A new experimental flu vaccine that was scheduled to be ready for testing later this year won’t be ready until next year, since it failed to meet one of the two goals it needed for accelerated approval.
According to a company press release, Novavax Inc. announced preliminary results from mid-stage testing of an experimental vaccine designed to protect against four strains of the influenza virus. The company reported that the 500-patient study of the vaccine achieved its primary goal of safely triggering an immune system response to the four viral strains.
However, the vaccine did not completely meet a second goal needed to win accelerated approval from the Food and Drug Administration. Patients achieved the FDA’s requirement for antibody production for three of the viral strains, but not the fourth.
The Phase II trial, conducted in Australia, enrolled 500 eligible subjects who were randomized into five treatment groups of approximately 100 subjects stratified by age and receipt of influenza immunization in the 2011 season. At day zero, study participants received a single intramuscular vaccine injection of the quadrivalent vaccine containing one of three ascending doses or one of two trivalent comparators: Novavax VLP vaccine or a standard dose of a licensed TIV. Study participants were evaluated at day 21 for HAI response and safety and tolerability of the vaccine; additional safety and immune response follow-up will continue with the subjects through six months.
This trial is the first trial evaluating the company’s quadrivalent seasonal influenza vaccine candidate produced using its single-use bioprocessing production system. This advanced manufacturing technology will be the basis for its commercial production of seasonal and pandemic influenza vaccines, as well as for the company’s RSV and rabies vaccines.
Stanley C. Erck, President and CEO of Novavax 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.”
“While the data from this trial were positive on balance, we are evaluating both process and assay refinements that we believe will further improve the immunogenicity profile of our vaccine, pushing the start of our next Phase II trial into 2013, rather than the fourth quarter of this year,” Mr. Erck continued.
“We are pleased to have the continued full support from the U.S. Department of Health and Human Services’ Office of Biomedical Advanced Research and Development Authority (BARDA) for our development plans.”
The company also announced completion of enrollment of its two Phase I clinical trials to evaluate the safety and immunogenicity of its monovalent VLP A/H5N1 pandemic influenza vaccine comparing two different adjuvanted vaccine candidates with an unadjuvanted vaccine candidate. Top line data from these trials are expected in the fourth quarter of this year.
The company is developing both seasonal and pandemic vaccine candidates under a multi-million dollar contract with BARDA, who has been an active partner in planning and evaluating the development of these products. Novavax will use the data from these trials in planning the next stage in the development of these products as they progress toward licensure.
Novavax expects to present the full findings from this Phase II trial at a future scientific meeting.
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