With the approval of Sputnik V, India reaches a new milestone to eliminate coronavirus

By Dr. Amir Ullah Khan

In the drive to eliminate Covid 19, India has reached a significant milestone with the DCGI approval for a third vaccine in the country for emergency use in India – Sputnik V. India will be the leading production hub of Sputnik V as per RDIF (Russian Direct Investment Fund). This Russia based vaccine is approved for about 40% of the global population in over 60 countries and ranks second among coronavirus vaccines globally in terms of the number of approvals issued by government regulators. India is the most populated country to register the Russian vaccine. This will also enable other foreign vaccines to start production in India where we face severe supply problems today.

After losing some valuable time, the Indian government has now decided that coronavirus vaccines that are being manufactured in foreign countries and those have been granted emergency approval for restricted use by authorities in the US, Europe, the UK, Japan or which are listed in the WHO Emergency use listing, may be granted emergency use approval in India. They will be given emergency use approval mandating the requirement of post-approval parallel bridging clinical trial in place of a local clinical trial under the provisions of the New Drugs and Clinical Trials Rules 2019.

With more than 14 million cases so far (and nearly 200,000 new cases every day 1.6), we are in seeing a spike in active Covid cases like never before. The government’s ambitious goal of vaccinating 300 million people by July 2021 has been hit by huge stock shortages of Covaxin and Covishield in many parts of the country. Ironically there is also a demand side problem due to vaccine hesitancy. Even for people waiting for their second shot, many states reported a delay in the same as per the scheduled date due the lack of availability of the vaccine. Considering all the above scenarios, it wouldn’t have been a better time for a third vaccine in India.

Also Read | India to become Russian Sputnik V vaccine’s production hub, to start making 50 mn doses per month by summer

The second wave, though not entirely surprising, is perplexing in the way it has reached new areas. States that were speared of the infection earlier, like UP and Chhattisgarh, are now witnessing a surge that is frightening. Health systems in these states are completely broken and the only ways the infection can be managed is through masks, distancing and vaccines. Mandating Masks and physical distancing has always been difficult, where the only toll we have is a police force that must penalize poor people who often don’t even know why they must take these precautions.

Vaccination therefore is the best bet against the spread of the virus and certainly against fatality. With only about 8 percent of the population vaccinated so far, we have a long way to go before we vaccinate even the most vulnerable. On one hand, there is even now tremendous reluctance in taking the vaccine and on the other hand is the supply chain that is disrupted at every level. Stock outs, poor storage conditions, huge wastages particularly in Tamil Nadu and UP have all combined to make the situation far more fragile than it was even during the peak seen last year.

According to Gamaleya National Research Center of Epidemiology and Microbiology of the Ministry of Health of the Russian Federation and the Russian Direct Investment Fund, Sputnik V vaccine demonstrated efficacy of 97.6%, based on the analysis of data on the infection rate of coronavirus among those in Russia vaccinated with both components of Sputnik V. Vaccines based on adenoviral vectors have significant differences in their structure and production technology. Therefore, there is no reason to extrapolate safety data from one vaccine to safety data from other vaccines. Sputnik V after all, is the world’s first registered vaccine based on a well-studied human adenoviral vector-based platform. The Sputnik V vaccine, developed by Gamaleya National Research Institute of Epidemiology and Microbiology in Moscow, uses two different viruses that cause the common cold (adenovirus) in humans.

After the start of the COVID-19 pandemic, Russian researchers extracted a fragment of genetic material from novel coronavirus SARS-COV-2, which codes information about the structure of the spike S-protein, which forms the virus’ ‘crown’ and is responsible for connection with human cells. They inserted it into a familiar adenovirus vector for delivery into a human cell creating the world’s first COVID-19 vaccine. To ensure lasting immunity, these Russian scientists came up with a breakthrough idea to use two different types of adenovirus vectors (rAd26 and rAd5) for the first and second vaccination, boosting the effect of the vaccine. Hence, Sputnik V is a two-vector vaccine against coronavirus.

As per RDIF, there are no strong allergies caused by Sputnik V and is indicated for immunization in individuals who are 18 years and above. The vaccine is injected intramuscularly in two doses of 0.5 ml each with an interval of 21 days. With the uphill rise of coronavirus that our country is witnessing at present, it has imperative that we have do not only have the availability of more vaccines in India but also been given more choice to vaccinate a large section of the population. Therefore, it has been a great drive that Indian government has looked beyond the existing vaccines and now Sputnik V has joined as the third vaccine to fight and reduce the incidence of Covid-19 and curb the spread of the virus.

(The author is Economist at MCRHRDI of the Government of Telangana and a former adviser with the Bill and Melinda Gates Foundation. Views expressed are personal and do not reflect the official position or policy of the Financial Express Online.)