Biological E gets DCGI nod to conduct phase 2/3 trial of Corbevax

The trials are to be conducted across 10 sites in the country.

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Biological E gets DCGI nod to conduct phase 2/3 trial of Corbevax

As India expects the third wave of coronavirus to grapple by October, the Drug Controller General of India granted permission to Hyderabad-based Biological E Limited to conduct phase 2 & 3 trials of COVID-19 vaccine on children between the age of 5-18 years with certain conditions. The Corbevax, which is ‘Made in India’ was given permission on Wednesday to conduct trials based on the recommendation given by the Subject Expert Committee (SEC) on Covid-19.

The trials are to be conducted across 10 sites in the country. The Corbevax Covid vaccine is based on the RBD protein subunit platform and is currently undergoing trials of phases 2 & 3 on adults. The Receptor Binding Domain (RBD) is a short immunogenic fragment from a virus that binds to a specific receptor sequence to gain entry into a host of cells. In other words, the RBD protein will be effective in intercepting the ‘S’ domain or the ‘Spike-Protein’ present in SARS- CoV.

The Hyderabad-based vaccine manufacturer will be providing a consignment of 30 crore doses of Corbevax vaccines by December to the central government, as announced by the health ministry in June. For this, the GoI has made provisional payment to Biological E Limited worth ₹1,500 crore and has additionally provided a grant-in-aid of over ₹100 crores.

Meanwhile, Zydus Calida’s needle-free COVID-19 vaccine ZyCoV-D has already received emergency usage from DCGI, making the first indigenously developed vaccine to be administered on children between the age group of 12-18 years. The other two COVID-19 vaccines, Covaxin and Covovax have been granted permission from DCGI to conduct phase 2 & 3 trials on children while maintaining SEC restrictions.

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Biological E gets DCGI nod to conduct phase 2/3 trial of Corbevax
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The trials are to be conducted across 10 sites in the country.
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THE POLICY TIMES
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