Hyd-based Biological E gets nod to conduct Corbevax phase II/III trials for children

The Drug Controller General of India (DCGI) has granted approval to Hyderabad-based Biological E to conduct phase II and III clinical trials for its anti-COVID shots Corbevax on children between 5-18 years.

By Newsmeter Network  Published on  3 Sep 2021 10:53 AM GMT
Hyd-based Biological E gets nod to conduct Corbevax phase II/III trials for children

Hyderabad: The Drug Controller General of India (DCGI) has granted approval to Hyderabad-based Biological E to conduct phase II and III clinical trials for its anti-COVID shots Corbevax on children between 5-18 years.

The approval comes after the recommendation from the Subject Expert Committee. The trial will be conducted in 10 locations.

Zydus Cadila's COVID-19 vaccine ZyCoV-D is the first vaccine in India that has been approved for children.

Meanwhile, Biological E Limited is expected to launch its coronavirus vaccine in October this year, Dr. V.K Paul, member (health) of NITI Aayog, said.

Biological E's phase III trial for adults is underway. "Stock is being produced. We should wait for the results. We hope it'll be in the next month or two. They've made a broad commitment that they'll supply a significant amount by the year-end," Dr. Paul added.

The Central government has pre-booked 30 crore doses of COVID-vaccine manufactured by Biological-E. This is despite the fact that the vaccine is still in the phase III clinical trials. The health ministry has already paid the firm Rs. 1,500 crore.

It will be the third made-in-India vaccine to be used in the country after Bharat Biotech's Covaxin and Zydus Cadila's needle-free COVID-19 vaccine ZyCoV-D.

In April, Biological E had got the nod from the Central Drugs and Standards Control Organization (CDSCO) to conduct phase III clinical trials of its COVID vaccine candidate developed in association with Baylor College of Medicine, US. It is modeled on the Hepatitis E vaccine.

The government said the department of biotechnology, which also partnered with the company to conduct various studies, has given Biological E Rs. 100 crore as financial assistance. This is part of the government's mission to support five to six new COVID-19 vaccine candidates.

The Centre had initially been reluctant to place advance orders for COVID-19 vaccines. However, it relented in April when the second COVID-19 wave took off. It gave an advance of Rs. 1,700 crore to the Serum Institute of India which manufactures Covishield and Rs. 700 crore to Bharat Biotech. These two vaccines have been part of India's immunization programme that was rolled out in January.

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