India finally has a third vaccine. Is it enough to save the country?

That in short has been the story of Sputnik V, the world’s first Covid-19 vaccine that was registered as early as August 2020. Back then, the world watched with dismay at how quickly Vladimir Putin and his government registered the Sputnik V vaccine as the world’s first Covid-19 vaccine. Even the Americans couldn’t boast a vaccine, as the world scrambled to find a solution to the pandemic that was wreaking havoc across the world.

A month into that announcement, Dr Reddy's Laboratories, the Hyderabad-based pharmaceutical company, currently the country’s fourth-largest pharmaceutical company, stunned the world when it struck up a deal with the Russian Direct Investment Fund (RDIF), the sovereign wealth fund of the Russian government responsible for selling Sputnik V.

The deal came at a time when some 40 scientists across the world had written an open letter raising concerns about the data, while also seeking access to the original data.

“Firstly, the partner is quite forthcoming,” GV Prasad, the co-chairman and managing director of Dr Reddy’s had told Forbes India earlier. “We have all the data. The Lancet published an article. It’s quite transparent what they’re trying to do, and I don’t see that as a concern. The vaccine has become a target of politics, but we will go with the science.”

On May 14, Dr Reddy’s finally rolled out the Sputnik V in India, in Hyderabad, eight months after it struck a deal with RDIF. The rollout came five months after India began what was touted as the world’s largest vaccination programme, on January 16, using vaccines that were registered long after the Sputnik V vaccine. It was also about a month after Dr Reddy’s received an approval from Drug Controller General of India [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 III immunogenicity data generated on Indian and Russian studies at various time points. Dr Reddy's was tasked with conducting the Phase 2 and Phase 3 trials in India.

The company has currently imported 150,000 doses of the vaccine that’s approved by the Indian government for inoculation and has received another 60,000 on May 16. The Sputnik V has an efficacy of 91.6 percent, one of the three vaccines anywhere in the world that has an efficacy of over 90 percent. The other two are the Pfizer-BioNTech Covid-19 vaccine and the mRNA-1273 vaccine manufactured by Moderna.

“We aim to vaccinate 125 million Indians in the next 8-12 months,” a spokesperson for Dr Reddy’s told Forbes India. “This translates to roughly 250 million doses. Our goal is to steadily ramp up to hit 20-25 million doses per month. The requirements of our cold chain infrastructure (-18 degrees) means that we will begin with metros and Tier-I cities and gradually scale up to reach the rest of India.”

Dr Reddy’s is currently responsible for the regulatory, safety, and pharmaco-vigilance aspects of the vaccine in India. The vaccine is currently priced at Rs995 including taxes and has already made its appearance on the Co-Win platform, promoted by the Indian government for vaccine registration.

The Sputnik V vaccine 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 Gamaleya National Research Institute of Epidemiology and Microbiology, with support from RDIF. A single-dose vaccine, Sputnik Light, is also being rolled out across the world after it was found to have an efficacy of 79.4 percent. In India, the single-dose vaccine is expected to be rolled out in June. The Sputnik Light is effectively the first dose of the two doses, and was authorised in Russia on May 06. 

The rollout of Sputnik V in India comes at a time when the World Health Organization (WHO), the European Medicines Agency and the US Food and Drug Administration (FDA) have all been vary about giving approval to the vaccine. In early May, Anvisa, the Brazilian drug regulator, decided not to approve the vaccine after technical staff had highlighted "inherent risks" and "serious" defects, citing a lack of information guaranteeing its safety, quality, and effectiveness.

In India, the RDIF has tie-ups with five manufacturers to make more than 850 million doses of Sputnik V a year for 425 million people, accounting for over half of Sputnik V’s global production this year. “India is slated to become the biggest global producer of Sputnik V by far. Production in the country could reach 50 million doses per month by the summer with a possible scale-up,” Kirill Dmitriev, CEO of RDIF, told Forbes India. In addition, Dr Reddy's has also separately struck a deal with Raichur-based Shilpa Medicare to manufacture 50 million doses of the vaccine. "The targeted production of the dual vector Sputnik V for the first 12 months is 50 million doses (50 million of Component 1 and 50 million of component 2), from the date of start of commercial production,” the company said in a statement.

The first batch of Sputnik V containing 1.5 lakh doses—imported from Russia by Dr Reddy’s—arrived in India on May 1, the day the country opened vaccinations for all adults aged above 18, roughly 60 percent of the country’s 1.34 billion population.

The second consignment carrying 60,000 doses arrived on May 16. “It is hard to say at the moment how much of India’s supply constraints Sputnik V can alleviate,” says Satyajit Rath, a scientist at the National Institute of Immunology and the adjunct professor at the Indian Institute of Science Education and Research. “Reports say that only 1.5 lakh doses have landed, and the Indian manufacturers have so far not given any indication of how many doses they will supply, and by when.”

As of May 17, India has so far vaccinated roughly 182 million people using two of the publicly approved vaccines, Covishield and Covaxin. Of these, 40 million people have received both doses, while 142 million have received the first dose. While India’s daily vaccination touched over 4 million (40,00,000) doses a day in April, the number has since fallen sharply to less than 700,000 doses in May.

Amidst that, India has also seen a massive surge in its Covid-19 cases, with daily Covid-19 cases spiking from 26,000 cases to over 400,000 cases a day in May. The country is currently the second worst-hit Covid-19 country in the world, with over 25 million cases. 

India had initially planned to vaccinate 300 million people, including health care and frontline workers, senior citizens, and persons with comorbidities by July, before vaccinating everyone else. On April 18, the Centre devolved inoculation responsibility to the states and the private sector, departing from its original plan. Since then, numerous states such as Rajasthan, Madhya Pradesh, Uttarakhand, Tamil Nadu, Maharashtra, Karnataka, Andhra Pradesh, Telangana, Haryana, and Delhi decided to float tenders, inviting global participation in procuring vaccines.

That means the likes of Sputnik V have a massive opportunity to inoculate a significant population in India. Until now, about 90 percent of the country’s vaccine needs were being met by Covishied, and the rest by Covaxin. The Serum Institute of India (SII), the maker of Covishield, makes between 60 and 70 million doses a month and is looking to ramp up production to 100 million doses monthly. On the other hand, Covaxin manufacturer Bharat Biotech has laid out plans to produce 700 million doses annually, up from the 5 million-odd doses it currently produces a month.

At a time when more Indians are willing to get vaccinated, any added capacity for vaccination is welcome. However, without ramping up the number of doses being made available, 1.5-odd lakh doses of Sputnik will only remain symbolic, says Anant Bhan, global health, bioethics, and health policy researcher. “Sputnik will certainly add to the kitty, but vaccine imports are unlikely to make a significant dent given the large population that needs to be vaccinated,” he adds. “This is why it is more important to watch out for manufacturers of the vaccine in India who are making it available locally. By when the vaccine will be made available and at what quantities and price points are also crucial.”

Sputnik V is priced at Rs 995 per dose, including taxes. “At this stage, all vaccines are important and are our best bet in the fight against Covid-19,” the spokesperson for Dr Reddy’s said. “It is important that as many people as possible get vaccinated in the shortest possible time. Sputnik V is a safe and efficacious vaccine and an important element in the overall vaccination drive for the country.”

In contrast, SII had announced that it would sell Covishield for Rs300 per dose to states and at Rs600 per dose to private hospitals. Bharat Biotech has pegged prices at Rs400 per dose for states and Rs1,200 for private hospitals. Both the companies were selling to the central government at Rs150 a dose.

“More than 850-million doses from Sputnik V overall seems like a decent number, but whatever is being made available in India needs to be ramped up because of the population requirements,” says Bhan. According to him, states that are procuring the vaccine directly should aim to administer it for free, so that there are no inequities in access.

That said, concerns around the effectiveness of both Sputnik V and Sputnik Light continue to remain a cause of worry. “The reported 80 percent effectiveness of Sputnik Light is almost certainly overstated, based on information that has been released on the methodology for arriving at that result,” says 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 “However, it does appear that Sputnik V is a safe and effective vaccine, even if not at the levels the RDIF is advertising and therefore could play an important role in helping India out of its current situation.”

Bhan agrees, pointing out that a few global regulators flagging concerns around Sputnik is all the more reason to track the vaccine closely despite its emergency use authorisation in India. There is another quality metric that Sputnik V fails to meet at this time, he explains, which is that of WHO’s Strategic Advisory Group of Experts on Immunization. The latter has given approvals for the emergency use of many vaccines, including Pfizer, Moderna, AstraZeneca, and Sinopharm from China.

That has meant that controversies continue to surround the vaccine. On May 12, in a letter to The Lancet, titled ‘Data discrepancies and substandard reporting of interim data of Sputnik V phase 3 trial’, an international group of scientists had said that notwithstanding previous issues related to lack of transparency [in previously published Phase 1/2 trials], the interim results from Phase 3 results of Sputnik V also raise concerns. In response, the Gamalaya Research Institute has disputed these claims, stating that the reporting of the interim analysis in the Phase 3 Sputnik V clinical trial fully complied with regulatory standards.

Despite all that, the Sputnik V vaccine certainly offers India a much-needed weapon in its vaccine armoury. Considering India's grim situation, it definitely needs the Sputnik V to fire.​