Novavax’s stock leapt 17% in pre-market trading on Monday after the US Food and Drug Administration (FDA) granted full approval for its protein-based COVID-19 vaccine, Nuvaxovid, according to Reuters.
The green light, however, comes with stringent conditions: the vaccine is limited to older adults and immunocompromised individuals aged 12+, narrowing its market potential amid dwindling pandemic demand.
The FDA’s decision aligns with recommendations from its vaccine advisory panel but underscores Novavax’s struggles to compete with mRNA rivals Moderna and Pfizer. Analysts at Leerink Partners noted the restrictions were “no more restrictive than we expected,” while BTIG’s Thomas Shrader called the labelling medically atypical but consistent with prior signals.
The approval unlocks a $175 million payment from Sanofi under a 2024 licensing deal, offering a lifeline to Novavax after years of manufacturing delays cost it a slice of the pandemic’s $100 billion vaccine windfall.
Novavax aims to begin US deliveries this autumn, contingent on FDA approval for an updated variant-targeting formula, a key agenda item at this week’s regulator meeting.
The approval follows public scepticism from US Health Secretary Robert F. Kennedy Jr., who questioned Nuvaxovid’s efficacy in a recent CBS interview. Meanwhile, Novavax shares remain down 16% year-to-date, reflecting investor caution over its ability to carve a niche against dominant mRNA players.
