August 11, 2009 UNC Global News

One of the most effective vaccines for Rotavirus, a devastating intestinal disease that affects millions of infants and small children each year, costs approximately $182.50 for the required three doses.

With two-thirds of the world surviving on less than two dollars a day, this vaccine is so completely beyond their means that, according to some in the global health field, it might as well not exist for this wide segment of the population.

One such person working to patch this burgeoning gap in vaccine accessibility is Dr. Robert Johnston, director of the Carolina Vaccine Institute at the University of North Carolina. He is also the founder and Executive Director of Global Vaccines, a non-profit dedicated to ensuring that the world’s population, from the Third World to more developed economies, are having their most basic healthcare needs met. 

As a virologist and immunologist, Dr. Johnston has devoted his life to the study and development of vaccines for an array of diseases from the Venezuelan Equine Encephalitis Virus to HIV. However, it has only been within the past decade that Dr. Johnston has begun to shift his focus to technology as an efficient and potentially successful solution to the soaring cost of vaccine production.

“To make a vaccine that is unaffordable to most of the world…is like inventing something and putting it in the garage, letting the spider webs start to form, because for most of the world, it essentially doesn’t exist,” said Dr. Johnston. “It became clear to me that new technologies were going to be needed to conquer many of these diseases and to create new vaccines. And those vaccines, in addition to being safe and effective, had to be cheap if they are to make any sort of difference in the lives of poor people around the world.”

From Idea to Fruition: The Founding of Global Vaccines

Coming to UNC as a professor in 1989, Dr. Johnston has embarked upon a number of interesting ventures, both at the University and beyond. In the early 1990s, Dr. Johnston and a colleague founded AlphaVax, a for-profit company with a similar focus of developing new vaccine technologies. However, the constant pressure of the bottom line did not mesh well with the doctor’s long-standing aspirations to improve health conditions around the world. Thus, he began developing the idea for Global Vaccines, which he eventually founded in 2003.

“Bob has always had this strong altruistic desire to make sure that everybody across the globe, regardless of their geographic location or their social economic standing, has access to equal healthcare, and that is kind of the driving force behind Global Vaccines,” remarked Jake Wiltshire, Director of Development for both Global Vaccines and the Carolina Vaccine Institute. “He saw that he couldn’t accomplish this goal through a for-profit company because the bottom line is always the driver, not global health needs, and those two factors don’t always meet up.”

Although Global Vaccines is a completely separate entity from the University, it works closely through contractual agreements with the Carolina Vaccine Institute. In fact, the 12-person company licenses lab space at both UNC and Research Triangle Park outside of Raleigh, North Carolina. The researchers are currently working on developing two innovative platform technologies that they are optimistic will help to revolutionize the field of vaccine development and production as it currently stands.

The first is a new hybrid microorganism, called a chimeric virus particle, which is created by taking fragments of different viruses and fusing them together. Like most live attenuated virus vaccines on the market today such as measles and rubella, the hybrid virus grows only in a limited fashion when injected into the body. This allows the body to recognize and begin fighting against the virus, thus preparing itself to battle the real thing in the future. Global Vaccines is currently developing this chimeric particle approach to fight against HIV and possibly Hepatitis C.

“We have taken pieces of Virus A, Virus B and Virus C and have created something that grows in the body but does result in a persistent clinical infection, so it is not dangerous.…We’re anticipating that it is going to induce a good immune response and that response will clear the chimeric vaccine out of the person’s body and will leave them immune to HIV. That is what we hope,” explained Dr. Johnston.

The second technology currently in development is called an adjuvant, which is, in essence, a catalyst that can be added to existing vaccines to make them more effective. With the addition of this adjuvant, smaller dose sizes will be made stronger and may produce immune responses in different parts of the body. This is especially beneficial for vaccines that had previously seemed promising but were not quite powerful enough when put through trials. Having tested the adjuvant in primates with a commercial flu vaccine, the results are proving very positive.

According to Dr. Johnston, the National Institutes of Health (NIH) has shown a high degree of interest in the adjuvant. Global Vaccines is hoping to receive grant funds to manufacture the technology to FDA standards, which will allow them to eventually test the product in human trials. 

“Not only did the adjuvant flu vaccine protect better, but it protected more consistently and lasted longer with a lower dose,” said Wiltshire. “We are hoping to use this new development in conjunction with vaccines that are already extremely effective to lower the dose that is needed, and therefore lower the cost for people in the poorest parts of the world.”

With the typical vaccine development timeline ranging from approximately ten to twelve years, these technologies are still very much in the early stages. Nonetheless, Dr. Johnston is already focused upon the future. In addition to developing pioneering new technologies, the doctor has also been working to transform the vaccine manufacturing model so as to ensure that these new discoveries are produced as inexpensively as possible. Global Vaccines is currently looking to establish licensing agreements with universities around the United States as well as with vaccine manufacturers outside of the advanced economies, in countries such as India, Brazil and Indonesia. Surprisingly, 75 percent of vaccines are produced outside of the First World each year. They churn a profit primarily by manufacturing vast quantities of generic brand vaccines that are no longer protected by patent.

Once the two technologies advance through extensive testing to reach what is called a “Proof of Content Stage,” Dr. Johnston hopes to have these manufacturing companies produce the vaccines, all at a cost much lower than is typically associated with vaccine production. They will then have the exclusive right to sell these vaccines outside of the advanced economies, with little financial obligation to Global Vaccines beyond sufficient funding to cover basic costs. The doctor believes this concept alone is incentive enough for these manufacturers to want to enter into partnership with the U.S based non-profit.

“We believe that we can offer these manufacturers a win here, because we’re going to take our already-proven concept and let them sell it as their own,” said Dr. Johnston. “They can make a profit by selling the vaccine in their countries and throughout the more developed Second World and then almost give it away in the Third World, all while still making a profit. And of course, the big winners, if we’re successful, will be the people receiving the vaccines in the developing world, which is what we want.”

A Global Mission with a Local Focus

Though Global Vaccines is dedicated to improving health conditions throughout the developing world, the non-profit’s initial geographic targets include Africa, Southeast Asia and South America. However, as a North Carolina-based organization, Dr. Johnston believes that there is tremendous opportunity to ensure increased access to proper health care right here in his home country. He therefore plans to license Global Vaccines technologies to commercial pharmaceutical companies as well, with the condition that they may only sell these products within the advanced economies. It is from these partnerships that Global Vaccines plans to make a sustainable profit, much of which it plans to share with university partners such as UNC. Funded entirely by grants and personal donations, the small non-profit is eagerly working toward this end goal, primarily so that it can begin to expand its focus to other vaccine projects within the next few years.

Describing Global Vaccines as a “mission-driven organization,” Dr. Johnston has a number of ambitious goals for his company that he hopes to achieve within the near future. Looking ten years down the road, the doctor would ideally like Global Vaccines to become a clearing house for vaccine technologies, helping academic researchers move their ideas to fruition in a real vaccine application. As for Dr. Johnston himself, his goal is a simple one: he would like to see at least one vaccine put into service in his lifetime.

“What makes Global Vaccines so unique, and the Carolina Vaccine Institute for that matter, is that everyone involved is here because they genuinely care about helping people,” said Wiltshire. “Our work is grounded in advanced science but it is ultimately mission driven. Vaccine work is not a place where you go to make your fortune, but it is a place that you go because you are passionate. And the mission is always there, driving the science.”

Having made UNC his home base for the past 20 years, Dr. Johnston is continually surprised at the entrepreneurial spirit that drives this traditional University. The doctor is also grateful for the support of his campus colleagues, particularly those at the UNC Office of Technology Development, for their willingness to take risks with his new revolutionary model for vaccine production. And in line with the University’s time-honored mission of serving the people of North Carolina, Dr. Johnston hopes that Global Vaccines will become a valuable resource for the poor populations that exist within this state. Whether in the Third World, or in communities across the United States, access to proper healthcare is a serious issue that Dr. Johnston believes must be addressed. And while Global Vaccines is still making a name for itself on the vaccine development scene, the researchers are already producing radical results that will undoubtedly allow them to make a positive impact for good in the not-so-distance future. 

“There are pockets of poverty in North Carolina and they do not have access - just like people in developing countries do not have access - to proper medical care, of which vaccines are a crucial part. We think that our products, with their self-imposed restriction of having to be affordable, will benefit these people and these pockets of poverty in North Carolina and throughout the United States,” said Dr. Johnston. “We haven’t gotten to that stage yet, but that’s where we’re headed. This is our mission at Global Vaccines…and we plan to get there.”

-  Story by Robyn Mitchell ‘09