Bharat Biotech has completed the Phase 2/3 trials of COVID-19 vaccine, Covaxin for use in children under 18 years of age and is expected to submit the data by next week to the Drugs Controller General of India (DCGI), Chairman and Managing Director of Bharat Biotech International Ltd, Krishna Ella said on Tuesday in Hyderabad.
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.
'Paediatric Covaxin just completed phase 2/3 trials. The data analysis is going on. We will be submitting the data ( to the regulator) by next week. The number of subjects (volunteers) is touching 1,000,' Ella said.
Intranasal immunisation 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.
On the production levels of Covaxin, Ella said 100 million doses per month can be possible if the other manufacturing partners are fully geared up with safety and other parameters are in place.
Other than its own facilities, Bharat Biotech has tied up with Indian Immunologiclas and Hester Biosciences, to manufacture Covaxin.
'We are supplying 35 million this month. Next month we will be definitely supplying 55 million doses. Production at Bangalore is catching up very fast,' he said replying to a query.
On exports of Covaxin to other countries, Ella said if the Centre permits, the firm is ready to export the jab, though the firm is not in a hurry to look for overseas markets.
According to him, the government's focus is to fulfill domestic requirements.
India will resume export of surplus Covid-19 vaccines in the fourth quarter of 2021 under the 'Vaccine Maitri' programme and to meet its commitment to the COVAX global pool, but vaccinating its own citizens remains the topmost priority of the government, Union Health Minister Mansukh Mandaviya said on Monday.
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