If there’s any single disease capable of provoking global panic it’s the one carried by swans, pigeons, chickens, and geese—popularly called bird flu and technically known as H5N1. Public health officials warn that when—not if, but when—a strain emerges that can easily spread from human to human, it could kill millions or even tens of millions of people in a single season. One of the most worrisome bits about bird flu is that current egg-based vaccines are at best effective on just 50 percent of the population—and even then against only selected strains of H5N1.

 

All of that is why Novavax, a small biotech startup in Rockville, Maryland, headed by a former Merck executive, set about creating a radically new approach to beating back H5N1. With positive results of its Phase I/II trials last December, the prospects for a deadly pandemic could change.

 

Most vaccines are based on viruses that are grown in fertilized hen eggs and then killed in order to produce human antibodies against the actual virus. Novavax took a recombinant technique used to make Hepatitis B and human papilloma virus vaccines, namely using the exterior walls of the virus—what Novavax CEO Rahul Singhvi calls “the outside surface decorations”—to create a so-called VLP (virus-like particle), or a “3D model” of the virus, to mimic a virus and stimulate the body’s immune reaction. However, the VLP contains no genetic material, so it cannot replicate and spread.

 

The VLP vaccine was injected into ferrets, the standard animal used to test flu viruses. Ferrets’ flu symptoms are almost exactly like human symptoms—runny noses, weepy eyes, sneezing. Then two groups of ferrets were exposed to the Indonesian strain of H5N1—one group that had been injected with the VLP vaccine and one group left unprotected. Within a week, three out of four of the unvaccinated ferrets were dead; those vaccinated with only one microgram of VLP showed no flu symptoms or weight loss.

 

 

A first series of Phase I/II human trials was recently completed at the U.S. Centers for Disease Control with 230 subjects using two different vaccine strengths—15 and 40 micrograms of VLP. While the human volunteers were not directly exposed to H5N1, researchers were able to monitor the level of protective antibody response to the VLP vaccine as a predictor of protection. The results were extremely encouraging. More trials will continue through the winter months.

 

If the trials prove as effective in humans as in ferrets, Singhvi expects to go into production by spring to produce up to 30 million doses. Novavax, founded in 1997, has also taken a novel strategy for production of the virus by engineering a mobile, disposable laboratory for sale around the world. “For a lab that could produce 100 million [doses],” Singhi says, “the client would need to spend $40 million versus a cost of $150 million on the older technology, and they also get the flexibility of adapting to strains of H5N1 that could show up locally.” General Electric’s GE Healthcare unit said on December 10 that it had agreed to help develop and market Novavax’s manufacturing platform, adding some serious backing to the effort.

 

Novavax expects to sell its “disposable” labs directly to government health ministries or medical centers, and then collect royalties on each dose. It’s a high-risk strategy since so far no H5N1 pandemic exists, though there’s little doubt that it’s only a matter of time before bird flu does become humanly transmissible. “It’s like selling a power plant to a developing country,” Singhvi says. “We give each country the capability to build its own capacity based on its own needs.”