Covovax recommended for emergency use authorisation by expert panel

The Subject Expert Committee on Covid-19 has reviewed and accepted the request to grant Serum Institute of India's Covovax vaccine Emergency Use Authorisation which would permit it to enter use, but under certain conditions.

Prakash Kumar Singh, Director, Government and Regulatory Affairs at Serum Institute of India (SII) had submitted an application to the Drugs Controller General of India (DCGI) in October for grant of market authorisation for Covovax for restricted use in emergency situations

The Serum Institute had been working with American vaccine manufacturer Novovax to use its technology to develop and manufacture the vaccine in India. It had provided extra data to the Expert Committee in November, including immunogenicity tests, and clinical trial data from phases 2 and 3 of vaccine trials in the US and UK.

A quantity of the vaccine was allowed to be manufactured and stockpiled by the Serum Institute under directions from the DCGI. Previously, the World Health Organisation had also given its approval to Covovax for emergency use across the globe on December 17.

The Subject Expert Committee on Monday also recommended granting permission to manufacture and market anti-Covid pill Molnupiravir for patients with low oxygen levels of who were likely to show worse progression of disease. Bharat Biotech's Corbevac has also been recommended for emergency use.

The decision to approve Covovax for limited use on an emergency basis has great significance in the wake of India's decision to begin vaccinating the 15-18 year old segment of the population, in an effort to get children back into schools. Currently, schoolchildren can apply for either Bharat Biotech's Covaxin or Zydus Cadila's innovative "nasal vaccine" which is delivered without injection, in three doses.

Schoolchildren aged 15 and above will be able to register on the CoWin portal from January 1 onwards using school identity cards. Vaccination will commence on January 3.