Biological E's Corbevax gets DCGI nod based on interim results from phase 2/3 studies
The expected cost of the vaccine is reportedly Rs 145, excluding taxes
DCGI has given approval to the Hyderbad-based pharmaceutical company Biological E to conduct phase 3 clinical trials
Corbevax has completed two Phase III clinical trials involving more than 3000 subjects between the ages of 18 and 80 at 33 study sites across India
On October 14, Biological E said that it would submit final data on COVID-19 vaccine Corbevax till November end, informed Government sources.
Firm plans to make a billion annual doses of the vaccine apart from 600 million J&J doses a year
Biological E has sought permission from India's drug regulator to conduct the phase-3 clinical trial for its COVID-19 vaccine Corbevax as a single booster dose
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The approval of the Drugs Controller General of India (DCGI) for conducting phase III comparator safety and immunogenicity trial in adults came after the Subject Expert Committee's (SEC) review
The Drug Controller General of India (DCGI) on Wednesday granted permission to Hyderabad-based Biological E Limited to conduct Phase 2 & 3 clinical trials for its anti-COVID shots called Corbevax on children between 5 and 18 years of age with certain conditions, sources told ANI.The trial will be conducted in ten locations.The permission has been given to Biological E after the recommendation from the Subject Expert Committee.Meanwhile, Zydus Cadila's needle-free COVID-19 vaccine ZyCoV-D has already received emergency use authorisation (EUA) to inoculate children in the age group of 12-18. It is expected to be administered from the first week of October.The trials of Bharat Biotech's Covaxin COVID-19 vaccine for phases 2 & 3 for children are underway, and its result is expected in September.It is to be noted that the government has made an advance payment of Rs 1,500 crore to Biological E for 30 crore vaccines.
DCGI granted permission to Biological E Limited to conduct phase 2/3 clinical trials of its 'Made in India' COVID-19 vaccine on children aged between 5 and 18 years with certain conditions
The Minister was briefed on the progress of Biological's upcoming Covid vaccine Corbevax.
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The vaccine, which is currently undergoing phase-3 clinical trials, is likely to be available in the next few months.
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The phase III clinical study, to be conducted in 15 sites across India, will evaluate the immunogenicity and safety of Biological E's vaccine candidate in 1,268 healthy subjects
Hyderabad-based Biological E's candidate has completed its phase one and two trials and is about to enter stage three
The results of this clinical trial are expected to be available by February 2021, the release said.