Vaccine makers call approval a giant leap

Hyderabad: Bharat Biotech on Sunday described the permission for emergency use of Covaxin, the company’s homegrown vaccine for Covid-19, as a “giant leap for innovation and novel product development in India.”

Serum Institute of India (SII) said it is ready to roll out Covishield vaccine in the coming weeks.

“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 Chief Executive Officer Adar Poonawalla said in a Tweet.

The company has stockpiled around 5 crore dosages of the vaccine and aims to produce up to 10 crore per month by March next year.

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.

Covaxin has been indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology. Bharat Biotech aims to recruit 26,000 volunteers across the country for the Phase-3 trials; it has crossed the 23,000-volunteer mark.

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, Zydus Cadila 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.

“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 3 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.