Setback For SII: Govt Panel Denies Clinical Trial Of Covovax On Children, Here's What Happened
In a minor setback to the Serum Institute of India (SII) an expert panel of the country's central drug authority recommended against granting permission to conduct the phase 2/3 trial of COVID-19 vaccine Covovax on children aged two to 17 years.
Pune-based SII, which had begun manufacturing Novavax's protein-based vaccine Covovax was aiming to start the clinical trials or children starting July.
On Monday, SII had applied to the Drugs Controller General of India (DCGI) seeking permission for conducting a trial of Covovax on 920 children, 460 each in the 12-17 and 2-11 age groups, at 10 sites.
Why was it denied?
According to reports, the Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) denied the request citing the fact that the vaccine has not been approved in any country.
Instead, the panel has asked SII to submit the safety and immunogenicity data of Covovax from the ongoing clinical trial in adults for considering the conduct of a clinical trial in children.
The clinical trials of Covovax began in India in March and the SII hopes to launch it by September for adults.
Covovax, which is developed by US-based vaccine maker Novavax Inc is being manufactured and marketed by the SII in India.
Two vaccines undergoing trials for children
Currently, only Bharat Biotech's COVAXIN and Zydus Cadila's vaccines are undergoing clinical trials for children in India.
Last month, the All India Institute of Medical Sciences (AIIMS) in Delhi began the screening of children in the age group of 6 to 12 years for the clinical trials of Covaxin, the indigenously developed Covid-19 vaccine.
AIIMS Delhi has already completed the clinical trial for a single dose of Covaxin for children aged 12-18 age group.
Last week, Centre had informed the Supreme Court that Zydus Cadila vaccines have concluded clinical trial for the age group of 12-18 years and these vaccines may be available soon.
"Zydus Cadila which is developing DNA vaccines has concluded its clinical trial for between the age group of 12 to 18 years and subject to the statutory permissions, the same may be available in near future for children of the age group of 12 to 18 years of age", the government said in an affidavit. The central government is expected to procure 5 crore Zydus Cadila DNA vaccines.
Last week, AIIMS Chief Dr Randeep Guleria had said that data of phase two and three trial of Bharat Biotech's Covaxin on two to 18 years age group is expected by September. The vaccine can be available for children in India around that time following approval from the drug regulator.
