Post approval to Sputnik V, India now has three authorized vaccines for COVID-19 treatment. Yet despite claiming higher efficacy, the Russian vaccine will have to meet the affordability criteria to gain broader acceptability in the country.

Earlier in February 2021, the union government had fixed a price of Rs. 150 for procurement of Covishield from Serum Institute of India and Covaxin from Bharat Biotech under a special contract with the respective companies. The overall price was later capped at Rs. 250 per dose (Rs. 150 per dose plus Rs. 100 service charges) for vaccination through private hospitals and offered for free by public hospitals.

However, in wake of fresh government order on April 19, 2021 to decentralize vaccine purchase and procurement, Serum Institute has priced Covishield at Rs. 600 for private facilities and Rs. 400 for the state governments. Bharat Biotech on the other hand is expected to offer Covaxin at a uniform price of Rs. 296 per dose to both state governments as well as private players.

In such a backdrop, the cost will be the only key for Sputnik V to gain a solid foothold in India. Priced approximately Rs. 750 per shot globally, the vaccine’s exact cost is currently under discussion between the Russian Direct Investment Fund (RDIF) and concerned government agencies. As per experts, the Russian vaccine’s proposed cost will be somewhere between Rs. 600 to Rs. 650 per dose.

Prashant Khadayate, Pharma Analyst, GlobalData feels that the overall COVID-19 competition will further intensify with the launch of foreign vaccines and Cadila Healthcare’s ZyCov-D soon in India. “Even though Sputnik V has better efficacy, its overall market penetration will depend on competitive pricing, government orders and the ability to meet soaring demand through timely supply.

“However, currently the vaccination drive dynamics are not expected to change in India as Covishield will continue to lead the overall vaccination drive, followed by Covaxin in terms of the daily doses administered,” added Khadayate. 

Meanwhile, RDIF has already announced a tie-up with Dr. Reddy’s Laboratories for the distribution of Sputnik V. The company will receive Sputnik V by mid-May 2021 and local production is expected to commence from July–September 2021 time frame.

Apart from Dr Reddy’s, the RDIF has announced similar production agreements with five Indian manufacturers for more than 800 million doses of the Sputnik V in a year. These include Virchow Biotech with 200 million doses; Stelis Biopharma with 200 million doses; Gland Pharma with 252 million doses; Panacea Biotec with 100 million doses; and Hetero Drugs with 100 million doses.

India accelerates approval process

According to the Government of India-operated Co-Win dashboard, as of 20 April 2021, Covishield accounts for 91.1% of the overall vaccine doses administered in India, whereas 8.9% belong to Covaxin. India has so far administered over 135 million COVID-19 vaccine doses. From 1st of May, 2021 onwards, the country will further expand the vaccination drive to everyone above 18 years of age, opening doors for India’s largest segment of the population.

Given the scale of population, India has fast-tracked the approval process for vaccines developed outside the country. As a result, vaccines developed by companies such as Pfizer, Moderna, and Johnson & Johnson are expected to get fast-track approval.

Khadayate cites the fast-spreading virus as one of the reasons for quick action on the part of the government. “India is witnessing the second wave of COVID-19 with over 300,000 confirmed cases reported so far. With supply issues for Covishield and Covaxin negatively impacting the vaccination drive, the approval of Sputnik V will further ramp up the overall efforts in India.”

Sputnik V is now approved for use in 60 countries globally. It is one of the three global vaccines with more than 90% efficacy besides the vaccines from Pfizer and Moderna. However, the data from the Phase II/Phase III bridging study in India is still unavailable publicly.

Public Health Expert, Dr. Gajendra Singh says there are enough encouraging results for Sputnik V. “The vaccine is backed by the peer-reviewed journal, Lancet which published interim analysis data of Phase III trials of the vaccine involving over 20,000 adults in Russia and found it 91.6% efficient. “It also shows that a sub-analysis of over 2,000 participants aged over 60 years indicates that the vaccine was similarly effective and well-tolerated in the elderly as well,” he opines.