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New Delhi (India)/Canadian-Media: Bharat Biotech's Covaxin's approval for emergency use after a lengthy and rigorous review period by the World Health Organization (WHO) has cleared the way for the 'made-in-India' vaccine to get recognized by other nations, sources said Wednesday.
Bharat Biotech, Covaxin. Image credit: Wikipedia.org
After applying for WHO's approval in April Bharat Biotech supplied the required data in July, assuring about the vaccine's safety, efficacy and stability as well as checks of production facilities.
Bharat Biotech was asked again last week 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".
The panel emphasized that the EUL approval normally depended on how fast the vaccine manufacturer is able to provide the required data and added,
"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."
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.