The Central Licensing Authority on Saturday granted permission to Hyderabad-based Bharat Biotech to manufacture 'Covaxin' for sale and distribution, after the indigenous coronavirus vaccine received regulatory approval for emergency use.
The pharmaceutical firm has also been asked to submit updated safety, efficacy, and immunogenicity data from the ongoing Phase I, Phase II, and Phase III clinical trials till the completion of the trials.
India's drugs regulator on Sunday approved Oxford COVID-19 vaccine Covishield, manufactured by the Serum Institute, and indigenously developed Covaxin of Bharat Biotech for restricted emergency use in the country, paving the way for a massive inoculation drive.
Controversy over Covaxin, Congress-BJP war of words
The granting of approval had, however, spurred a war of words between political leaders of the ruling dispensation, led by the Bharatiya Janata Party (BJP) against the Congress.
A few Congress leaders had questioned the approval process for Bharat Biotech's COVID-19 vaccine and raised seious concerns over allowing Bharat Biotech's COVID-19 vaccine for restricted use, saying it is "premature" and can prove dangerous.
"I would be happy and proud if more Indian vaccines are approved - but only after a full 3-phase trial confirms they are safe & effective. Short-circuiting the process is unprecedented, inadvisable & risks lives," Congress MP Shashi Tharoor had said, noting that the complete extent of the Phase-III trial data for Covaxin has not been made available in public domain as of yet.
"We are baffled to understand what scientific logic has motivated the SEC (subject expert committee) to approve this vaccine posthaste... in violation of the criteria in the draft regulatory guidelines for the development of Covid-19 vaccines published by CDSCO on 21/9/20," he tweeted, referring to Bharat Biotech's Covaxin.
Veteran Congress leader Jairam Ramesh had earlier said that Bharat Biotech is a first-rate enterprise while adding that it is puzzling that internationally-accepted protocols relating to phase three trials are being modified for Covaxin. He asked Health Minister Harsh Vardhan to clarify.
Meanwhile, BJP national president JP Nadda later slammed the Congress and other opposition parties for questioning India's drug regulator's approval to two COVID-19 vaccines for restricted emergency use in the country.
Taking to Twitter, the BJP chief said that Congress comes up with wild theories whenever India achieves something commendable.
For 'restricted use', only in 'emergency situations'
The Subject Expert Committee of Central Drugs Standards Control Organisation had recommended restricted use of Covaxin "in emergency situation in public interest as an abundant precaution, in clinical trial mode, specially in the context of infection by mutant strains". Officals say that it will be used as backup in case of 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 is India's first indigenous vaccine for coronavirus. The inactivated virus vaccine is 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 firm had said following the approval.