Novavax (NVAX) stock soared 19.02% in pre-market trading on Monday, following the U.S. Food and Drug Administration's (FDA) long-awaited approval of the company's COVID-19 vaccine. The approval, which came after a delay and substantial back-and-forth with regulators, marks a significant milestone for the biotech firm, despite some limitations on its use.

The FDA has restricted the use of Novavax's vaccine, marketed as Nuvaxovid, to individuals aged 65 and older, as well as those between 12 and 64 who have at least one underlying condition that increases their risk of severe COVID-19. This more targeted approach aligns with the growing consensus that universal vaccine recommendations may no longer be necessary, according to Novavax's Chief Corporate Affairs and Advocacy Officer, Silvia Taylor.

While the limited approval might seem restrictive, Novavax remains optimistic. CEO John Jacobs hailed the approval as a "significant milestone" that solidifies a path for people to access the vaccine. The company will need to file for additional approval if it needs to change the targeted virus strain for the upcoming immunization season. Despite missing out on the initial pandemic vaccine windfall due to manufacturing issues and regulatory hurdles, this approval could potentially boost Novavax's position in the evolving COVID-19 vaccine market, as reflected in the substantial pre-market stock surge.