scorecardresearch
Wednesday, Feb 08, 2023
Advertisement

Bharat Biotech likely to launch Covaxin in second quarter next year

"The trial to be conducted in 25 to 30 sites across 13-14 states will provide two doses each for the vaccine and placebo recipients. About 2,000 subjects could be enrolled per hospital," Prasad said.

coronavirus india latest updates, coronavirus vaccine, covid vaccine india, covaxin, Bharat Biotech vaccine dateIt said its immediate focus is to conduct the Phase 3 trials successfully across sites in the country.

Bharat Biotech is planning to launch its vaccine for COVID-19 in the second quarter next year if it gets the requisite approvals from the Indian regulatory authorities, a top company official said.

It said its immediate focus is to conduct the Phase 3 trials successfully across sites in the country.

The company’s vaccine candidate -Covaxin- has been developed in collaboration with the Indian Council of 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 lab.

“If we get all the approvals after establishing strong experimental evidence and data, and efficacy and safety data in our last stage of trials, we aim to launch the vaccine in Q2 of 2021,” Bharat Biotech International Executive Director,” Sai Prasad told PTI.

Subscriber Only Stories
Delhi Confidential: Hardeep Singh Puri takes part in novel demonstration ...
Come forward, lift the veil, don’t let men attend your meetings: At V-C’s...
Rejuvenated water bodies, new ponds breathe new life in this Bengal district
India’s big millets push, and why it makes sense to have these grains

After the company received approval from the Drugs Controller General of India (DCGI) to conduct Phase 3 clinical trial to establish the efficacy of the vaccine candidate, it has begun site preparatory exercises for Phase 3, recruitment and dosage will begin in November, he added.

“The trial to be conducted in 25 to 30 sites across 13-14 states will provide two doses each for the vaccine and placebo recipients. About 2,000 subjects could be enrolled per hospital,” Prasad said.

Asked about the investment on the vaccine, he said: “Our investment is about Rs 350-400 crore for the development of vaccine and the new manufacturing facilities, which include our investments for conducting the Phase 3 clinical trial, in the next six months”.

Advertisement

On the company’s plan to sell the vaccine to the government or to private players, Prasad said: “We are looking to supply for both government and private markets. We are also in preliminary discussions with other countries for probable supply.”

Prasad said the price of the vaccine is yet to be determined, as the company is still looking at the cost of product development.

“Our immediate focus is to conduct Phase 3 trial successfully across sites,” he added.

First published on: 01-11-2020 at 11:44 IST
Next Story

IGNOU admission 2020 deadline for July session extended again

Latest Comment
Post Comment
Read Comments
Advertisement
Advertisement
Advertisement
Advertisement
close