Bharat Biotech plans to launch its Covid-19 vaccine at the time of next year if it obtains the required approvals from Indian regulators, said a senior corporate official, who stated that its early purpose is to conduct Phase 3 trials effectively at all sites across the country. Country.
The company’s candidate vaccine, Covaxin, was developed in collaboration with the Medical Research Council of India (ICMR) – The National Institute of Virology (NIV) Sars-Cov-2 inactivated, the virus that causes Covid-19. Laboratory.
“If we get all approvals after false tests and experimental knowledge, as well as knowledge of efficacy and protection at our final level of testing, our goal is to launch the vaccine at the time of the 2021 quarter,” said Sai Prasad, Bharat’s CEO. Biotech International.
After the company obtained approval from the Comptroller General of Medicines of India (DCGI) for a Phase 3 clinical trial on the efficacy of the candidate vaccine, site preparation training for Phase 3 began, recruitment and dosing will begin in November, he added. . « The trial, which will be conducted at 25 to 30 sites in thirteen to 14 states, will provide two doses each for vaccine and placebo receptors. Approximately 2,000 subjects can enroll according to the hospital,” Prasad said.
When asked about the investment in the vaccine, he said, “Our investment is approximately 350-4 billion rupees for vaccine progression and new production facilities, which come with our investments to achieve the Phase 3 clinical trial over the next six months. “
Regarding the company’s plan to sell the vaccine to the government or personal actors, Prasad said, “We’re going to get public and personal acquisitions. We are also in initial talks with other countries for a more likely source. “Prasad said the value of the vaccine has not yet been determined, as the company is still reading the charge of presenting the product.
“Our immediate goal is to effectively conduct phase 3 testing across all sites,” he added.
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