Photo by: Harsha Vadlamani
In September last year, amidst all the uncertainties about the raging coronavirus pandemic, GV Prasad, the co-chairman and managing director of Dr Reddy's Laboratories, India’s third largest pharmaceutical company, took a big gamble.
His company struck a deal with Russia’s Gamaleya National Research Institute of Epidemiology and Microbiology, to manufacture the Sputnik V vaccine in India. Back then, there was no efficacy data surrounding the vaccine, even though Russia had begun inoculating its people with the vaccine and approved wide scale production. It was certainly a big gamble, especially since questions were being asked in the scientific world about the claims surrounding the efficacy of the vaccine.
“The vaccine has become a target of politics, but we will go with the science,” Prasad had told Forbes India immediately after partnering with the Russian government. “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.”
Today, eight months later, that gamble seems to have finally paid off. On April 12, a Subject expert committee (SEC) of India’s health ministry has recommended granting an emergency use authorisation to the Sputnik V manufactured by Dr Reddy after the company submitted the immunogenicity data. The SEC is part of the Central Drugs Standard Control Organisation (CDSCO) headed by the Drugs Controller General of India. The latter will take the final call on the approval based on the SEC's recommendation. If approved, the Sputnik V will be the third Covid-19 vaccine to be available in India.
Just 12 days ago, the committee had asked the company to submit data pertaining to immunogenicity parameter and a comparative analysis of Phase III immunogenicity data generated on Indian and Russian studies at various time points. Globally, the Sputnik V vaccine is n use in nearly 60 countries including Russia, Belarus, Argentina, Bolivia, and the UAE among others.
The approval for Sputnik V comes at a time when India is in the midst of a second wave of coronavirus infections. Cases in the country have been hitting record highs over the last week, and has been more intense than the first wave. Many states have announced partial lockdowns to combat the crisis, even as many states have complained of a shortage for vaccines in the country. On April 12, India recorded 168,912 new cases, pushing the country's total cases to over 1.35 crore.
Approval for Sputnik can certainly add more arsenal to the national capacity. Apart from Dr Reddy’s, additionally, Hyderabad-based Virchow Biotech Private Limited will also produce 200 million doses of Sputnik V, while Bengaluru-based Stelis Biopharma has also decided to produce 200 million doses. Hyderabad-based Gland Pharma will produce 252 million doses and Hyderabad-based Hetero Drug will produce 100 million doses, in the coming months.
India is currently in the midst of the world’s largest vaccination program involving two vaccines. The first one, Covishield, commonly known as the AstraZeneca vaccine is manufactured by the Pune based Serum Institute of India, the world’s largest vaccine maker and has an efficacy of 79 percent. Serum institute had tied up with British pharmaceutical company, AstraZeneca to manufacture and sell the vaccine in India and is based on a genetically modified version of a common cold virus that infects chimpanzees. The other vaccine supplier is the Hyderabad-based Bharat Biotech, whose Covaxin boasts an interim efficacy rate of 81 percent.
An outside view of BKC Vaccination Centre in Greater Mumbai. Due to unavailability of Covid19 Vaccine the Vaccine Centre is forced to close for a limited period. Mumbai, 9th April 2021. Photo by Deepak Turbhekar for Forbes India.
So far, the Indian government has administered 104 million vaccines as part of its vaccination program that began on January 16. Of this, as many as 12 million people have received their second dose, while 92 million have received the first dose.
"The efficacy of Sputnik V was reported to be 91.6 percent by the Lancet, which is an impressive development in the fight against Covid-19,” Prasad, had said on Feb 19 while applying for the emergency use. “The initiation of the EUA process will be a critical step forward for us in ensuring speedy access to the Sputnik V vaccine in India.”
In September 2020, Dr Reddy's had partnered with the Russian Direct Investment Fund (RDIF) to conduct the clinical trials of the Sputnik V and for its distribution rights in India. As part of the review process, Dr Reddy's had presented the safety profile of the phase 2 study, and interim data of the phase 3 study. “Sputnik V has demonstrated an efficacy rate of 91.6 percent in the interim analysis of the phase 3 clinical trial, which included data on 19,866 volunteers in Russia, who received both the first and second doses of the vaccine,” Dr Reddy’s had said in a statement on February 19. “Sputnik V maintained a consistent efficacy at 91.8 percent even among the group of 2, 144 volunteers over 60 years old.”
Sputnik V was developed by Russia’s Gamaleya National Research Institute of Epidemiology and Microbiology and registered by the Russian health ministry as the world’s first Covid-19 vaccine based on the human adenoviral vector platform. Dr Reddy’s, which barely had any vaccines in its portfolio had moved in July to quickly partner with the institute despite global concerns about the efficacy of the vaccine. At that time, the company was already late into the vaccine race, with all the other Indian pharmaceutical companies already developing their vaccines or having partnered with other global makers.
“All the players had tied up with somebody or the other, so it was our turn to tie up with the Russian Gamaleya Research Institute and RDIF,” Prasad had told Forbes India soon after the company partnered with the Russian government. The Sputnik V is based on human adenovirus, a common cold virus that is fused with the spike protein of Sars-CoV-2 to stimulate an immune response.
Late to the party
Dr Reddy’s currently has a deal to distribute 100 million doses of the vaccine in India, although it hasn’t disclosed how much the deal was struck at. In addition, the company has also not ruled out the eventual possibility of manufacturing the vaccine in India.
“We understand we are late in the game, so we need to accelerate whatever we’re doing through partnerships,” Prasad had told Forbes India. “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 in India and make it available to patients.”
India is the second-worst affected country in terms of Covid-19 cases and has seen a surge in cases after recording less than 10,000 cases in early February. That trend had reversed since the end of March, when cases have been spiking at record levels. “Our spend is only for the clinical trial and it’s not large,” Prasad had told Forbes India. “Money is not what we are looking at. We are looking at the solution, and at some point economics will become important… we will deal with it at that time.
The company’s decision to foray into the vaccine race also came at a time when it had stayed away from vaccines for more than two decades. The last time the company had dabbled with vaccines was in the early 2000’s when it manufactured vaccines for Hepatitis B. “Vaccine is not a big play for us,” Prasad had told Forbes India. “But we see this as something we’re doing for our patients. Certainly, we are looking at vaccines as a space. We were never a big player, in fact, not a player at all in vaccines.”
All that changed as India’s Covid-19 cases surged and the company decided to foray into partnering with a global drug maker for Covid-19 vaccine sometime in July this year.
GV Prasad and his brother in law, Satish Reddy, the chairman of Dr Reddy’s had given the mandate to Deepak Sapra, the CEO of API (active pharmaceutical ingredient) and pharmaceutical division to initiate the talks with the Russian government. For long, Dr Reddy’s had a special relationship with Russia. In 1992, Russia was the first country it forayed into
, barely eight years after it began operations. Today, its business in Russia accounts for over ₹2,000 crore annually—over 10 percent of the consolidated revenue.
“The meetings would go on for long and sometimes run late into midnight or on Sundays,” Sapra had told Forbes India. “By then, we had become used to working round the clock. They were able to communicate the science behind it, and were forthcoming.” The deal was finally struck in September.
By January, the company announced that it had received approval from the Drugs Control General of India (DCGI) to conduct phase 3 clinical trial on 1,500 subjects. Earlier, the Data and Safety Monitoring Board (DSMB) reviewed the safety data from the phase 2 clinical trial, conducted on some 100 volunteers, and found no safety concerns.
What happens now
With the approvals in place, Dr Reddy’s is likely to sell the vaccine to the Indian government who will then make it part of its large vaccination drive. On April 1, the government had announced that those above 45 years of age will be vaccinated at 10,000 govt and over 20,000 private vaccination centre. The vaccine will be given free of cost at govt centres.
According to the government’s plan, the phased rollout of the vaccine will initially see ten million health care and 20 million frontline workers being vaccinated, followed by 270 million senior citizens and people with co-morbidities like diabetes, hypertension, organ transplants etc. In all, 300 million people are going to be inoculated by July this year.
“One major limitation in the national Covid-19 vaccination campaign is the supply of vaccine doses, and adding Sputnik V to that supply chain will certainly help,” Satyajit Rath, a scientist at the National Institute of Immunology and the adjunct professor at the Indian Institute of Science Education and Research had told Forbes India earlier. “Sputnik V is similar to the Oxford-AstraZeneca-SII vaccine in being adenovirus-based, although it uses a different pair of adenoviruses. There is some effort globally to mix adenovirus-based vaccines from different sources in the dosing schedule; if those efforts begin to show good results, having both these vaccines available will help a bit further, too. This is not going to be the only one; there will be more and more vaccines passing the regulatory requirements for emergency usage and adding to the vaccine supply available. The logistical catch is going to be how to decide which vaccine is to be supplied where and when, for the most optimal vaccine distribution plan.
The Sputnik V, with its high efficacy rates claims very low allergies after administering, and can be stored between 2 degree Celsius and 8 degrees, making it easier for countries such as India in handling and logistics, since the country doesn’t boast a robust cold storage ecosystem. In early February, India had rejected global pharmaceutical major, Pfizer’s request for emergency use authorization following certain serious adverse events (SAEs) globally and because it had not generated adequate information from local trials in the country.
“Even if approval is given, supply schedules will be the real test. We should keep in mind that, even by government data, only one-tenth of all vaccine doses in the country so far have been of the ICMR-Bharat Biotech vaccine,” adds Rath.
Meanwhile, the developers of the Sputnik V vaccine are also working collaboratively with AstraZeneca on a joint clinical trial to improve the efficacy of AstraZeneca vaccine, or the Covishield vaccine. The vaccine currently sells at less than $10 (Rs 750) per shot according to the RDIF and has already The vaccine has already been administered to more than 2 million people worldwide.
“If there is a solution, this world can afford it,” Prasad had earlier said. “Nobody is going to profiteer from the vaccine.”
On this day (April 12) , Yuri Gagarin, a Russian pilot, changed the world when who became the first human to journey into outer space. Now, 60 years later, it’s up to a Russian made vaccine to help change the course of India’s Covid-19 fight.