Novavax has announced that its experimental influenza vaccine has met its primary objectives of demonstrating safety and immune response in a phase two clinical trial.
The US-based company said the quadrivalent seasonal influenza virus-like particle (VLP) vaccine, tested on 500 people in Australia, triggered an immune response against all four strains of the bug after 21 days.
The vaccine was also well-tolerated with no serious adverse events observed.
Novavax also noted that the vaccine has the potential to fulfill the US Food and Drug Administration (FDA) Center for Biologics Evaluation and Research criteria for accelerated approval.
The FDA grants accelerated approval to drugs that target an unmet medical need, or ones that are more beneficial than current treatments.
Novavax president and CEO Stanley Erck said, "The topline data from our seasonal influenza trial released today show that our VLP quadrivalent vaccine candidate was well-tolerated and produced significant HAI responses. Based on our analysis of these data, we believe we have a path forward for our VLP seasonal influenza vaccine."
The company will now evaluate process and assay refinements that require improvement and begin the next phase two trial in 2013.
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