In the past 15 months, DRL or RDIF has not been particularly successful in finding takers for the vaccine in India
In September 2020, when India’s third largest pharmaceutical company Dr Reddy’s Laboratories (DRL), decided to partner with Russia’s sovereign wealth fund, RDIF, to bring the Sputnik V vaccine to India, it seemed like a potential gamechanger.
In Russia, the vaccine had entered its phase 3 trials, after its phase 1 and 2 studies had shown that it was safe to use. Russia had already authorised a limited rollout of the vaccine in August 2020, and Sputnik V became the first Covid-19 vaccine to be registered in the world. . The vaccine was registered with the Russian Ministry of Health, allowing the government to vaccinate its population with it. Back then, the world was still scrambling to find a Covid-19 vaccine, and most of the candidates were still under development, with uncertainty over their efficacy.
Sputnik V is based on the human adenovirus, a common cold virus that is fused with the spike protein of Sars-CoV-2 to stimulate an immune response, and was developed by Moscow’s Gamaleya National Research Institute of Epidemiology and Microbiology, with support from RDIF.
“We understand we are late in the game, so we need to accelerate whatever we’re doing through partnerships,” GV Prasad, managing director of DRL, had told Forbes India earlier. “Our business initially will depend on partnerships before we build our own capabilities. That is the idea… for us right now, the priority is short term—to see how we can help the Russian vaccine succeed in India, manufacture it in India and make it available to patients.”
In the past 15 months, DRL or RDIF has not been particularly successful in finding takers for the vaccine in India. So far, only a little over a million doses (about 11 lakh) of Sputnik V have been administered, accounting for about 0.9 percent of all vaccinations in India so far. In sharp contrast, Covishield, which received approvals the Drugs Controller General of India (DCGI) in January 2021, has so far been used in over 88 percent of vaccinations in the country, followed by Covaxin at 11 percent. In all, India has administered over 117 crore vaccine doses, as of November 22.
“The two-dose Sputnik V was launched as a soft pilot in India in May 2021,” says a spokesperson for DRL. “Subsequently, it was rolled out commercially from July onwards, based on imported consignments from RDIF. We partnered with major hospitals around India, and set up our cold chain infrastructure since the vaccine requires a temperature of -18 degree Celsius.”
The rollout came five months after India began its vaccination programme, on January 16. It was also about a month after DRL received an approval from DCGI to import the vaccine into India for emergency use authorisation. The long delay had largely to do with India's drug regulators scrutinising data pertaining to immunogenicity parameters and a comparative analysis of phase 3 immunogenicity data generated from Indian and Russian studies. DRL was tasked with conducting the phase 2 and 3 trials in India.
Around the same time, RDIF ventured out to scale up the manufacturing of the vaccine in India and signed up numerous deals that would see as many as 100 crore doses being manufactured out of India. These included deals with Hyderabad-based pharmaceutical company Hetero, Bengaluru-based Stelis Biopharma, Gland Pharma, Panacea Biotec and Virchow Biotech.
“In the June-August period, there were challenges with regard to the supply of the second dose component, as imports were affected by the surge of Covid-19 cases in Russia,” DRL tells Forbes India. “In early September, with supply commencing from a partner in India [Panacea Biotec], our market supply received fresh momentum. We were able to supply equivalent quantities of the first and second dose components to partner hospitals. By September, in terms of the market situation, with heavy scale-up in overall vaccine production in India and free distribution through the government and private market sales overall started to see a sharp dip and Sputnik V was solely private.” Hetero and Panacea Biotec has not yet responded to queries sent by Forbes India.
During the pandemic’s second wave in April and May, India had reported the most Covid-19 caseloads and deaths in the world, but despite the festive season of Navratri and Diwali in October and November, new infections are on the downside. According to data from the Ministry of Health and Family Welfare, India registered 8,488 new cases on November 22, the lowest since May 2020, taking the total tally of Covid-19 cases in India to 3.45 crore.
Of the 117 crore vaccine doses that India has so far administered, 103 crore were Covishield, and 13 crore were Covaxin. The pace had particularly picked up over the past four months, with more than 50 lakh doses being administered a day across 1 lakh sites across the country. A significant portion of these is free of cost, provided by the central government, with options to pay at private facilities. This is something that seems to have hurt Sputnik—which costs Rs948 per dose, with added service charges—quite hard. At private facilities, Covishield costs Rs 780 and Covaxin costs Rs 1,410 for a single dose. Since May 2021, the government allowed the private sector to purchase 25 percent of total vaccines domestically manufactured every month.
The fact that the supply of Sputnik V has still not been ramped up in India, along with the government deciding to supply 75 percent of vaccines free of cost, have been the primary reasons for Sputnik V not playing a meaningful role in India’s vaccination programme, says Vishal Manchanda, research analyst for pharma at Nirmal Bang Institutional Equities. “Now, with over 100 crore doses being largely fulfilled by Covishield and Covaxin, there is little scope for Sputnik V’s penetration in India.”
Sputnik V continues to be “relevant and meaningful in the vaccination programme”, says DRL. “Our lifecycle management of Sputnik will see us take a multi-pronged approach with the single-dose Sputnik Light vaccine [first dose of the two-dose Sputnik V] as a standalone vaccine, as a booster dose, and Sputnik for the paediatric population with relevant clinical trials. We are in the midst of clinical trials for Sputnik Light and expect to update the status of the trial after our submission to the DCGI soon.”
Sputnik Light can provide immunity of nearly 80 percent, significantly higher than Covishield (70 percent). Sputnik V boasts an efficacy of 92 percent, according to phase 3 trials published in The Lancet in February. The vaccine also claims an efficacy of 83 percent against the Delta variant. Yet, global health authorities are yet to approve the vaccine. Both the World Health Organization (WHO) and the European Medicines Agency (EMA) have said they still need more data on Sputnik V before authorising it.
“The Sputnik Light vaccine significantly reduces the possibility of severe cases leading to hospitalisation, and only one injection is needed,” Kirill Dmitriev, CEO of RDIF had told Forbes India earlier. “The single-dose regimen solves the challenge of immunising large groups within a shorter time—which is important during the acute phase of the spread of Covid-19—achieving herd immunity faster.” RDIF is yet to respond to questions from Forbes India for the current article.
What’s in store?
Sputnik V does not have a major stake in Covid-19 vaccinations even globally, not just in India, says Surajit Pal, AVP and pharma analyst at Prabhudas Lilladher, a financial services organisation. “The reason is that currently, the production of Sputnik V has the biggest yield issue with the second dose,” he says.
Sputnik V, a viral vector vaccine, uses two different weakened adenoviruses, adenovirus 26 (rAd26) and adenovirus 5 (rAd5) for dose 1 and dose 2 respectively. Companies can commit to the availability of the vaccine only if components of both doses are available, Pal explains. “That is why DRL could not go in for mass marketing of the product in India, because they do not have much inventory of dose 2. Same is the case for the originator of the vaccine in Russia.”
It is after recognising this problem in production of dose 2 that the RDIF launched Sputnik Light in May. “To date, Russia has struggled to produce enough Sputnik V domestically to meet global commitments. It appears that production in Russia of the first dose has been more successful than the second, and Sputnik Light is just the first dose,” Judyth L Twigg, a professor of political science at the Virginia Commonwealth University and senior associate at the Global Health Policy Center of the Washington-based Center for Strategic and International Studies, had told Forbes India in May.
Then, in September this year, DRL, which signed a pact with RDIF to sell the first 125 million people doses (250 million vials) of Sputnik V in India, said that both doses of the vaccine should be administered from the same hospital. The vaccine is to be taken in two doses at a gap of 21 days.
Twigg had also told Forbes India that the reported efficacy of Sputnik Light is “almost certainly overstated”, based on information that had been released on the methodology for arriving at that result. Sputnik V has had its share of regulatory hurdles from the get-go, with the WHO flagging concerns around insufficient data and quality control. Experts say that this is all the more reason to track the vaccine closely despite its emergency use authorisation in India.
Given the new realities of the pandemic in India, and the looming threat of the Delta variant, Sputnik Light is unlikely to play a huge role in India’s vaccination programme even in the near future, says Satyajit Rath, scientist at the National Institute of Immunology and the adjunct professor at the Indian Institute of Science Education and Research.
There is some indication that with the Delta variant, single-dose vaccines are less efficient compared to two-dose vaccines, he explains. “Even a single-dose provides some degree of protection; it is not impossible. But it would be surprising if a single-dose vaccine, at this stage, will become a major throughput,” he says. “So Sputnik Light makes even less sense than it did at this time last year.”
A vaccine booster shot is an additional dose of the vaccine given after the protection provided by the original shots start to decrease over time. The booster is designed to help people maintain their immunity levels for longer. Policymakers and scientists world over have been discussing the need for booster doses, whether it needs to be administered to only the elderly, health workers and persons with comorbidities, or even to the general population. The US regulators, for instance, recently expanded the eligibility for booster shots to all adults.
Pal adds that while the local manufacturers in India can focus on export of the vaccines, it is too early to talk about how much money they might actually stand to make. In October this year, the Indian government had permitted the export of 40 lakh doses of the vaccine to Russia.
A November 21 report in The Times of India quoted a senior member of the National Technical Advisory Group on Immunisation (NTAGI), the government’s advisory body on immunisation, saying that a policy on booster doses is likely to be announced soon, but priority remains primary vaccinations for the adult population. As of November 22, 77 crore people have received the first dose and 41 crore people have received both. The government’s target was to administer 181 crore doses by year-end.
Manchanda says that in India, while booster shots are mainly being considered for people above 65 years of age, and those who are immunocompromised, “the preference for the booster dose could likely be whichever primary vaccine one has received, which, in India, is mostly either Covishield or Covaxin”, he says. Studies are still ongoing about whether vaccines can be mixed, and it might be difficult for Sputnik Light to get a significant space in India’s vaccination even from a booster dose perspective in the near future, Manchanda says.
Rath also thinks that the vaccine is unlikely to play a major role, “in part because uptake of Covishield—another adenoviral vector vaccine—and the real world data on it, is far more substantial than the data on Sputnik V or even Sputnik Light,” he says. “It is also not as if Sputnik will have a practical advantage because it is a different platform like mRNA, so I suspect it might remain a relatively minor vaccine in India.”