Biological E bags CDSCO nod for clinical trials on nextgen XBB1.5 Covid-19 variant vax, ET HealthWorld


Hyderabad: Amid rising cases of COVID-19 globally, especially those of Omicron subvariants such as JN.1, Hyderabad-based Biological E Ltd on Tuesday said has received final approval from the Central Drugs Standard Control Organisation (CDSCO) to begin clinical trials of its next generation XBB.1.5 variant vaccine in India.

The company said it has been working on the next generation COVID-19 vaccine based on the XBB1.5 variant of SARS-CoV-2 and expects it to conform to WHO TAG-CO-VAC recommendations.

The company said its new vaccine candidate, being developed for the XBB1.5 Omicron sub-variant, has completed all the requisite pre-clinical animal studies and clinical trials would be commencing soon at various trial sites in India.

Biological E said the results of studies done so far suggest that the vaccine candidate will be able to provide adequate protection against the currently circulating variants. Currently, the Omicron subvariant JN.1 is circulating in countries such as the US, China, UK and India.

The company said it already has qualified manufacturing infrastructure for producing variant vaccines to initiate supply at a short notice.

  • Published On Jan 17, 2024 at 02:30 PM IST

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