New Delhi: The Sputnik V Covid vaccine is likely to be available for supply by next month, the Russian Direct Investment Fund’s (RDIF) top official told ThePrint.
“We are working closely with the regulators and hope for a regulatory approval as early as in January 2021 and are ready to supply the vaccine to a wider population within the same timeframe,” said Kirill Dmitriev, CEO, RDIF.
The Sputnik V vaccine is being developed by the Gamaleya National Research Center for Epidemiology and Microbiology of the Ministry of Health of the Russian Federation, in collaboration with the Russian Direct Investment Fund (RDIF), the country’s sovereign wealth fund.
It was registered by the Russian Ministry of Health on 11 August, according to the Sputnik-V website, becoming “the first registered Covid-19 vaccine on the market”.
‘India should strengthen cold chain system, have foolproof plan’
On vaccine distribution in India, Dmitriev said while India has experience in implementing vaccination programmes in the country, it “should have a foolproof plan in place before it starts mass Covid-19 vaccination.”
“As we understand, the country’s government is working on a special Covid-19 inoculation programme that would be using the processes, technology and network of the Universal Immunisation Programme (UIP) currently in place,” Dmitriev said.
“Strengthening the cold chain systems and deploying trained personnel to ensure vaccine safety would be key to the inoculation process’s ultimate success. Another important thing would be to prioritise socio-demographic groups that would be among the first to gain access to the vaccine apart from healthcare professionals,” he added.
Joint effort between India & Russia
Dmitriev said Sputnik V is a joint effort between India and Russia. “We currently have four manufacturing partners in India to produce the vaccine locally. To a large extent, this vaccine is a joint effort between our two countries because most of the production will be in India. We truly appreciate the Indian pharma industry’s expertise and capabilities.”
“Russia, as has been said by President Vladimir Putin on my occasions, is very keen to collaborate with other countries on the development of Covid-19 vaccines. Obviously, that includes fellow BRICS countries and India in particular,” he added.
“India is a global leader in vaccine production, accounting for about 60 per cent of all vaccines manufactured globally. The country is an important logistics and manufacturing hub and has extensive experience with large-scale, country-wide immunisation programmes,” he said.
In September, RDIF tied up with Dr Reddy’s to conduct clinical trials of Sputnik V in India and to work together on its local distribution. As part of this deal, 100 million doses of the vaccine will be supplied to Dr Reddy’s upon regulatory approval in India.
“As the country’s Drug Controller General has allowed us to conduct adaptive phase 2 and 3 human clinical trials for our vaccine, we believe we will secure all the regulatory approvals to distribute the vaccine in India.
“According to our deal with Hetero, one of India’s leading pharma companies and the world’s biggest maker of anti-retroviral drugs, which we announced on 27 November, the company will be producing 100 million doses of the Sputnik V vaccine per year starting from 2021,” he said.
Claiming its vaccine is safe and effective, Dmitriev said, “We would want Sputnik V to be part of the World Health Organization’s Covax portfolio of vaccines.”
“We see this initiative as crucial in delivering the vaccines globally, including to countries that need them most. The world is in need of a whole portfolio of Covid-19 vaccines and we should all work together to produce and deliver them safely and to all who need them.”
Covax is a global alliance involving 172 countries, co-led by Gavi, the Coalition for Epidemic Preparedness Innovations (CEPI) and WHO. It aims to accelerate the development and manufacture of the vaccine and ensure its access to low and middle income countries.
Globally, RDIF has received applications for over 120 crore doses of the vaccine from more than 50 countries.
According to the agreements already signed, the vaccine will be manufactured internationally for 50 crore people every year from 2021. “We are currently considering additional applications from a number of countries and, based on the unprecedented interest we are seeing, production numbers could be increased even further,” Dmitriev said.
Vaccines should be subject to scrutiny
Commenting on the recent halt of Astra Zeneca’s trial in the UK due to a suspected adverse reaction on a candidate, Dmitriev, said, “Unlike Sputnik, the vaccine developed by AstraZeneca uses a chimpanzee adenovirus. This technology does not have long-term safety studies similar to human adenoviral vaccines that have been around for decades.”
“All vaccines should, as a rule, be subject to the most rigorous scrutiny by the scientific community as well as regulators. Only then, a top quality product will be guaranteed,” he said, adding that till now, no case of side-effect has been observed for Sputnik V.