Bharat Biotech, based in Hyderabad, said on Monday (July 13) that it expects to receive an emergency use listing (EUL) from the global body as soon as possible.
“As of July 9, all documents required for Covaxin’s emergency use listing (EUL) had been submitted to WHO. The review process has now begun, and we expect to receive EUL from the WHO as soon as possible,” said Dr Krishna Ella, Chairman and Managing Director of Bharat Biotech.
A WHO pre-qualification, also known as an EUL, is required for a vaccine manufacturer to supply vaccines to global facilities such as Covax or for international procurement.
Pfizer-BioNTech, AstraZeneca-SK Bio/SII, Johnson & Johnson Janssen, Moderna, and Sinopharm vaccines have been approved for emergency use by the WHO.
The indigenous vaccine demonstrated 63.6% efficacy against the Delta variant of COVID-19, which has spread to many other countries. Covaxin was 93.4 percent effective against severe symptomatic Covid-19 and 63.6 percent effective against asymptomatic Covid-19.
The trial included 25,800 people, and the data presented to the Subject Expert Committee (SEC) revealed that the vaccine was “well-tolerated.”