“The benchmark for the effectiveness of our covid-19 vaccine is 60%. We will conduct the largest Phase III trial for Covaxin and the effectiveness effects will be achieved in early April-May 2021,” sai Prasad, CEO of Bharat Biotech International Ltd told the Hindustan Times.
“WHO, the U. S. Food and Drug Administration (FDA) and even the Central Organization for Standard Drug Control (CDSCO) in India approve a respiratory vaccine if it is 50% effective; for Covaxin, our goal is to succeed by at least 60%, but it can also be more. The chances of the vaccine being less than 50% effective are low, as noted through the effects of our trials so far, which come with the effects of animal studies,” Prasad said.
“The candidate vaccine was found to generate physically powerful immune responses. Therefore, the prevention of infections and diseases in primates is superior to exposure to the SARS-CoV-2 virus alive,” the drug manufacturer said earlier.
Covaxine derived from a strain of the new remote coronavirus through the National Institute of Virology of Pune. Bharat Biotech has developed an “inactivated” vaccine at its high genome valley containment facility in Hyderabad.
“Once the vaccine is injected into a human being, it has no prospect of infection or replication, as it is a dead virus. It serves the immune formula as a dead virus and generates an antibody reaction opposite the virus,” Bharat Biotech said. .
For the Phase III trial, the drugmkaer plans to recruit 26,000 volunteers over the age of 18. The trial will be conducted in 10 states, Delhi, Mumbai, Patna and Lucknow. The application of the Phase III clinical trial proposed a dose of 0. 5 ml on days 0 and 28, resources told PTI.
“We have started site preparation training for Phase III; recruitment and dosing will begin in November. The trial will provide two doses for vaccine and placebo receptors. The variety of the site and recruitment count at various points, such as the attack rate, how the disease spreads locally, etc. Approximately 2,000 subjects can enroll according to the hospital,” Prasad said.
The company is spending about 150 million rupees for the Phase 3 test, Prasad told Mint.
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