BRIEF—Novavax initiates Phase II Covid-19 vaccine trial in USA and Australia

Despite today announcing that the first volunteers have been enrolled in the Phase II portion of its ongoing clinical trial in the USA and Australia to evaluate the immunogenicity and safety of its COVID-19 vaccine candidate, US clinical-stage biotech Novavax’ shares were down more than 14% at $117.87 by late-morning trading.

The Phase II clinical trial expands on the age range of the Phase I portion by including older adults 60-84 years of age as around 50% of the trial’s population.

“We expect this Phase II portion of the trial to expand on the encouraging Phase I safety and immunogenicity data for NVX-CoV2373, and we will now look for robust immune responses in older adults,” said Dr Gregory Glenn, president, R&D, at Novavax.

“Our Phase III trial of NanoFlu, which we reported in March of 2020, provided us with a deep understanding of the unique needs of older adults, who are particularly vulnerable to COVID-19. We know that the world is closely watching all of these trials, and we anticipate interim data from this trial in the fourth quarter of this year,” he added.

The trial is supported by funding of up to $388 million from the Coalition for Epidemic Preparedness Innovations (CEPI).

Novavax has also been awarded $1.6 billion by the US federal government as part of Operation Warp Speed (OWS), a project to deliver COVID-19 vaccines for Americans.