Bharat Biotech's COVAXIN gets WHO approval
New Delhi/IBNS: The World Health Organization (WHO) has given emergency use approval to Bharat Biotech's Covaxin, sources said Wednesday, clearing the way for the 'made-in-India' vaccine to get recognised by other nations and Indians inoculated with the shot would no longer need to self-quarantine or face restrictions when going abroad.
The emergency listing, or EUL, came after a lengthy and rigorous review period.
Bharat Biotech first applied for WHO's approval in April and supplied the required data in July, assuring about the vaccine's safety, efficacy and stability as well as checks of production facilities.
Last week again Bharat Biotech was asked to provide "additional clarifications" to conduct a "final risk-benefit assessment" by the Technical Advisory Group (an independent panel that provides the WHO with recommendations).
The WHO had also said it understood "many people are waiting for Covaxin to be included in the COVID-19 Emergency Use Listing" but also stressed "we cannot cut corners before recommending a product for emergency use... we must evaluate thoroughly to make it is safe and effective".
It emphasised that the EUL approval normally depended on how fast the vaccine manufacturer is able to provide the required data.
"When the information provided addresses all questions raised, the WHO and the Technical Advisory Group will complete the assessment and come to a final recommendation," it said.
Covaxin is manufactured by Hyderavad-based Bharat Biotech in collaboration with the Indian Council of Medical Research - National Institute of Virology.
As of this evening over 12.14 crore people have been vaccinated with Covaxin, according to Union Ministry of Health.
Covaxin has shown 77.8 percent effectiveness against symptomatic COVID-19 and 65.2 percent protection against the new Delta variant.