Homegrown Biological E Gets DGCI Nod To Conduct Phase 2 & 3 Clinical Trials On 5-18 Age Group

Zydus Cadila's needle-free vaccine ZyCoV-D has got Emergency Use Authorisation from the drug regulator, making it the first vaccine to be administered in the age group of 12-18 years in the country.

New Delhi: After the Drugs Controller General of India (DCGI) approved second homegrown Zydus Cadila’s three-dose Covid-19 DNA vaccine for emergency use in adults and children aged 12 years and above, Hyderabad-based Biological E Limited has also been given the approval to conduct phase 2/3 clinical trials of its vaccine on children aged between 5 and 18 years with certain conditions.

What are the phases of approval?

The vaccine’s phase 2 and 3 clinical trials are conducted as per the approved protocol titled 'A  Prospective, Randomised, Double-blind, Placebo-controlled, Phase-2/3 Study to Evaluate Safety, Reactogenicity, Tolerability and Immunogenicity of Corbevax Vaccine in Children and Adolescents', as per the news agency PTI.

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The trial will be carried out across 10 regions in the country. This approval is given on the recommendations by the Subject Expert Committee (SEC) on Covid-19.

Which drugmaker got approval for the 12-18 age group?

So far, Zydus Cadila's needle-free vaccine ZyCoV-D has got Emergency Use Authorisation from the drug regulator, making it the first vaccine to be administered in the age group of 12-18 years in the country.

It is to be noted that the data of phase 2/3 clinical trials of Bharat Biotech's Covaxin in the age group 2 to 18 years is in the process. While Serum Institute of India (SII) got approval in July for conducting phase 2/3 trials of Covovax on children aged 2 to 17 years with certain conditions.

What is Biological E's anti-coronavirus shot?

Known as Corbevax, an RBD protein sub-unit vaccine is currently undergoing phase 2/3 clinical trials on adults, as per the agency source. It is expected that Biological E will start supplying 30 crore doses of Corbevax by December, as announced by the Union Health Ministry in June.

The Biological E Covid-19 vaccine candidate has government backing and received support from the preclinical stage to phase 3 studies. Apart from offering financial assistance to the tune of over Rs 100 crore, the Department of Biotechnology has also partnered with Biological E to conduct all animal challenge and assay studies through its Research Institute Translational Health Science Technology Institute (THSTI), Faridabad, a Health Ministry statement had stated, as per PTI.