The first candidate vaccine to oppose coronavirus disease (Covid-19) in India, Covaxin, which is being developed through Bharat Biotech, is likely to be effective by at least 60%.
On Thursday night, the company obtained approval from the Indian Comptroller General of Medicines (DCGI) for a phase 3 clinical trial to identify the effectiveness of its vaccine candidate. The provisional effects of the Phase 3 trial are expected to last until April or May next year. .
“The benchmark for the effectiveness of our covid-19 vaccine is 60%. We will conduct the largest Phase 3 trial for Covaxin, and the effectiveness effects will be obtained in early April-May 2021,” sai Prasad, CEO of Bharat Biotech International Ltd, told HT.
Prasad is part of Bharat Biotech’s product progression team.
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The World Health Organization (WHO) on the quality, protection and efficacy of respiratory syncytial vaccines approves a vaccine with at least 50% efficacy.
“WHO, the U. S. Food and Drug Administration (FDA) and even India’s Central Pharmaceutical Standards Control Organization (CDSCO) approve a respiratory vaccine if it reaches 50% efficacy; for Covaxin, our goal is to succeed at least 60%, but this can “Only be more. The chances of the vaccine being effective at less than 50% are low, as noted through the effects of our trials to date, which come with the effects of animal studies,” Prasad said.
According to the existing plan, the Phase 3 trial for vaccine efficacy will begin from early to mid-November with 26,000 subjects examined at 25 to 30 sites in thirteen to 14 states. For the Phase 1 trial, the company recruited 375 subjects and in Phase 2, 400 subjects participated.
“We have started site preparation training for Phase 3; 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 be recruited according to the hospital,” Prasad said.
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Bharat Biotech completed the Phase 1 trial and sent the effects to DCGI. The effects involved primary protection issues. For Phase 2, protection control is complete and immunogenicity control (to verify the body’s immune reaction to the vaccine) is underway recently. .
“Tracking the immunogenicity of a candidate vaccine takes longer, about a month or two. Provisional knowledge for Phase 2 will be released in November,” Prasad said.
Covaxine was developed in collaboration with the Indian Council for Medical Research (ICMR) – National Institute of Virology (NIV) Sars-Cov-2 inactivated, the virus that causes Covid-19. The virus was remoted in an ICMR lab.
Experts say many things would depend on the effects of the Phase 3 trial. “Due to the gigantic length of the Phase 3 clinical trial pattern, its effects will be on determining whether the vaccine will work. Phase 1/2 trials are promising, while Phase 3 is about performance,” said Dr. K Srinath Reddy, founder of the Indian Public Health Foundation.
The corporate expects a production capacity of around 150 million doses consistent with the year. However, the cost of the vaccine remains to be determined. “Prices have not yet been decided, as we are still in charge of product development. For Phase 3 clinical trial, we will spend about 150 million rupees over the next six months,” Prasad said.
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