Novavax delays US trial of COVID vaccine candidate to Nov, phase 3 trials expanded in UK

The latest biotechnology company developing next-generation vaccines for serious infectious diseases, Novavax, Inc., has announced updates on its phase 3 development program of ‘NVX-CoV2373’- its COVID-19 vaccine candidate. It was announced that the trials in the United States and Mexico will begin in late November. Previously, the trials were expected to begin this month. With this, it has been announced that the trial in the United Kingdom has been expanded to 15,000 people. Another crucial announcement said that the company will present data from its ongoing Phase 1/2 clinical trial, including new Phase 2 reactogenicity data on October 30. 

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Significant progress in large-scale manufacturing

Postponing trials in the United States, Novavax said, “The Company has made significant progress in large-scale manufacturing, with delays experienced versus original timing estimates”. It added that the company has been developing “large-scale manufacturing processes at multiple sites around the world”. The objective is to use production from its contract manufacturing site at FUJIFILM Diosynth Biotechnologies’ Morrisville, in this Phase 3 clinical trial.

The trial in the US is supported from the US Government through Operation Warp Speed. Novavax explained, “the trial design is harmonized with those of other leading companies, and calls for the enrollment of up to 30,000 participants in the U.S. and Mexico, with proportional representation among diverse populations most vulnerable to COVID-19 distributed across race/ethnicity, age and those living with co-morbidities”.

Read: Drugmaker Novavax Begins Late-stage Vaccine Trial In UK

The trial in the UK will now involve 15,000 participants. The aim is to facilitate assessment of safety and efficacy in a shorter time. The trial is expected to be fully enrolled by the end of November. Gregory M. Glenn, M.D., President of Research and Development at Novavax said, “We are pleased with the significant progress made in our Phase 3 clinical trial since it began in the United Kingdom at the end of September”. He further thanked the U.K. Government’s Vaccines Taskforce (VTF) and the National Institute for Health Research (NIHR) for the support that they have offered. He said, “Recognizing the recent, large increase in the number of COVID-19 cases in the U.K., as well as the rapid progress in participant enrollment for our trial, in consultation with the VTF and NIHR, we adjusted our plans and increased enrollment”. 

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