Novavax vaccine shows fewer side effects in study

GAITHERSBURG, Md. - Novavax, Inc. (NASDAQ:NVAX), a biotechnology company currently valued at approximately $1 billion and trading at modest revenue multiples according to InvestingPro data, released preliminary results from a study indicating that its latest COVID-19 vaccine formulation causes fewer and less severe side effects compared to the Pfizer-BioNTech vaccine. The SHIELD-Utah study, conducted between September and December 2024, compared the reactogenicity, or the physical response following vaccination, of the two vaccines in healthcare workers and first responders.

The study, in collaboration with the University of Utah Health and presented today at the Congress of the European Society of Clinical Microbiology and Infectious Diseases 2025, found that participants receiving Novavax’s adjuvanted vaccine experienced on average fewer symptoms (1.7 vs. 2.8) and a lower impact on daily activities than those who received the Pfizer-BioNTech mRNA vaccine. This development comes as Novavax maintains a solid financial position with more cash than debt on its balance sheet, though InvestingPro analysis indicates the company faces near-term profitability challenges.

Specifically, 43.8% of Pfizer-BioNTech recipients reported at least one Grade 2 or higher symptom, compared to 24.2% of those vaccinated with Novavax’s product. Additionally, Novavax recipients reported fewer hours of reduced activity due to vaccination side effects.

"The risk of side effects or reactogenicity has been a major decision factor for vaccination," said Sarang K. Yoon, DO, MOH, Principal Investigator at the University of Utah Health. "Our findings... add valuable insights to the public debate."

The study included a mix of physicians, nurses, nurse practitioners, and medical assistants who were given the choice of vaccine and asked to report their symptoms and the impact on their daily activities.

Ruxandra Draghia-Akli, MD, PhD, Executive Vice President and Head of Research and Development at Novavax, emphasized the tolerability of their vaccine and mentioned Novavax’s focus on developing more assets based on their protein-based nanoparticle technology and Matrix-M adjuvant.

Novavax’s growth strategy involves diversifying partnerships and investing in an early-stage pipeline, primarily in infectious disease, with the potential to expand into other areas.

The full results of the SHIELD-Utah study are expected to be published later this year. The information for this article is based on a press release statement from Novavax.

In other recent news, Novavax Inc. is facing delays in the approval of its COVID-19 vaccine by the U.S. Food and Drug Administration (FDA). The company’s Biologics License Application (BLA) was expected to be decided upon by April 1, 2025, but the FDA has postponed its decision, citing the need for additional data. This delay has implications for Novavax’s plans to transition from emergency use authorization to full approval, a milestone already achieved by competitors such as Pfizer-BioNTech and Moderna. Additionally, comments from Health and Human Services Secretary Robert F. Kennedy Jr. have cast doubt on Novavax’s vaccine technology, leading to a significant drop in the company’s stock. Kennedy indicated a shift in government focus towards vaccines utilizing multiple antigens, which diverges from Novavax’s single antigen approach. In light of these developments, BofA Securities adjusted its price target for Novavax stock from $12 to $10, maintaining a Neutral rating. The analyst highlighted potential risks, including the loss of a $175 million milestone payment from Sanofi, contingent on BLA approval. The recent shakeup at the FDA, involving the resignation of top vaccine official Dr. Peter Marks, has also contributed to market uncertainty, affecting the broader biotech sector.

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