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Novavax Begins Test on New Vaccine Technology

Share prices for biotech vaccine developer Novavax Inc. (NASDAQ: NVAX) climbed a respectable 8 percent over the course of the day today, thanks to the news that the company has started the first human clinical trial of its vaccine for the pandemic flu virus.

According to the latest statement from the company, Novavax has begun vaccinating 230 healthy human volunteers for the trial of its Virus-Like Particle (VLP)-based H5N1 clade 2 pandemic influenza vaccine to determine both the safety and immunogenicity – that is, the ability of any particular substance in a biological system to provoke an immune response – of the vaccine. At this point, the tests are still in the Phase I/IIa phase; if the tests prove positive, then the vaccine will move to a Phase IIb immunogenicity study.

One of the most interesting things about the vaccine isn’t the vaccine itself, but the VLP technology used to develop and transmit it. According to Novavax CEO Rahul Singhvi, the whole purpose of VLP technology is to create a protein replica of the virus in question to make the body think it’s been infected, thus promoting an immune response, when in reality the patient is quite safe.

“VLP is an attempted reconstruction of the virus using microbiology or genetic engineering. By that, I mean that you take the genetic material and extract it to create a new protein, and if you extract two or three of these proteins from the virus, you can reconstruct the structure of the virus without having the ‘guts’ of the virus which are responsible for replication,” Singhvi told MN1. “So what you have is a decoy, or a ‘ghost’ virus, that has all the decorations of the real virus but none of the ability to replicate itself and cause disease.

“The immune system thinks it’s been infected by the virus, so it gets all its antibodies [up and working] to protect itself,” Singhvi added. “The product is unable to overrun the immune system by causing the disease, so you have the best of both worlds – you have a strong immune response, but at the same time you’re completely safe.”

While working on a vaccine for the flu virus may not sound very important, it’s important to note that a flu pandemic – or any pandemic – can wreck havoc in any civilized area. Need examples? Take the influenza pandemic of 1918, better known as “Spanish Flu” or “La Grippe.” Within the span of a single year, somewhere between 50 million and 100 million people reportedly died from the disease. Since then, at least two large-scale influenza pandemics have been reported, both in Asia, proving that the danger of a large-scale influenza outbreak is possible even in today’s advanced world.

And that’s why companies like Novavax are so important these days. While there aren’t any reported influenza pandemics currently coursing through the world currently, that’s no guarantee one couldn’t crop up in the increasingly poor conditions in some Third World countries. After all, it’s better to be safe than sorry – a viewpoint Singhvi supports whole-heartedly.

“Just because there’s not a pandemic doesn’t mean there’s never going to be one,” Singhvi said. “I think there’s a responsibility that every government has to put together some sort of insurance policy for protecting their citizens in case a threat ever materializes. I think one of the best insurance policies you can buy is to have a vaccine that can be given to the people and can be used to protect against an eventual pandemic whenever it comes. If the pandemic materializes, it could devastate economies around the world; it could not only take millions of lives, but it can bring even a developed country to its knees. There’s a great need for a better product, and I think what we’ve done is apply our technology to an important medical problem.”

And since the vaccine creation process behind the vaccine is much safer than other methods – no virus eggs or live viruses are used, just a mimic of the virus’s shell – Novavax’s VPL technology could mean wonders for the industry. Still, M.D. Penny Heaton, Novavax’s chief medical officer and vice president, said the company will be monitoring the tests for any problems.

“We’ll be monitoring the safety of all the participants in the trial very closely,” Heaton said. “Given that the vaccine does not replicate, we don’t anticipate any major side-effects, but we will monitor the safety of the vaccine very closely as we would with any investigational product.

“We’re estimating the study will take about a year, and we’re looking at announcing our final results by this time next year,” Heaton added.

Novavax closed at $2.97 a share, 21 cents higher than its opening price of $2.76. There were almost 200 trades of the stock today, and the dollar volume hit just over $1.9 million.

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