Novavax Inc. (NASDAQ:NVAX), in partnership with the UK’s Vaccine Taskforce government, has commenced a late-stage study of its investigational vaccine candidate in the country, sending its shares up 6%.
Novavax expects data from the Phase III study by December
The company enrolled 10,000 participants in the study aged 18-84 years, which comes after Novavax’s vaccine produced enhanced antibodies levels against the SARS-CoV-2 in an early-stage clinical trial. The NVX-CoV2373 vaccine had a positive outcome in producing antibodies in healthy volunteers that received two doses more than those found in individuals who have recovered from COVID-19. Equally, Novavax’s Matrix-M adjuvant, which is also designed also to enhance immune response, demonstrated improved effect in the subjects.
Data from the study, which is likely to take around four to six weeks, is likely to support regulatory applications for a license in the UK, Europe, and other countries. Previously, Novavax had implied that it planned to apply for the vaccine’s approval in the US. According to reports, the EU is almost finalizing preliminary talks with the company about its vaccine candidate. The company’s chief of research indicated that the late-stage Phase III trial will potentially produce adequate data for the company to submit regulatory approvals by December.
Novavax received funding from the US government
Novavax is among the companies in the race to develop a vaccine for the novel coronavirus that doesn’t have any vaccines or treatments currently approved. The third phase trial plans to enroll around 25% of the participants aged 65 years and prioritize the most affected groups by COVID-19.
The NVX-CoV 2373 vaccine program is among the handful programs that the US has singled out for funding under its Operation Warp Speed to accelerate access to treatments and vaccines against the coronavirus. Having effective vaccines and treatment is necessary for stopping the pandemic that has resulted in over 695,000 lives globally. In July, the US government committed $1.6 billion to Novavax to cover the testing and manufacturing costs of the vaccine.