India’s first coronavirus disease (Covid-19) candidate vaccine, Covaxin, which is being developed by Bharat Biotech, is likely to be at least 60% effective.
On Thursday evening, the company received approval from the Controller General of Medicines of India (DCGI) to conduct a phase 3 clinical trial to establish the efficacy of its candidate vaccine. Interim results of the phase 3 trial are likely to be released in April or May next year.
“The benchmark for the efficacy of our Covid-19 vaccine is 60%. We will conduct the largest Phase 3 trial for Covaxin, and the efficacy results should be available in early April-May 2021, ”Sai Prasad, CEO of Bharat Biotech International Ltd., told HT.
Prasad is part of the product development team at Bharat Biotech.
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The World Health Organization (WHO) guidelines on the quality, safety and efficacy of vaccines against respiratory syncytial virus approve a vaccine with at least 50% efficacy.
“The WHO, the US FDA (Food and Drug Administration) and even the Central Standard Drug Control Organization of India (CDSCO) approve a respiratory vaccine if it is 50% effective; For Covaxin, our goal is to achieve at least 60%, but it could also be more. The chances of the vaccine being less than 50% effective are remote, as suggested by the results of our trials so far, which include results from animal studies, ”said Prasad.
Under the current plan, the phase 3 trial to determine the efficacy of the vaccine will begin in early to mid-November with 26,000 study subjects at 25 to 30 sites in 13-14 states. For the phase 1 trial, the company recruited 375 subjects and 400 subjects participated in phase 2.
“We have started the site preparatory exercises for Phase 3; recruitment and dosing will begin in November. The trial will provide two doses for each of the vaccine and placebo recipients. Site selection and recruitment depend on various factors such as attack rate, how the disease spreads locally, etc. About 2,000 subjects could be enrolled per hospital, ”Prasad said.
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Bharat Biotech completed the phase 1 trial and submitted the results to DCGI. The results did not point to any major safety concerns. For Phase 2, safety testing has been completed and immunogenicity testing (to check the body’s immune response to the vaccine) is currently underway.
“Monitoring to determine the immunogenicity of a vaccine candidate takes longer, around one or two months. Provisional data for Phase 2 will come out in November, ”said Prasad.
Covaxin has been developed in collaboration with the Indian Council for Medical Research (ICMR) – National Institute of Virology (NIV) using inactivated Sars-Cov-2, the virus that causes Covid-19. The virus was isolated in an ICMR laboratory.
According to experts, much would depend on the results of the phase 3 trial. “Due to the large sample size for the phase 3 clinical trial, your results will be crucial in determining whether the vaccine would work. Phase 1/2 trials are promising, while phase 3 is all about performance, ”said Dr K Srinath Reddy, founder of the Public Health Foundation of India.
The company anticipates a production capacity of about 150 million doses per year. However, the cost of the vaccine has yet to be decided. “Pricing is not yet decided, as we are still considering the cost of product development. For the phase 3 clinical trial, we will spend around 150 million rupees in the next six months, ”said Prasad.
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