Novavax Bullish On Potential FDA EUA Nod For COVID-19 Vaccine By May

Novavax Inc’s (NASDAQ: NVAX) COVID-19 shot can probably win FDA emergency use nod as early as May, said the company’s CEO Stanley Erck, in an interview on CNBC’s “Closing Bell”.

• Dubbed as NVX-CoV2373, its recombinant protein-based vaccine candidate against COVID-19 is still undergoing Phase 3 study (PREVENT-19) in the U.S. with 30,000 participants. 
• In late January, Novavax released Phase 3 trial results in the U.K., showing the vaccine was 89.3% effective overall, though slightly less effective against the variant strains found in the U.K. and South Africa.
• The company hopes the FDA will allow it to use data from its clinical trial conducted in the U.K. when it files its emergency use application later this year, Stanley Erck added.
• He said that “U.K. health regulators will potentially review the vaccine in April, followed by the FDA, probably a month after that. This timeline could move back by a month or two if the agency chooses to wait for the U.S.-based trial data.”
• Novavax has agreed to supply 110 million doses to the U.S. government, and the shipments are expected to complete around June or July.
• Recently, the company announced a Memorandum of Understanding with Gavi, an international vaccine alliance, to provide 1.1 billion cumulative doses of NVX-CoV2373.
• Price Action: NVAX shares closed 3.9% higher at $240.29 on Monday.