New Delhi: In a major development in the fight against the Covid-19, the Subject Expert Committee (SEC) of the drug regulator has recommended granting an emergency use authorisation to Bharat Biotech's Covaxin for children and adolescents in the 2 to 18 years age group with certain conditions. The SEC has submitted its recommendation to the Drugs Controller General of India (DCGI) for final approval.
If approved by the 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.
Notably, Hyderabad-based 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 SEC on Covid-19 examined the data and deliberated on the EUA application on Monday.
Citing the findings of the data that the company submitted, the official sources said, "The vaccine has been found to be safe and effective in children and after reviewing the data, the experts recommended it for allowing for the use in children."
"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.
Bharat Biotech had presented its proposal for grant of market authorisation of its Whole Virion, Inactivated coronavirus Vaccine (BBV152) in the 2 to 18 years age group for restricted use in emergency situation along with the interim safety and immunogenicity data of phase 2/3 clinical trial conducted.
Notably, the drugs controller general of India VG Somani had permitted Bharat Biotech to conduct phase 3 clinical trials of its Covid-19 vaccine on 525 child volunteers in May this year and after it ended in September, the trial data was submitted to the drugs regulator in the first week of October.
However, the experts, who were involved in the clinical trials, have claimed that the safety and efficacy of Covaxin in the age group of 2 to 18 years has been found to be similar to that in adults that was 77.8 per cent.
In an official statement, Bharat Biotech said, "We submitted data from clinical trials in the 2-18 years age group for Covaxin (BBV152) to CDSCO. The data has been thoroughly reviewed by the CDSCO and subject experts committee and they have provided their positive recommendations."
"This represents one of the first recommendations worldwide for Covid-19 vaccines for the 2-18 age group. Bharat Biotech sincerely thank the DCGI, SEC and CDSCO for their expedited review process," the vaccine major said, adding that we now await further regulatory approvals from the CDSCO prior to product launch and market availability of Covaxin for Children.
According to the conditions, the firm should continue the study as per the approved clinical trial protocol and provide updated prescribing information/package insert (Pl), summary of product characteristics (SmPC) and factsheet.