[Press Release] VaxArray Potency Kit for “Pandemic” Vaccines Fills Gap in Pandemic Preparedness

InDevR’s game-changing VaxArray potency test for influenza H5, H7, and H9 vaccines published in npj Vaccines

BOULDER (10/8/18) — The development of vaccines against potentially pandemic influenza strains is a critical component of the global response to an influenza pandemic. However, the tests needed to determine the potency of pandemic vaccines often represent a bottleneck delivering those vaccines when they can be most effective. Immediate access to a potency assay for monitoring of immunogenic HA concentrations would streamline the development, production, release, and ongoing stability monitoring of pandemic vaccines.  InDevR’s recent publication describes the development and performance of the VaxArray Influenza Pandemic HA potency assay for vaccines containing H5, H7, and H9 subtypes:  Byrne-Nash, R. T. et al. VaxArray potency assay for rapid assessment of “pandemic” influenza vaccines. npj Vaccines https://doi.org/10.1038/s41541-018-0080-6 (2018).

“With the 100th year anniversary since the 1918 influenza pandemic, there has been much discussion at every level of government and within the global vaccine industry about the gaps that remain in our ability to rapidly respond to deadly pandemic.  We have addressed a critical gap with this new potency test.  The VaxArray platform represents a breakthrough that could significantly streamline delivery of safe and efficacious influenza vaccines in the event of a pandemic,” said InDevR’s CEO Dr. Kathy Rowlen.

The assay demonstrated high sensitivity, accuracy, precision, and detection of a large panel of influenza viruses with pandemic potential spanning 16 years of antigenic drift, including the most recent pre-pandemic vaccine being developed against the “5th wave” A/H7N9 virus. The assay was also shown to be compatible with low dose and adjuvanted vaccines as well as upstream crude in-process samples, which would allow manufacturers to use the test to optimize yield.  The VaxArray system outperformed the current labor- intensive assay for influenza vaccine potency, SRID, in terms of sample-to-result time (2 hours versus 2 days), limit of detection, sensitivity, and compatibility with crude and adjuvanted samples.

According to Dr. Nancy Cox, retired former director of the Influenza Division within the Centers for Disease Control and Prevention, “History has taught us that time is of the essence when it comes to making pandemic influenza vaccines available to the public. The VaxArray assay represents a breakthrough in reducing a key bottleneck that has slowed vaccine delivery during past influenza pandemics, including the 2009 H1N1 pandemic.  Reducing bottlenecks in pandemic vaccine production allows earlier vaccine administration which will result in fewer illnesses, hospitalizations, and deaths.”

Find more information about the complete VaxArray product line at: https://www.indevr.com/products/vaxarray/

This work was sponsored as part of the Department of Health and Human Services’ inter-agency Influenza Vaccine Improvement Initiative.  Specifically, product development was supported by a Small Business Innovation Research grant R44AI102318 through the National Institute of Allergy and Infectious Diseases, which is part of the National Institutes of Health (NIH).  The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.


Shannon Rodriguez