R.Bilenchi
31.01.2003, 21:05
hab mich mal mit dem jetzigen Stand der Biodefense Vaccines im Hinblick auf die zu erwartenden Investitionen und Forschungsgelder befasst,auch weil hier immer wieder starke Phantasie die Preise beflügelt,leider nur auf englisch,soviel Zeit zu übersetzen hab ich auch nicht.Die Impfungen sind offenbar auch umstritten
A reason against mass vaccination is that the risks could outweigh any benefits, particularly if no smallpox case ever appears.
Another problem with mass vaccination is that there are many strains of smallpox virus in existence, most of them uncharacterised, and vaccines against one strain may not protect against other strains, particularly if genetic engineered strains are designed to escape immune detection, as they can be So, the ‘standard epidemiologic response’ to smallpox, we are told, is to identify the disease, isolate the cases, vaccinate everyone known to have had direct contact with infected people since the first week of symptoms and then monitor their state of health
A mathematical model published in the current issue of Emerging Infectious Diseases suggests that a stockpile of 40 million doses is needed just for the US under those circumstances [7]. In other words, a new vaccine has to be made. But how can the efficacy, let alone the safety of the new vaccine be ascertained, when the disease has been globally eradicated? And it would not be ethical to deliberately challenge human subjects with Variola in order to study the vaccine
The FDA is attempting to overcome this deadlock. It published and requested comments on a proposed rule for approving new drug and biological products developed to prevent serious or life-threatening conditions based only on evidence of effectiveness derived from appropriate studies in animals, without adequate and well-controlled efficacy studies in humans. In other words, in a state of emergency, human beings will have to be guinea-pigs. Large pharmaceutical companies are being compelled to manufacture some 300 million doses of smallpox vaccine within a few months as an unlicensed "investigational new drug".
There is no effective cure or treatment for smallpox. Antiviral drug cidofovir proved effective against 31 strains of variola, the smallpox virus, but only in the test tube. It also protected monkeys exposed to monkeypox. But will it protect human beings against smallpox?
Anthrax vaccine already exists, but the company, BioPort of Lansing Michigan has ceased production since 1998. Of the 2 million doses it had, 1.8 were used by the Clinton Administration for mass vaccination of troops, the remaining 24 000 doses are dedicated to the military. Bioport’s vaccine is a complex broth of proteins filtered from a non-threatening strain of anthrax. Six shots are required for full protection, plus an annual booster. But this vaccine is at the centre of a new controversy [9].
Amid pressure to vaccinate civilians at risk for anthrax, evidence has emerged that unauthorized changes in the vaccine manufacturing process were made before the Gulf War that may have boosted the potency of the vaccine to dangerous levels.
veteran groups and armed services personnel have complained that the anthrax vaccine is unsafe. Researchers at the Army's biological warfare defence lab found as much as a 100-fold increase in the concentration of the anthrax vaccine’s active ingredient in batches produced after a switch to new filters in 1990.
The previously unpublished report was uncovered by investigators of the General Accounting Office, which has been studying the complaints from veterans and military personnel, and released its findings towards the end of October.
The report has bolstered suspicions by veterans that the anthrax vaccine they were given in 1990 is somehow related to Gulf War Syndrome, the symptoms of which include chronic pain, skin rashes, nausea, memory loss and concentration problems.
Not surprisingly, current efforts by the Pentagon to vaccinate 2.4 million military personnel have run into stubborn opposition by soldiers, sailors and airmen who maintain that a disproportionate number of those taking the shots have suffered dangerous side effects.
Army Spc. Sandra Larson of Spokane died of aplastic anemia after taking the sixth shot in the series. Last week, her family filed suit against vaccine maker Bioport Corp., of Lansing, Mich., alleging that the vaccine is at fault.
The company maintains that the vaccine is no more dangerous than childhood vaccines used against diphtheria and whooping cough (which also has its own critics as it turns out [10]). Bioport acquired rights to anthrax vaccine manufacturing in 1998 from Michigan Department of Public Health, which had been making it since 1970. Vaccines can be worse than useless for biodefence. The now officially recognised ‘side-effects’ of vaccinations may be far more extensive, as independent research by physicians and virologists are revealing
http://quotes.barchart.com/texpert.asp?sym=DOR
Jan. 29, 2003-- DOR BioPharma Inc . (AMEX:DOR -; "DOR") announced today that it will host a webcast on Friday, January 31st at 12:00 noon Eastern Time. DOR will discuss the implications of President Bush's $6 billion Project Bioshield biodefense vaccine stockpile initiative unveiled in his State of the Union address last evening as it relates to DOR's biodefense vaccines and business. Jan. 14, 2003 ("DOR" or the "Company") announced today that it has executed a letter of intent to exclusively license international patent applications covering intranasal microencapsuled vaccine technology, including anthrax and plague invented and tested by the U.K.'s Ministry of Defence (Porton Down), The only FDA approved anthrax vaccine, BioThrax(TM), requires six injections given over 18 months, with annual booster injections recommended thereafter.
This novel intranasal anthrax vaccine has been developed in the laboratory of Dr. Diane Williamson and Dr. Helene Flick-Smith at Porton Down, the United Kingdom's leading military research laboratory, in collaboration with Dr. Oya Alpar at the University of London School of Pharmacy The research was recently reported in the journal Infection and Immunity.
The microencapsulated anthrax vaccine technology and data already generated by the MOD should allow DOR to quickly develop an intranasal anthrax vaccines for human use which could potentially provide for rapid systemic and mucosal immunity without needles. The U.S. Government has indicated that it is seeking to procure an initial 25 million doses of a "Next Generation Anthrax Vaccine." DOR is aggressively pursuing this and other anthrax vaccine contract opportunities as well as application of its patented Microvax(TM) synthetic (non-live) mucosally administered vaccine technology to a number of other biodefense threats.
DOR heute minus 23%!
Monday January 27, 2:42 am ET
Edited Press Release
LONDON -(Dow Jones)- Acambis said Monday that the level of revenue it anticipated recording from the second (ACAM2000) smallpox contract with the U.S. Government would be in the range $70 million to $90 million for the 12 months ended Dec. 31 2002.
Acambis also said it expects to report revenues around the top end of this range when it announces preliminary results for the year ended Dec. 31 on March 11.
Jan 28, 2003 British drugs developer Acambis has met a strict deadline to supply the US
government with millions of smallpox vaccines to combat a possible bioterrorist
attack.
The Cambridge-based firm confirmed that in the past year it has delivered
vaccine worth close to UKpound 56 million - part of a UKpound 260 million order
for 155 million doses. Industry sources say the quantities are ahead of what was
expected.
Acambis played down speculation that the Americans had asked it to speed up
supplies because of the imminent prospects of war with Iraq. A spokesman
insisted: "It is down to the timing of the deliveries."Acambis ACM in London minus 5% heute
DynPort Vaccine Company LLC (DVC), a leading vaccine development company focused on biodefense vaccines, announced today that it will enter into a Phase I clinical trial consisting of approximately 70 volunteers for a new, injectable recombinant anthrax vaccine. The vaccine consists of a highly purified protein, protective antigen. Using recombinant technology and advanced production processes acquired from AVANT Immunotherapeutics, Inc ., of Needham, Massachusetts (Nasdaq: AVAN ), DVC hopes this vaccine will offer a safe, effective product to support the country's need for a new-generation anthrax vaccine.
Today, DynPort and Acambis are making
smallpox vaccines that are essentially the
same—both with help from BioReliance.
Last September, CDC awarded a
20-year, $343 million contract to OraVax,
a Cambridge, Massachusetts, biotech.
The price: $1.38 per dose. Both DynPort
and OraVax subcontracted
with
yet another outfit,
BioReliance of
Rockville, Maryland,
for help.concerns. (OraVax,
which in December
2000 changed its
name to Acambis),
The vaccine, called DryVax, is a dry powder made by the pharmaceutical firm
Wyeth , which produced some 15 million doses that have been stored in Atlanta by
the U.S. Centers for Disease Control and Prevention for decades.
More vaccine is being manufactured as a result of the 9/11 terrorist attacks.
Drug maker Aventis has provided a frozen supply of 70 million to 90 million
doses to the U.S. government , and a United Kingdom manufacturer, Acambis, is
under a recent contract to supply another 200 million doses .
Officials want enough to treat the entire U.S. population in case of a
bioterrorism attack with the virus causing smallpox, called variola.
http://www.dynport.com/
Dynport Vaccine Company A joint venture of DynCorp
and Porton International Inc Porton International Inc is a wholly-owned subsidiary of Beaufour-Ipsen , one of France's largest pharmaceutical companies, and is headquartered in Paris
4:01 PM ET Jan. 22, 2003
NEW YORK (CBS.MW) - Shares of Avant Immunotherapeutics soared Wednesday after the company secured a deal from the Defense Department to develop an oral vaccine to combat anthrax and the plague.The company estimates revenue from the agreement could approach $8 million over a two-year period that would cover development and pre-clinical testing.
The stock jumped 19 cents, or 18.3 percent, to close at $1.23, on heavy volume of 10.3 million shares.
The award comes to Avant from DynPort Vaccine Co. LLC, the prime contractor for the Defense Department's joint vaccine acquisition program, and the company sees its arrival as a financial boon.
. BRISBANE, Calif. and KUMAMOTO, Japan, Dec. 17 /PRNewswire-FirstCall/ -- VaxGen, Inc. (Nasdaq: VXGN , news) and the Chemo-Sero-Therapeutic Research Institute (Kaketsuken) announced today that they have entered into initial agreements that will allow VaxGen to initiate development of Kaketsuken's attenuated smallpox vaccine for use in the United States. VaxGen believes that the vaccine, licensed in Japan in 1980, will have a better safety profile, yet be equally effective, compared to smallpox vaccines currently available in the United States.
The vaccine, LC16-Kaketsuken, already has been administered to approximately 50,000 Japanese children, in whom no serious side effects were observed. " ... In a field trial of 50,000 persons, (the vaccine) was found to produce a markedly lower frequency of reactions than that noted for other strains" of vaccinia used to make smallpox vaccines, according to the authoritative reference, Vaccines. (Stanley A. Plotkin, M.D., and Walter A. Orenstein, M.D., 1999)
The vaccine gives a pock, or "take," at the site of injection at a rate similar to smallpox vaccines currently stockpiled in the United States. The "take" has long been accepted by public health authorities as evidence of successful immunization against smallpox. The vaccine is based on the LC16m8 clone of the internationally accepted Lister strain of vaccinia virus.
The agreement calls for VaxGen to initiate clinical trials with LC16-Kaketsuken in the U.S., which VaxGen expects to start early next year, subject to consent from the U.S. Food and Drug Administration (FDA). VaxGen will be responsible for clinical development and related activities necessary to meet the requirement for licensure through the FDA. VaxGen and Kaketsuken are currently negotiating the extension of their partnership to address vaccine supply and commercialization.
"LC16-Kaketsuken may offer a valuable alternative to conventional and new non-attenuated vaccines for protecting people against the threat of smallpox as a bioterrorist weapon," said Lance K. Gordon, Ph.D., VaxGen's chief executive. "We believe this vaccine could be an essential tool in the U.S. biodefense arsenal if it can be shown to meet U.S. requirements."
[Kaketsuken official] added: "We look forward to working with VaxGen on this very important initiative. Through this partnership, we intend to make LC16-Kaketsuken available to the United States to help protect its citizens against the threat of smallpox."
bei Vaxgen ist wohl Vorsicht angesagt,bisher hat kein einziger Impfstoff gegen Aids Erfolg gehabt,im Gegenteil s.:
http://www.i-sis.org.uk/isisnews/i-sisnews11-19.php
die Entscheidung wird im März erwartet. :D
A reason against mass vaccination is that the risks could outweigh any benefits, particularly if no smallpox case ever appears.
Another problem with mass vaccination is that there are many strains of smallpox virus in existence, most of them uncharacterised, and vaccines against one strain may not protect against other strains, particularly if genetic engineered strains are designed to escape immune detection, as they can be So, the ‘standard epidemiologic response’ to smallpox, we are told, is to identify the disease, isolate the cases, vaccinate everyone known to have had direct contact with infected people since the first week of symptoms and then monitor their state of health
A mathematical model published in the current issue of Emerging Infectious Diseases suggests that a stockpile of 40 million doses is needed just for the US under those circumstances [7]. In other words, a new vaccine has to be made. But how can the efficacy, let alone the safety of the new vaccine be ascertained, when the disease has been globally eradicated? And it would not be ethical to deliberately challenge human subjects with Variola in order to study the vaccine
The FDA is attempting to overcome this deadlock. It published and requested comments on a proposed rule for approving new drug and biological products developed to prevent serious or life-threatening conditions based only on evidence of effectiveness derived from appropriate studies in animals, without adequate and well-controlled efficacy studies in humans. In other words, in a state of emergency, human beings will have to be guinea-pigs. Large pharmaceutical companies are being compelled to manufacture some 300 million doses of smallpox vaccine within a few months as an unlicensed "investigational new drug".
There is no effective cure or treatment for smallpox. Antiviral drug cidofovir proved effective against 31 strains of variola, the smallpox virus, but only in the test tube. It also protected monkeys exposed to monkeypox. But will it protect human beings against smallpox?
Anthrax vaccine already exists, but the company, BioPort of Lansing Michigan has ceased production since 1998. Of the 2 million doses it had, 1.8 were used by the Clinton Administration for mass vaccination of troops, the remaining 24 000 doses are dedicated to the military. Bioport’s vaccine is a complex broth of proteins filtered from a non-threatening strain of anthrax. Six shots are required for full protection, plus an annual booster. But this vaccine is at the centre of a new controversy [9].
Amid pressure to vaccinate civilians at risk for anthrax, evidence has emerged that unauthorized changes in the vaccine manufacturing process were made before the Gulf War that may have boosted the potency of the vaccine to dangerous levels.
veteran groups and armed services personnel have complained that the anthrax vaccine is unsafe. Researchers at the Army's biological warfare defence lab found as much as a 100-fold increase in the concentration of the anthrax vaccine’s active ingredient in batches produced after a switch to new filters in 1990.
The previously unpublished report was uncovered by investigators of the General Accounting Office, which has been studying the complaints from veterans and military personnel, and released its findings towards the end of October.
The report has bolstered suspicions by veterans that the anthrax vaccine they were given in 1990 is somehow related to Gulf War Syndrome, the symptoms of which include chronic pain, skin rashes, nausea, memory loss and concentration problems.
Not surprisingly, current efforts by the Pentagon to vaccinate 2.4 million military personnel have run into stubborn opposition by soldiers, sailors and airmen who maintain that a disproportionate number of those taking the shots have suffered dangerous side effects.
Army Spc. Sandra Larson of Spokane died of aplastic anemia after taking the sixth shot in the series. Last week, her family filed suit against vaccine maker Bioport Corp., of Lansing, Mich., alleging that the vaccine is at fault.
The company maintains that the vaccine is no more dangerous than childhood vaccines used against diphtheria and whooping cough (which also has its own critics as it turns out [10]). Bioport acquired rights to anthrax vaccine manufacturing in 1998 from Michigan Department of Public Health, which had been making it since 1970. Vaccines can be worse than useless for biodefence. The now officially recognised ‘side-effects’ of vaccinations may be far more extensive, as independent research by physicians and virologists are revealing
http://quotes.barchart.com/texpert.asp?sym=DOR
Jan. 29, 2003-- DOR BioPharma Inc . (AMEX:DOR -; "DOR") announced today that it will host a webcast on Friday, January 31st at 12:00 noon Eastern Time. DOR will discuss the implications of President Bush's $6 billion Project Bioshield biodefense vaccine stockpile initiative unveiled in his State of the Union address last evening as it relates to DOR's biodefense vaccines and business. Jan. 14, 2003 ("DOR" or the "Company") announced today that it has executed a letter of intent to exclusively license international patent applications covering intranasal microencapsuled vaccine technology, including anthrax and plague invented and tested by the U.K.'s Ministry of Defence (Porton Down), The only FDA approved anthrax vaccine, BioThrax(TM), requires six injections given over 18 months, with annual booster injections recommended thereafter.
This novel intranasal anthrax vaccine has been developed in the laboratory of Dr. Diane Williamson and Dr. Helene Flick-Smith at Porton Down, the United Kingdom's leading military research laboratory, in collaboration with Dr. Oya Alpar at the University of London School of Pharmacy The research was recently reported in the journal Infection and Immunity.
The microencapsulated anthrax vaccine technology and data already generated by the MOD should allow DOR to quickly develop an intranasal anthrax vaccines for human use which could potentially provide for rapid systemic and mucosal immunity without needles. The U.S. Government has indicated that it is seeking to procure an initial 25 million doses of a "Next Generation Anthrax Vaccine." DOR is aggressively pursuing this and other anthrax vaccine contract opportunities as well as application of its patented Microvax(TM) synthetic (non-live) mucosally administered vaccine technology to a number of other biodefense threats.
DOR heute minus 23%!
Monday January 27, 2:42 am ET
Edited Press Release
LONDON -(Dow Jones)- Acambis said Monday that the level of revenue it anticipated recording from the second (ACAM2000) smallpox contract with the U.S. Government would be in the range $70 million to $90 million for the 12 months ended Dec. 31 2002.
Acambis also said it expects to report revenues around the top end of this range when it announces preliminary results for the year ended Dec. 31 on March 11.
Jan 28, 2003 British drugs developer Acambis has met a strict deadline to supply the US
government with millions of smallpox vaccines to combat a possible bioterrorist
attack.
The Cambridge-based firm confirmed that in the past year it has delivered
vaccine worth close to UKpound 56 million - part of a UKpound 260 million order
for 155 million doses. Industry sources say the quantities are ahead of what was
expected.
Acambis played down speculation that the Americans had asked it to speed up
supplies because of the imminent prospects of war with Iraq. A spokesman
insisted: "It is down to the timing of the deliveries."Acambis ACM in London minus 5% heute
DynPort Vaccine Company LLC (DVC), a leading vaccine development company focused on biodefense vaccines, announced today that it will enter into a Phase I clinical trial consisting of approximately 70 volunteers for a new, injectable recombinant anthrax vaccine. The vaccine consists of a highly purified protein, protective antigen. Using recombinant technology and advanced production processes acquired from AVANT Immunotherapeutics, Inc ., of Needham, Massachusetts (Nasdaq: AVAN ), DVC hopes this vaccine will offer a safe, effective product to support the country's need for a new-generation anthrax vaccine.
Today, DynPort and Acambis are making
smallpox vaccines that are essentially the
same—both with help from BioReliance.
Last September, CDC awarded a
20-year, $343 million contract to OraVax,
a Cambridge, Massachusetts, biotech.
The price: $1.38 per dose. Both DynPort
and OraVax subcontracted
with
yet another outfit,
BioReliance of
Rockville, Maryland,
for help.concerns. (OraVax,
which in December
2000 changed its
name to Acambis),
The vaccine, called DryVax, is a dry powder made by the pharmaceutical firm
Wyeth , which produced some 15 million doses that have been stored in Atlanta by
the U.S. Centers for Disease Control and Prevention for decades.
More vaccine is being manufactured as a result of the 9/11 terrorist attacks.
Drug maker Aventis has provided a frozen supply of 70 million to 90 million
doses to the U.S. government , and a United Kingdom manufacturer, Acambis, is
under a recent contract to supply another 200 million doses .
Officials want enough to treat the entire U.S. population in case of a
bioterrorism attack with the virus causing smallpox, called variola.
http://www.dynport.com/
Dynport Vaccine Company A joint venture of DynCorp
and Porton International Inc Porton International Inc is a wholly-owned subsidiary of Beaufour-Ipsen , one of France's largest pharmaceutical companies, and is headquartered in Paris
4:01 PM ET Jan. 22, 2003
NEW YORK (CBS.MW) - Shares of Avant Immunotherapeutics soared Wednesday after the company secured a deal from the Defense Department to develop an oral vaccine to combat anthrax and the plague.The company estimates revenue from the agreement could approach $8 million over a two-year period that would cover development and pre-clinical testing.
The stock jumped 19 cents, or 18.3 percent, to close at $1.23, on heavy volume of 10.3 million shares.
The award comes to Avant from DynPort Vaccine Co. LLC, the prime contractor for the Defense Department's joint vaccine acquisition program, and the company sees its arrival as a financial boon.
. BRISBANE, Calif. and KUMAMOTO, Japan, Dec. 17 /PRNewswire-FirstCall/ -- VaxGen, Inc. (Nasdaq: VXGN , news) and the Chemo-Sero-Therapeutic Research Institute (Kaketsuken) announced today that they have entered into initial agreements that will allow VaxGen to initiate development of Kaketsuken's attenuated smallpox vaccine for use in the United States. VaxGen believes that the vaccine, licensed in Japan in 1980, will have a better safety profile, yet be equally effective, compared to smallpox vaccines currently available in the United States.
The vaccine, LC16-Kaketsuken, already has been administered to approximately 50,000 Japanese children, in whom no serious side effects were observed. " ... In a field trial of 50,000 persons, (the vaccine) was found to produce a markedly lower frequency of reactions than that noted for other strains" of vaccinia used to make smallpox vaccines, according to the authoritative reference, Vaccines. (Stanley A. Plotkin, M.D., and Walter A. Orenstein, M.D., 1999)
The vaccine gives a pock, or "take," at the site of injection at a rate similar to smallpox vaccines currently stockpiled in the United States. The "take" has long been accepted by public health authorities as evidence of successful immunization against smallpox. The vaccine is based on the LC16m8 clone of the internationally accepted Lister strain of vaccinia virus.
The agreement calls for VaxGen to initiate clinical trials with LC16-Kaketsuken in the U.S., which VaxGen expects to start early next year, subject to consent from the U.S. Food and Drug Administration (FDA). VaxGen will be responsible for clinical development and related activities necessary to meet the requirement for licensure through the FDA. VaxGen and Kaketsuken are currently negotiating the extension of their partnership to address vaccine supply and commercialization.
"LC16-Kaketsuken may offer a valuable alternative to conventional and new non-attenuated vaccines for protecting people against the threat of smallpox as a bioterrorist weapon," said Lance K. Gordon, Ph.D., VaxGen's chief executive. "We believe this vaccine could be an essential tool in the U.S. biodefense arsenal if it can be shown to meet U.S. requirements."
[Kaketsuken official] added: "We look forward to working with VaxGen on this very important initiative. Through this partnership, we intend to make LC16-Kaketsuken available to the United States to help protect its citizens against the threat of smallpox."
bei Vaxgen ist wohl Vorsicht angesagt,bisher hat kein einziger Impfstoff gegen Aids Erfolg gehabt,im Gegenteil s.:
http://www.i-sis.org.uk/isisnews/i-sisnews11-19.php
die Entscheidung wird im März erwartet. :D