Serum Institute applies for WHO Emergency Usage Listing of Covovax COVID-19 vaccine

The Serum Institute of India (SII) has filed for the emergency use listing (EUL) for its upcoming COVID-19 vaccine, Covovax, with the World Health Organization (WHO), reported Zee Media on Friday quoting sources, who said that the WHO has accepted SII's application. 

SII is manufacturing Covovax in collaboration with US-based vaccine maker Novavax. 

They said that there was also a pre-submission meeting held between the Serum Institute and the WHO on August 10. After getting the WHO's approval, Covovax will be become second COVID-19 vaccine by the Pune-based Serum Institute, after Covishield, which is AstraZeneca vaccine made in collaboration with Oxford by SII. 

This comes after in July an expert panel of India's Central Drug Authority recommended granting permission to SII to conduct phase 2/3 trials of Covovax on children aged 2 to 17 years with certain conditions. The trials, according to reports, would cover 920 children, 460 each from the age group of 12-17 and 2-11, across 10 cities. 

SII had submitted a revised protocol for inclusion of pediatric cohort in the ongoing phase 2 and 3 trials of Covovax observer-blind, randomised, controlled study in Indian for people aged 18 years and above in order to determine the safety and immunogenicity of its shot. 

SII CEO Adar Poonawalla on August 6 had said that Covovax will most likely be launched in October for adults, and for children by the first quarter of 2022.