- India’s first indigenous coronavirus vaccine ‘COVAXIN’ successfully enters human trials.
- The vaccine will be tested on more than 1,100 people in the first two phases of clinical trials.
- Bharat Biotech says the vaccine has shown safety and immune response in preclinical studies.
New Delhi: Hyderabad-based Bharat Biotech is expected to begin human trials of its COVID-19 vaccine, candidate, COVAXIN, next week. COVAXIN, which is India’s first indigenous vaccine against the novel coronavirus and has been developed by Bharat Biotech in collaboration with ICMR and NIV, Pune, will be tested on more than 1,100 people in phase 1 and 2 clinical trials.
Last week, the inactivated vaccine received DCGI approval for phase 1 and 2 clinical trials. COVAXIN is derived from a strain of SARS-CoV-2 virus isolated in NIV, Pune, and transferred to Bharat Biotech to develop into a vaccine candidate.
According to a report in Bloomberg, an ICMR spokesperson said that Bharat Biotech plans to enroll 375 people in the first phase of clinical trials and 750 people in the second phase. The company has set July 13 as the final date of enrollment for the trials. The company said COVAXIN has demonstrated safety and immune response in preclinical studies.
On July 2, ICMR Director chief Dr Balram Bhargava wrote to 12 trial sites for the indigenous vaccine, stating that all clinical trials need to be completed by August 15. However, the August 15 target was criticised by experts who said that fast-tracking vaccine trials in four weeks could pose serious health risks. In a statement on Monday, the Indian Academy of Sciences, a Bengaluru-based body of scientists, said that while it wishes the vaccine is quickly made available for public use, the announced timeline is únfeasible’ and unrealistic’.
Meanwhile, Zydus Cadila’s plasmid DNA vaccine candidate for COVID-19 (ZyCoV-D) developed indigenously at its Vaccine Technology Centre in Ahmedabad, became the second Indian vaccine to receive regulatory approval for clinical trials. According to the company, the vaccine was found to be immunogenic in multiple animal species. Preclinical toxicity studies showed the vaccine to be well-tolerated, safe and immunogenic.
Zydus announced that it has already manufactured clinical GMP batches of the vaccine candidate and plans to initiate the clinical trials in July 2020 across multiple sites in India in over 1000 subjects.
On Sunday, the government said that six Indian companies are working on a vaccine for COVID-19, which has so far infected as many as 11,522,750 people and claimed at least 535,025 lives worldwide.