https://arab.news/2uhfm
- Regulator says decision was made after ‘adequate examination’ and the vaccines are ‘110 percent safe’
NEW DELHI: Health experts have voiced concerns over India’s “too early” move to approve two coronavirus vaccines as the country’s drug regulator on Sunday gave the go ahead for restricted use of locally produced Covishield and Covaxin.
Drug Controller General of India V.G. Somani approved Covishield, developed by the Pune-based Serum Institute of India (SII) in collaboration with the University of Oxford and AstraZeneca, and Covaxin by Hyderabad-based Bharat Biotech and the Indian Council of Medical Research.
He said the decision was made after “adequate examination,” and added the vaccines are “110 percent safe.” According to experts, however, there is no clarity yet regarding the results of their late-stage clinical trials.
“This would amount to rolling out an untested and unproven vaccine to the public which raises concerns,” Malini Aisola, co-convenor of All India Drug Action Network (AIDAN), a civil society group advocating rational drug policy, told Arab News.
She said in the case of Covaxin, phase 3 trials are still underway and available human data on safety and immunogenicity is available from just 755 participants from phase 1 and 2 trials.
“We ask that the regulator (to) make publicly available all the data and analyses that were the basis of these decisions, in the interest of transparency and the public’s welfare before these vaccines are rolled out,” Aisola said.
BACKGROUND
Covaxin developed by Bharat Biotech and the Indian Council of Medical Research has yet to complete Phase 3 clinical trials.
Prominent virologist Dr. T. Jacob John of the Christian Medical College in Vellore explained, however, that the approved vaccines are only for emergency use.
“That means the vaccines are not available for the general public yet. They would be available for the masses only after registering the vaccines or licensing them,” he told Arab News, adding that the “restricted emergency use” means the vaccine shots would be given only to persons chosen by the government.
“The companies can sell vaccines outside only after licensing; now they cannot do that,” Dr. Jacob said, expressing worry that the vaccine may not gain public trust due to the absence of “essential” details.
“Regulatory agencies need not divulge all the results — they must, however, give essential details to the public,” he said.
According to government plans, frontline healthcare workers will be the first to receive the vaccines.
Following the drug regulator’s announcement, Prime Minister Narendra Modi said in a series of tweets that the rolling out of the vaccines was a “proud” moment and a “turning point” for India’s coronavirus fight.
“It would make every Indian proud that the two vaccines that have been given emergency use approval are made in India,” he said.
With over 10.3 million people infected, India has the world’s second-highest coronavirus caseload, after the US.