Novavax had earlier licensed its COVID-19 vaccine technology to SII with no upfront, milestone, or technology transfer payments.
3 | Pfizer to start pilot delivery program for its COVID-19 vaccine in four US states: Pfizer Inc has launched a pilot delivery program for its experimental COVID-19 vaccine in four U.S. states, as the U.S. drugmaker seeks to address distribution challenges facing its ultra-cold storage requirements. Pfizer’s vaccine, which was shown to be more than 90% effective in preventing COVID-19 based on initial data, must be shipped and stored at -70 degrees Celsius (minus 94°F), significantly below the standard for vaccines of 2-8 degrees Celsius (36-46°F).
The Subject Experts Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) on Wednesday granted permission to Serum Institute of India (SII) to conduct Phase 2/3 bridge trial of Novavax COVID-19 vaccine.
“Firm presented justification for the design of proposed Phase II/III clinical trial as observer blind instead of double blind along with the literature,” as per the minutes of the 147th meeting held on March 15 at CDSCO, headquarter in Delhi .
“The firm stated that the clinical development process carried out by the reference vaccine manufacturer Novavax is by observer blind clinical trial design,” the minutes of the meeting said.
The panel met to examine COVID-19 related proposal under accelerated approval process, after detailed deliberation, recommended for the conduct of the clinical trial with observer blind design.
Novavax had earlier licensed its COVID-19 vaccine technology to SII with no upfront, milestone, or technology transfer payments.
SII will manufacture and distribute Novavax COVID-19 vaccine in the low-, middle, and upper-middle-income countries, (LMICs, UMICs), while Novavax will supply doses primarily to high-income countries (HICs).
Viswanath Pilla is a business journalist with 14 years of reporting experience. Based in Mumbai, Pilla covers pharma, healthcare and infrastructure sectors for Moneycontrol.
