Written By: Longjam Dineshwori | Updated : November 22, 2020 10:04 AM IST
Covaxin is developed using an inactivated strain of SARS-CoV-2, the virus which causes COVID-19.
Bharat Biotech, the developer of India's first indigenous coronavirus vaccine vaccine 'Covaxin', has rejected reports that it did not report an adverse incident during phase I clinical trials in August.
Hyderabad-based vaccine maker issued a statement on Saturday clarifying that that the company reported the adverse incident within 24 hours.
"The adverse event during phase I clinical trials in August 2020 was reported to the CDSCO-DCGI, within 24 hours of its occurrence and confirmation," it said in the statement.
It added that the adverse incident was probed thoroughly, and it was found that the event was not related to the vaccine.
As per the guidelines laid down by the Centre, all adverse events should be reported to the site ethics committee, CDSCO-DCGI, data safety monitoring board and sponsors.
"The adverse event was investigated thoroughly, and presented to the CDSCO-DCGI, prior to obtaining permission for Phase II and Phase III clinical trials," said Bharat Biotech.
"Bharat Biotech is one of the few companies to conduct human challenge studies at Oxford University, United Kingdom while it's is also conducting other clinical trials in USA and UK. Bharat Biotech has supplied more than 4 billion doses, to more than 80 countries, with an excellent track report of safety during vaccine development," it added.
Developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV) Covaxin, Pune, is one of the promising coronavirus vaccine candidates in India.
The Central Drugs Standard Control Organisation (CDSCO) has already given its approval for the phase III trials of Covaxin. The vaccine entered the phase I clinical trial in July while phase-2 trials started in September. The company had submitted the interim data of phase 1 and 2 clinical trials while seeking approval for conducting phase-3 clinical trials.
Earlier this month, Sai Prasad, Executive Director, Bharat Biotech International Limited (BBIL) told IANS that Covaxin was found to be safe without any major adverse events in the first two stages of the trials involving about 1,000 participants.
Phase-3 trial of Covaxin has begun at the Preventive and Therapeutic Clinical Trial Unit (PTCTU) of the Institute of Medical Sciences and SUM Hospital in Odisha. The final stage trial will be conducted at 21 other medical institutes across the country.
While phase-1 trial was aimed at measuring its safety and phase-2 to test its immunogenicity, the phase-3 trial will check the efficacy of the vaccine.
The company is aiming to apply for regulatory approval for the vaccine in the second quarter of 2021.
Covaxin is developed using an inactivated strain of SARS-CoV-2, the virus which causes COVID-19. The inactivated strain doesn't multiply inside human cells but primes the immune system and stimulates its antibody response towards the virus. This technology has already been used in several vaccines including seasonal influenza, polio, pertussis, rabies, and Japanese Encephalitis.
The inactivated strain of Covaxin was isolated by NIV and ICMR transferred it to Biotech Bharat on May 9. After receiving the isolated strain, Bharat Biotech developed the first set of vaccines and conducted preclinical animal trials within 50 days.
