Covaxin Gets Emergency Use Approval For Kids Aged 2-18 Years: How It Will be Given, EXPLAINED

The Subject Expert Committee on Covid-19 has granted emergency use approval to Bharat Biotech's Covaxin for children in the 2-18 years age group.

Covaxin Gets Emergency Use Approval For Kids Aged 2-18 Years: The Subject Expert Committee on Covid-19 has granted emergency use approval to Bharat Biotech’s Covaxin for children in the 2-18 years age group. “After detailed deliberation, the committee recommended for grant of market authorization of the vaccine for the age group of 2 to 18 years for restricted use in emergency situation,” the subject expert panel quoted in a statement.

Highlights

The Subject Expert Committee on Covid-19 has granted emergency use approval to Bharat Biotech's Covaxin for children in the 2-18 years age group.

The made in India vaccine will be administered in two doses, with a gap of 20 days between the first and second dose. Hyderabad-based Bharat Biotech had completed Phase-2 and Phase-3 trials of Covaxin on children below 18 years of age in September and submitted the trial data to DCGI at the start of this month. The emergency use authorisation, conditions: The developer of Covaxin will continue the study as per Whole Virion, Inactivated Corona Virus Vaccine the approved clinical trial protocol.

Provide updated prescribing information/package Insert (PI), Summary of Product Characteristics (SmPC) and factsheet. Moreover, the firm should submit safety data including the data on AEFI and AESI, with due analysis, every 15 days for the first two months. Meanwhile, the WHO is yet to grant emergency use authorisation to Covaxin.

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