Serum institute gets CDSCO panel nod for Phase 2, 3 trials for Novavax COVID-19 vaccine

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.