Jahnavi Sarma
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Written By: Jahnavi Sarma | Updated : January 5, 2021 5:04 PM IST
Bharat Biotech's Covaxin and Oxford-AstraZeneca's Covishield are approved for 'restricted emergency use' in India..
The controversy over Covaxin's approval for emergency use is raging on and many experts are questioning the prudency of approving this vaccine despite the fact that it has not yet completed phase 3 trials. They are raising questions about its efficacy though they do concur that this vaccine may indeed be safe. But if it is not effective against the COVID-19 virus, then what is the use of granting emergency use approval to this vaccine candidate? After all, safety and efficacy are both equally important. Many experts rightly raise the question that if phase 3 trials are the only way to establish efficacy, why not just wait for the trials to get over, collect the data, establish efficacy and then give the approvals?
Some experts in the know claim that the approval granted to Covaxin was actually an approval for a backup vaccine. Covishield will be the vaccine that will be rolled out for mass vaccinations. But Bharat Biotech refuted these claims.
Some experts are of the view that Covaxin was granted approval for use in case there is a sudden surge in COVID-19 cases. Hence the term 'backup vaccine'. This may be because it is an inactivated vaccine and is therefore safe. But the efficacy of this vaccine is not proven. Therefore, though its safety is assured, nobody knows just how effective it will be against the deadly virus that has had the world in its grip for the past one year. Though Bharat Biotech has rubbished the debate raging on, it is logical to question why the authorities did not think it necessary to wait another couple of months till the phase 3 clinical trial results were out.
Meanwhile, Bharat Biotech Chairman Krishna Ella said on Monday that the company does not deserve the backlash it is receiving in the light of the India's drugs regulator granting its coronavirus vaccine Covaxin approval for emergency use. "Don't accuse us of inexperience. We are a global company... have manufactured 16 vaccines," he said, highlighting that "200 per cent honest" clinical trials were conducted. Ella said the company conducts clinical trials not only in India but also many other countries.
His comments assume significance as Covaxin has been given an emergency approval despite allegedly only two of the required three trial phases being completed. However, Ella pointed at the number of journal articles Bharat Biotech published and claimed that it was the first to identify Zika virus and file a patent for Zika and Chikungunya viruses. Bharat Biotech was the only company to have a Bio Safety Level 3 (BSL- 3) production facility, he noted. "We do 200 per cent honest clinical trials and yet we receive a backlash. If I am wrong, tell me. Some companies have branded me 'water'. I want to deny that. We are scientists," he said.
(With inputs from IANS)
