The data for the approval has been submitted by the company to the Subject Expert Committee for beneficiaries between 5-12 years of age, the sources told ANI.
New Delhi: Pharma giant Biological E on Wednesday (March 9) has applied for the Emergency Use Authorisation (EUA) for Corbevex, its Covid-19 vaccine for the 5-12 year age group, ANI reported quoting official sources.
The data for the approval has been submitted by the company to the Subject Expert Committee for beneficiaries between 5-12 years of age, the sources told ANI.
This comes after recently, the Subject Expert Committee recommended Emergency Use Authorization (EUA) for Corbevax for the age group of 12 to 18 years but under certain conditions.
As per the reports, the Drugs Controller General of India (DCGI) is expected to give the final EUA to Corbevax soon.
The SEC recommended EUA only after seeing the safety and immunogenicity data amongst this group.
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What is Corbevax?
Corbevax is a ‘recombinant protein subunit vaccine, which means it is made up of a specific part of SARS-CoV-2 — the spike protein on the virus’s surface.
It is developed for the administration in the 5-12 year age group.
What will be the cost of Corbevax, if approved?
The expected cost of the vaccine is Rs 145 excluding taxes. It will be administered two times within prescribed intervals.
The sources told ANI that the Central government has already purchased about 5 crore Biological E vaccines Corbevax and also delivered them to some states.
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Trials
Vaccine maker Biological E applied for the phase 2 and phase 3 clinical trials during the month of September 2021 last year. India reported 4,575 new COVID-19 cases in the past 24 hours informed the Ministry of Health and Family Welfare on Wednesday.
Meanwhile, the Ministry of Health and Family Welfare informed today, “More than 18.69 lakh doses (18,69,103) vaccine doses have been administered in the last 24 hours.
With this, India`s COVID-19 vaccination coverage has exceeded 179.33 crores (1,79,33,99,555) as per provisional reports till 7 am today.”
