COVID Vaccine For Children – Covaxin gets EUA for children aged 2-18 years
The subject Expert Committee gave emergency use approval for administering the Covaxin – COVID19 vaccine to children between 2-18 years. Bharat Biotech had completed a phase 2/3 study of the Covaxin COVID19 vaccine for children under 18 years last week.
Last week, Bharat Biotech submitted the data to the CDSCO for verification and consequent permission for the vaccine’s Emergency Use Authorisation (EUA).
Covaxin becomes India’s 1st COVID-19 vaccine authorized for use in children.
The WHO is yet to decide on whether to grant Covaxin Emergency Use Listing (EUL) status; probably, the organization will make a conclusive decision this week.
The firm had submitted data to WHO continuingly, and on 27th Sept 2021, it provided added information at WHO’s request. WHO authorities are presently reviewing this data, and if it clarifies all of the queries put forward, the WHO assessment will be completed next week.
As per the WHO, its authorities and Technical Advisory Group of independent experts are expected to conduct a meeting this week to conduct a benefit/risk analysis before making a last decision on whether to give Covaxin with a EUL. The EUL process, whichis carried out by WHO and the independent group of experts, is focused on concluding whether a manufactured product is of high quality, safe, and effective.
However, the EUA is subjected to few restrictions. The Bharat Biotech will have to submit the updated prescribing information/Package Insert (PI), Summary of Product Characteristics (SmPC), and factsheets.
The company should also submit safety data after proper study, every 15 days for the first 2 months and then on a monthly basis.
Covaxin from Bharat Biotech is one of the 6 vaccines that have got emergency use authorization from the Drug Regulator of India and are used in the national anti-COVID19 inoculation program alongside Covishield and Sputnik V.
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