This is the second coronavirus vaccine to get approval for human trials in India. Novel coronavirus infections continue to climb here with India becoming the world’s fourth worst-hit nation.
On Friday, coronavirus cases in India stood at 6,25,544 with 20,903 new cases being registered in a single day.
With drug manufacturers across the world scrambling to develop a vaccine for Covid-19, the disease caused by the novel coronavirus, Ahmedabad-based Zydus Cadila said it has received approval from the Drugs Controller General of India (DCGI) to conduct human studies for its coronavirus vaccine candidate.
Earlier, the drug regulator had given approval to India’s first indigenous coronavirus vaccine candidate Covaxin. Covaxin has been developed by the Hyderabad-based Bharat Biotech in collaboration with the Indican Council of Medical Research (ICMR) and the National Institute of Virology (NIV).
INDIA NOW HAS 2 VACCINES SET FOR TRIALS: ALL YOU NEED TO KNOW
1. Zydus Cadila Healthcare Ltd said it has received approval from DCGI for human clinical trials of its coronavirus vaccine candidate.
2. The approval process was fast-tracked following a recommendation by the subject expert committee on coronavirus, considering the emergency and unmet medical need during the pandemic.
3. The potential vaccine showed a “strong immune response” in animal studies, and the antibodies produced were able to completely neutralise the wild type virus, Zydus said in a statement.
4. Sources have said that the company submitted data of clinical trials on animals to the DCGI, in which the vaccine candidate was found to be successful with respect to “safety and immunogenicity”. After this Zydus Cadila was given the approval to begin human trials.
5. Zydus will begin human trials this month in over 1,000 subjects in multiple sites in India, the company said. Phase I and II trials will take around three months to complete.
6. Meanwhile, the ICMR has written to select medical institutions and hospitals to fast-track clinical trial approvals for the vaccine candidate Covaxin.
7. Given the urgency, ICMR is aiming to launch the coronavirus vaccine by August 15. Twelve clinical trial sites have been identified at present.
8. Covaxin is derived from a strain of SARS-CoV-2 isolated by the ICMR’s National Institute of Virology.
9. Bharat Biotech is working expeditiously to meet the target, however, the final outcome will depend on the cooperation of all clinical trial sites involved in this project, the ICMR told the selected institutes.
10. The indigenous inactivated vaccine was developed and manufactured in Bharat Biotech’s BSL-3 (Bio-Safety Level 3) High Containment facility located in Genome Valley, Hyderabad, India.
No vaccine has yet been approved for commercial use against coronavirus in the world but more than a dozen from over 100 candidates globally are currently being tested on humans.