U.S.: Big Push to Accelerate Vaccine Effort (smallpox etc)

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Headline: Big Push to Accelerate Vaccine Effort

Source: New York Times, 28 September 2001

URL: http://www.nytimes.com/2001/09/28/business/28BIO.html

With concerns growing about the threat of terrorism using biological weapons, the government is stepping up its effort to enlist biotechnology companies to develop and produce vaccines, drugs and other defenses against such an attack, according to industry executives. But many of the projects, like the manufacture of a smallpox vaccine, are years from completion.

The Biotechnology Industry Organization, the main trade group for biotechnology companies, sent out an "urgent official request for information" on Monday after meetings with Tommy G. Thompson, the health and human services secretary, and Department of Defense officials. The request asks the roughly 1,000 members what technologies they have that could be used to defend against biological or chemical attacks.

The letter also said the government wanted to make sure companies were safeguarding their own technology from being used to create biological agents. Specifically it urged that procedures be set up to raise an alert if the companies get an unusual order for their products.

Carl B. Feldbaum, president of the trade group, said the response to the letter had been "overwhelming," though he would not discuss the content of the answers.

Even before the attacks on the World Trade Center and Pentagon, the government had begun working with a number of biotechnology companies. Last year the Department of Health and Human Services gave a $343 million contract to OraVax, a company in Cambridge, Mass., to produce 40 million doses of a new smallpox vaccine. But the first doses are not expected to be delivered until 2004.

Executives at the company, which is now owned by Acambis, a British drug maker, said they would try to speed up manufacture of the vaccine if the government asked, but would not say to what degree they could do that. "Certain things are in our control and certain things are not," said Gordon Cameron, the chief financial officer at Acambis. "This is a new vaccine that has to be tested."

The Defense Department has paid for the production of an anthrax vaccine for soldiers for years, but that program has been plagued by problems. Bioport, a Lansing, Mich., company, now has the government contract, but it is currently unable to produce the vaccine because its factory is being renovated to meet Food and Drug Administration standards.

Last year, the Defense Department entered into a research partnership with EluSys Therapeutics, a small private company in Pine Brook, N.J., to develop an antidote to anthrax. "You will never have the entire population of the United States vaccinated against these problems so you need to have a therapeutic available," said Stephen G. Sudovar, president. But even if the company succeeds in its research, the antidote will not be available for about two years, he said.

The Defense Advanced Research Projects Agency, an arm of the Pentagon, is working with academic scientists and more than a dozen other companies on research that could take a decade to bear fruit. Isis Pharmaceuticals in Carlsbad, Calif., for instance, is working on drugs that could kill all bacteria. Egea Biosciences of San Diego is working on ways to quickly develop vaccines to any pathogen. Cepheid of Sunnyvale, Calif., is working on a briefcase-size machine that could perform a genetic analysis to identify an infectious agent in 30 minutes, rather than the hours or days such a job normally takes.

After the terrorist attacks, the government is likely to increase spending on defenses against biological warfare. Two days after the attacks, the Army called Bruker Daltonics to see if the company was prepared to manufacture many more of its bioagent detection machines than were included in a $10 million contract the government had just signed. "They are getting ready to react," said Frank H. Laukien, president of Bruker, based in Billerica, Mass.

In the past, the Pentagon has had trouble working with vaccine manufacturers. Wyeth Laboratories, a division of American Home Products, stopped producing the adenovirus vaccine for military recruits in 1996 after the Pentagon declined to pay for factory improvements needed to meet safety standards. Wyeth was unwilling to invest itself since sales of the vaccine, made only for the Defense Department, were tiny and dwindling. The military ran out of the vaccine in 1999 and there has been a surge in respiratory illnesses among military recruits, including two deaths. A new contract to produce the vaccine has now been awarded to Barr Laboratories, an Army spokesman said.

Given that big drug companies are reluctant to make vaccines because of the small market size, the Pentagon has been considering building its own vaccine plant to produce eight vaccines for military use the existing anthrax vaccine and a new one, plus vaccines for smallpox, plague, tularemia, botulinum, ricin and equine encephalitis. It would cost $1.56 billion to build and run over 25 years, including $386 million in construction costs, the department estimated in a report to Congress in July. But production at the plant would not begin until 2008. David Satcher, the surgeon general, wrote to the Pentagon in January urging that the factory also be used to produce vaccines for civilian use.

In contrast with the large drug companies, smaller biotech companies have welcomed the Pentagon contracts because they provide money and because many of the projects can lead to commercial products. "For the research programs here it was our largest single source of funding," said Matthew M. Loar, vice president for finance at Genelabs Technology Inc. in Redwood City, Calif. Genelabs had a $14 million three-year grant from the research projects agency to use the company's DNA-binding technology to develop antimicrobial drugs. The company is using the technology to develop commercial antibiotics.

Experts say it is vital for companies and scientists to become involved in developing vaccines and other defenses against bioterrorism. At a Senate hearing in the summer, Dr. Tara O'Toole, a senior fellow at the Center for Civilian Biodefense Studies at Johns Hopkins University, said that responding to bioterrorism with only the vaccines and drugs now available would be like "asking firefighters to battle a 12-alarm blaze without water or foam."

-- Andre Weltman (aweltman@state.pa.us), September 28, 2001


Don't have time to explicate in detail all that could be said about this, but a few quick points:

Re: smallpox vaccine, the reason they comment it's a "new" vaccine is that the old vaccinia (cowpox) vaccine against smallpox was made by infecting animals -- calves and goats I think -- and recovering live virus from lesions on the animals. This technique requires infrastructure that mostly no longer exists and I suppose doesn't meet "modern" standards. My understanding is that for mass production nowadays, ramping up to use more modern techniques doesn't take any more time than going back to the older methods would.

Re: anthrax vaccine, Bioport (the Pentagon contractor) has been plagued (no pun intended) with problems in making the controversial vaccine for the military.

Re: adenovirus, the Wall Street Journal had a very interesting article about the vaccine business, and the decision to stop using adenovirus vaccine in military recruits...I don't have the article electronically to offer; not sure of the print date but it was earlier this year. Front page story as I recall.

Re: the various other devices and antibiotics being touted: this stuff is all fine and well once available for mass use and real-world limitations are understood. New antibiotics? Great, yes please, but such things take years to bring to market and nothing can be expected to be a "magic bullet." As regards detectors, much of this technology seems to me more suited for limited use at key installations or on the battlefield. As a matter of sheer logistics, it's not clear to me how one could use such "space age" technology to cover a whole city or country in any really meaningful way.

-- Andre Weltman, M.D. (aweltman@state.pa.us), September 28, 2001.

Regarding anthrax and Bioport, I meant to say, Yeah, that's an understatement...

-- Andre Weltman (aweltman@state.pa.us), September 28, 2001.

How about massive doses of Vitamin C to take care of all the bio problems? There is much anecdotal evidence that this is effective. When I say massive doses I mean massive, something like 40,000-100,000 grams a day. I'm 77 years old and have been doing this over the past 30 years. I do this at the first sign of any kind of infectious illness. It works just fine. In all those 30 years I have not had more than a 2 day cold or 3 day flu, always very mild. In fact, my general health has been excellent. I credit these huge doses of Vitamin C as having much to do with this.

In reality, I don't suppose anything like this would even be considered though. Conventional medicine, as advocated by the American Medical Association, has always looked upon this form of alternative medicine as quackery.

-- Sparky (case@webtown.com), September 28, 2001.

I suggest this isn't the forum to get into an extended discussion of allopathic medicine versus various alternatives (vitamins, colloidal silver, whatever floats your boat). Nor do I have any interest in such a discussion.

I rather doubt there's any good evidence to support the use of these various alternatives against smallpox or anthrax. Frankly, as has correctly been noted even in some of the newspaper articles, the data for say Cipro are not as good as we would like. But personally I'll place my bets on the Cipro before vitamin C.

Good luck to you. Do drink lots of water if you're taking that much ascorbic acid!

-- Andre Weltman (aweltman@state.pa.us), September 28, 2001.

Everything about smallpox and then some.


-- Martin Thompson (mthom1927@aol.com), September 28, 2001.

From the GICC archives.

US on alert for smallpox terror attack

By Jeremy Laurence, health editor 22 April 2001 The US government has ordered 40 million doses of smallpox vaccine from a British company in a sign of the growing alarm that terrorists could unleash lethal viruses in future battles against Western states.

The astonishing size of the contract worth $343m (200m) highlights the fears on both sides of the Atlantic about the threat of biological terrorism. If a virus such as smallpox was released, the speed of modern communications could spread the infection all over the world in days.


-- Martin Thompson (mthom1927@aol.com), September 28, 2001.

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