CDSCO expert panel suggests Covovax for emergency use

DCGI WILL NOW ISSUE A FORMAL APPROVAL AFTER WHICH THE GOVT NEEDS TO INCLUDE THE DOSE IN THE IMMUNISATION PROGRAMME

NEW DELHI: The subject expert committee (SEC) of the central drugs standard control organisation (CDSCO) on Monday recommended an emergency use authorisation be granted to Covovax, the second coronavirus vaccine manufactured by Pune-based Serum Institute of India (SII), which is expected to be available in large supplies once approved.

According to a person aware of the process, the Drugs Controller General of India (DCGI) will now issue a formal approval following which the Union government needs to include the dose in the immunisation programme. “The application was thoroughly examined and the expert panel has recommended it for restricted use in emergency situation,” said a government official aware of the matter, on condition of anonymity. SEC recommendations are typically accepted within days.

SII has the license to produce over two billion doses of the vaccine, and according to a government assessment in June, the company could provide millions of doses by December. The Covovax vaccine license and branding is similar to Covishield’s: both have been developed by foreign companies (Us-based Novavax Inc in case of Covovax and UK’S University of Oxford and Astra

Zeneca) and have been licensed to SII for mass production in an effort to allow cheap and mass production.

The World Health Organization on December 17 first approved Covovax, fulfilling an important precondition that may have been a part of the decision by the SEC on Monday.

The vaccine is a protein subunit vaccine that delivers a full spike of the Sars-cov-2 to train the immunity. It is the only other dose apart from the MRNA platform doses to demonstrate an efficacy of over 90% against symptomatic disease (against the original Sars-cov-2 virus), but its production and development was delayed due to several factors, including raw material shortages.

In May, the company began at risk production of its second anti Covid vaccine, according to people familiar with the matter, even though there is no clarity on the number of doses that have been already manufactured.