DCGI puts Covovax vaccine trials in children on hold

An expert panel of India's drug regulator has asked Serum Institute of India (SII) to submit the safety and immunogenicity data from the ongoing clinical trials of Novavax's Covid-19 vaccine on adults before applying for conducting trials on children aged 2-17 years.

At its meeting on Wednesday, the Subject Expert Committee on Covid-19 of the Central Drugs Standard Control Organisation noted that the vaccine candidate submitted by SII had not been approved in any country.

The SII had sought the Drugs Controller General of India (DCGI) approval for conducting a trial of Covovax on 920 children, 460 each in the 12-17 and 2-11 age groups, at 10 sites.

The Committee also 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 Committee also told Dr Reddy’s Laboratories, which is manufacturing Sputnik vaccines in India, that it need not conduct a separate Phase 3 trial of the vaccine candidates and the data from trials in Russia would be enough for grant of market authorisation.

“After detailed deliberation, the Committee recommended that the firm should present the safety, immunogenicity and efficacy data of Phase 3 clinical trial in Russia for considering the proposal for grant of market authorisation in the country,” according to the minutes of the SEC meeting held on Wednesday.

Dr Reddy’s Laboratories had applied for market authorisation for Sputnik Light component 1 along with the interim safety and efficacy data generated from Phase 1 & 2 clinical trials in Russia and had presented the Phase 3 clinical trial protocol before the committee.

In August last year, US-based vaccine maker Novavax Inc. had entered into a licence agreement with the SII for the development and commercialisation of NVX-CoV2373, its Covid-19 vaccine candidate, in low and middle-income countries and India.

The clinical trials of Covovax began in India in March and the SII hopes to launch it by September for adults.

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