Big Blow To Serum Institute As Govt Panel Denies To Conduct Trials Of Covovax On Children Aged 2-17 Yrs

The Subject Expert Committee of the Central Drugs Standard Control Organisation denied the approval for its trial on children noting that the vaccine has not been approved in any country.

Covid Vaccination Update: India's largest Covid vaccine manufacturer Serum Institute Of India has recieved a big blow on Wenesday. An expert panel of the country's central drug authority on Wednesday recommended against granting permission to the Serum Institute of India (SII) to conduct the phase 2/3 trial of COVID-19 vaccine Covovax on children aged two to 17 years.

The SII had applied to the Drugs Controller General of India (DCGI) on Monday 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.

"The Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO), which deliberated on the application, noted that the vaccine has not been approved in any country," a source said, as quoted by PTI.
The recommendations are learnt to have been approved by the DCGI.

The SII has been asked to submit the safety and immunogenicity data (of Covovax) from the ongoing clinical trial in adults before proceeding with the trials on children, PTI reported.

Novavax had announced last month that NVX-CoV2373 demonstrated 100% protection against moderate and severe disease, and 90.4% overall efficacy, in its Phase 3 trial.

If approved Covovax would become the third vaccine to begin trials on children in India after Bharat Biotech’s Covaxin and Zydus Cadilla’s ZyCov-D.

Meanwhile, Zydus Cadila applies for Emergency Use Authorisation (EUA) seeking approval from the Drugs Controller General of India (DCGI) for the launch of their DNA vaccine for 12 years & above. The vaccine has completed the third phase of trial.

(with agency inputs)