COVAXIN for children: Bharat Biotech completes Phase 2/3 trials
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 DCGI, Chairman, and Managing Director of Bharat Biotech International Ltd., Krishna Ella said. He said COVAXIN production would touch 55 million doses in October as against 35 million in September.
Phase 2 trials of intranasal vaccine might end in October
"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. He also said the Phase 2 trials of the firm's intranasal vaccine against COVID-19 are expected to be over by next month.
Intranasal immunization can create an immune response in the nose
"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.
Intranasal vaccine trials being conducted on three cohorts
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.
Possible to produce 100 million doses per month: Ella
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 in place.
We are supplying 35 million doses this month: Ella
Other than its own facilities, Bharat Biotech has collaborated with Indian Immunologicals and Hester Biosciences to manufacture COVAXIN. "We're supplying 35 million this month. Next month we will be supplying 55 million doses. Production at Bengaluru is catching up very fast," he said. On exports of COVAXIN to other countries, Ella said if the Centre permits, the firm is ready to export the jab.
Vaccinating Indian citizens is government's topmost priority: Health Minister
"The firm is not in a hurry to look for overseas markets. The government's focus is to fulfill domestic requirements," Ella said. "India will resume export of surplus COVID-19 vaccines in fourth quarter of 2021 under Vaccine Maitri program and to meet its commitment to COVAX global pool, but vaccinating its own citizens remains the government's topmost priority," Union Health Minister Mansukh Mandaviya said.
