New Delhi: The Drugs Controller General of India (DCGI), which is evaluating the data for Bharat Biotech’s Covaxin for children, may take some more time to give its final approval. Earlier, an expert panel of India’s Central Drug Authority has recommended granting emergency use authorisation to Covid vaccine Covaxin for children in the age group of 2 to 18 years, subject to certain conditions.
The recommendations were later forwarded to the Drugs Controller General of India (DCGI) for final approval.
If the vaccine gets approval from the Drugs Controller General of India (DCGI), it will be the second Covid-19 vaccine after Zydus Cadila’s needle-free ZyCoV-D to receive EUA for use in those below 18 years.
Last year, Bharat Biotech, which completed the phase 2/3 trials of COVID-19 vaccine Covaxin for use in children aged between 2 and 18 years, had submitted the data to the Central Drugs Standard Control Organisation (CDSCO) for its verification and subsequent approval for emergency use authorisation (EUA) for the jab in the beginning of this month.
The Subject Expert Committee (SEC) on COVID-19 examined the data and deliberated on the EUA application on Monday. “After detailed deliberation, the committee recommended grant of market authorisation of the vaccine for the age group of 2 to 18 years for restricted use in emergency situations subject to the certain conditions,” the SEC recommendations stated.
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