Novavax announced Wednesday that its investigational vaccines—both a combined COVID-19 and flu shot and a standalone influenza vaccine—triggered a robust immune reaction in seniors aged 65 and up, comparable to the responses seen with currently authorized vaccines.
The company reported that both vaccines were generally well tolerated by participants, with no unexpected safety issues emerging from the study.
Following the news, Novavax’s stock climbed 1.3% in premarket trading, reaching $7.29.
Roughly 2,000 people took part in the trial, which was designed to evaluate the safety and immune response of Novavax’s new flu-COVID combo vaccine and its independent flu shot. These were tested against its approved COVID-19 vaccine, Nuvaxovid, and Sanofi’s high-dose influenza shot, Fluzone HD.
While the trial was not set up to deliver statistically significant efficacy comparisons, Novavax said the results would guide the structure of a future pivotal trial intended to support regulatory approval.
Based in Maryland, Novavax is now aiming to expand the reach of its vaccine programs by partnering with other companies to bring its pipeline products to market. It noted ongoing efforts to secure collaborators who can help move these vaccines through further development stages.
In 2023, Novavax signed a major licensing agreement with Sanofi valued at up to $1.2 billion. The deal aims to support commercialization and additional advancement of Nuvaxovid, Novavax’s protein-based COVID-19 vaccine.
Nuvaxovid finally received approval in the U.S. last month, though the decision came after the FDA missed its initial April 1 deadline. The vaccine has been greenlit specifically for use in adults aged 65 and older and for those at higher risk aged 12 and up.
Unlike the widely used mRNA vaccines developed by Pfizer/BioNTech and Moderna, Nuvaxovid is based on traditional protein technology, providing an alternative for those seeking a non-mRNA option.
Meanwhile, Health Secretary Robert F. Kennedy Jr., who has a long history of expressing doubts about vaccines, drew fresh controversy this week by dismissing the entire panel of vaccine advisors at the U.S. Centers for Disease Control and Prevention—a decision that public health officials warn may erode public trust in current vaccination programs.
{Matzav.com}