Bharat Biotech International Ltd and Zydus Cadila have got an approval from the Drugs Controller General of India (DCGI) for human clinical trials for their indigenously developed vaccine candidates against Sars-Cov-2, the virus which causes the coronavirus disease.
The drug regulator’s approval for Zydus’ ZyCoV-D comes days after Bharat Biotech got a similar nod for human trials for its vaccine candidate as the coronavirus infections continue to surge in the world’s fourth worst-hit country.
Bharat Biotech is among seven Indian firms working on Covid-19 vaccines. It was the first to get the regulatory nod to begin phase 1 and phase 2 human trials.
More than a dozen Covid-19 vaccines from over 100 candidates globally are currently being tested in humans, and some have shown potential in early-stage trials. However, no vaccine has yet been approved for commercial use.
The number of cases of the coronavirus disease in India is more than 625,000 and the country’s death toll is above 18,000.
Here what you need to know about the two vaccine candidates:
* Bharat Biotech had claimed on Monday to have successfully developed India’s first Covid-19 vaccine, Covaxin, and said it has the permission from the drug controller to start human clinical trials.
* The Hyderabad-based biotechnology giant has said that the human clinical trials of its vaccine against the coronavirus disease (Covid-19) will start from July.
* The company said the vaccine was developed in collaboration with the Indian Council of Medical Research (ICMR) and National Institute of Virology (NIV).
* The strains of Sars-CoV-2 that causes Covid-19 was isolated by ICMR-NIV and transferred to Bharat Biotech in May. Scientists have managed to isolate and culture 11 strains that can be used to develop vaccines and aid research.
* Bharat Biotech completed comprehensive pre-clinical studies in two months after receiving regulatory approvals. It said results from these studies have been promising and show extensive safety and effective immune responses.
* On Friday, Indian Council of Medical Research (ICMR) said that it is attempting to launch the world’s first Covid-19 vaccine on August 15.
* The plan was disclosed in a letter by the country’s topmost medical research body to 12 institutes where human trials are to be held for Covaxin, ordering them to secure necessary approvals from internal committees by July 7 with a warning that “non-compliance will be viewed very seriously”.
* Zydus said on Friday that its potential vaccine showed a “strong immune response” in animal studies and the antibodies produced were able to completely neutralize the wild type virus.
* “In animal studies the vaccine was found to elicit a strong immune response in multiple animal species like mice, rats, guinea pigs and rabbits. The antibodies produced by the vaccine were able to completely neutralize the wild type virus in virus neutralization assay indicating the protective potential of the vaccine candidate,” Zydus, part of Cadila Healthcare Ltd, said in a statement to stock exchanges.
* The company said it will begin human trials this month in more than 1,000 subjects in multiple sites in India. It also plans to ramp up its production capacity for the vaccine contender to serve Indian and global demand, it added.
* It said there were no safety concerns for the vaccine candidate in repeat-dose toxicology studies. In rabbits, up to three times the intended human dose was found to be safe, well-tolerated and immunogenic.
* It intends to rapidly ramp up the production capacities of ZyCoV-D at “multiple sites and facilities to cater to Indian and global demand.”
Source: Hindustan Times
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