Novavax Manufactures VLP Vaccine Against H1N1

Novavax has manufactured a virus-like particle (VLP) vaccine candidate against the H1N1 pandemic influenza virus, under current good-manufacturing practices (cGMP) at its new vaccine manufacturing facility in Rockville.

The milestone was accomplished in only 11 weeks after receiving the gene sequence for the H1N1 strain from the US Centers for Disease Control.

The company said that it was able to reach this manufacturing goal by employing novel production technology, which is not dependent on growing influenza virus in eggs.

In addition, Novavax has produced essential reagents for measuring vaccine potency. The company also has plans to produce additional batches of the pandemic H1N1 VLP vaccine, to support human clinical studies and stands ready to assist with additional public health needs in the US as well as foreign countries.

Jim Robinson, vice president of Manufacturing and Quality Operations at Novavax, said: Demonstration of our ability to construct and produce GMP-quality influenza vaccine within 12 weeks under real pandemic conditions is an important and successful test of our VLP technology. With further scale up, recombinant influenza VLP vaccine technology has the potential to expand vaccine surge capacity and significantly reduce the timeline for vaccine release.

We are proud of our staff who worked tirelessly to achieve this important milestone while working concurrently to produce materials for a clinical study in the elderly population with our Seasonal Flu vaccine, he added.