Pharmaceutical and biotech firms are racing to find treatments and vaccines for severe acute respiratory syndrome (SARS), but they worry that by the time they come up with an actual product, the virus may not be the health crisis it appears to be today.
"To be competitive, you need to get into this fast and work fast," said Gordon Cameron, president and chief financial officer of Acambis Inc, the firm supplying small pox vaccine for a national stockpile. "We're certainly looking at SARS. But we're still trying to figure out what the market will be and what the technical hurdles might be. We have to decide shortly. In the next couple months, we either have a program or we don't."
Despite the urgency, much uncertainty remains. Scientists identified the virus causing SARS just a month ago. SARS has infected more than 5,400 people and killed more than 350 since it first appeared in China late last year. But no one knows how fast or how far the virus will spread.
PHOTO: AFP
Few infectious disease specialists believe SARS will disappear. But they can't predict whether SARS will turn into an epidemic, wax and wane with the seasons like the common cold, or remain a relatively rare illness. Even in a best-case scenario, a vaccine or treatment is years away and by the time it is available, many firms worry the sense of urgency may have faded and too few people will want to be vaccinated to justify the hundreds of millions of dollars it takes to develop a drug or a vaccine.
The drug industry is seeking assurances from various federal health agencies that they will streamline the testing process and buy large quantities if a SARS vaccine pans out. Drug companies say they are willing to take the risk for now because the early research into a drug or vaccine is the least expensive part of the process. But developing, testing and then gaining regulatory approval to get a drug to market can cost hundreds of millions of dollars.
"We're not looking for risk-free, nothing we do is risk-free," said Len Lavenda, a spokesman for Aventis Pasteur, the world's biggest vaccine maker, based in Lyon, France. "But we are looking for assurance the government is going to be there in five years."
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said the agency is exploring various options for funding research and partnering with industry. But, he said, it is not yet clear that the government would promise to buy a successful vaccine.
The hurdles in developing vaccines are even more considerable than with other types of drugs. Since they are given to healthy people, they must be safer than most other medications. They are often tested in tens of thousands of patients to ferret out uncommon side effects before reaching the market.
Even then problems arise. A vaccine for rotavirus, a stomach illness that kills a million children worldwide each year, was tested in 10,000 infants in 27 clinical trials over 15 years before it was approved. After all that, a rare side effect only emerged later, causing the vaccine to be pulled off the market.
But the industry is plowing ahead. Pharmaceutical giant Merck and Co, based in Whitehouse Station, New Jersey, is screening its stable of drugs to see if any of them will help treat SARS. Merck asked the government for a copy of the virus and dozens of its researchers are beginning work to discover a vaccine.
Chiron Corp, an Emeryville, California, biotech, deciphered the genetic code of one strain of the SARS virus and has 15 scientists searching for a vaccine.
GenVec Inc, a Gaithersburg, Maryland, firm, teamed up with government scientists to hunt for a vaccine based on the same technology it is using to develop an HIV vaccine. GenVec already had a US$10 million contract with the National Institute of Health's (NIH) Vaccine Research Center to work with federal scientists on an AIDS vaccine. As more was learned about the SARS virus, Paul Fischer, GenVec's president and chief executive, suspected its vaccine technology might also be applied to SARS.
That afternoon, GenVec researchers began brainstorming with colleagues at NIH to put together a work plan. Two weeks later, GenVec and NIH hammered out a modified contract in which NIH gave another US$420,000 to start a SARS program. Fischer expects the collaboration to begin making various experimental vaccines in coming weeks that can be tested in animals. If the researchers get lucky, Fischer said, a vaccine could begin human testing in a year.
"In the best of all possible worlds, this virus dies out quickly," Fischer said. "But most people think it will probably return as a seasonal virus. The worst case is that it becomes a terrible epidemic worldwide. In either of the last two scenarios, speed is key."
The history of vaccine development is filled with research efforts that take years to bear fruit. In the 1980s, when researchers first set out to discover a vaccine for HIV, they hoped to have one in hand in a few years. Now, nearly 20 years later, several HIV vaccines are in clinical trials but none has yet reached the market.
Another company in the race is Medarex Inc. Based in Princeton, New Jersey, it joined forces with state researchers in Jamaica Plain and Worcester in search of a molecule that would specifically target the virus and prevent infection in those exposed to the disease.
Dr. Donna Ambrosino, director of the Massachusetts Biologics Lab in Jamaica Plain, part of the University of Massachusetts Medical School, approached Medarex earlier this month with an idea she hopes could control outbreaks of SARS. The state lab was working with Medarex for more than a year on another project. The company genetically engineers mice to produce monoclonal antibodies, hailed as the body's version of guided missiles for their ability to seek out and destroy specific disease-causing cells. In some cases, monoclonal antibody therapies have been easier to develop than vaccines.
"Vaccines are just tough," Ambrosino said. "When you get one that works, it's the best approach. But it takes a long time. That doesn't mean we shouldn't start today. But that's why I feel our effort also needs to begin now."
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