Serum institute gets CDSCO panel nod for Phase 2, 3 trials for Novavax COVID-19 vaccine
New Delhi: The Subject Expert Committee of India's central drug regulatory authority has given a go-ahead to the Serum Institute of India to conduct Phase 2 and 3 clinical trials for Novavax's Covid vaccine candidate in the country.
According to the minutes of meetings accessed by IANS, the Pune-based vaccine manufacturing giant will be conducting bridging trials of American vaccine manufacturer's Covid vaccine in India.
The SII had applied for the trails earlier but the SEC was not satisfied with the trial protocols and recommended 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 said.
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