Expert panel recommends Covovax for emergency use

Updated on Dec 28, 2021 02:36 AM IST

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

A healthcare worker inoculating a beneficiary with a dose of the Covid-19 vaccine during a door to door vaccination campaign. (Somnath Sen)
A healthcare worker inoculating a beneficiary with a dose of the Covid-19 vaccine during a door to door vaccination campaign. (Somnath Sen)
By, Hindustan Times, 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 AstraZeneca) 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, this year, 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.

In March, the company chief executive officer, Adar Poonawalla, tweeted to inform that Covovax clinical trials had begun in India.

On November 27, the subject expert committee evaluated and deliberated on SII’s application and sought additional data from the pharma company.

The review of their application took time as the expert panel was looking at the opinion of other drugs regulators, especially the USFDA.

SII submitted interim safety and immunogenicity data of phase 2/3 bridging clinical trial conducted in the country as well as interim clinical trial data of safety and efficacy from phase 3 clinical trials conducted in the UK and the US along with its application.

The government recently permitted export of 20 million doses of Covovax to Indonesia produced in India by SII, as the vaccine was not yet approved for emergency use in the country.

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