Novavax (NASDAQ:NVAX) stock popped 11% on Monday after the company announced updates from its COVID-19 vaccine trials. The company expects to releases results from the late-stage study of its vaccine candidate, NVX-CoV2373, in the UK early next year, with results from the US study expected months later.
Novavax to commence Phase 3 COVID-19 vaccine study in the US
The biotech company had initially said that it would start its Phase 3 study in the US and Mexico in November, but it is expected to commence the trials in the coming weeks. Currently, Novavax is preparing for the manufacture of its COVID-19 vaccine in North Carolina. The company plans to use commercial-scale production at Fujifilm Diosynth Biotechnologies in North Carolina but will have to iron out related manufacturing barriers with the FDA.
In the UK, the company says that it has finalized the enrolment of 15,000 subjects in the study. Novavax expects preliminary data from the Phase 3 study in Q1 2021, but this timing is subject to the UK’s COVID-19 infection rate. If the trial is successful, data will support the application for regulatory approval in the U and EU.
The company has also completed the enrolment of 4,422 participants in South Africa in a Phase 2b study of the vaccines. The number of enrolled participants includes 245 medically stable participants who are HIV positive.
NVX-CoV2373 on track for regulatory approval
Stanley Erck, Novavax’s CEO, said that the company is leading to contribute to the need for efficacious and safe vaccines to address the COVID-19 pandemic. Despite the company lagging to some drugmakers, it is still on course to receive regulatory approval and start rolling out its vaccines in 2021 once it proves to be effective. NVX-CoV2373 employs spike proteins to offer patients protection against COVID-19.
Other companies such as Moderna (NASDAQ:MRNA), Pfizer (NYSE:PFE), and BioNtech SE (NASDAQ:BNTX) are already leading the vaccine race after successful late-stage studies. They are about to commence the distribution of the vaccine this year or early 2021.