Vaccine / Bharat Biotech completes Covaxin Phase 2-3 clinical trials for children

New Delhi: Hyderabad-based Bharat Biotech has completed the Phase 2 and 3 clinical trials of coronavirus vaccine, Covaxin for use in the age group of 2 to 18 years. The Hyderabad-based vaccine maker is expected to submit the data by next week to the DCGI.

Speaking to reporters on Tuesday, Krishna Ella, Chairman and Managing Director of Bharat Biotech International Ltd, said Covaxin production would touch 55 million doses next month as against 35 million in September. 

Ella also said the Phase 2 trials of the company's intranasal vaccine against coronavirus 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 1000," the founder and chairman of Bharat Biotech said.

On intranasal Covid vaccine

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. 

As per 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 nations, Ella said if the government permits, the company is ready to export the jab, though the firm is not in a hurry to look for overseas markets. 

According to Ella, the Centre’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 has said.