New Delhi, Jan 4 (IANS): Congress leader Shashi Tharoor has criticised the government for giving the nod to Bharat Biotech's Covid vaccine without phase-3 trials.
The central licensing authority has granted permission to Bharat Biotech to manufacture 'Covaxin' for sale and distribution, after the indigenous coronavirus vaccine received regulatory approval for emergency use.
Tharoor said, "This is all we are saying. Of course, we will be proud if the vaccine turns out to work effectively. But offering it before phase-3 clinical trials have proven its efficacy is a violation of every scientific protocol and unheard of in the world. Jingoism is no substitute for common sense."
Earlier on Sunday, Drug Controller General of India (DCGI) V.G. Somani announced that Bharat Biotech's 'Covaxin' has been approved for "restricted use in emergency situations". The approval has also been given to Serum Institute of India's 'Covishield' vaccine.
Tharoor added, "But the Health Minister saying 'it's more likely to work' and 'it's likely to have similar protective efficacy reported for others' is not reassuring. 'Likely' can only be 'certain' after phase-3 clinical trials."
The Subject Expert Committee of the Central Drugs Standards Control Organisation had recommended restricted use of Covaxin "in emergency situations in public interest as an abundant precaution, in clinical trial mode, specially in the context of infection by mutant strains".
Officials say that it will be used as backup in case of a spike in cases.
Covaxin has to be administered in two doses and can be stored at 2-8 degree Celsius. This is a major relief for India which has the second highest number of infections in the world after the US.
Bharat Biotech has made India's first indigenous vaccine for coronavirus. The inactivated virus vaccine has been developed in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV).
"Covaxin has generated excellent safety data with robust immune responses to multiple viral proteins that persist," Krishna Ella, Chairman and Managing Director of the pharmaceutical company said following the approval.