Serum Institute applies for bridging trial approval for Novavax Covid vaccine

Bridging trial is a supplementary trial performed in a new region or country to get more clinical data on efficacy, safety and dose regimen

The Serum Institute of India (SII) has applied to India’s drugs controller for permission to conduct small bridging study in India for Novavax’s Coronavirus disease (Covid-19) vaccine candidate, which is the second Covid-19 vaccine that the company will be manufacturing locally.

The drugs controller general of India and the committee of subject experts at Central Drugs Standard Control Organisation are in the process of examining SII’s application. (File photo)

“We have already applied to the drug controller’s office for the bridging trial, a few days ago,” Poonawalla said. “So they should also give that approval soon now,” SII chief executive officer, Adar Poonawalla, told Reuters.

Bridging trial is a supplementary trial performed in a new region or country to get more clinical data on efficacy, safety and dose regimen.

The drugs controller general of India, VG Somani, and the committee of subject experts at Central Drugs Standard Control Organisation are in the process of examining the application.

Poonawalla had earlier mentioned that SII will also start stockpiling Novavax’s vaccine candidate from April like it did with Oxford-AstraZeneca vaccine candidate, which is currently being used in India as Covishield for its mass Covid-19 vaccination drive.

Meanwhile, Novavax has announced that NVX-CoV2373, its protein-based Covid-19 vaccine candidate had the efficacy of 89.3%, in its Phase 3 clinical trial conducted in the United Kingdom (UK).

The study assessed efficacy during a period with high transmission and with a new UK variant strain of the virus emerging and circulating widely.

“With today’s results from our UK Phase 3 and South Africa Phase 2b clinical trials, we have now reported data on our Covid-19 vaccine from Phase 1, 2 and 3 trials involving over 20,000 participants. In addition, our PREVENT-19 US and Mexico clinical trial has randomised over 16,000 participants toward our enrollment goal of 30,000. NVX-CoV2373 is the first vaccine to demonstrate not only high clinical efficacy against Covid-19 but also significant clinical efficacy against both the rapidly emerging UK and South Africa variants,” said Stanley C. Erck, president and chief executive officer, Novavax, in a statement.