The licensure of Covaxin has been changed to emergency use authorisation from earlier approved restricted emergency use in clinical trial mode by India's drug regulatory authority
A senior citizen takes a COVID-19 vaccine shot. Pic/Ashish Raje
Bharat Biotech's Covaxin has a negligible number of side effects reported among the beneficiaries of the Covid-19 vaccine, NITI Aayog's Member (Health), V.K. Paul said on Thursday.
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"The vaccine has been administered so far to 19 lakh people and only 311 individuals of them have reported minimal side effects.
"It has stood the test of time with great safety," Paul said at a press briefing.
The government also announced that Covaxin is now allowed for regular emergency use among the public.
The licensure of Covaxin has been changed to emergency use authorisation from earlier approved restricted emergency use in clinical trial mode by India's drug regulatory authority.
Calling the development good news, Paul said that now Covaxin is at the same level as the other vaccine authorised in India.
"It is a good news. This has taken the authorisation for Covaxin to the next level where Covishield has been operating," he said.
Covishield, a Covid-19 vaccine developed by AstraZeneca and the Oxford University, is manufactured by Serum Institute of India (SII) here.
"It (Covaxin) was approved for REU but we scaled its authorisation under abundant precaution citing public interest. That restriction has been removed. Both the vaccines have the same intensity of licensure now," Paul added.
A day ago, the Central Drugs Standard Control Organisation's Subject Expert Committee approved Covaxin for emergency use authorisation.
Earlier, the vaccine's emergency use was permitted only in the clinical trial mode. This condition has now been waived off by the Drug Controller General of India (DCGI) now.
The decision was taken after the expert panel studied the interim result of the Phase 3 trial of the vaccine which demonstrated 81 per cent efficacy.
Bharat Biotech had announced results of Phase 3 clinical trials of Covaxin on March 3.
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