‘India to be ‘leading manufacturer’ of Russia’s ‘doubtful’ trial vaccine’

India would be one of the leading manufacturers of the vaccine and ensure a major supply to the external world. Russia would start exporting the vaccine only when its domestic demands are fulfilled. Till that time, it would rely on India to fulfil global demand and its own domestic demand. 

• Amid the race for a potential vaccine against the novel coronavirus, Russiahas been in the news for developing the "world's first Covid-19 vaccine," Sputnik V.
• Now, the Russian government has reached out to the Indian government seeking a collaboration for manufacturing their COVID-19 vaccine, Sputnik V, and conducting its phase 3 trial, a source in the government said.
• The Department of Biotechnology (DBT) along with the Department of Health Research has been asked to lead and look into the matter.
• They (Russian government officials) have shared some information and data on Sputnik V, while more data related to the safety and efficacy of the vaccine is awaited.
• Around the world, more than 30 vaccines — out of a total of more than 165 under development — are now in various stages of human trials.
  • Currently, eight vaccines have entered the final phase of mass human testing, including ones produced by Moderna in the United States, Oxford University and AstraZeneca in Britain, and several Chinese companies.
• The major powers are locked in a global race for a vaccine that President Donald Trump, Putin and China’s president, Xi Jinping, are treating as a proxy war for their personal leadership and competing national systems.
  • The United States, with an effort called Operation Warp Speed.
  • China has poured billions into the pursuit, and health officials worry that Russia is trying to snatch a victory by cutting corners.
• By skipping large-scale clinical trials, the Russian dash for a vaccine has raised widespread concern that it is circumventing vital steps — and potentially endangering people — in order to score global propaganda points.
• However, Russia maintained that its vaccine is based on a design developed years ago by Russian scientists to counter the Ebola virus.

• The vaccine has been developed by the Gamaleya Institute in Moscow in collaboration with Russia's Defence Ministry.
• Russian President Vladimir Putin had earlier hailed Sputnik V named after the Soviet Union's 1957 launch of the world's first satellite into space, as the first vaccine globally to receive clearance.
• The Russian vaccine uses adapted strains of the adenovirus, a virus that usually causes the common cold, to trigger an immune response.
• The vaccine consists of two components
  • a recombinant adenovirus type 26 (rAd26) vector
  • a recombinant adenovirus type 5 (rAd5) vector
• Both are carrying the gene for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike glycoprotein (rAd26-S and rAd5-S).
• Adenoviruses commonly affect humans and primates and have emerged as a sought-after platform to develop a vaccine against COVID-19. Adenoviruses are commonly used as vectors in vaccines.

• A vector-based vaccine is one where a part of the coronavirus is inserted into another virus and delivered to the body, following which the inserted coronavirus part, usually the spike protein molecule, is discharged.
• The body then recognises this as a foreign pathogen and mounts an immune response. 
• The vector used here is the human adenovirus, a group of respiratory viruses that cause common cold and flu-like illnesses in humans and animals.

There are many grey areas regarding the trials which are yet to be addressed. 

• Underpowered trial: The Phase-1 and Phase-2 trials of the vaccine had just 38 participants. Of these, the second phase had 20. This is a highly underpowered trial.
• Non-randomised trial: Second, the trial was non-randomised. A clinical trial has two arms-
  • one group receives the active experimental vaccine
  • the other, the placebo
• Whether a study participant would be assigned an active or placebo group is decided randomly. Hence, such a trial is called randomised, blind and placebo control trial.
• However, the Russian trial was neither randomised nor blind nor had a placebo arm.

• Historically, India is a very important part of vaccine manufacturing. India produces 60 per cent of the world’s vaccines.
• India, a leader in the pharma sector, and supplier of low cost vaccines to the whole world, has the capacities to quickly scale up production of any vaccine for quick availability on a large scale at affordable prices to fight the pandemic.
• As Russia saw a huge surge in COVID-19 cases, India had supplied more than 90 tonnes of medical supplies to Russia including hydroxychloroquinone.

Conclusion

India would be one of the leading manufacturers of the vaccine and ensure a major supply to the external world. Russia would start exporting the vaccine only when its domestic demands are fulfilled. Till that time, it would rely on India to fulfil global demand and its own domestic demand.