Pitched as an option for children soon to be available in India, Hyderabad-based Biological E’s Covid-19 vaccine Corbevax may be delayed further. The vaccine maker was to submit data for phase 1 and 2 clinical trials by the end of September or even early October for emergency use authorisation. But government sources are now saying the final data of Corbevax will be submitted by the end of November, according to news agency Asian News International (ANI).
The homegrown vaccine is currently undergoing third phase clinical trials on adults at a large scale. It will also be available for children aged between five and 18. The DCGI had granted permission to the company to conduct phase 2/3 clinical trials of Corbevax on children on September 1.
The shot is an RBD protein sub-unit vaccine, which is the third made-in-India jab against coronavirus, after Bharat Biotech’s Covaxin and Zydus Cadila’s ZyCoV-D. It is a two-dose vaccine with an interval of 28 days.
The company was asked to submit phase 1 and phase 2 trial data after completing interim analysis of its efficacy, and the government had then said the data would be submitted by end of September or early October.
The government had said if approved on the basis of phase 2 clinical data, the same rules applied to Covaxin earlier will be followed for Corbevax as well. The Centre has placed an advance order for 30 crore vaccine doses.
According to the study protocol, the efficacy of the vaccine will be tested against Serum Institute of India’s Covishield. Biological E has also sought permission from DCGI to conduct phase-3 clinical trial for Corbevax as a single booster dose for those fully vaccinated with Covishield or Covaxin, even as the government is monitoring studies regarding the efficacy of booster doses in already vaccinated populations.
Corbevax has been developed with support from the Department of Biotechnology, which has not only provided financial assistance in terms of grant-in-aid of over Rs 100 crore but 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, as per the health ministry.