Covid-19 vaccine in India’s battle against the virus that has infected more than 1.3 crore and killed over 1.7 lakh of its citizens.

Some experts feel the approval would also ease the pressure on Serum Institute of India (SII) and Bharat Biotech to rapidly scale up production of their vaccines – Covishield and Covaxin – amid the ongoing surge. However, this would also depend on how soon RDIF can supply the 200 million doses promised to DRL as part of their tie-up, and whether India may receive more doses from the companies that RDIF has contracted to make the vaccine in the country.

DRL only has an agreement to distribute the vaccine, but RDIF has tied up with several other Indian firms, including Hetero Biopharmaceuticals, Gland Pharma, Stelis Biopharma, Virchow Biotech, and Panacea Biotec, to make upwards of 600 million doses in a year.

“We will have to see in the end how much of this total capacity is going to be available for India,” Public Health Foundation of India (PHFI) president Professor Srinath Reddy said.

“Dr. Reddy’s and RDIF are working diligently with the Indian regulatory authorities to obtain the approval for Sputnik V. We are fully committed to playing our part in India’s fight against COVID,” DRL said in a statement. The company declined to comment on the pricing of Sputnik V, and its expected supply for India.

Sputnik V, developed by Moscow’s Gamaleya Research Institute of Epidemiology and Microbiology, was tested by DRL in a bridging study on around 1,500 Indian volunteers. The company had approached the Central Drugs Standard Control Organisation (CDSCO) for restricted permission approval on February 19 this year. However, approval had been held up as the Subject Expert Committee (SEC) looking into Dr Reddy’s request felt that the data was incomplete.

The SEC in its meetings in March repeatedly asked DRL to submit more up-to-date information regarding the vaccine’s safety and ability to prompt an immune response in people in the tests conducted in India. On Monday, the SEC was finally satisfied with the additional data provided by DRL, according to sources.

“Whatever data was required was provided. There was nothing missing regarding the safety and immunogenicity data,” one of these sources told The Indian Express on condition of anonymity.

Other information sought by the panel earlier included a factsheet on the vaccine, and information regarding its stability – a marker of how long its safety and potency would last when stored at specified temperatures. The vaccine has to be stored at minus 18°C in liquid form, but its lyophilized (freeze dried) form can be stored at 2°C to 8°C, according to RDIF.

The next step now is for Drugs Controller General of India Dr V G Somani to provide the final approval for the vaccine’s restricted use in an emergency situation in India. This would allow the government to procure doses from DRL after price negotiations. RDIF had earlier said that it intended to price each dose of Sputnik V at “less than $10” (around Rs 750).

Batches of the vaccine will also have to undergo quality tests at the Central Drugs Laboratory (CDL) in Kasauli before it is cleared for use in the population, a senior government official said on condition of anonymity.

“We do need more vaccines at the moment, so the availability of this vaccine would be helpful in India’s vaccination campaign against Covid-19,” PHFI’s Professor Reddy said.

The two-dose Sputnik V may be the vaccine in India’s immunisation programme with the highest efficacy so far – it has the ability to bring down symptomatic Covid-19 by nearly 92 per cent in those vaccinated when compared with those who have not received any vaccine, as per a publication in The Lancet medical journal.

By comparison, Covishield has an efficacy of around 51 per cent when the second dose is given at 6-8 weeks, as per SII’s product insert. Covaxin has an interim efficacy of nearly 81 per cent, but updated data on this is still awaited.