Pune: India’s premier vaccine manufacturer, Serum Institute of India (SII), has sought permission from Drugs Controller General of India (DCGI) to conduct a study trial using US-based Novavax’s COVID-19 vaccine. SII will be manufacturing this vaccine locally.
“We have already applied to the drug controller’s office for the bridging trial, a few days ago,” SII’s chief executive officer Adar Poonawalla said. “They should give the approval soon,” he told Reuters.
This bridging trial will help get more clinical data on efficacy, safety and dose regimen in a different region of the world. Poonawalla has said his company will be stockpiling Novavax’s vaccine from April.
Novavax’s vaccine is protein-based and has 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 enrolment 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.
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