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Bharat Biotech Says Covaxin at Least 60% Effective; No Data Shared

Updated
Bharat Biotech Says Covaxin at Least 60% Effective; No Data Shared

An official from the Hyderabad-based company BharatBiotech has said that its COVID vaccine will be at least 60% effective based on earlier trial results, reported The India Today on Sunday, 22 November.

COVAXIN, India's indigenous COVID-19 vaccine by Bharat Biotech is developed in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV).

However, some caution must be observed here.

Phase III trials for the vaccine on 26,000 volunteers from 22 sites in India began only earlier this month and are yet to conclude. Moreover, The company has not shared the results from its phase 1, 2 or preclinical trials either.

So essentially, there is absolutely no publicly available data regarding COVAXIN’s efficacy or safety. Bharat Biotech is yet to even share the phase 3 trial’s design.

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NITI Aayog member VK Paul, member of the Centre’s expert group on vaccines, told News18 that the data from the earlier trials would be available after completion of phase 3 trials.

The vaccine has so far been evaluated in 1,000 subjects in Phase I and Phase II clinical trials, and ICMR scientist Rajni Kant expressed hope that Covaxin might be available as early as February, although Bharat Biotech told Reuters on Friday that results of the late-stage trials were expected only between March and April.

India on Monday, 23 November, reported 44,059 new coronavirus cases, taking the tally in the country to 91,39,866. The death toll increased by 511 to 1,33,738.

Indian officials have said they expect to rely on Covaxin and four other locally-tested candidates to control COVID-19, as they do not expect early access to sufficient quantities of those developed by Pfizer and Moderna, reported Reuters.

Earlier this month, US drug manufacturer Pfizer said that its vaccine showed 95 percent efficacy in phase three trials, followed by an announcement by the biotechnology company Moderna, saying its vaccine candidate is 94.5 percent effective in phase three trials.

These are based on interim results and the efficacy may come down as the trials are concluded and more people are analysed. Speaking about the Pfizer vaccine, Dr Shahid Jameel, Virologist and Director, Trivedi School of Biosciences at Ashoka University, had told FIT,

“They were expecting the vaccine to be about 70 percent efficacious. It turned out to be more than 90 percent. For now, you have to go by the data. Its possible that when the analysis is done at a later time point, the efficacy may drop from 90 percent to, maybe, 85 or 80 percent. It would still be a good vaccine.”
Dr Shahid Jameel

“These early results are extremely encouraging and positive, but let’s wait for the final data to come out,” he said.

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