Srinagar, Aug 12 (KNO): While Russia has approved the worldâs first COVID-19 vaccine for public use, Doctors Association Kashmir (DAK) on Wednesday said they are skeptical about the claim as the vaccine has been granted license for civilian use even before the clinical trials are completed.
âMass vaccination with an incompletely tested vaccine is unethical,â said DAK President and influenza expert Dr Nisar ul Hassan in a statement issued to the news agencyâKashmir News Observer (KNO).
âRussia has conducted just two trials of the vaccine with the third clinical trial yet to start,â he said. âThe normal approval process of a new vaccine is to gather data from phase 1 and phase 2 clinical trials and then expand the pool of study participants in phase 3 to create enough evidence that the vaccine is effective and safe.
Dr Nisar said to fully assess the efficacy and safety of a vaccine phase 3 trials are required. âThe phase 3 trial is the pivotal study on which the decision on whether to grant the license is based,â he said.
He said Russia has not made data from the earlier trials public and the data has not been peer-reviewed which is important for regulatory approval. âLack of published data on vaccine - including how it is made and details on safety, immune response and whether it can prevent COVID-19 infection has left health experts and the public across the globe in dark,â he added.
Dr Nisar said the rush to start using the vaccine before phase 3 trials, which normally lasts for months and involve thousands of people could backfire.
âOne of the biggest concerns about approving a new vaccine before clinical trials are complete is that it could jeopardize public trust in the vaccine development process and people may not use it,â he said.
âEven the Moscow-based Association of Clinical Trials Organization, a trade body representing the worldâs top drug makers in Russia had urged the Russian health ministry to postpone vaccine approval until the final trial is successfully completed.
The World Health Organization has made it clear that any WHO stamp of approval on Russiaâs COVID-19 vaccine would require a rigorous safety data review,â said Dr Nisarâ(KNO)Â