Covaxin Gets WHO Approval for Emergency Use Listing

Bharat Biotech, situated in Hyderabad, got a boost on Wednesday when the World Health Organization (WHO) approved India’s first indigenous Covid vaccine, Covaxin, for emergency use listing (EUL).

The WHO approval is a key step toward international governments accepting Covaxin. It will take away the fear of Indians who have been immunized with this vaccine traveling abroad. Furthermore, EUL is a requirement for vaccines to be supplied through COVAX, Covid’s global vaccine equity scheme.

Covaxin, along with Covishield and Sputnik V, is one of six vaccines that have acquired emergency use authorization from India’s medicines regulator and are being used in the country’s statewide vaccination program.

Bharat Biotech reported the safety and efficacy analysis findings from their vaccine’s Phase III clinical trials in July, claiming that Covaxin showed 77.8% efficiency against symptomatic Covid-19 and 65.2 percent protection against the novel Delta form.

In the same month, the government informed the Rajya Sabha that Bharat Biotech had filed the essential paperwork for the WHO’s EUL, and that the global health organization had begun the evaluation process. Last month, the WHO stated that Bharat Biotech would provide “one further piece of information.”

The WHO claimed in a series of tweets at the time that it could not “cut corners” and that the timetable for its EUL was contingent on vaccine producers’ ability to deliver the essential data as promptly as possible. The WHO stated it and its Technical Advisory Group would “finish the review and come to a final decision whether to award Emergency Use Listing to the vaccine” once “the material presented resolves all problems highlighted.”

In addition to Covaxin, the WHO has licensed for emergency use vaccines developed by Pfizer-BioNTech, Johnson & Johnson, Moderna, Sinopharm of China, and Oxford-AstraZeneca.

Bharat Biotech said earlier today that the Central Drugs Standard Control Organization (CDSCO) had approved the extension of Covaxin’s shelf life to 12 months from the date of manufacturing.

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