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We are working on it. Scientists at USAMRIID (That's the US Army Medical Research Institute of Infectious Diseases, if acronyms are hard to decode.) are developing a candidate smallpox vaccine (vaccinia virus) that is currently in early human testing. The "Old" (FDA-licensed) smallpox vaccine was made by methods that current FDA rules, according to the "Good Manufacturing Practices" act, would not allow.

The licensed vaccine was made by scratching the vaccine virus all over the bellies of calves. Then, the skin reaction oozes a whitish ooze called lymph that accumulates on the skin surface, and some of it drips off. This stuff, containing vaccinia virions, is collected, cleaned up, and bottled with a green bacteriostatic chemical added to keep contamination to fewer than 300 bacteria per milliliter. Even cruder preparations than this were used outside the US by the WHO (world health organization) teams during the huge effort of "eradicating smallpox" in the world between 1966 and 1977. They went very quickly from calf belly ooze to vaccinations as they moved from town to town.

An "improved" smallpox vaccine candidate was prepared from a selected virus clone that was in the original licensed vaccine. This virus was then adapted for growth in tissue culture and monitored according to Good Manufacturing Practices regulations. The FDA regards it as an investigational new drug (IND) right now as it is being tested for safety in humans. It also may be used as a "vector" for expressing proteins encoded by genes for important antigens needed for vaccines such as one for Hantavirus Pulmonary Syndrome.

All of this is done very carefully with multiple successive reviews and approvals, and it is monitored by many interested agencies including the DOD, FDA, CDC and National Vaccine Commissions.

With regard to the other fears. I believe it would have been a mistake for us to just "Declare Smallpox Eradicated" and then go home and watch TV. Even if we did not imagine that some new or old "evil empire candidate" was harboring virulent smallpox, we might still have been at risk because of global travel, extreme sports and eco-tourism (ie mountain climbing, desert sailing, trekking and visits to places like antarctica and the north pole.)

I mention this because virulent smallpox viruses survive quite well in freezing temperatures and in dry hot climates. On the day that D. A. Henderson declared the WHO program successful, I held my breath that the next new Egyptian mummy, or Inca grave site on the top of the Andes would not launch the next smallpox epidemic.

The fearful situation Richard Preston brings to the fore in his recent "NewYawka" article creates a more honest perspective. A certain amount of justifiable fear has created an environment that gives support to scientists who are devoted to developing technology for ways of detecting these agents and for providing new vaccines and drugs for protection. The only way you can be sure you are protected is to know what "it" is and to have a means of actually generating protection. There must be vaccines available and perhaps antiviral drugs.

When the known lots of smallpox were destroyed in all but a freezer in Russia and a freezer at the CDC in Atlanta. The laboratories of the US Department of Defense do not, I repeat, do not have smallpox virus. No one wearing "uniforms" guards those virus lots in the US, they are in a civilian organization, the CDC.

It is important to test promising antiviral drugs to see if they can cure smallpox in experimental animals. There are many pox viruses like foul pox, monkey pox and cowpox (vaccinia is cowpox and cross reactive immunity to it is the basis of our smallpox vaccines efficacy). It is also important to develop newer and faster means of diagnosing smallpox before the virus completes incubating and causes disease. One of us, Dr. Sofi Ibrahim, is responsible for having generated important orthopox virus primers for use in polymerase chain reaction PCR-based diagnostics.

The lab I am associated with is developing high-tech "rapid diagnostic" devices and analyte-specific reagents in cooperative R&D relationships merging several government labs and industry. Our success in this arena has actually strained our manpower resources because big cities like New York and LA and major Federal Agencies keep calling our guys to brief them on our "research diagnostics." Fortunately, we are getting some help from the FDA's Television Station in preparing educational programs that can be beamed to municipal and government health care facilities instead of having to send our people in person.

When I refer to our diagnostic tests I use the term "research diagnostics" because all of these new tests have been developed in the past several years and none of them are licensed by the FDA. Yes, diagnostic tests must also be licensed and the process is time consuming and rigorous.

I actually am involved in the regulatory affairs and oversight aspects of test development because of both hats I wear, I direct our clinical pathology department and I chair our Institutional Review Board that reviews protocols involving ethical use of humans as volunteer subjects. Under the "Clinical Laboratory Improvement Act of 1988" and guidelines provided by the FDA's branch for medical devices, any use of these tests to diagnose human diseases while the tests are still regarded as investigational. Results must go out to the care-giver in a letter I write, or there must be a protocol my committee reviewed and approved, regardless which scientist actually does the test.

In many situations where America's very own "extremist" organizations send "letters labeled with the name of some scary infectious agent" to abortion clinics, I am the guy who has to tell my scientist that the results they send out to the worried "exposees" must have the caveat that the test is still considered research.

Anxiety is healthy. Without it people would step into holes out of which they might never emerge. This healthy anxiety is fueling an increased effort to develop lots of new and rapid remedies to Bio-terrorism. A beneficial spin-off of this effort is that we are speeding up the development of technologies that will make medicine cheaper, easier to access and better. People will no longer have to be satisfied when their doctor says sorry no antibiotic, it's a virus. Technologies we are developing now will make it possible in the near future to be able to find out what it is in time to be treated (if its a bad one) or not treated if it is only a cold.

Of course, I would be remiss if I neglected to mention that all of the above are my own personal opinions and do not represent any official position of any of the mentioned agencies, my lab, the Department of Defense or the Federal Government.

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