For vaccines and treatments aimed at vanquishing infectious diseases, it’s a long, bumpy road from the laboratory to the doctor’s office, a journey that can take years and cost hundreds of millions of dollars — if it happens at all.
Now, academic researchers, biotechnology specialists, and pharmaceutical leaders in Boston and elsewhere are offering tantalizing evidence that vaccines against Ebola and other killer diseases can be made faster and cheaper than previously believed.
In a study accepted for publication in the journal Human Vaccines & Immunotherapeutics, a Boston research consortium, called VaxCelerate, details how it produced a vaccine ready for animal testing against lassa fever, a hemorrhagic disease similar to Ebola, for less than $1 million and in four months.
“In an era where everything is faster, we’re taking too long as academics to make things happen,” said Dr. Mark Poznansky, an infectious disease specialist at Massachusetts General Hospital. “It still takes time, but it should take less time, less money.”
Their work grows out of frustration among researchers and disease specialists over the lack of vaccines for diseases such as Ebola, a problem highlighted by the world’s most severe outbreak of the viral illness, which has left nearly 1,400 people dead in recent months in West Africa. And there is no approved treatment for the disease either.
The outbreak, which the World Health Organization declared a public health emergency earlier this month, highlights a fundamental flaw in vaccine research and development, physicians and researchers said — one VaxCelerate hopes to begin fixing. Without a crisis, researchers and pharmaceutical companies have scant incentive to quickly develop vaccines and drugs for little-seen diseases, said Poznansky, director of VaxCelerate and Massachusetts General’s Vaccine and Immunotherapy Center.
And then there’s the not-so-trivial matter of economics: Vaccines, which are taken once or twice in a lifetime, do not provide nearly the same financial rewards for pharmaceutical companies as daily drugs, such as the cholesterol-busting pill Lipitor.
The importance of vaccines and virus-fighting drugs was cast into high relief by the worst Ebola outbreak in history. It started in the rural forests of Guinea, but spread to Liberia, Sierra Leone, and most recently, Nigeria. The virus, which has infected nearly 2,500, is outpacing health officials’ abilities to respond.
VaxCelerate, based within Mass. General’s vaccine center, is part of a broader push by the US government to improve — even transform — vaccine development to better respond to emerging infectious diseases. The US Department of Health and Human Services and Department of Defense are working with several Boston-area companies and scientists on vaccine initiatives.
The time and cost of creating vaccines has steadily increased over the past 40 years, from an average of $199 million and six years to make it to market in the 1970s, to $1.5 billion and more than 13 years today, said Dr. Kendall Hoyt, assistant professor of medicine at the Geisel School of Medicine at Dartmouth.
The Pentagon solicits research proposals aimed at expediting vaccine creation, with research consortiums, such as VaxCelerate, receiving millions of dollars. If successful vaccines are discovered, the Department of Health and Human Services works with biotechnology and pharmaceutical companies on mass production.
“Our concern is the current processes are the same as they have been for a very long time,” said Colonel Dan Wattendorf, a program manager in the Defense Department’s research branch. “They’re not suitable for all the infectious diseases that occur naturally or are being engineered to harm us.”
Traditionally, vaccines have been designed with a highly specific combination of proteins, peptides, and other biological components. That means each vaccine design must start from scratch, rather than building upon past successes.
But VaxCelerate has come up with a way to rapidly develop vaccines that is somewhat akin to a car maker using the same chassis for different models.
They stockpile the core ingredients to brew the basics of a new vaccine and then, once an infectious disease is identified, add in ingredients designed to block that particular disease.
“The whole point here is to not start with every vaccine looking differently,” said Dr. Jeffrey Gelfand, an infectious disease physician at Massachusetts General and senior scientist with VaxCelerate. “Get 90 percent of the vaccine skeleton made so you can quickly respond to an emergency.”
Consortiums such as VaxCelerate are only one piece of the complex vaccine development puzzle, said Hoyt, the Dartmouth professor. Animal and human testing are rigorous, time-consuming endeavors, and vaccine candidates often fail before they make it to patients. A vaccine that makes it to animal testing has only a 1 in 250 chance of receiving federal licensing.
But VaxCelerate hopes to continue piecing together that puzzle. It is negotiating a federal contract to develop a vaccine against a disease, which cannot be named under conditions of the contract, using test animals whose immune systems more closely resemble those of humans. That way, the vaccine can be more specifically designed to be safe and effective in humans.
One day, Poznansky hopes, VaxCelerate’s model will prevent diseases such as Ebola from spreading to uncontainable levels.
“You can sometimes sit in an academic lab with your Nature paper and say, ‘I have got the cure for cancer,’ and feel you’ve championed something. But the bridge between that feeling and a product that actually helps the patient is like $10 billion, 10 years, and all the rest of it,” Poznansky said. “We’re trying to find a way to bridge the gap between those two thoughts.”