Shares of Novavax shifted higher as the biotech announced positive Phase 3 results for its combination flu-COVID vaccine, a single shot designed to replace two annual injections. The data lands at a pivotal moment: the combination vaccine market could be worth $5–$10 billion annually by 2028, and Novavax is racing larger, better-funded rivals to get there first.
• The Trial Hit Its Marks, But a Bigger Study Is Still Needed
The Phase 3 trial enrolled roughly 2,000 adults aged 65 and older and showed that the combination vaccine generated antibody responses comparable to licensed vaccines for both flu and COVID.
More than 98% of adverse events were mild or moderate. However, the study was not powered to evaluate real-world efficacy — these findings will instead inform the design of a future registrational trial that regulators will require before approval. Investors should note this is a stepping stone, not a finish line.
• Sanofi's Partnership Is Where the Money Lives Novavax isn't going it alone. Sanofi confirmed it is in advanced discussions with regulators regarding Phase 3 combination trial timing and intends to be among the first movers in the combination vaccine segment.
Initiation of that trial in the U.S. or EU would trigger a $125 million milestone payment to Novavax.
Novavax is eligible for royalties in the high teens to low twenties as a percentage of Sanofi's global net sales. For a company guiding to just $230–$270 million in 2026 adjusted revenue , those milestones are material.
• Moderna Already Has a Head Start in Europe
European regulators issued a positive recommendation for Moderna's combination flu-COVID vaccine in February 2026 for adults 50 and older — making it the first such shot to clear a major regulatory body. The FDA demanded additional flu efficacy data from Moderna, slowing its U.S. path , which buys Novavax time but doesn't eliminate the competitive gap. Pfizer also has a combination vaccine in Phase 3 with FDA Fast Track designation.
• The Stock Still Reflects Deep Skepticism At $10.71, Novavax trades well below an average analyst target of $13.78 , and the company ended 2025 with $751 million in cash . Yet high volatility and significant short interest persist as investors assess the partnership-driven pivot.
Novavax doesn't expect profitability until 2028 , meaning shareholders are betting on milestone payments and future royalties from products that don't yet exist commercially. Today's data is encouraging — but the gap between promising immune responses and a revenue-generating product remains wide.