Covaxin, Bharat Biotech's Covid-19 vaccine, has shown 77.8% efficacy in phase 3 trials, news agency ANI reported quoting its sources.
The data of the 3rd phase trials conducted on 25,800 subjects was reviewed by the Subject Expert Committee, according to the report.
The meeting between the Subject Expert Committee and Bharat Biotech officials was held on Tuesday. A day later, Bharat Biotech held a ‘pre-submission' meeting with the World Health Organisation (WHO) where the Indian drug producer had requested approval for their COVID vaccine.
The Hyderabad based drug maker had submitted the official reports from the 3rd phase trials to the Drug Controller General of India (DCGI) on the weekend, according to Business Standard.
Covaxin is among the three vaccines being used in India. The other two being Serum Institute of India (SII) produced Covishield and the Russian Sputnik V, whose dosage would be commenced from June 25th.
Bharat Biotech had got into controversy for the absence of its third phase trials, which were crucial for determining its efficacy. The phase 3 data of the vaccine has been questioned several times and that is what makes the data crucial.
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The company has developed the vaccine in association with the Indian Council of Medical Research (ICMR).
Earlier in May, Bharat Biotech had sent an Emergency Use Listing (EUL) to the WHO for the emergency approval of their vaccine. The approval is expected between July and September.
