According to the US Center for Disease Control and Prevention, subjects in Novavax Inc.’s (NASDAQ: NVAX) late-stage COVID-19 vaccination trial can be taken as fully immunized two weeks after finishing their two-dose vaccine program.
Novavax’s vaccine is yet to receive US approval
According to the CDC, the recommendation does not imply approval of the vaccine, which is yet to receive FDA approval in The US. The company plans to file for emergency use authorization (EUA)in the US in Q4 2021. Last month the company said it was delaying its timeline to seek US approval for its COVID-19 vaccine pushing it to 2021. Early plans were for the company to file the EUA with the FDA in Q3 2021.
Novavax CEO Stanley Erck said, “It’s a matter of getting validation work done” to show the vaccine manufacturing process’s consistency to the FDA. He added that regulators in other countries have been aggressive in taking Novavax’s vaccine through approval.
Despite the Maryland-based company having encouraging clinical data regarding its COVID-19 vaccines, it has lagged competitors such as Johnson & Johnson, Pfizer Inc. it has been delaying regulatory filing and schedule for production ramp-up due to challenges in access of necessary equipment and raw materials.
Novavax to file for EUA for NCX-CoV2373
The guidance the company received from the CDC offers clarity to US participants in its clinical vaccine trials at a time when employers across the US are pushing staff to get immunized against the virus.
Already the company has filed for regulatory approval for NCX-CoV2373 in Indonesia, the Philippines, and India. In addition, it anticipates filing for WHO emergency listing for the shot. This is a requirement in exports to several countries party to the COVAX international vaccine sharing program. The CEO indicated that the company was on track to file a regulatory application in the UK this month, followed by submissions in Canada and Australia.
