NOW, SII SEEKS TRIAL APPROVAL FOR NOVAVAX COVID VACCINE
NEW DELHI: The Serum Institute of India (SII) has applied to start trials of another Covid-19 vaccine, hoping to launch it by June this year, the firm’s chief executive officer Adar Poonawalla said on Saturday.
SII is currently manufacturing Covishield, which has been developed by the University of Oxford and Astrazeneca and is one of the two coronavirus vaccines approved in the country.
“Our partnership for a Covid-19 vaccine with @Novavax has also published excellent efficacy results. We have also applied to start trials in India. Hope to launch #COVOVAX by June 2021!,” Poonawalla tweeted. SII has applied to India’s drugs controller for permission to conduct a small bridging study for Novavax’s Covid-19 vaccine candidate. A bridging trial is a supplementary assessment performed in a new region or country to get more clinical data on efficacy, safety and dose regimen.
Novavax has announced that its vaccine was effective in big trials in the UK and South Africa, though its effectiveness appeared to be reduced in South Africa, where a mutation is prevalent. It announced that NVX-COV2373, its proteinbased vaccine candidate, had the efficacy of 89.3% in its Phase 3 clinical trial conducted in the UK.
The Drugs Controller General of India (DCGI), VG Somani, and a committee of subject experts at the Central Drugs Standard Control Organisation (CDSO) are in the process of examining the application, according to a person aware of the developments.