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
In addition to securing pandemic influenza vaccine supply, this technology approach offers other advantages. First, this technology
makes it possible to customize vaccine for a given region. Some regions do not get great benefit from the recommended vaccine
formulation. When influenza strains emerge in Southeast Asia, they mutate as they migrate across Asia into Europe and North
America, then Africa and South America. The strains recommended for Europe and North America have already passed through Southeast
Asia and a different vaccine formula would be advantageous in that 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.
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, firstname.lastname@example.org