A proud moment for India, say Serum Institute, Bharat Biotech as DGCI approves Covaxin, Covishield vaccines for emergency use

With the Indian government approving two COVID-19 vaccines for emergency use, Serum Institute of India on Sunday said it is ready to roll out Covishield vaccine in India in the coming weeks, while Bharat Biotech termed the nod to Covaxin as a giant leap for novel product development.

Even as the two companies gear up to roll out the vaccines, another homegrown pharma major Zydus Cadila said it has received Drug Controller General of India (DCGI) approval to initiate Phase III clinical trials of its COVID-19 vaccine ZyCoV-D.

Pune-based Serum Institute of India (SII) had entered into a collaboration with the University of Oxford and AstraZeneca to manufacture the Covishield vaccine.

"Happy new year, everyone! All the risks @SerumInstIndia took with stockpiling the vaccine, have finally paid off. COVISHIELD, India's first COVID-19 vaccine, is approved, safe, effective, and ready to roll-out in the coming weeks," SII CEO Adar Poonawalla said in a tweet.

The company has already stockpiled around 50 million dosages of the vaccine and aims to produce up to 100 million dosages per month by March next year.

The Oxford-AstraZeneca vaccine has already been approved by the UK government.

Commending SII for its approach on the vaccine, Mahindra Group Chairman Anand Mahindra tweeted,

"Risk-taking is a fundamental characteristic of business. A bet can go either way, but when it succeeds, it's hugely rewarding. @adarpoonawalla took a huge risk in creating capacity. But his bet was not just about financial rewards. It will help save millions of lives. A salute."

Reacting to the move by the DCGI, Bharat Biotech Chairman and Managing Director Krishna Ella said, "The approval of COVAXIN for emergency use is a giant leap for innovation and novel product development in India. It is a proud moment for the nation and a great milestone in India's scientific capability, a kickstart to the innovation ecosystem in India."

"While this vaccine addresses an unmet medical need during this pandemic, the company's goal is to provide global access to populations that need it the most," Ella said in a statement.

Covaxin has generated excellent safety data with robust immune responses to multiple viral proteins that persist, he added.

Covaxin has been indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR). Its Phase III human clinical trials began in mid-November last year, among 26,000 volunteers across India. So far, it has crossed the 23,000 volunteers-mark.

The Hyderabad-based firm said Covaxin has been evaluated in around 1,000 subjects in Phase I and Phase II clinical trials, with promising safety and immunogenicity results, with acceptance in international peer-reviewed scientific journals.

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The DCGI approved the two vaccines based on the recommendations submitted by a COVID-19 subject expert committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO).

"After adequate examination, CDSCO has decided to accept the recommendations of the expert committee, and accordingly, vaccines of M/s Serum and M/s Bharat Biotech are being approved for restricted use in an emergency," DCGI Dr V G Somani said in a press conference.

This paves the way for the roll-out of at least two vaccines in India in the coming days.

Meanwhile, Zydus Cadila said it has received DCGI approval to initiate Phase III clinical trials of its COVID-19 vaccine ZyCoV-D. It will be initiating a Phase III clinical trial in around 30,000 volunteers.

ZyCoV-D was found to be safe, well-tolerated, and immunogenic in Phase I and II clinical trials, the company said in a statement.

The Phase II study of ZyCoV-D had been conducted in over 1,000 healthy adult volunteers as part of the adaptive Phase I/II dose-escalation, multi-centric, randomised, double-blind, placebo-controlled study, the drug firm said.

An independent data safety monitoring board has reviewed the trial and reports were submitted to the CDSCO regularly for the update on safety outcome.

"We are reaching a critical milestone in our vaccine development programme and towards our goal of helping people fight the pandemic with an indigenously discovered, safe, and efficacious vaccine," Zydus Group Chairman Pankaj R Patel said.

The launch of the Phase III trial will determine the efficacy of the company's vaccine in preventing COVID-19, which continues to pose a major threat world over, he added.