SEC Allows Serum Institute To Conduct Novavax’s Bridging Trials In India

New Delhi: Serum Institute of India (SII) got the approval to conduct Phase 2 and 3 clinical trials for Novavax’s COVID-19 vaccine candidate in the country. The green signal came from Subject Expert Committee (SEC) of India’s central drug regulatory authority.

The Pune-based vaccine manufacturing giant will be holding bridging trials of American manufacturer’s vaccine in India, according to the minutes of the meeting accessed by news agency IANS.

The SII’s earlier application for trials was not accepted as the SEC was not satisfied with the trial protocols and asked the firm to re-submit the revised protocols.

“In light of recommendations of SEC committee dated 18.12.2020 and 13.01.2021, the firm presented its proposal along with a revised protocol for conducting Phase II/III clinical trial of SARS-CoV-2 rS Protein Nanoparticle Vaccine with Matrix-M1 Adjuvant before the committee,” the SEC’s observation in the minutes’ document was reported by IANS.

The experts found the revised protocol satisfactory and it recommended SII to conduct late trials bridging studies for the Novavax vaccine.

“After detailed deliberation, the committee recommended for grant of permission to conduct Phase II/III clinical trial,” the SEC said.

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