Vaccine has been granted license for civilian use even before the clinical trials are completed
“Mass vaccination with an incompletely tested vaccine is unethical,”
“Russia has conducted just two trials of the vaccine with the third clinical trial yet to start,”
Srinagar, Aug 12: While Russia has approved the world’s first Covid-19 vaccine for public use, Doctors Association Kashmir (DAK) on Wednesday said we are skeptical about the claim as the vaccine has been granted license for civilian use even before the clinical trials are completed.
“Mass vaccination with an incompletely tested vaccine is unethical,” said DAK President and influenza expert Dr Nisar ul Hassan.
“Russia has conducted just two trials of the vaccine with the third clinical trial yet to start,” he said.
“The 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 vaccine is effective and safe.
Dr Nisar said to fully assess the efficacy and safety of a vaccine phase 3 trials are required.
The phase 3 trial is the pivotal study on which the decision on whether to grant the license is based.
He said Russia has not made data from the earlier trials public and the data has not been peer-reviewed which is important for regulatory approval.
Lack 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 public across the globe in dark.
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.
“One 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,” he said.
“Even the Moscow-based Association of Clinical Trials Organization, a trade body representing the world’s top drug makers in Russia had urged the Russian health ministry to postpone vaccine approval until final trial is successfully completed.
The World Health Organization has made it clear that any WHO stamp of approval on Russia’s Covid-19 vaccine would require a rigorous safety data review,” said Dr Nisar.