Bharat Biotech has already completed the Phase 2/3 trials of Covaxin for use in children under 18 years of age.
New Delhi, India, September 28 : Emergency use authorization (EUA) for Bharat Biotech’s Covaxin has been further delayed by the World Health Organisation. The WHO has asked for more data from Bharat Biotech for the COVID-19 vaccine. The development comes after Bharat Biotech had said it has submitted all data required for clearance of Covaxin. Without the EUA, Covaxin will not be considered an accepted vaccine by most countries around the world, making it difficult for Indians who have taken the dose to travel internationally.
Bharat Biotech has already completed the Phase 2/3 trials of Covaxin for use in children under 18 years of age and is expected to submit the data to the DCGI, Chairman and Managing Director of Bharat Biotech International Ltd, Krishna Ella had said last week.
Speaking to reporters, he said Covaxin production would touch 55 million doses in October as against 35 million in September.
He also said the Phase 2 trials of the firm’s intranasal vaccine against COVID-19 is expected to be over by next month.
Intranasal immunization can create an immune response in the nose, which is the point of entry for the virus—thereby protecting against the disease, infection, and transmission also, he noted.
According to Ella, the intranasal vaccine trials are conducted on three cohorts in which one group is administered Covaxin as the first dose and intranasal as the second.
Similarly intranasal-intranasal for the second group and Intranasal- Covaxin for the third cohort, 28 days apart.
He said the trials will be conducted on about 650 volunteers.