The Phase 2/3 trials of COVID-19 vaccine, Covaxin for use in children under 18 years of age has been completed by Bharat Biotech and is expected to submit the data by next week to the DCGI announced Krishna Ella, Chairman and Managing Director of Bharat Biotech International Ltd on Tuesday. Covaxin manufacture would reach 55 million doses in October for against 35 million in September, said Ella while speaking to the reporters.
By next month the Phase 2 trials of the firm’s intranasal vaccine against COVID-19 is expected to be done, he said. Paediatric Covaxin just completed phase 2/3 trials and the data analysis is still going on. She said, they will be submitting the data (to the regulator) by next week. The number of subjects (volunteers) is reaching 1000, Ella said.
He said, intranasal vaccination can make an immune response in the nose, which is the point of entry for any virus which will protect against the disease, infection, and transmission also.
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 for the second group intranasal-intranasal and Intranasal- Covaxin for the third cohort that to with a time gap of 28 days apart. On about 650 volunteers the trials will be conducted he informed.
Talking about the production levels of Covaxin, Ella said 100 million doses per month is possible if the other manufacturing partners are fully prepared with safety and other constraints are in place.
Other than its own facilities, to manufacture Covaxin, Bharat Biotech has tied up with Indian Immunologicals and Hester Biosciences, they said they will be supplying 35 million this month and next month they will be positively supplying 55 million doses as being reported. He said replying to a query that production at Bangalore is catching up very quickly.
According to him, the government’s focus is to fulfil domestic requirements. Hence on exports of Covaxin to other countries, Ella said if the Centre allows or is ready to export the vaccines, though the firm is not in a hurry to look for foreign markets.
India will restart the 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
