Bharat Biotech finishes stage 2/3 trials of Covaxin for kids under 18 years
Hyderabad: Bharat Biotech has actually finished the Stage 2/3 trials of COVID-19 vaccine, Covaxin for use in kids under 18 years of age and is anticipated to send the information by next week to the DCGI, Chairman and Managing Director of Bharat Biotech International Ltd, Krishna Ella said on Tuesday here.
Talking to press reporters, he said Covaxin production would touch 55 million dosages in October as against 35 million in September.
He also stated the Stage 2 trials of the firm’s intranasal vaccine versus COVID-19 is expected to be over by next month.
” Paediatric Covaxin just completed stage 2/3 trials. The information analysis is going on. We will be submitting the data (to the regulator) by next week. The variety of topics (volunteers) is touching 1000, ” Ella stated.
Intranasal immunization can develop an immune reaction in the nose, which is the point of entry for the virus — thus safeguarding versus the disease, infection, and transmission likewise, he noted.
According to Ella, the intranasal vaccine trials are performed on 3 mates in which one group is administered Covaxin as the first dosage and intranasal as the 2nd. 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 stated 100 million dosages per month can be possible if the other making partners are fully geared up with security and other criteria are in place.
Other than its own facilities, Bharat Biotech has actually tied up with Indian Immunologiclas and Hester Biosciences, to produce Covaxin.
” We are providing 35 million this month. Next month we will be definitely providing 55 million dosages. Production at Bangalore is catching up very quick, ” he stated replying to an inquiry.
On exports of Covaxin to other countries, Ella said if the Centre permits, the firm is ready to export the jab, though the company is not in a hurry to look for abroad markets.
According to him, the federal 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’ program and to fulfill its dedication to the COVAX global pool, but vaccinating its own residents remains the topmost concern of the federal government, Union Health Minister Mansukh Mandaviya said on Monday.
Released at Tue, 21 Sep 2021 03:54:27 -0500