Covaxin gets approval for emergency use for Kids

Guwahati: An expert panel of India’s Central Drug Authority has recommended Bharat Biotech’s COVID-19 vaccine Covaxin (BBV152) for Emergency Use Authorisation (EUA) for children aged 2 to 18.

According to reports, the Subject Expert Committee (SEC) stated that it had submitted data from clinical studies in the 2-18 age category to the Central Drugs Standard Control Organisation (CDSCO). After a thorough assessment by the company, the positive suggestions were forwarded to the Drugs and Comptroller General of India (DCGI).

In September, the Hyderabad-based vaccine producer conducted Phase 2 and Phase 3 trials of Covaxin on children under the age of 18 and the trial data was submitted to the Drugs and Comptroller General of India (DCGI) at the beginning of October.

As per the national media reports, Dr. (Maj.) Manish Mannan, head of department, Pediatrics, and Neonatology, Paras Hospitals, Gurugram, stated that the vaccination can only be started after getting the final approval from the DCGI and as the doctors are working with children the officials will closely go through the data.

He added that he will start with the vaccination and see how the data comes from the fourth phase of the trial.

Despite the number of children that participated in the clinical research is small, the outcomes have been promising. We’ll watch how the vaccination procedure goes when it begins, and then we’ll decide whether or not to use this vaccine, Mannan added.

It may be mentioned that after a detailed consultation, the committee recommended a grant of market authorization of the vaccine for the age group of 2 to 18 years for restricted use in emergency situations subject to certain conditions.

 

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