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.
The revised protocol was found satisfactory by the experts' committee after which it recommended to grant permission 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.
However, the recommendation was given to a condition that the participants randomised in the trial for the placebo arm may be unblinded 60 days after the second dose upon request of the clinical trial participant only.
"Such participant may be offered investigational vaccine as per the dose and schedule prescribed in the protocol," the committee said.
A week ago, Novavax said that its Covid vaccine was 89.3 per cent effective in preventing the Covid-19 in a trial conducted in the UK.
Meanwhile, its preliminary analysis and was nearly as effective in protecting against the variant found in the UK.
In September last year, Novavax had announced its deal with the SII to produce 2 billion doses of coronavirus vaccines.