Sure, pharmaceutical companies have a complex legal and regulatory framework to navigate.
The vaccine industry is drastically different.
It’s a much smaller industry (less than one-10th of the size), the profit margins are smaller and it still faces the same regulatory scrutiny.
Is it any wonder that just four companies control 80 percent of the market?
Wayne Pisano of Cranbury-based VaxInnate explained the market’s size and returns leave something to be desired.
“And it’s a lot smaller than the pharmaceutical industry: It’s a $25 billion market,” he said. “There’s such a high barrier to entry in a market that’s generally high-volume and relatively low-priced.
“If you’ve ever received a flu shot, and if you paid $25, it was probably a lot.”
That being said, Pisano feels the cutting-edge manufacturing technology implemented by his VaxInnate makes the industry a whole lot less daunting.
It’s why he’s hopeful his company can get a bigger share of a market currently dominated by companies with Jersey ties such as Sanofi and Merck, as well as GSK and Pfizer.
Typically, Pisano said, the vaccine industry takes a large capital investment to enter.
“You’re working with live viruses and bacteria, so from a manufacturing perspective you have to build dedicated facilities,” Pisano said. “Establishing an egg-based facility (to develop) influenza vaccines can cost $250 million … and can take up to half a city block of space.
“A cell culture facility costs up to $750 million.”
Using new technology, VaxInnate would be able to manufacture commercial vaccines with equipment costing $25 million or less. And it occupies a comparably small amount of space in the company’s 20,000-square-foot Cranbury base.
The company, which has been in existence for 12 years, is pioneering the application of technology first developed at Yale University. It involves genetically fusing vaccine antigens to the bacterial protein flagellin, a potent stimulator of the immune system.
Lynda Tussey, chief scientific officer, said the process consists of sequencing and cloning the DNA of a virus and bonding it with this highly purified flagellin protein, which is grown and deconstructed at the Cranbury lab.
“The process is a huge advantage on the manufacturing side (compared to older techniques),” Pisano said. “It’s a high-yield, low-cost production technique. And it requires less capital investment.”
The vaccine platform is based on technology that “dramatically improves vaccine immunogenicity and efficacy.”
Pisano said it also allows for quick turnaround on manufacturing.
“And that’s essential to have a rapid response, to be ready for the onset of pandemics,” he added.
VaxInnate can generate at least 50 million doses within five months, with some doses available within two or three months. Older techniques would take around six for the first doses. That’s a product of VaxInnate’s technology, which provides the same immunogenic protection in one-fifth the dosage amount as typical vaccines.
VaxInnate’s vaccines have applications for infectious diseases, including seasonal and pandemic flu, as well as dengue fever and other mosquito-borne diseases that have started to make an appearance in the U.S.
And the Cranbury company’s leaders believes its quick and efficient manufacturing process might have made a difference during the H1N1 flu pandemic. The U.S. saw this illness spread from its initial appearance in April 2009 until the end of that year before a vaccine was made widely available.
“While it spread quickly, it wasn’t that virulent in terms of mortality,” Pisano said. “Had it been like the 1918 Spanish flu, during which there was a 10 percent mortality, there would’ve been tens of millions of deaths around the world.”
The company already has secured $100 million in governmental funding to prepare the U.S. for future medical countermeasures and influenza pandemics.
Being in the R&D stages, VaxInnate can’t yet call a share of thr market its own. The company is still demonstrating to regulatory bodies that its vaccines are safe and effective.
But in the vaccine industry, just getting the manufacturing right is an accomplishment all its own.
“Invariably, flu strains regularly change. And so it’s like a new product every six months,” Pisano said. “That’s different from pharmaceuticals or anything else, where you can build inventory. That’s why manufacturing is key.”
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The regulatory situation for a vaccine company is somewhat different than a drug company, but it’s no less formidable.
A study to prove a vaccine’s efficacy for FDA licensing, for example, requires that a company demonstrate that it can prevent disease, which is challenging for something like the flu.
“This past flu season, the virus that was most prevalent circulating in the Northern Hemisphere was an H3N2 strain that was not in the (World Health Organization-selected) flu vaccine,” Wayne Pisano said. “The vaccine missed the target.
“So if you were trying to do a study that showed that you prevent disease, you would’ve failed. And it wasn’t your vaccine that failed, it was the wrong strain in the vaccine.”
Regardless, it’s a step VaxInnate will need to take to bring its still-in-development vaccines to the market.
“Also, quality control is critical in this industry,” Pisano added. “When you’re sick, you’re willing to put up with some side effects if the drug helps you. When you’re feeling well, as you would be getting a vaccine, you’re not going to want adverse events.”
In his youth, Wayne Pisano of VaxInnate remembers seeing kids crippled by polio.
People don’t see that anymore, Pisano said. He believes that being estranged from the experience of seeing a vaccine’s potential benefits is part of why people are starting to question their necessity.
“The problem is, polio is still around in Pakistan, in Afghanistan and in Nigeria,” he said. “It’s a plane ride away.
“And if you don’t have immunization rates of 80 percent or more in a population, then the disease will re-enter. That’s happening with measles. … The disease is real again.”
Pisano warns people still questioning vaccines to be skeptical of information found on the Internet.
“The National Vaccine Information Center sounds like the most reputable source for information,” he said. “It’s run by (the head of) the anti-vaccine movement.”