Proof of Concept

To demonstrate this concept, Novavax has built a pilot plant and commercial launch facility in Rockville, MD, with a fully disposable process capability. The facility houses a single 1,000-L Xcellerex Bioreactor for VLP production, supported by two Wave bioreactors and a 200-L Xcellerex bioreactor for seed preparation. At current yields, the existing process equipment can produce up to 30 million doses of H5N1 vaccine in six months (at 15 mcg/dose). We expect yield to increase such that the facility can support up to 80 million doses in six months, once the new bioreactor conditions are optimized. The facility was built for less than $6 million. The facility is a prototype of what we could place "in-border" to support a government's desire to secure its supply of pandemic vaccine. The overall cost for a facility would be higher than the quoted price, as the Rockville facility does not include formulation, filling, packaging, or media and buffer preparation, which will be contracted out. The cost also does not include quality control or quality assurance space. It still represents a good order-of-magnitude savings over what would be possible with traditional flu vaccine manufacturing approaches and provides countries with a proof of concept for the approach. The construction and qualification was completed in 120 days, which shows the time savings of the disposable approach as well. The facility became fully operational at the end of 2008.

Customizing Vaccine Supply by Region

Further, additional antigens may be warranted in a region, because multiple B strains can circulate and choosing just one for the seasonal formula has the potential to reduce a vaccine's effectiveness if the alternate strain were to become prominent. Therefore, having local capacity gives governments an opportunity to add an additional strain (even a prepandemic avian strain) to the formula to add value to the seasonal vaccination program.

Next, there are sometimes 'late-breaking' strains of influenza that are antigenically variant from the seasonal formula. The speed and yield of the process in insect cells affords the local government the opportunity to make an additional vaccine in a timely manner to address this risk as needed.

A Flexible Facility

Finally, the process that Novavax has developed for influenza vaccine production is also effective at making other VLP vaccines. The company is developing other VLP vaccine candidates in collaboration with the US National Institute of Health (NIH) that use the same process as influenza manufacturing in insect cells. A change of the clone alone is required to make alternate VLPs. As these and other similar vaccines are developed and approved, pandemic facilities can be used to manufacture these products for local markets. This increases facility utilization and provides a "warm base" operation so the facility is always ready to switch to pandemic influenza vaccine manufacturing mode.

Because Novavax is a 100-person vaccine development company, the ability of this company alone to help the world create a better solution to pandemic influenza is limited. In December 2007, Novavax signed a collaboration with GE Healthcare to expand its ability to provide a pandemic solution to governments around the world. GE is a large company with a history of innovation and a track record for delivering large projects, and the company already serves many governments by constructing hospitals and utility plants. GE will provide the facility engineering, project management, and government access to support the Novavax technology application in delivering in-border or regional vaccine manufacturing capabilities to those that have recognized the need to create this valuable resource.

Summary

An influenza pandemic is a recognized global health risk and many solutions are being developed to attempt to address this serious threat. To date, most solutions fall short of providing an effective response to protect the global population. Vaccination is thought to be a preferred solution, although access to a timely and sufficient supply of vaccine against a new emerging pandemic strain is inadequate in every country around the world. Novavax, Inc., teamed with GE Healthcare, can offer a solution that answers the call for a fast vaccine response to a novel influenza vaccine strain using an affordable technology for many developed and emerging countries. With the help of government and nongovernmental organizations, the technology can also be available to developing countries. This approach is economically rational and its implementation may actually be capable of halting a pandemic in the countries where it is most likely to start, where those populations have no defense today.

James M. Robinson is vice-president of technical and quality operations at Novavax, Inc., Rockville, MD 20850, 240.268.2019, j.robinson@novavax.com