Novavax sales surge despite FDA delay on updated COVID shot

USA — Novavax has reported a major jump in revenue, even as uncertainty lingers over the full approval of its updated COVID-19 vaccine.

In its Q1 2025 earnings call, the Maryland-based biotech announced US $667 million in total revenue, marking a 610% increase from the US $94 million reported in the same quarter last year.

The bulk of this came from Nuvaxovid, its COVID-19 vaccine, which generated $608 million, up from US $82 million in Q1 2024.

While the vaccine dominated the earnings call, executives also provided updates on other pipeline developments, including a COVID-19 and flu combination shot currently in Phase III trials. However, most investor attention remained on Nuvaxovid’s regulatory status.

The FDA missed its April 1 deadline to decide on full approval of the vaccine, which is still being used under emergency authorization.

That delay has sparked debate, especially after The Wall Street Journal revealed that the agency has asked Novavax to conduct an additional randomized trial.

Though Novavax has insisted the study is meant for postmarketing, FDA Commissioner Marty Makary cast doubt on that interpretation.

He pointed out that new products should be backed by new trials, suggesting the current data may not be sufficient for full approval.

CEO John Jacobs appeared visibly frustrated when asked repeatedly about the vaccine’s status, stating: “When we have it, we’ll have it. Until then, we don’t have it.”

Jacobs clarified that, as of now, the FDA has only requested a post-approval study. CFO Jim Kelly added that Novavax is working with Sanofi, its partner under a licensing deal signed in May 2024, to plan for the study’s costs.

Despite the regulatory fog, Novavax is moving ahead with its partnership strategy. The Sanofi deal includes co-commercialization of Nuvaxovid and joint development of the COVID/flu combo shot, an area the company now considers a top priority.

They also highlighted results from the SHIELD-Utah study, which compared their updated Nuvaxovid shot to Pfizer and BioNTech’s Comirnaty. Early data suggested that Novavax’s vaccine caused fewer and milder side effects.

Looking ahead, the company has raised its full-year 2025 revenue forecast from US $975 million to US $1.03 billion, signaling optimism despite ongoing regulatory hurdles.