COVID-19: Serum Institute of India files for WHO Emergency Use Listing for its Covovax vaccine

New Delhi: The Serum Institute of India (SII) has filed for World Health Organization (WHO) emergency use listing (EUL) for its upcoming COVID-19 vaccine Covovax, sources confirmed to Zee Media on Friday (August 21, 2021). The sources said that the global health body has accepted the application of the Pune-based pharmaceutical company and a pre-submission meeting was also held between the Serum Institute of India and WHO on August 10. 

Covovax will become SII's second coronavirus vaccine to get a WHO nod after Covishield.

An expert panel of India's Central Drug Authority in July had recommended granting permission to Serum Institute of India for conducting phase 2/3 trials of Covovax on children aged 2 to 17 years with certain conditions. The trials would reportedly cover 920 children, 460 each in the age group of 12-17 and 2-11 across 10 sites.

The company had also submitted a revised protocol for inclusion of pediatric cohort in the ongoing Covovax phase 2 and 3 observer-blind, randomised, controlled study in Indian adults aged 18 years and above to determine the safety and immunogenicity of the jab.

Earlier on August 6, Serum Institute of India CEO Adar Poonawalla had said that he is hopeful that Covovax will be launched in October for adults and for children by the first quarter of 2022.

This is to be noted that the Serum Institute of India will manufacture Covovax in collaboration with US-based vaccine maker Novavax. 

India has so far approved six COVID-19 vaccines with the indigenously developed Zydus Cadila's vaccine 'ZyCoV-D' being the latest one. It is the world's first DNA shot against the coronavirus, in adults and children aged 12 years and above. The ZyCoV-D vaccine uses a section of genetic material from the virus that gives instructions as either DNA or RNA to make the specific protein that the immune system recognises and responds to. Unlike most COVID-19 vaccines, which need two doses or even a single dose, ZyCoV-D is administered in three doses.

The generic drugmaker, listed as Cadila Healthcare Ltd, aims to make 100 million to 120 million doses of ZyCoV-D annually and has already begun stockpiling the vaccine.

Zydus Cadila's vaccine is the second home-grown shot to get emergency authorization in India after Bharat Biotech's Covaxin.

(With agency inputs)

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