More than 10 million cases have been reported worldwide, with more than 110 independent scientific institutions competing for the potential COVID-19 vaccine. India is currently working on more than seven vaccines, and this week, two candidate groups have been approved to begin human clinical trials of their prototypes.
After the development of a potential coronavirus vaccine “Covaxin” by Bharat Biotech, Ahmedabad based Zydus Cadila, received a green light to start phase I and phase II human trials of another coronavirus vaccine.
Last Friday, the number of coronavirus cases in India was 6,25,544, and 20,903 new cases were recorded in a single day. Today, India has replaced Russia as the third most severely affected country by a coronavirus. After an increase of 24,248 cases in the past 24 hours, the total of coronavirus cases reached 6,97,413.
Novel coronavirus infections continue to rise here, with India becoming the world’s third worst-hit nation. In such a situation, ZyCov-D is the second coronavirus vaccine to get endorsement for human trials in India.
As pharmaceutical manufacturers across the world are working hard to develop a vaccine against Covid-19, which is a disease caused by a novel coronavirus, Zydus Cadila stated that it has been approved by the Drugs Controller General of India (DCGI) to conduct human trials for its coronavirus vaccine candidate.
In animal studies, the vaccine was found to obtain a strong immune response in various animal species (such as guinea pigs, mice, rats, and rabbits). The antibodies produced by the vaccine can completely neutralize the wild-type virus in the virus neutralization evaluation, indicating that the candidate vaccine has protective potential, Zydus of Cadila Healthcare Ltd. said in the statement.
The company announced that it will start human trials in more than 1,000 cases in multiple locations in India in this month. It also appended that the company has also planned to enhance the production capacity for its vaccine rivals to meet Indian and global demand.
There are 2 vaccines ready for a human trial in India: COVAXIN and ZyCov-D
- Earlier, India’s first indigenous coronavirus vaccine “Covaxin” approved by drug regulatory agency. Covaxin was developed by Hyderabad-based Bharat Biotechnology Company in collaboration with the Indian Medical Research Council (ICMR) and the National Institute of Virology (NIV).
- Zydus Cadila Healthcare Ltd. said it has obtained DCGI endorsement for human clinical trials of its coronavirus vaccine. Taking into account the emergency caused by the pandemic and unmet medical needs, in accordance with the instructions of the COVID-19 expert committee, the endorsement process was accelerated.
- Zydus said in a statement that this potential vaccine has shown a “strong immune response” in animal studies and that the antibodies produced can completely neutralize the wild-type virus.
- According to the sources, the company has submitted data to DCGI on clinical trials of animals in which the candidate vaccine proved to be successful in terms of “safety and immunogenicity”. After then, Zydus Cadila has been allowed to start human trials.
- The company stated that this month Zydus will begin human trials on more than 1,000 subjects in multiple locations in India. Phase I and Phase II trials will take approximately three months to complete.
- At the same time, ICMR has written to selected medical institutions and hospitals to expedite the clinical trial approval of Covaxin candidate vaccines.
- In view of the emergency, ICMR plans to launch the coronavirus vaccine by August 15. Currently, 12 clinical human trial sites have been identified.
- Covaxin develops from the SARS-CoV-2 strain isolated from the ICMR National Institute of Virology.
- ICMR told the selected institutions that Bharat Biotech is working hard to achieve this goal, but the results will depend on the cooperation of all clinical trial sites involved in the project.
- Provincially inactivated vaccines are developed and produced in the BSL-3 (Biosafety Level 3) high-closed facility of Bharat Biotechnology Corporation in the Hyderabad Genomics Valley, India.
India is one of the world’s leading vaccine manufacturers and suppliers. It takes a lot of time for vaccines to pass, but trials are rapidly being conducted around the world in order to meet the massive destruction of this epidemic.
Although no commercial use of coronavirus vaccine has yet been approved in the world, more than a dozen out of more than 100 candidates worldwide are currently being tested in humans.