Trials prove Covaxin safe for kids: Bharat Bio

Hyderabad: While the whole world is worried about children vulnerable to Covid-19 pandemic, city-based Bharat Biotech has once again shown a ray of hope. It has completed all trials of Covaxin for below 18 years of age. Currently, analysis is going on and the company will submit the data by next week to the Drugs Controller General of India (DCGI).

As the third wave of Covid-19 is expected to cause much damage to children, people in India are eagerly waiting for the pediatric vaccine. Bringing solace to every parentin the country, Bharat Biotech Chairman and Managing Director Dr Krishna Ella said that the second and third trials of Covaxin proved to be safe among kids in the age group of 2-18 years.The sample size was around 850-1,000.

He spoke to media here after delivering a keynote address at VanijyaSaptah – 'Showcasing the strengths of India as a rising economic Force and reinvigorating exports of Telangana' organised by Pharmexcil in association with Telangana government to commemorate 75 years of independence on Tuesday.

After successful completion of phase-1 trials of intranasal vaccine for Covid-19, the company is further conducting phase-2 trials at 10 centres across the country, including two hospitals in Hyderabad. Dr Ella observessome immunological issues during phase-1 trials. "We will address them very soon. The sample size, which was about 350-400 in the first phase, is set to increase to 650 in the second phase," he adds.

The nasal vaccine trials are conducted on three cohorts -Covaxin in first dose and nasal vaccine in second dose, nasal vaccine in both doses, and nasal vaccine and Covaxin in the first and second doses respectively – all with a gap of 28 days. "We will know which cohort is better by next month. Injectible vaccines only prevent disease but not transmission, whereas nasal prevents all infections," he informed.

When asked about the Covaxin production, he said: "This month, we are supplying 3.5 crore doses, of which 3 crore doses are from Hyderabad including the drug substance supplied by Indian Immunologics Ltd (IIL).We will supply 5.5 crore doses next month. Bengaluru facility is catching up as the company received license one week back. He further said, "We have increased the production capacity in Gujarat. It is possible to reach 10 crore doses by the year-end with the help of all partners– IIL, Haffkine Institute, Bharat Immunologicals& Biologicals Co Ltd and Hester Lifesciences. Commercial batches of Covaxin from Chiron Behring plant will be available for supplies from this month and productionjust started at Hester Lifesciences plant."