After more than a month of speculation over how the FDA will rule on Novavax’s application for an updated formulation of its COVID-19 shot, CEO John Jacobs said on the company’s Q1 earnings call: “When we have it, we’ll have it. Until then, we don’t have it.”
Novavax’s updated COVID-19 vaccine has been in limbo after the FDA missed its PDUFA deadline and subsequently requested another trial—though it’s unclear if that trial needs to happen before approval. But today, the company gave investors some good news, reporting a massive year-over-year increase in sales for the original product on a first-quarter earnings call Thursday.
In its Q1 2025 earnings report, the Maryland-based company reported $667 million for the quarter, an increase of 610% over the $94 million brought in during the first three months of last year. The majority of this revenue came from sales of the COVID-19 vaccine, Nuvaxovid, which clocked $608 million—a dramatic increase over the $82 million it generated in Q1 2024.
Nuvaxovid was the primary theme running through the call, in which executives also touched on the company’s earlier-stage pipeline—including a combination COVID-19/flu vaccine currently in Phase III studies—as well as partnerships and a recently reported reactogenicity study.
On April 1, the FDA did not announce a decision regarding full approval of Nuvaxovid, which is currently marketed under an emergency use authorization (EUA). The missed PDUFA ignited significant controversy and placed Novavax at the heart of the vaccines debate currently broiling under Health and Human Services Secretary Robert F. Kennedy Jr.
At one point during the Q&A period, which was riddled with questions regarding the vaccine’s BLA, CEO John Jacobs appeared to show some exasperation, saying: “When we have it, we’ll have it. Until then, we don’t have it.”
On April 25, The Wall Street Journal reported that the FDA was requesting the company complete an additional randomized clinical trial, a fact Novavax has confirmed. While executives have maintained—including on Thursday’s call—that this would be a postmarketing study, FDA Commissioner Marty Makary raised questions when he posted on X: “To be clear, this is a new product that Novavax is trying to introduce to the market with a study of a different product from 2021. New products require new clinical studies.”
Makary’s statement presaged a new policy revealed by HHS last week requiring all new vaccines to be tested in placebo-controlled trials before they are approved.
Jacobs sought to clarify any ambiguity in responding to a question regarding the potential for an additional clinical trial prior to approval of the BLA. “Based on what we’ve received to date, formally from FDA, they’re asking for a postmarketing commitment, and by definition, it’s our understanding that a postmarketing commitment comes after approval when you’ve begun to market that product,” he said.
Novavax CFO Jim Kelly added that the company is “working closely with our partner Sanofi to determine the potential approach to funding” the postmarketing study. Notably, Novavax did not provide full-year 2025 guidance for sales of Nuvaxovid, and Kelly said that potential costs of a postmarketing study should be considered in terms of Novavax’s multi-year guidance.
Despite the recent attention on the COVID-19 vaccine, Jacobs said that Novavax has now pivoted focus to its partnerships, including the licensing agreement with Sanofi, which Jacobs called a first priority. Signed in May 2024, the deal covers the co-commercialization of Nuvaxovid and development of the novel COVID-19/flu combo shot.
Meanwhile, Novavax touted the results of the SHIELD-Utah study, comparing the updated JN.1 Nuvaxovid shot to Pfizer and BioNTech’s Comirnaty in terms of reactogenicity. Preliminary data, reported on April 15, showed that Novavax’s protein-based vaccine “induced lower frequency and severity of short-term side effects and impact on daily life” compared to the mRNA-based Comirnaty.
Novavax raised its full-year 2025 guidance from $975 million to $1.03 billion.
