Bioterrorism Vaccines: No Quick Fixes


Flu season is approaching, but, right now, doctors are taking frantic calls from patients asking if their flu-season coughs and sore throats mean they should be tested for anthrax infection. Small wonder. With authorities investigating cases of anthrax infection in Florida and in New York as well as anthrax-tainted letter in Nevada, the threat of bioterrorism is suddenly all too real.

Despite widespread fears, the likelihood of a major biological attack remains slim. But it's understandable why so many people suddenly want to be immunized against biological agents such as anthrax. Unlike bombs or chemical weapons, a biological attack could devastate an entire community before it had time to defend itself.

Although anthrax is not contagious (it doesn't spread person-to-person), it could be disbursed across a wide area or used in a densely populated building or stadium in a manner capable of infecting thousands of people. What may at first seem like a mild case of the flu could turn deadly in a matter of days -- as it did for one Florida man infected with anthrax in late September.

BIOTECH'S ROLE. The harsh reality, however, is that, in the near term, average citizens can do almost nothing to prepare for bioterrorism. Only the military is vaccinated against anthrax, and what small stockpiles of the vaccine remain are reserved for the armed forces. Also, only 7 million to 15 million doses of smallpox vaccine are stored in government freezers for emergencies. These are a tiny fraction of the supplies that would be needed in the event of a massive attack.

Because such a threat now exists, the biotech sector will play a crucial role in the Pentagon's newest defense priority: countering bioterrorism. Although the Defense Dept. already has a program to create better vaccines, that goal won't be reached overnight. "There are so many challenges on the vaccine front," says Dr. Craig Shimasaki, vice-president for research and development at ZymeTx, an Oklahoma City company that established an influenza- and biological-infection surveillance network for public-health authorities nationwide.

Under current conditions, widespread immunizations for anthrax and smallpox could take at least a year because of safety issues involved in producing the vaccines and making sure they work effectively, Shimasaki says. He cites the flu-vaccine supply as an example of how difficult large-scale vaccine production can be. Due to manufacturing setbacks, stockpiles are this fall are 54% below necessary levels. As Shimasaki notes: "It's not easy to make a vaccine in large quantity."

NOT SO SIMPLE. It would likely take at least 12 months to 18 months to prepare large-scale supplies of anthrax vaccine -- and perhaps longer for smallpox, which hasn't been mass-produced since the '70s. (Smallpox, arguably the most contagious, persistent, and deadly killer in the history of civilization, was eradicated worldwide in the late '70s.) Acambis (ACAM) is already making smallpox vaccine. A $343 million contract with the federal government called for 40 million doses to be prepared by 2003, although the company says it could proceed much faster than that. The biggest problem will be proving the vaccine is effective and safe.

Mass-producing drugs to counter bioterrorism won't be as straightforward as ramping up production of cruise missiles or warplanes since biological drugs are tricky to engineer and reproduce on a mass scale. "It must be done with tremendous care and oversight," says Dr. George Georgiou, a University of Texas molecular biology professor who is developing a method to fight anthrax infection.

Given the obstacles, three steps will likely be taken in the drug and biotech industries and public-health circles in the aftermath of September 11. First, Defense and the Centers for Disease Control & Prevention are likely to increase funding for larger-scale vaccine, antiviral, and antibiotic research and production. In 2000, the federal government spent several hundred million dollars on protection against bioterrorism, out of an estimated $8.4 billion counterterrorism budget. Both the total budget and the level spent on fighting bioterrorism threats are likely to increase several times over in the next few years.

FAST-TRACK PRESSURE. Second, the biotech industry will begin raising hundreds of millions of public and private research dollars for the creation of vaccines and anti-bioterrorism drugs. The number of companies that position themselves to fight bioterrorist threats could triple, even quadruple, in the next 12 months.

Third, the Food & Drug Administration most likely will devote far greater resources to oversight of biological-drug development and vaccine research to ensure that new compounds are effective and safe. "The pressure will build on federal regulators for fast-track approval of new vaccines and drugs to fight bioterrorism," says John Apathy, a life-sciences industry adviser for PA Consulting in Princeton, N.J.

Who will take the lead in the biotech industry? The likely beneficiaries of new research dollars are companies such as Corixa (CRXA), which among other things works on vaccine development in Seattle. Others include Wyeth Lederle, a division of drug giant American Home Products (AHP) in Madison, N.J., as well as Aventis and GlaxoSmithKline (GSK), the two largest European drug producers and major vaccine developers.

MARKET REWARDS. Many other niche companies such as Cepheid (CPHD), a Sunnyvale (Calif.) diagnostics maker that uses DNA technology to capture and detect anthrax, are developing novel ways to rapidly test for biological infections within the crucial incubation period after an attack -- when antibiotics or antivirals may still be effective.

The markets have already begun rewarding the stocks of companies that could play a role in securing the nation against bioterrorist threats. Acambis saw its stock price rise more than 50% since September 11, to close at $28 a share on Oct. 12. Likewise, Cepheid has seen its stock more than triple, from $1.80 a share before September 11 to $7.90 on Oct. 12.

So far, however, only a few companies are at the forefront of the push for larger-scale vaccine production. BioPort, a 220-person private company in Lansing, Mich., has received much attention because it holds the only FDA license to make the anthrax vaccine. But at this point, it has only a small stockpile reserved for the military and isn't producing anthrax vaccine for nonmilitary use.

NO QUICK FIX. BioPort has publicly acknowledged it has had difficulties in making operational a refurbished manufacturing facility. The company did not return phone calls for this story, but BioPort Chief Scientific Officer Robert Myers earlier this year told the Lansing Economic Club he expects FDA approval for the facility by the end of 2001.

"Our No. 1 objective now and into the future will be to provide all the anthrax vaccine necessary to protect our servicemen and -women," Dr. Myers said. "Once that is accomplished, we expect to have private and international sales of anthrax vaccine, but those more profitable propositions are still some time off in the future."

DynPort is another company that has received government contracts for the study of improved defenses against anthrax, plague, and other biological agents. The Reston (Va.) company declined to comment for this story, but a consultant who works with DynPort says it has a $350 million Defense Dept. contract for the study of new biological-warfare defenses. DynPort is a division of DynCorp, a private government-technology supplier with $1.8 billion in annual revenues and dozens of multiyear technology contracts with the Pentagon.

PLAGUES APLENTY. Many more biotech companies are sure to take advantage of the higher federal priority on domestic safety in the wake of September 11. But the solutions are far from simple. For now, federal health authorities are not ready to say all U.S. citizens should be vaccinated against anthrax or the plague. But even if that were the case, many other forms of microorganisms for which there are no known defenses could be used for bioterrorism.

Deadly and contagious pathogens such as ebola, dengue, or even a lab-engineered form of influenza could theoretically be used as weapons. The same is true of the highly contagious smallpox. Given the unsettling new reality of bioterrorism, the new defense initiative being created in this country puts the drug industry and biotech sector on the front lines of national defense. By David Shook in New York


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