The World Health Organization on Wednesday granted Bharat Biotech’s Covaxin an emergency use listing (EUL), adding to a growing portfolio of vaccines validated by the global body for the prevention of COVID-19.
The EUL comes at the end of a lengthy and rigorous review period – Bharat Biotech first applied in April and provided required data in July – that involves assurances about the vaccine’s safety, efficacy and stability, as well as checks of production facilities.
The Technical Advisory Group (TAG), an independent advisory committee of the WHO had on October 26 sought “additional clarifications” from the company for Covaxin to conduct a final “risk-benefit assessment” for EUL.
“The Technical Advisory Group of WHO has recommended emergency use listing status for Covaxin,” a source said.
The delay in WHO recognition had left millions of Indians – students, working professionals, families divided by the pandemic – waiting anxiously for news that Covaxin will be accepted by other countries.
The TAG-EUL is an independent advisory group that provides recommendations to WHO on whether a COVID-19 vaccine can be listed for emergency use under the EUL procedure.
Covaxin has demonstrated 77.8 per cent effectiveness against symptomatic COVID-19 and 65.2 per cent protection against the new Delta variant.
Following the WHO approval Union Health Minister Mansukh Mandaviya praised Prime Minister Narendra Modi’s leadership.
“This is a sign of capable leadership. This is the story of Modiji’s resolution. This is the language of the faith of Indians. This is the Diwali of a self-reliant India,” the health minister wrote, thanking the WHO.
Bharat Biotech’s Covaxin and AstraZeneca and Oxford University’s Covishield are the two widely used vaccines in India.