Sputnik V -the phase 3 trials hit a roadblock...

 Ever since the Pandemic broke loose courtesy-a virus known as nCoV2019, one thing the governments world over has been looking for with bated breath is a vaccine-a vaccine which is considered a panacea to provide immunity against the killer virus.


More than nine months have elapsed since the first fatality of the deadly virus, named Corona virus, was reported from Wuhan province of China. After initial hiccups and the customary disbelief as to its severity the Premier Health Organisation WHO declared it a pandemic way late on March 11 this year. The damage had already been done. China who exported the virus world over maintained an eerie  silence over the issue. The governments world over failed to guage the seriousness and people across globe continued to travel internationally unmindful of the fact that they carried the virus with them. The blame games continued and the virus started playing havoc. Death rate in European nations shot up dangerously in April with countries like Italy, France , Spain and Britain recorded maximum casualties. The virus took turns to spread worldover and even the powerful nation like the United States was not spared. It is then the need of a vaccine was felt more than anything and scientists from over 150 countries got engaged in research in order to find one. 


A vaccine, in order to be fully foolproof, needs to go through four phases of clinical trials. Russia was the first country to declare having prepared the first corona virus vaccine named Sputnik V in August 20. It is said that Sputnik V, an adenovirus, vector based virus was developed by Gamaleya Scientific Research Institute of Epidemiology and Microbiology alongside Russian Direct Investment Fund ( RDIF). The vaccine was declared safe and well tolerated by the authorities in the beginning. However, it was soon revealed that the vaccine was released without proper clinical trials as mandated being customary. Phase 3 trials were to begin in India this month. IDRF and Dr Reddy’s Laboratories who are marketing the vaccine in India stressed for the said phase 3 trials. Media reports are agog that The Central Drugs Standard Control. Organisation ( CDSCO) has put a spoke in the proposed phase 3 trials on the grounds that the safety and immunogenicity data of earlier trials are not available to make a decisive conclusion. The CDSCO directives need to be lauded as India being one of the most affected countries by the deadly virus, with more than one lakh fatalities already recorded,  could not have allowed any laxity seep into the most important phase 3 trials. The decision taken in best public interest and according to strict norms hitherto adopted might delay the proposed trials but then  health safety measures could not be compromised.


India itself is getting ready to launch its own vaccine somewhere middle of next year. A massive exercise to build infrastructure to handle, store and distribute the doses to masses across the length and breath of the country, is underway. The Indian vaccine will not arrive through any short cuts for sure as India’s commitment to its own citizens as to its safety standards and efficacy is globally respected. 


The world is under challenge to fight COVID-19 and India’s efforts to that is second to none. A safe and secure world is everyone’s responsibility. Till that goal is achieved , till a vaccine arrives in the scene,it is our duty to abide by every health directive issued by Government and other governmental authorities scrupulously. There cannot be any short cuts. Let’s not get swayed away by any false or misleading claims.Let’s keep our fingers crossed and hope for the best. Let us put faith above everything. At this juncture when human belief is shaken at the alter of hopelessness, let us draw inspiration from Gurudev’s famous lines:


“Nishi din harosha rakhis ore mon , hobeyi hobey;

Jodi pan korey thakis se pan tomar robeyi robey..”


[Hold thy faith firm,my heart, the day will dawn.

The seed of promise is deep in the soil, it will sprout...]



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Comments

  1. Nice and informative.
    India has never compromised on its ethics in medical research. The vaccine, irrespective of who manufactures it, must pass through all the trials . There in deed can't be any short cuts.

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