For those interested... -- more info on HPV vaccine

[Guest guest]

HPV is Human Papilloma Virus, predominantly a sexually transmitted disease. The vaccine is given to males and females, between the ages of 3 months and 77 years. VAERS reports involving this vaccine are now 15 to 20 percent of all VAERS reports filed (VAERS = Vaccine Adverse Events Reporting Service). More information on this vaccine can be found at NVIC's (National Vaccine Information Center's) site, given at the end of the article. ~~ for immediate releaseFebruary 21, 2007 VACCINE SAFETY GROUP RELEASES GARDASIL REACTION REPORTCalls on FDA and CDC to Warn Doctors and Parents to Report to VAERS Washington, D.C. - The National Vaccine Information Center (NVIC) today released a new analysis of the federal

Vaccine Adverse Event Reporting System (VAERS) reports of serious health problems following HPV vaccination (Merck's GARDASIL) during the last six months of 2006. Out of the 385 individual GARDASIL adverse event reports made to VAERS, two-thirds required additional medical care and about one-third of all reports were for children 16-years-old and under, with nearly 25 percent of those children having received simultaneously one or more of the 18 vaccines that Merck did not study in combination with GARDASIL. NVIC is calling on the FDA and CDC to warn parents and doctors that GARDASIL should not be combined with other vaccines and that young girls should be monitored for at least 24 hours for syncopal (collapse/fainting) episodes that can be accompanied by seizure activity, as well as symptoms of tingling, numbness and loss of sensation in the fingers and limbs, all of which should be reported to VAERS immediately. "Because Merck only studied GARDASIL in fewer than 1200 girls under age 16 in pre-licensure trials, it is critical that doctors and parents be made aware of the nature of the initial adverse event reports coming into VAERS and that they report serious health problems after vaccination when they occur," said NVIC President Barbara Loe Fisher. "There are twice as many children collapsing and four times as many children experiencing tingling, numbness and loss of sensation after getting a GARDASIL vaccination compared to those getting a Tdap (tetanus-diphtheria -acellular pertussis) vaccination. There have been reports of facial paralysis and Guillain-Barre Syndrome. And doctors who give GARDASIL in combination with other vaccines are basically conducting an experiment on their young patients because Merck has not published any safety data for simultaneous vaccination with any vaccine except hepatitis B vaccine." According to NVIC's report, a majority of GARDASIL adverse event reports to VAERS involved those who suffered fever, nausea, headache or pain; 14 percent were for syncopal episodes with or without neurological signs; and 8 percent experienced tingling, numbness and loss of sensation, facial paralysis or Guillain-Barre Syndrome. Although adverse event reports to VAERS do not prove causation, they can provide an early warning sign that a new vaccine may be causing health problems that could be important. For example, reports to VAERS of bowel blockage (intussusception) in babies following receipt of Merck's Rota Teq (rotavirus) vaccine prompted the FDA to issue a public warning to doctors and consumers on Feb. 13. [1] "About 4 reports per day were filed with VAERS in December 2006 for the HPV vaccine," said NVIC Health Policy Analyst Vicky Debold, RN, Ph.D. "Some of these girls are being injured when they collapse after getting the vaccine and others are complaining of neurological symptoms that should not be ignored. Doctors and nurses should take note of the patient safety issues related to giving this vaccine. Giving GARDASIL simultaneously with any of the 18 vaccines Merck did not study in combination is not an evidence-based guideline and should involve informed consent and a signed patient release. To avoid unnecessary injuries, teenage girls should be vaccinated laying down, not be left unattended and probably should not walk or drive themselves home from the doctor's office after

they get vaccinated." NVIC also found that there were several VAERS reports of HPV infection, genital warts and cervical lesions after GARDASIL vaccination. It is unknown if the girls were infected with HPV before being vaccinated or if GARDASIL failed to protect them. One case of HPV infection occurred in a 22-year-old girl who had participated in a Merck GARDASIL trial in 2003 when she had shown "strong conversion to all 4 vaccine types" but "tested positive for high risk HPV" in 2006, according to the VAERS report. In a May 18, 2006 Background Document for the FDA Vaccines and Related Biological Products Advisory Committee (VRPBAC), the FDA staff stated that Merck clinical trial data indicated there may be "the potential for GARDASIL to enhance cervical disease in subjects who had evidence of persistent

infection with vaccine-relevant HPV types prior to vaccination. " [2] Girls and women now being vaccinated with GARDASIL are not routinely being tested for active HPV infection before vaccination. The FDA staff also questioned whether the “HPV types not contained in the vaccine might offset the overall clinical effectiveness of the vaccine.” There are more than 15 types of HPV associated with cervical cancer but GARDASIL only contains HPV types 16 and 18. It is unknown whether non-vaccine HPV types will become more dominant in the future. However, there are indications this could occur because some of the seven strains of pneumococcal contained in Wyeth’s PREVNAR vaccine, which was recommended by the CDC for universal use in all babies in 2000, have been replaced by some of the

more than 80 other pneumococcal strains not contained in the vaccine. [4] [5] [6] VAERS is a passive surveillance system and depends upon voluntary reporting of serious health problems following vaccination, even though safety provisions in the National Childhood Vaccine Injury Act of 1986 mandated that health care providers report vaccine adverse events. There have been estimates that fewer than 10 percent, even as low as 1 to 4 percent, of adverse events which occur after prescription drug or vaccine use are ever reported to government adverse event reporting systems. [7] [8] [9] [10] "If only 1 to 4 percent of all adverse events associated with GARDASIL vaccination are being reported to VAERS, there could have been up to 38,000 health problems after GARDASIL vaccination in 2006 which were never reported," said Fisher. "How many girls are really having short-term health problems associated with getting this vaccine that could turn into long-term neurological or immune system disorders? And how many will go on to develop fertility problems, cancer or damage to their genes, all of which Merck admits in its product insert that it has not studied at all? We just don't know enough to be mandating GARDASIL for anyone, much less vulnerable 11 to 12 year old girls entering puberty." For a copy of NVIC's Report on VAERS and GARDASIL, references for this statement and information about how to report a vaccine reaction to VAERS, go to www.nvic.org. __________________________________________________

[Guest guest]

What they are not saying is there have been deaths. There have been serious disabilities

For those interested... -- more info on HPV vaccine

HPV is Human Papilloma Virus, predominantly a sexually transmitted disease. The vaccine is given to males and females, between the ages of 3 months and 77 years. VAERS reports involving this vaccine are now 15 to 20 percent of all VAERS reports filed (VAERS = Vaccine Adverse Events Reporting Service). More information on this vaccine can be found at NVIC's (National Vaccine Information Center's) site, given at the end of the article.

~~

for immediate releaseFebruary 21, 2007

VACCINE SAFETY GROUP RELEASES GARDASIL REACTION REPORTCalls on FDA and CDC to Warn Doctors and Parents to Report to VAERS

Washington, D.C. - The National Vaccine Information Center (NVIC) today released a new analysis of the federal Vaccine Adverse Event Reporting System (VAERS) reports of serious health problems following HPV vaccination (Merck's GARDASIL) during the last six months of 2006. Out of the 385 individual GARDASIL adverse event reports made to VAERS, two-thirds required additional medical care and about one-third of all reports were for children 16-years-old and under, with nearly 25 percent of those children having received simultaneously one or more of the 18 vaccines that Merck did not study in combination with GARDASIL. NVIC is calling on the FDA and CDC to warn parents and doctors that GARDASIL should not be combined with other vaccines and that young girls should be monitored for at least 24 hours for syncopal (collapse/fainting) episodes that can be accompanied by seizure activity, as well as symptoms of tingling, numbness and loss of sensation in the fingers and limbs, all of which should be reported to VAERS immediately.

"Because Merck only studied GARDASIL in fewer than 1200 girls under age 16 in pre-licensure trials, it is critical that doctors and parents be made aware of the nature of the initial adverse event reports coming into VAERS and that they report serious health problems after vaccination when they occur," said NVIC President Barbara Loe Fisher. "There are twice as many children collapsing and four times as many children experiencing tingling, numbness and loss of sensation after getting a GARDASIL vaccination compared to those getting a Tdap (tetanus-diphtheria -acellular pertussis) vaccination. There have been reports of facial paralysis and Guillain-Barre Syndrome. And doctors who give GARDASIL in combination with other vaccines are basically conducting an experiment on their young patients because Merck has not published any safety data for simultaneous vaccination with any vaccine except hepatitis B vaccine."

According to NVIC's report, a majority of GARDASIL adverse event reports to VAERS involved those who suffered fever, nausea, headache or pain; 14 percent were for syncopal episodes with or without neurological signs; and 8 percent experienced tingling, numbness and loss of sensation, facial paralysis or Guillain-Barre Syndrome.

Although adverse event reports to VAERS do not prove causation, they can provide an early warning sign that a new vaccine may be causing health problems that could be important. For example, reports to VAERS of bowel blockage (intussusception) in babies following receipt of Merck's Rota Teq (rotavirus) vaccine prompted the FDA to issue a public warning to doctors and consumers on Feb. 13. [1]

"About 4 reports per day were filed with VAERS in December 2006 for the HPV vaccine," said NVIC Health Policy Analyst Vicky Debold, RN, Ph.D. "Some of these girls are being injured when they collapse after getting the vaccine and others are complaining of neurological symptoms that should not be ignored. Doctors and nurses should take note of the patient safety issues related to giving this vaccine. Giving GARDASIL simultaneously with any of the 18 vaccines Merck did not study in combination is not an evidence-based guideline and should involve informed consent and a signed patient release. To avoid unnecessary injuries, teenage girls should be vaccinated laying down, not be left unattended and probably should not walk or drive themselves home from the doctor's office after they get vaccinated."

NVIC also found that there were several VAERS reports of HPV infection, genital warts and cervical lesions after GARDASIL vaccination. It is unknown if the girls were infected with HPV before being vaccinated or if GARDASIL failed to protect them. One case of HPV infection occurred in a 22-year-old girl who had participated in a Merck GARDASIL trial in 2003 when she had shown "strong conversion to all 4 vaccine types" but "tested positive for high risk HPV" in 2006, according to the VAERS report.

In a May 18, 2006 Background Document for the FDA Vaccines and Related Biological Products Advisory Committee (VRPBAC), the FDA staff stated that Merck clinical trial data indicated there may be "the potential for GARDASIL to enhance cervical disease in subjects who had evidence of persistent infection with vaccine-relevant HPV types prior to vaccination. " [2] Girls and women now being vaccinated with GARDASIL are not routinely being tested for active HPV infection before vaccination.

The FDA staff also questioned whether the “HPV types not contained in the vaccine might offset the overall clinical effectiveness of the vaccine.” There are more than 15 types of HPV associated with cervical cancer but GARDASIL only contains HPV types 16 and 18. It is unknown whether non-vaccine HPV types will become more dominant in the future. However, there are indications this could occur because some of the seven strains of pneumococcal contained in Wyeth’s PREVNAR vaccine, which was recommended by the CDC for universal use in all babies in 2000, have been replaced by some of the more than 80 other pneumococcal strains not contained in the vaccine. [4] [5] [6]

VAERS is a passive surveillance system and depends upon voluntary reporting of serious health problems following vaccination, even though safety provisions in the National Childhood Vaccine Injury Act of 1986 mandated that health care providers report vaccine adverse events. There have been estimates that fewer than 10 percent, even as low as 1 to 4 percent, of adverse events which occur after prescription drug or vaccine use are ever reported to government adverse event reporting systems. [7] [8] [9] [10]

"If only 1 to 4 percent of all adverse events associated with GARDASIL vaccination are being reported to VAERS, there could have been up to 38,000 health problems after GARDASIL vaccination in 2006 which were never reported," said Fisher. "How many girls are really having short-term health problems associated with getting this vaccine that could turn into long-term neurological or immune system disorders? And how many will go on to develop fertility problems, cancer or damage to their genes, all of which Merck admits in its product insert that it has not studied at all? We just don't know enough to be mandating GARDASIL for anyone, much less vulnerable 11 to 12 year old girls entering puberty."

For a copy of NVIC's Report on VAERS and GARDASIL, references for this statement and information about how to report a vaccine reaction to VAERS, go to www.nvic.org.

__________________________________________________

[Guest guest]

What they are not saying is there have been deaths. There have been serious disabilities

For those interested... -- more info on HPV vaccine

HPV is Human Papilloma Virus, predominantly a sexually transmitted disease. The vaccine is given to males and females, between the ages of 3 months and 77 years. VAERS reports involving this vaccine are now 15 to 20 percent of all VAERS reports filed (VAERS = Vaccine Adverse Events Reporting Service). More information on this vaccine can be found at NVIC's (National Vaccine Information Center's) site, given at the end of the article.

~~

for immediate releaseFebruary 21, 2007

VACCINE SAFETY GROUP RELEASES GARDASIL REACTION REPORTCalls on FDA and CDC to Warn Doctors and Parents to Report to VAERS

Washington, D.C. - The National Vaccine Information Center (NVIC) today released a new analysis of the federal Vaccine Adverse Event Reporting System (VAERS) reports of serious health problems following HPV vaccination (Merck's GARDASIL) during the last six months of 2006. Out of the 385 individual GARDASIL adverse event reports made to VAERS, two-thirds required additional medical care and about one-third of all reports were for children 16-years-old and under, with nearly 25 percent of those children having received simultaneously one or more of the 18 vaccines that Merck did not study in combination with GARDASIL. NVIC is calling on the FDA and CDC to warn parents and doctors that GARDASIL should not be combined with other vaccines and that young girls should be monitored for at least 24 hours for syncopal (collapse/fainting) episodes that can be accompanied by seizure activity, as well as symptoms of tingling, numbness and loss of sensation in the fingers and limbs, all of which should be reported to VAERS immediately.

"Because Merck only studied GARDASIL in fewer than 1200 girls under age 16 in pre-licensure trials, it is critical that doctors and parents be made aware of the nature of the initial adverse event reports coming into VAERS and that they report serious health problems after vaccination when they occur," said NVIC President Barbara Loe Fisher. "There are twice as many children collapsing and four times as many children experiencing tingling, numbness and loss of sensation after getting a GARDASIL vaccination compared to those getting a Tdap (tetanus-diphtheria -acellular pertussis) vaccination. There have been reports of facial paralysis and Guillain-Barre Syndrome. And doctors who give GARDASIL in combination with other vaccines are basically conducting an experiment on their young patients because Merck has not published any safety data for simultaneous vaccination with any vaccine except hepatitis B vaccine."

According to NVIC's report, a majority of GARDASIL adverse event reports to VAERS involved those who suffered fever, nausea, headache or pain; 14 percent were for syncopal episodes with or without neurological signs; and 8 percent experienced tingling, numbness and loss of sensation, facial paralysis or Guillain-Barre Syndrome.

Although adverse event reports to VAERS do not prove causation, they can provide an early warning sign that a new vaccine may be causing health problems that could be important. For example, reports to VAERS of bowel blockage (intussusception) in babies following receipt of Merck's Rota Teq (rotavirus) vaccine prompted the FDA to issue a public warning to doctors and consumers on Feb. 13. [1]

"About 4 reports per day were filed with VAERS in December 2006 for the HPV vaccine," said NVIC Health Policy Analyst Vicky Debold, RN, Ph.D. "Some of these girls are being injured when they collapse after getting the vaccine and others are complaining of neurological symptoms that should not be ignored. Doctors and nurses should take note of the patient safety issues related to giving this vaccine. Giving GARDASIL simultaneously with any of the 18 vaccines Merck did not study in combination is not an evidence-based guideline and should involve informed consent and a signed patient release. To avoid unnecessary injuries, teenage girls should be vaccinated laying down, not be left unattended and probably should not walk or drive themselves home from the doctor's office after they get vaccinated."

NVIC also found that there were several VAERS reports of HPV infection, genital warts and cervical lesions after GARDASIL vaccination. It is unknown if the girls were infected with HPV before being vaccinated or if GARDASIL failed to protect them. One case of HPV infection occurred in a 22-year-old girl who had participated in a Merck GARDASIL trial in 2003 when she had shown "strong conversion to all 4 vaccine types" but "tested positive for high risk HPV" in 2006, according to the VAERS report.

In a May 18, 2006 Background Document for the FDA Vaccines and Related Biological Products Advisory Committee (VRPBAC), the FDA staff stated that Merck clinical trial data indicated there may be "the potential for GARDASIL to enhance cervical disease in subjects who had evidence of persistent infection with vaccine-relevant HPV types prior to vaccination. " [2] Girls and women now being vaccinated with GARDASIL are not routinely being tested for active HPV infection before vaccination.

The FDA staff also questioned whether the “HPV types not contained in the vaccine might offset the overall clinical effectiveness of the vaccine.” There are more than 15 types of HPV associated with cervical cancer but GARDASIL only contains HPV types 16 and 18. It is unknown whether non-vaccine HPV types will become more dominant in the future. However, there are indications this could occur because some of the seven strains of pneumococcal contained in Wyeth’s PREVNAR vaccine, which was recommended by the CDC for universal use in all babies in 2000, have been replaced by some of the more than 80 other pneumococcal strains not contained in the vaccine. [4] [5] [6]

VAERS is a passive surveillance system and depends upon voluntary reporting of serious health problems following vaccination, even though safety provisions in the National Childhood Vaccine Injury Act of 1986 mandated that health care providers report vaccine adverse events. There have been estimates that fewer than 10 percent, even as low as 1 to 4 percent, of adverse events which occur after prescription drug or vaccine use are ever reported to government adverse event reporting systems. [7] [8] [9] [10]

"If only 1 to 4 percent of all adverse events associated with GARDASIL vaccination are being reported to VAERS, there could have been up to 38,000 health problems after GARDASIL vaccination in 2006 which were never reported," said Fisher. "How many girls are really having short-term health problems associated with getting this vaccine that could turn into long-term neurological or immune system disorders? And how many will go on to develop fertility problems, cancer or damage to their genes, all of which Merck admits in its product insert that it has not studied at all? We just don't know enough to be mandating GARDASIL for anyone, much less vulnerable 11 to 12 year old girls entering puberty."

For a copy of NVIC's Report on VAERS and GARDASIL, references for this statement and information about how to report a vaccine reaction to VAERS, go to www.nvic.org.

__________________________________________________

[Guest guest]

What they are not saying is there have been deaths. There have been serious disabilities

For those interested... -- more info on HPV vaccine

HPV is Human Papilloma Virus, predominantly a sexually transmitted disease. The vaccine is given to males and females, between the ages of 3 months and 77 years. VAERS reports involving this vaccine are now 15 to 20 percent of all VAERS reports filed (VAERS = Vaccine Adverse Events Reporting Service). More information on this vaccine can be found at NVIC's (National Vaccine Information Center's) site, given at the end of the article.

~~

for immediate releaseFebruary 21, 2007

VACCINE SAFETY GROUP RELEASES GARDASIL REACTION REPORTCalls on FDA and CDC to Warn Doctors and Parents to Report to VAERS

Washington, D.C. - The National Vaccine Information Center (NVIC) today released a new analysis of the federal Vaccine Adverse Event Reporting System (VAERS) reports of serious health problems following HPV vaccination (Merck's GARDASIL) during the last six months of 2006. Out of the 385 individual GARDASIL adverse event reports made to VAERS, two-thirds required additional medical care and about one-third of all reports were for children 16-years-old and under, with nearly 25 percent of those children having received simultaneously one or more of the 18 vaccines that Merck did not study in combination with GARDASIL. NVIC is calling on the FDA and CDC to warn parents and doctors that GARDASIL should not be combined with other vaccines and that young girls should be monitored for at least 24 hours for syncopal (collapse/fainting) episodes that can be accompanied by seizure activity, as well as symptoms of tingling, numbness and loss of sensation in the fingers and limbs, all of which should be reported to VAERS immediately.

"Because Merck only studied GARDASIL in fewer than 1200 girls under age 16 in pre-licensure trials, it is critical that doctors and parents be made aware of the nature of the initial adverse event reports coming into VAERS and that they report serious health problems after vaccination when they occur," said NVIC President Barbara Loe Fisher. "There are twice as many children collapsing and four times as many children experiencing tingling, numbness and loss of sensation after getting a GARDASIL vaccination compared to those getting a Tdap (tetanus-diphtheria -acellular pertussis) vaccination. There have been reports of facial paralysis and Guillain-Barre Syndrome. And doctors who give GARDASIL in combination with other vaccines are basically conducting an experiment on their young patients because Merck has not published any safety data for simultaneous vaccination with any vaccine except hepatitis B vaccine."

According to NVIC's report, a majority of GARDASIL adverse event reports to VAERS involved those who suffered fever, nausea, headache or pain; 14 percent were for syncopal episodes with or without neurological signs; and 8 percent experienced tingling, numbness and loss of sensation, facial paralysis or Guillain-Barre Syndrome.

Although adverse event reports to VAERS do not prove causation, they can provide an early warning sign that a new vaccine may be causing health problems that could be important. For example, reports to VAERS of bowel blockage (intussusception) in babies following receipt of Merck's Rota Teq (rotavirus) vaccine prompted the FDA to issue a public warning to doctors and consumers on Feb. 13. [1]

"About 4 reports per day were filed with VAERS in December 2006 for the HPV vaccine," said NVIC Health Policy Analyst Vicky Debold, RN, Ph.D. "Some of these girls are being injured when they collapse after getting the vaccine and others are complaining of neurological symptoms that should not be ignored. Doctors and nurses should take note of the patient safety issues related to giving this vaccine. Giving GARDASIL simultaneously with any of the 18 vaccines Merck did not study in combination is not an evidence-based guideline and should involve informed consent and a signed patient release. To avoid unnecessary injuries, teenage girls should be vaccinated laying down, not be left unattended and probably should not walk or drive themselves home from the doctor's office after they get vaccinated."

NVIC also found that there were several VAERS reports of HPV infection, genital warts and cervical lesions after GARDASIL vaccination. It is unknown if the girls were infected with HPV before being vaccinated or if GARDASIL failed to protect them. One case of HPV infection occurred in a 22-year-old girl who had participated in a Merck GARDASIL trial in 2003 when she had shown "strong conversion to all 4 vaccine types" but "tested positive for high risk HPV" in 2006, according to the VAERS report.

In a May 18, 2006 Background Document for the FDA Vaccines and Related Biological Products Advisory Committee (VRPBAC), the FDA staff stated that Merck clinical trial data indicated there may be "the potential for GARDASIL to enhance cervical disease in subjects who had evidence of persistent infection with vaccine-relevant HPV types prior to vaccination. " [2] Girls and women now being vaccinated with GARDASIL are not routinely being tested for active HPV infection before vaccination.

The FDA staff also questioned whether the “HPV types not contained in the vaccine might offset the overall clinical effectiveness of the vaccine.” There are more than 15 types of HPV associated with cervical cancer but GARDASIL only contains HPV types 16 and 18. It is unknown whether non-vaccine HPV types will become more dominant in the future. However, there are indications this could occur because some of the seven strains of pneumococcal contained in Wyeth’s PREVNAR vaccine, which was recommended by the CDC for universal use in all babies in 2000, have been replaced by some of the more than 80 other pneumococcal strains not contained in the vaccine. [4] [5] [6]

VAERS is a passive surveillance system and depends upon voluntary reporting of serious health problems following vaccination, even though safety provisions in the National Childhood Vaccine Injury Act of 1986 mandated that health care providers report vaccine adverse events. There have been estimates that fewer than 10 percent, even as low as 1 to 4 percent, of adverse events which occur after prescription drug or vaccine use are ever reported to government adverse event reporting systems. [7] [8] [9] [10]

"If only 1 to 4 percent of all adverse events associated with GARDASIL vaccination are being reported to VAERS, there could have been up to 38,000 health problems after GARDASIL vaccination in 2006 which were never reported," said Fisher. "How many girls are really having short-term health problems associated with getting this vaccine that could turn into long-term neurological or immune system disorders? And how many will go on to develop fertility problems, cancer or damage to their genes, all of which Merck admits in its product insert that it has not studied at all? We just don't know enough to be mandating GARDASIL for anyone, much less vulnerable 11 to 12 year old girls entering puberty."

For a copy of NVIC's Report on VAERS and GARDASIL, references for this statement and information about how to report a vaccine reaction to VAERS, go to www.nvic.org.

__________________________________________________

[Guest guest]

There always are. Sad isn't it?

Challis

For those interested.. . -- more info on HPV vaccine

HPV is Human Papilloma Virus, predominantly a sexually transmitted disease. The vaccine is given to males and females, between the ages of 3 months and 77 years. VAERS reports involving this vaccine are now 15 to 20 percent of all VAERS reports filed (VAERS = Vaccine Adverse Events Reporting Service). More information on this vaccine can be found at NVIC's (National Vaccine Information Center's) site, given at the end of the article.

~~

for immediate releaseFebruary 21, 2007

VACCINE SAFETY GROUP RELEASES GARDASIL REACTION REPORTCalls on FDA and CDC to Warn Doctors and Parents to Report to VAERS

Washington, D.C. - The National Vaccine Information Center (NVIC) today released a new analysis of the federal Vaccine Adverse Event Reporting System (VAERS) reports of serious health problems following HPV vaccination (Merck's GARDASIL) during the last six months of 2006. Out of the 385 individual GARDASIL adverse event reports made to VAERS, two-thirds required additional medical care and about one-third of all reports were for children 16-years-old and under, with nearly 25 percent of those children having received simultaneously one or more of the 18 vaccines that Merck did not study in combination with GARDASIL. NVIC is calling on the FDA and CDC to warn parents and doctors that GARDASIL should not be combined with other vaccines and that young girls should be monitored for at least 24 hours for syncopal (collapse/fainting) episodes that can be accompanied by seizure activity, as well as symptoms of

tingling, numbness and loss of sensation in the fingers and limbs, all of which should be reported to VAERS immediately.

"Because Merck only studied GARDASIL in fewer than 1200 girls under age 16 in pre-licensure trials, it is critical that doctors and parents be made aware of the nature of the initial adverse event reports coming into VAERS and that they report serious health problems after vaccination when they occur," said NVIC President Barbara Loe Fisher. "There are twice as many children collapsing and four times as many children experiencing tingling, numbness and loss of sensation after getting a GARDASIL vaccination compared to those getting a Tdap (tetanus-diphtheria -acellular pertussis) vaccination. There have been reports of facial paralysis and Guillain-Barre Syndrome. And doctors who give GARDASIL in combination with other vaccines are basically conducting an experiment on their young patients because Merck has not published any safety data for simultaneous vaccination with any vaccine except hepatitis B

vaccine."

According to NVIC's report, a majority of GARDASIL adverse event reports to VAERS involved those who suffered fever, nausea, headache or pain; 14 percent were for syncopal episodes with or without neurological signs; and 8 percent experienced tingling, numbness and loss of sensation, facial paralysis or Guillain-Barre Syndrome.

Although adverse event reports to VAERS do not prove causation, they can provide an early warning sign that a new vaccine may be causing health problems that could be important. For example, reports to VAERS of bowel blockage (intussusception) in babies following receipt of Merck's Rota Teq (rotavirus) vaccine prompted the FDA to issue a public warning to doctors and consumers on Feb. 13. [1]

"About 4 reports per day were filed with VAERS in December 2006 for the HPV vaccine," said NVIC Health Policy Analyst Vicky Debold, RN, Ph.D. "Some of these girls are being injured when they collapse after getting the vaccine and others are complaining of neurological symptoms that should not be ignored. Doctors and nurses should take note of the patient safety issues related to giving this vaccine. Giving GARDASIL simultaneously with any of the 18 vaccines Merck did not study in combination is not an evidence-based guideline and should involve informed consent and a signed patient release. To avoid unnecessary injuries, teenage girls should be vaccinated laying down, not be left unattended and probably should not walk or drive themselves home from the doctor's office after they get vaccinated."

NVIC also found that there were several VAERS reports of HPV infection, genital warts and cervical lesions after GARDASIL vaccination. It is unknown if the girls were infected with HPV before being vaccinated or if GARDASIL failed to protect them. One case of HPV infection occurred in a 22-year-old girl who had participated in a Merck GARDASIL trial in 2003 when she had shown "strong conversion to all 4 vaccine types" but "tested positive for high risk HPV" in 2006, according to the VAERS report.

In a May 18, 2006 Background Document for the FDA Vaccines and Related Biological Products Advisory Committee (VRPBAC), the FDA staff stated that Merck clinical trial data indicated there may be "the potential for GARDASIL to enhance cervical disease in subjects who had evidence of persistent infection with vaccine-relevant HPV types prior to vaccination. " [2] Girls and women now being vaccinated with GARDASIL are not routinely being tested for active HPV infection before vaccination.

The FDA staff also questioned whether the “HPV types not contained in the vaccine might offset the overall clinical effectiveness of the vaccine.” There are more than 15 types of HPV associated with cervical cancer but GARDASIL only contains HPV types 16 and 18. It is unknown whether non-vaccine HPV types will become more dominant in the future. However, there are indications this could occur because some of the seven strains of pneumococcal contained in Wyeth’s PREVNAR vaccine, which was recommended by the CDC for universal use in all babies in 2000, have been replaced by some of the more than 80 other pneumococcal strains not contained in the vaccine. [4] [5] [6]

VAERS is a passive surveillance system and depends upon voluntary reporting of serious health problems following vaccination, even though safety provisions in the National Childhood Vaccine Injury Act of 1986 mandated that health care providers report vaccine adverse events. There have been estimates that fewer than 10 percent, even as low as 1 to 4 percent, of adverse events which occur after prescription drug or vaccine use are ever reported to government adverse event reporting systems. [7] [8] [9] [10]

"If only 1 to 4 percent of all adverse events associated with GARDASIL vaccination are being reported to VAERS, there could have been up to 38,000 health problems after GARDASIL vaccination in 2006 which were never reported," said Fisher. "How many girls are really having short-term health problems associated with getting this vaccine that could turn into long-term neurological or immune system disorders? And how many will go on to develop fertility problems, cancer or damage to their genes, all of which Merck admits in its product insert that it has not studied at all? We just don't know enough to be mandating GARDASIL for anyone, much less vulnerable 11 to 12 year old girls entering puberty."

For a copy of NVIC's Report on VAERS and GARDASIL, references for this statement and information about how to report a vaccine reaction to VAERS, go to www.nvic.org.

____________ _________ _________ _________ _________ __

[Guest guest]

Thanks for the info Challis.

My daughter Hannah has had two of the shots in the HPV vaccine series. So far,

no effects. She goes in for the third shot in November. I pushed her into

having it because of all the cancer we have in our family. Hannah is 16 so

maybe that is why she isn’t effected by an adverse reaction.

Connie

From: MSersLife [mailto:MSersLife ] On Behalf Of Smyelin groovy

Sent: Wednesday, October 24, 2007

8:32 PM

To: MSersLife

Subject: Re: For those

interested... -- more info on HPV vaccine

There always are. Sad isn't it?

Challis

For those

interested.. . -- more info on HPV vaccine

HPV is Human Papilloma Virus, predominantly a sexually transmitted

disease. The vaccine is given to males and females, between the ages of 3

months and 77 years. VAERS reports involving this vaccine are now 15 to

20 percent of all VAERS reports filed (VAERS = Vaccine Adverse Events Reporting

Service). More information on this vaccine can be found at NVIC's (National Vaccine Information

Center's) site, given at

the end of the article.

~~

for immediate release

February 21, 2007

VACCINE

SAFETY GROUP RELEASES GARDASIL REACTION REPORT

Calls on FDA and CDC to Warn Doctors and Parents to Report to VAERS

Washington, D.C. - The

National Vaccine Information Center (NVIC) today released a new analysis of the

federal Vaccine Adverse Event Reporting System (VAERS) reports of serious

health problems following HPV vaccination (Merck's GARDASIL) during the last

six months of 2006. Out of the 385 individual GARDASIL adverse event reports

made to VAERS, two-thirds required additional medical care and about one-third

of all reports were for children 16-years-old and under, with nearly 25 percent

of those children having received simultaneously one or more of the 18 vaccines

that Merck did not study in combination with GARDASIL. NVIC is calling on the

FDA and CDC to warn parents and doctors that GARDASIL should not be combined

with other vaccines and that young girls should be monitored for at least 24

hours for syncopal (collapse/fainting) episodes that can be accompanied by

seizure activity, as well as symptoms of tingling, numbness and loss of sensation

in the fingers and limbs, all of which should be reported to VAERS immediately.

" Because Merck only studied GARDASIL in fewer than 1200

girls under age 16 in pre-licensure trials, it is critical that doctors and

parents be made aware of the nature of the initial adverse event reports coming

into VAERS and that they report serious health problems after vaccination when

they occur, " said NVIC President Barbara Loe Fisher. " There are twice

as many children collapsing and four times as many children experiencing

tingling, numbness and loss of sensation after getting a GARDASIL vaccination

compared to those getting a Tdap (tetanus-diphtheria -acellular pertussis)

vaccination. There have been reports of facial paralysis and Guillain-Barre

Syndrome. And doctors who give GARDASIL in combination with other vaccines are

basically conducting an experiment on their young patients because Merck has

not published any safety data for simultaneous vaccination with any vaccine

except hepatitis B vaccine. "

According to NVIC's report, a majority of GARDASIL adverse

event reports to VAERS involved those who suffered fever, nausea, headache or

pain; 14 percent were for syncopal episodes with or without neurological signs;

and 8 percent experienced tingling, numbness and loss of sensation, facial

paralysis or Guillain-Barre Syndrome.

Although adverse event reports to VAERS do not prove

causation, they can provide an early warning sign that a new vaccine may be

causing health problems that could be important. For example, reports to VAERS

of bowel blockage (intussusception) in babies following receipt of Merck's Rota

Teq (rotavirus) vaccine prompted the FDA to issue a public warning to doctors

and consumers on Feb. 13. [1]

" About 4 reports per day were filed with VAERS in

December 2006 for the HPV vaccine, " said NVIC Health Policy Analyst Vicky

Debold, RN, Ph.D. " Some of these girls are being injured when they

collapse after getting the vaccine and others are complaining of neurological

symptoms that should not be ignored. Doctors and nurses should take note of the

patient safety issues related to giving this vaccine. Giving GARDASIL

simultaneously with any of the 18 vaccines Merck did not study in combination

is not an evidence-based guideline and should involve informed consent and a

signed patient release. To avoid unnecessary injuries, teenage girls should be

vaccinated laying down, not be left unattended and probably should not walk or

drive themselves home from the doctor's office after they get vaccinated. "

NVIC also found that there were several VAERS reports of HPV

infection, genital warts and cervical lesions after GARDASIL vaccination. It is

unknown if the girls were infected with HPV before being vaccinated or if GARDASIL

failed to protect them. One case of HPV infection occurred in a 22-year-old

girl who had participated in a Merck GARDASIL trial in 2003 when she had shown

" strong conversion to all 4 vaccine types " but " tested positive

for high risk HPV " in 2006, according to the VAERS report.

In a May 18, 2006 Background Document for the FDA Vaccines

and Related Biological Products Advisory Committee (VRPBAC), the FDA staff

stated that Merck clinical trial data indicated there may be " the

potential for GARDASIL to enhance cervical disease in subjects who had evidence

of persistent infection with vaccine-relevant HPV types prior to vaccination.

" [2] Girls and

women now being vaccinated with GARDASIL are not routinely being tested for

active HPV infection before vaccination.

The FDA staff also questioned whether the “HPV types not

contained in the vaccine might offset the overall clinical effectiveness of the

vaccine.” There are more than 15 types of HPV associated with cervical cancer

but GARDASIL only contains HPV types 16 and 18. It is unknown whether

non-vaccine HPV types will become more dominant in the future. However, there

are indications this could occur because some of the seven strains of

pneumococcal contained in Wyeth’s PREVNAR vaccine, which was recommended by the

CDC for universal use in all babies in 2000, have been replaced by some of the

more than 80 other pneumococcal strains not contained in the vaccine. [4] [5] [6]

VAERS is a passive surveillance system and depends upon

voluntary reporting of serious health problems following vaccination, even

though safety provisions in the National Childhood Vaccine Injury Act of 1986

mandated that health care providers report vaccine adverse events. There have

been estimates that fewer than 10 percent, even as low as 1 to 4 percent, of

adverse events which occur after prescription drug or vaccine use are ever

reported to government adverse event reporting systems. [7] [8] [9] [10]

" If only 1 to 4 percent of all adverse events

associated with GARDASIL vaccination are being reported to VAERS, there could

have been up to 38,000 health problems after GARDASIL vaccination in 2006 which

were never reported, " said Fisher. " How many girls are really having

short-term health problems associated with getting this vaccine that could turn

into long-term neurological or immune system disorders? And how many will go on

to develop fertility problems, cancer or damage to their genes, all of which Merck

admits in its product insert that it has not studied at all? We just don't know

enough to be mandating GARDASIL for anyone, much less vulnerable 11 to 12 year

old girls entering puberty. "

For a copy of NVIC's Report on VAERS and GARDASIL, references

for this statement and information about how to report a vaccine reaction to

VAERS, go to www.nvic.org.

____________

_________ _________ _________ _________ __

[Guest guest]

It isn't the age though.

I'm glad she's not shown signs of trouble.

Challis

For those interested.. . -- more info on HPV vaccine

HPV is Human Papilloma Virus, predominantly a sexually transmitted disease. The vaccine is given to males and females, between the ages of 3 months and 77 years. VAERS reports involving this vaccine are now 15 to 20 percent of all VAERS reports filed (VAERS = Vaccine Adverse Events Reporting Service). More information on this vaccine can be found at NVIC's ( National Vaccine Information Center 's) site, given at the end of the article.

~~

for immediate releaseFebruary 21, 2007

VACCINE SAFETY GROUP RELEASES GARDASIL REACTION REPORTCalls on FDA and CDC to Warn Doctors and Parents to Report to VAERS

Washington, D.C. - The National Vaccine Information Center (NVIC) today released a new analysis of the federal Vaccine Adverse Event Reporting System (VAERS) reports of serious health problems following HPV vaccination (Merck's GARDASIL) during the last six months of 2006. Out of the 385 individual GARDASIL adverse event reports made to VAERS, two-thirds required additional medical care and about one-third of all reports were for children 16-years-old and under, with nearly 25 percent of those children having received simultaneously one or more of the 18 vaccines that Merck did not study in combination with GARDASIL. NVIC is calling on the

FDA and CDC to warn parents and doctors that GARDASIL should not be combined with other vaccines and that young girls should be monitored for at least 24 hours for syncopal (collapse/fainting) episodes that can be accompanied by seizure activity, as well as symptoms of tingling, numbness and loss of sensation in the fingers and limbs, all of which should be reported to VAERS immediately.

"Because Merck only studied GARDASIL in fewer than 1200 girls under age 16 in pre-licensure trials, it is critical that doctors and parents be made aware of the nature of the initial adverse event reports coming into VAERS and that they report serious health problems after vaccination when they occur," said NVIC President Barbara Loe Fisher. "There are twice as many children collapsing and four times as many children experiencing tingling, numbness and loss of sensation after getting a GARDASIL vaccination compared to those getting a Tdap (tetanus-diphtheria -acellular pertussis) vaccination. There have been reports of facial paralysis and Guillain-Barre Syndrome. And doctors who give GARDASIL in combination with other vaccines are basically conducting an experiment on their young patients because Merck has not published any safety data for simultaneous

vaccination with any vaccine except hepatitis B vaccine."

According to NVIC's report, a majority of GARDASIL adverse event reports to VAERS involved those who suffered fever, nausea, headache or pain; 14 percent were for syncopal episodes with or without neurological signs; and 8 percent experienced tingling, numbness and loss of sensation, facial paralysis or Guillain-Barre Syndrome.

Although adverse event reports to VAERS do not prove causation, they can provide an early warning sign that a new vaccine may be causing health problems that could be important. For example, reports to VAERS of bowel blockage (intussusception) in babies following receipt of Merck's Rota Teq (rotavirus) vaccine prompted the FDA to issue a public warning to doctors and consumers on Feb. 13. [1]

"About 4 reports per day were filed with VAERS in December 2006 for the HPV vaccine," said NVIC Health Policy Analyst Vicky Debold, RN, Ph.D. "Some of these girls are being injured when they collapse after getting the vaccine and others are complaining of neurological symptoms that should not be ignored. Doctors and nurses should take note of the patient safety issues related to giving this vaccine. Giving GARDASIL simultaneously with any of the 18 vaccines Merck did not study in combination is not an evidence-based guideline and should involve informed consent and a signed patient release. To avoid unnecessary injuries, teenage girls should be vaccinated laying down, not be left unattended and probably should not walk or drive themselves home from the doctor's office after they get vaccinated."

NVIC also found that there were several VAERS reports of HPV infection, genital warts and cervical lesions after GARDASIL vaccination. It is unknown if the girls were infected with HPV before being vaccinated or if GARDASIL failed to protect them. One case of HPV infection occurred in a 22-year-old girl who had participated in a Merck GARDASIL trial in 2003 when she had shown "strong conversion to all 4 vaccine types" but "tested positive for high risk HPV" in 2006, according to the VAERS report.

In a May 18, 2006 Background Document for the FDA Vaccines and Related Biological Products Advisory Committee (VRPBAC), the FDA staff stated that Merck clinical trial data indicated there may be "the potential for GARDASIL to enhance cervical disease in subjects who had evidence of persistent infection with vaccine-relevant HPV types prior to vaccination. " [2] Girls and women now being vaccinated with GARDASIL are not routinely being tested for active HPV infection before vaccination.

The FDA staff also questioned whether the “HPV types not contained in the vaccine might offset the overall clinical effectiveness of the vaccine.” There are more than 15 types of HPV associated with cervical cancer but GARDASIL only contains HPV types 16 and 18. It is unknown whether non-vaccine HPV types will become more dominant in the future. However, there are indications this could occur because some of the seven strains of pneumococcal contained in Wyeth’s PREVNAR vaccine, which was recommended by the CDC for universal use in all babies in 2000, have been replaced by some of the more than 80 other pneumococcal strains not contained in the vaccine. [4]

[5] [6]

VAERS is a passive surveillance system and depends upon voluntary reporting of serious health problems following vaccination, even though safety provisions in the National Childhood Vaccine Injury Act of 1986 mandated that health care providers report vaccine adverse events. There have been estimates that fewer than 10 percent, even as low as 1 to 4 percent, of adverse events which occur after prescription drug or vaccine use are ever reported to government adverse event reporting systems. [7] [8] [9] [10]

"If only 1 to 4 percent of all adverse events associated with GARDASIL vaccination are being reported to VAERS, there could have been up to 38,000 health problems after GARDASIL vaccination in 2006 which were never reported," said Fisher. "How many girls are really having short-term health problems associated with getting this vaccine that could turn into long-term neurological or immune system disorders? And how many will go on to develop fertility problems, cancer or damage to their genes, all of which Merck admits in its product insert that it has not studied at all? We just don't know enough to be mandating GARDASIL for anyone, much less vulnerable 11 to 12 year old girls entering puberty."

For a copy of NVIC's Report on VAERS and GARDASIL, references for this statement and information about how to report a vaccine reaction to VAERS, go to www.nvic.org.

____________ _________ _________ _________ _________ __

[Guest guest]

It isn't the age though.

I'm glad she's not shown signs of trouble.

Challis

For those interested.. . -- more info on HPV vaccine

HPV is Human Papilloma Virus, predominantly a sexually transmitted disease. The vaccine is given to males and females, between the ages of 3 months and 77 years. VAERS reports involving this vaccine are now 15 to 20 percent of all VAERS reports filed (VAERS = Vaccine Adverse Events Reporting Service). More information on this vaccine can be found at NVIC's ( National Vaccine Information Center 's) site, given at the end of the article.

~~

for immediate releaseFebruary 21, 2007

VACCINE SAFETY GROUP RELEASES GARDASIL REACTION REPORTCalls on FDA and CDC to Warn Doctors and Parents to Report to VAERS

Washington, D.C. - The National Vaccine Information Center (NVIC) today released a new analysis of the federal Vaccine Adverse Event Reporting System (VAERS) reports of serious health problems following HPV vaccination (Merck's GARDASIL) during the last six months of 2006. Out of the 385 individual GARDASIL adverse event reports made to VAERS, two-thirds required additional medical care and about one-third of all reports were for children 16-years-old and under, with nearly 25 percent of those children having received simultaneously one or more of the 18 vaccines that Merck did not study in combination with GARDASIL. NVIC is calling on the

FDA and CDC to warn parents and doctors that GARDASIL should not be combined with other vaccines and that young girls should be monitored for at least 24 hours for syncopal (collapse/fainting) episodes that can be accompanied by seizure activity, as well as symptoms of tingling, numbness and loss of sensation in the fingers and limbs, all of which should be reported to VAERS immediately.

"Because Merck only studied GARDASIL in fewer than 1200 girls under age 16 in pre-licensure trials, it is critical that doctors and parents be made aware of the nature of the initial adverse event reports coming into VAERS and that they report serious health problems after vaccination when they occur," said NVIC President Barbara Loe Fisher. "There are twice as many children collapsing and four times as many children experiencing tingling, numbness and loss of sensation after getting a GARDASIL vaccination compared to those getting a Tdap (tetanus-diphtheria -acellular pertussis) vaccination. There have been reports of facial paralysis and Guillain-Barre Syndrome. And doctors who give GARDASIL in combination with other vaccines are basically conducting an experiment on their young patients because Merck has not published any safety data for simultaneous

vaccination with any vaccine except hepatitis B vaccine."

According to NVIC's report, a majority of GARDASIL adverse event reports to VAERS involved those who suffered fever, nausea, headache or pain; 14 percent were for syncopal episodes with or without neurological signs; and 8 percent experienced tingling, numbness and loss of sensation, facial paralysis or Guillain-Barre Syndrome.

Although adverse event reports to VAERS do not prove causation, they can provide an early warning sign that a new vaccine may be causing health problems that could be important. For example, reports to VAERS of bowel blockage (intussusception) in babies following receipt of Merck's Rota Teq (rotavirus) vaccine prompted the FDA to issue a public warning to doctors and consumers on Feb. 13. [1]

"About 4 reports per day were filed with VAERS in December 2006 for the HPV vaccine," said NVIC Health Policy Analyst Vicky Debold, RN, Ph.D. "Some of these girls are being injured when they collapse after getting the vaccine and others are complaining of neurological symptoms that should not be ignored. Doctors and nurses should take note of the patient safety issues related to giving this vaccine. Giving GARDASIL simultaneously with any of the 18 vaccines Merck did not study in combination is not an evidence-based guideline and should involve informed consent and a signed patient release. To avoid unnecessary injuries, teenage girls should be vaccinated laying down, not be left unattended and probably should not walk or drive themselves home from the doctor's office after they get vaccinated."

NVIC also found that there were several VAERS reports of HPV infection, genital warts and cervical lesions after GARDASIL vaccination. It is unknown if the girls were infected with HPV before being vaccinated or if GARDASIL failed to protect them. One case of HPV infection occurred in a 22-year-old girl who had participated in a Merck GARDASIL trial in 2003 when she had shown "strong conversion to all 4 vaccine types" but "tested positive for high risk HPV" in 2006, according to the VAERS report.

In a May 18, 2006 Background Document for the FDA Vaccines and Related Biological Products Advisory Committee (VRPBAC), the FDA staff stated that Merck clinical trial data indicated there may be "the potential for GARDASIL to enhance cervical disease in subjects who had evidence of persistent infection with vaccine-relevant HPV types prior to vaccination. " [2] Girls and women now being vaccinated with GARDASIL are not routinely being tested for active HPV infection before vaccination.

The FDA staff also questioned whether the “HPV types not contained in the vaccine might offset the overall clinical effectiveness of the vaccine.” There are more than 15 types of HPV associated with cervical cancer but GARDASIL only contains HPV types 16 and 18. It is unknown whether non-vaccine HPV types will become more dominant in the future. However, there are indications this could occur because some of the seven strains of pneumococcal contained in Wyeth’s PREVNAR vaccine, which was recommended by the CDC for universal use in all babies in 2000, have been replaced by some of the more than 80 other pneumococcal strains not contained in the vaccine. [4]

[5] [6]

VAERS is a passive surveillance system and depends upon voluntary reporting of serious health problems following vaccination, even though safety provisions in the National Childhood Vaccine Injury Act of 1986 mandated that health care providers report vaccine adverse events. There have been estimates that fewer than 10 percent, even as low as 1 to 4 percent, of adverse events which occur after prescription drug or vaccine use are ever reported to government adverse event reporting systems. [7] [8] [9] [10]

"If only 1 to 4 percent of all adverse events associated with GARDASIL vaccination are being reported to VAERS, there could have been up to 38,000 health problems after GARDASIL vaccination in 2006 which were never reported," said Fisher. "How many girls are really having short-term health problems associated with getting this vaccine that could turn into long-term neurological or immune system disorders? And how many will go on to develop fertility problems, cancer or damage to their genes, all of which Merck admits in its product insert that it has not studied at all? We just don't know enough to be mandating GARDASIL for anyone, much less vulnerable 11 to 12 year old girls entering puberty."

For a copy of NVIC's Report on VAERS and GARDASIL, references for this statement and information about how to report a vaccine reaction to VAERS, go to www.nvic.org.

____________ _________ _________ _________ _________ __

[Guest guest]

It isn't the age though.

I'm glad she's not shown signs of trouble.

Challis

For those interested.. . -- more info on HPV vaccine

HPV is Human Papilloma Virus, predominantly a sexually transmitted disease. The vaccine is given to males and females, between the ages of 3 months and 77 years. VAERS reports involving this vaccine are now 15 to 20 percent of all VAERS reports filed (VAERS = Vaccine Adverse Events Reporting Service). More information on this vaccine can be found at NVIC's ( National Vaccine Information Center 's) site, given at the end of the article.

~~

for immediate releaseFebruary 21, 2007

VACCINE SAFETY GROUP RELEASES GARDASIL REACTION REPORTCalls on FDA and CDC to Warn Doctors and Parents to Report to VAERS

Washington, D.C. - The National Vaccine Information Center (NVIC) today released a new analysis of the federal Vaccine Adverse Event Reporting System (VAERS) reports of serious health problems following HPV vaccination (Merck's GARDASIL) during the last six months of 2006. Out of the 385 individual GARDASIL adverse event reports made to VAERS, two-thirds required additional medical care and about one-third of all reports were for children 16-years-old and under, with nearly 25 percent of those children having received simultaneously one or more of the 18 vaccines that Merck did not study in combination with GARDASIL. NVIC is calling on the

FDA and CDC to warn parents and doctors that GARDASIL should not be combined with other vaccines and that young girls should be monitored for at least 24 hours for syncopal (collapse/fainting) episodes that can be accompanied by seizure activity, as well as symptoms of tingling, numbness and loss of sensation in the fingers and limbs, all of which should be reported to VAERS immediately.

"Because Merck only studied GARDASIL in fewer than 1200 girls under age 16 in pre-licensure trials, it is critical that doctors and parents be made aware of the nature of the initial adverse event reports coming into VAERS and that they report serious health problems after vaccination when they occur," said NVIC President Barbara Loe Fisher. "There are twice as many children collapsing and four times as many children experiencing tingling, numbness and loss of sensation after getting a GARDASIL vaccination compared to those getting a Tdap (tetanus-diphtheria -acellular pertussis) vaccination. There have been reports of facial paralysis and Guillain-Barre Syndrome. And doctors who give GARDASIL in combination with other vaccines are basically conducting an experiment on their young patients because Merck has not published any safety data for simultaneous

vaccination with any vaccine except hepatitis B vaccine."

According to NVIC's report, a majority of GARDASIL adverse event reports to VAERS involved those who suffered fever, nausea, headache or pain; 14 percent were for syncopal episodes with or without neurological signs; and 8 percent experienced tingling, numbness and loss of sensation, facial paralysis or Guillain-Barre Syndrome.

Although adverse event reports to VAERS do not prove causation, they can provide an early warning sign that a new vaccine may be causing health problems that could be important. For example, reports to VAERS of bowel blockage (intussusception) in babies following receipt of Merck's Rota Teq (rotavirus) vaccine prompted the FDA to issue a public warning to doctors and consumers on Feb. 13. [1]

"About 4 reports per day were filed with VAERS in December 2006 for the HPV vaccine," said NVIC Health Policy Analyst Vicky Debold, RN, Ph.D. "Some of these girls are being injured when they collapse after getting the vaccine and others are complaining of neurological symptoms that should not be ignored. Doctors and nurses should take note of the patient safety issues related to giving this vaccine. Giving GARDASIL simultaneously with any of the 18 vaccines Merck did not study in combination is not an evidence-based guideline and should involve informed consent and a signed patient release. To avoid unnecessary injuries, teenage girls should be vaccinated laying down, not be left unattended and probably should not walk or drive themselves home from the doctor's office after they get vaccinated."

NVIC also found that there were several VAERS reports of HPV infection, genital warts and cervical lesions after GARDASIL vaccination. It is unknown if the girls were infected with HPV before being vaccinated or if GARDASIL failed to protect them. One case of HPV infection occurred in a 22-year-old girl who had participated in a Merck GARDASIL trial in 2003 when she had shown "strong conversion to all 4 vaccine types" but "tested positive for high risk HPV" in 2006, according to the VAERS report.

In a May 18, 2006 Background Document for the FDA Vaccines and Related Biological Products Advisory Committee (VRPBAC), the FDA staff stated that Merck clinical trial data indicated there may be "the potential for GARDASIL to enhance cervical disease in subjects who had evidence of persistent infection with vaccine-relevant HPV types prior to vaccination. " [2] Girls and women now being vaccinated with GARDASIL are not routinely being tested for active HPV infection before vaccination.

The FDA staff also questioned whether the “HPV types not contained in the vaccine might offset the overall clinical effectiveness of the vaccine.” There are more than 15 types of HPV associated with cervical cancer but GARDASIL only contains HPV types 16 and 18. It is unknown whether non-vaccine HPV types will become more dominant in the future. However, there are indications this could occur because some of the seven strains of pneumococcal contained in Wyeth’s PREVNAR vaccine, which was recommended by the CDC for universal use in all babies in 2000, have been replaced by some of the more than 80 other pneumococcal strains not contained in the vaccine. [4]

[5] [6]

VAERS is a passive surveillance system and depends upon voluntary reporting of serious health problems following vaccination, even though safety provisions in the National Childhood Vaccine Injury Act of 1986 mandated that health care providers report vaccine adverse events. There have been estimates that fewer than 10 percent, even as low as 1 to 4 percent, of adverse events which occur after prescription drug or vaccine use are ever reported to government adverse event reporting systems. [7] [8] [9] [10]

"If only 1 to 4 percent of all adverse events associated with GARDASIL vaccination are being reported to VAERS, there could have been up to 38,000 health problems after GARDASIL vaccination in 2006 which were never reported," said Fisher. "How many girls are really having short-term health problems associated with getting this vaccine that could turn into long-term neurological or immune system disorders? And how many will go on to develop fertility problems, cancer or damage to their genes, all of which Merck admits in its product insert that it has not studied at all? We just don't know enough to be mandating GARDASIL for anyone, much less vulnerable 11 to 12 year old girls entering puberty."

For a copy of NVIC's Report on VAERS and GARDASIL, references for this statement and information about how to report a vaccine reaction to VAERS, go to www.nvic.org.

____________ _________ _________ _________ _________ __

[Guest guest]

Connie & Challis,

I'm still playing catch up so I'm not sure how late this post is but I wanted to pipe in here. just finished her 3rd shot and it seems her 3rd shot was her toughest yet. It seemed to hurt the worst and the lump from the medicine didn't disperse as quickly as the first two shots.

I was pretty sure it was where the shot was given and partly the nurse who gave the shot. You know each nurse gives a shot differently. Those were the only side effects, if you want to even call them that, that she had.

As for the info I read that you provided Challis, I'm confused. Are they talking about giving this vaccine to babies as young as 3 months? No doctor I know would ever recommend that. As far as I know the youngest age is I believe and I could be wrong here is 9 and the onlest is I think 26. Don't quote me on that though, goodness knows my brain can't retain much, lol!!! I don know that the ages that were originally quoted in literature were wrong and they could only give the vaccine to women or girls who were never sexually active. That is also incorrect.

As with any vaccine that is not required by schools and not against a persons religion to receive is totally up to the parent if their child should/shouldn't receive. I discussed this with as she is 17 and as some of you know or maybe you don't she became sexually active at the age of 13(broke my heart, literally), peer pressure is a huge thing today. Only slept with the boy 2 times, little comfort and then was raped by a 21 year old "man" at the age of 14. Unfortunately what a parent wants for their child is not what is realistic and against her fathers wishes I put her on the pill, better safe than sorry in my book, and I am a realist, even though sometimes I'd rather have my blinders on, lol!!! Our relationship is alot more open and honest about that and I finally asked her if her and her boyfriend now that she has been seeing for over a year are having sex as he was a virgin. Well, I kind of said to her, "I take it Carmen is no longer a virgin." and she just kind of smiled at me. I told her as long as he was using protection as well and they were both protecting themselves and each other. I also said that I had hoped that they would have chosen to wait until they were married but I can't be a hypocrite because I was her age when I became active with her father. He was however my one and only.

Boy did I get off topic. I tend to do that very easily lately. I apologize. It seems to be a bad habit of mine. Cancer runs in my husbands side of the family. My MIL just passed from cancer of several organs, but when she was younger she had cancer of the uterus and had to have a complete hysterectomy. I believe we all carry the cancer gene. Whether it lies dormant or is triggered at some time in our lives is the key. Maybe I'm wrong. All I know is it is a terrible, scary, painful way to lose someone

[Guest guest]

Hi Peggy,

I hope everyone knows the sharing of this information wasn't to persuade for or against vax, nor criticize those who feel any particular vax is right for their family, it's only to add to the information had.

Cancer is horrible, hurtful thing to go through. For those with it and those who watch them suffer.

My Great-Aunt died a terrible death from lung cancer. 's Grandfather of stomach cancer. My Grandfather of Prostate cancer, which spread to his bones. Great-Great-Uncle of Esophageal cancer, at the same time a very old and dear family friend was dying of the same cancer. On and on it goes. Horrible stuff.

My seventeen year old watched a program on the venom of certain scorpions being found to kill a certain brain cancer. When in the body, it goes directly to those cells ands kills them. They're working on getting it right and on the market. Fascinating!

I've had those "precancerous" cells taken care of myself. It wasn't my favorite thing, but all was well in the end. Thank goodness! LOL

Regs differ from state to state and not all states offer the Philosophical exemption (though they should). Most offer only Medical and Religious, and a couple offer only Medical. While schools or day care, etc., may require proof of vax, if a child is not vaxed then a waiver (exemption filled and filed) is used in it's place.

Yep, what experienced is a reaction.

You can find out the information for the vax (ages and all) on NVIC's site. Yes, three months. I was surprised, too.

Here's a link with more info:

NVIC Analysis of Vaccine Adverse Events Reporting System Reports: Part lll, August 15, 2007

http://www.nvic.org/Diseases/HPV/HPV_Vaccine_Safety_Report_-_Part_III_(081507_revised)[1].pdf

<begin quote>

Age. The age of persons for whom VAERS reports were submitted following receipt of Gardasil ranged from 3 months to 77 years (see Figure 2). Readers should note that the vaccine is only licensed by the Food and Drug Administration (FDA) for use in females between the ages of 9 and 26.4 Age was not noted in over one-quarter of VAERS reports (26.1 percent). Among those who were too young to have received the vaccine, 14 reports were filed, almost one percent of all VAERS reports for Gardasil. Among those too old to receive the vaccine, age 27 and up, 73 reports were filed, over three

percent of all VAERS reports for the vaccine. Thus, four percent of all VAERS reports were filed for persons who should not have received the vaccine had it been given as licensed by the FDA.

<end quote>

Both men and women hare at risk for cancers associated with HPV. The vaccine is reccomended before becoming sexually active for this reason:

"The highest prevalence of HPV infection is seen in sexually active adolescents and young adults, most of whom initially acquire HPV shortly after they become sexually active. Most HPV infections are subclinical (asymptomatic) and resolve without sequelae within 1 to 2 years."

While HPV is predominately sexually transmitted, it isn't only an STD, it is also a casual contact disease. It is the reason we wear underwear when trying on bathing suits, it is one reason we don't sit on toilet seats, and it is why we should take care in sharing clothing with friends, etc. As an STD, it has been estimated that 50% of young adults will have contracted at least one strain of HPV by the time they are 25 years old. Some strains of HPV are responsible for venereal warts.

With cervical cancer a concern (and HPV is the leading cause of cervical cancer), regular paps are a good idea. The vax does not target all strains of HPV (over 216) nor all which are known to cause cancer. One hundred percent efficacy cannot be expected of any vaccine. Condoms can't be expected to protect against HPV either, as the virus is also found in the "surrounding" areas. But, whether it's one of the cancer causing strains of HPV or another cause of cervical cancer, regular paps can detect it and stop it before it goes too far, or becomes cancerous.

Lots of debate yet as to whether or not HPV is a life long virus for all, or only some.

Which STD do we discuss next? ROFL

Challis

Re: For those interested... -- more info on HPV vaccine

Connie & Challis,

I'm still playing catch up so I'm not sure how late this post is but I wanted to pipe in here. just finished her 3rd shot and it seems her 3rd shot was her toughest yet. It seemed to hurt the worst and the lump from the medicine didn't disperse as quickly as the first two shots.

I was pretty sure it was where the shot was given and partly the nurse who gave the shot. You know each nurse gives a shot differently. Those were the only side effects, if you want to even call them that, that she had.

As for the info I read that you provided Challis, I'm confused. Are they talking about giving this vaccine to babies as young as 3 months? No doctor I know would ever recommend that. As far as I know the youngest age is I believe and I could be wrong here is 9 and the onlest is I think 26. Don't quote me on that though, goodness knows my brain can't retain much, lol!!! I don know that the ages that were originally quoted in literature were wrong and they could only give the vaccine to women or girls who were never sexually active. That is also incorrect.

As with any vaccine that is not required by schools and not against a persons religion to receive is totally up to the parent if their child should/shouldn' t receive. I discussed this with as she is 17 and as some of you know or maybe you don't she became sexually active at the age of 13(broke my heart, literally), peer pressure is a huge thing today. Only slept with the boy 2 times, little comfort and then was raped by a 21 year old "man" at the age of 14. Unfortunately what a parent wants for their child is not what is realistic and against her fathers wishes I put her on the pill, better safe than sorry in my book, and I am a realist, even though sometimes I'd rather have my blinders on, lol!!! Our relationship is alot more open and honest about that and I finally asked her if her and her boyfriend now that she has been seeing for over a year are having sex as he was a virgin. Well, I kind of said to her, "I take

it Carmen is no longer a virgin." and she just kind of smiled at me. I told her as long as he was using protection as well and they were both protecting themselves and each other. I also said that I had hoped that they would have chosen to wait until they were married but I can't be a hypocrite because I was her age when I became active with her father. He was however my one and only.

Boy did I get off topic. I tend to do that very easily lately. I apologize. It seems to be a bad habit of mine. Cancer runs in my husbands side of the family. My MIL just passed from cancer of several organs, but when she was younger she had cancer of the uterus and had to have a complete hysterectomy. I believe we all carry the cancer gene. Whether it lies dormant or is triggered at some time in our lives is the key. Maybe I'm wrong. All I know is it is a terrible, scary, painful way to lose someone

[Guest guest]

Challis,

Who in the heck would give a 3 month old this vaccine??? If a 77 yr old wants to consent to it then fine but what parent would do that?

Maybe because the FDA only approves for the ages of 9-26 is why I knew of those numbers. In the beginning I didn't think that they were even going as young as 9 and that would even be able to get it because she had already been sexually active. We, of course spoke to the gyno about it first and this was after her first pap and she had blood work done.

I know you weren't trying to persuade or criticize anyone. Any information is good information as far as I'm concerned especially when it comes to the health of ourselves and our kids. We had this very same discussion on my ODD Support group and I was amazed at the number of Moms who were dead set against it for the simple fact that they were not well informed.

They were reacting to the politics of their state possibly "telling" them their daughter would HAVE to have it to go to school, they were also worried that it would give their daughter the idea that it was now ok to go ahead and have sex.

We spoke with at length about it and then with her and the doctor and ultimately decided together based on the facts and the family history. It's no gaurantee, we all know there are none when it comes to life, but any preventative measure that can be taken, I'm all for it. That's just me though.

As for the scorpion thing, that is just plain AWESOME!!!!

I'm sorry to hear that you had to deal with the precancerous cells, but I am happy to hear that they caught it early and were able to do away with it. Like I said in my earlier post, I honestly believe we all carry the Cancer gene. In some it lies dormant until something triggers it, whether it is environmental or what, I don't know, but I believe it is there. There are just too many people out there that have it.

Hugs

Peggy> >> > Thanks for the info Challis. > > > > > > My daughter Hannah has had two of the shots in the HPV vaccine series. So> > far, no effects. She goes in for the third shot in November. I pushed her> > into having it because of all the cancer we have in our family. Hannah is 16> > so maybe that is why she isn't effected by an adverse reaction.> > > > > > > > Connie> > > > > > > > _____ > > > > From: MSersLife@yahoogrou ps.com [mailto:MSersLife@ yahoogroups. com] On Behalf> > Of Smyelin groovy> > Sent: Wednesday, October 24, 2007 8:32 PM> > To: MSersLife@yahoogrou ps.com> > Subject: Re: For those interested.. . -- more info on HPV vaccine> > > > > > > > There always are. Sad isn't it?> > > > > > > > Challis> > > > > > > > > > > > For those interested.. . -- more info on HPV vaccine> > > > > > > > HPV is Human Papilloma Virus, predominantly a sexually transmitted disease.> > The vaccine is given to males and females, between the ages of 3 months and> > 77 years. VAERS reports involving this vaccine are now 15 to 20 percent of> > all VAERS reports filed (VAERS = Vaccine Adverse Events Reporting Service).> > More information on this vaccine can be found at NVIC's (National Vaccine> > Information Center's) site, given at the end of the article.> > > > > > > > ~~> > > > for immediate release> > February 21, 2007> > > > > > > > VACCINE SAFETY GROUP RELEASES GARDASIL REACTION REPORT> > Calls on FDA and CDC to Warn Doctors and Parents to Report to VAERS> > > > > > > > Washington, D.C. - The National Vaccine Information Center (NVIC) today> > released a new analysis of the federal Vaccine Adverse Event Reporting> > System (VAERS) reports of serious health problems following HPV vaccination> > (Merck's GARDASIL) during the last six months of 2006. Out of the 385> > individual GARDASIL adverse event reports made to VAERS, two-thirds required> > additional medical care and about one-third of all reports were for children> > 16-years-old and under, with nearly 25 percent of those children having> > received simultaneously one or more of the 18 vaccines that Merck did not> > study in combination with GARDASIL. NVIC is calling on the FDA and CDC to> > warn parents and doctors that GARDASIL should not be combined with other> > vaccines and that young girls should be monitored for at least 24 hours for> > syncopal (collapse/fainting) episodes that can be accompanied by seizure> > activity, as well as symptoms of tingling, numbness and loss of sensation in> > the fingers and limbs, all of which should be reported to VAERS immediately.> > > > > > > > "Because Merck only studied GARDASIL in fewer than 1200 girls under age 16> > in pre-licensure trials, it is critical that doctors and parents be made> > aware of the nature of the initial adverse event reports coming into VAERS> > and that they report serious health problems after vaccination when they> > occur," said NVIC President Barbara Loe Fisher. "There are twice as many> > children collapsing and four times as many children experiencing tingling,> > numbness and loss of sensation after getting a GARDASIL vaccination compared> > to those getting a Tdap (tetanus-diphtheria -acellular pertussis)> > vaccination. There have been reports of facial paralysis and Guillain-Barre> > Syndrome. And doctors who give GARDASIL in combination with other vaccines> > are basically conducting an experiment on their young patients because Merck> > has not published any safety data for simultaneous vaccination with any> > vaccine except hepatitis B vaccine."> > > > > > > > According to NVIC's report, a majority of GARDASIL adverse event reports to> > VAERS involved those who suffered fever, nausea, headache or pain; 14> > percent were for syncopal episodes with or without neurological signs; and 8> > percent experienced tingling, numbness and loss of sensation, facial> > paralysis or Guillain-Barre Syndrome.> > > > > > > > Although adverse event reports to VAERS do not prove causation, they can> > provide an early warning sign that a new vaccine may be causing health> > problems that could be important. For example, reports to VAERS of bowel> > blockage (intussusception) in babies following receipt of Merck's Rota Teq> > (rotavirus) vaccine prompted the FDA to issue a public warning to doctors> > and consumers on Feb. 13. [1> > <http://www.909shot. com/Diseases/ HPV/www.fda. gov/cber/ safety/phnrota02 1307.h> > tm> ]> > > > > > > > "About 4 reports per day were filed with VAERS in December 2006 for the HPV> > vaccine," said NVIC Health Policy Analyst Vicky Debold, RN, Ph.D. "Some of> > these girls are being injured when they collapse after getting the vaccine> > and others are complaining of neurological symptoms that should not be> > ignored. Doctors and nurses should take note of the patient safety issues> > related to giving this vaccine. Giving GARDASIL simultaneously with any of> > the 18 vaccines Merck did not study in combination is not an evidence-based> > guideline and should involve informed consent and a signed patient release.> > To avoid unnecessary injuries, teenage girls should be vaccinated laying> > down, not be left unattended and probably should not walk or drive> > themselves home from the doctor's office after they get vaccinated."> > > > > > > > NVIC also found that there were several VAERS reports of HPV infection,> > genital warts and cervical lesions after GARDASIL vaccination. It is unknown> > if the girls were infected with HPV before being vaccinated or if GARDASIL> > failed to protect them. One case of HPV infection occurred in a 22-year-old> > girl who had participated in a Merck GARDASIL trial in 2003 when she had> > shown "strong conversion to all 4 vaccine types" but "tested positive for> > high risk HPV" in 2006, according to the VAERS report.> > > > > > > > In a May 18, 2006 Background Document for the FDA Vaccines and Related> > Biological Products Advisory Committee (VRPBAC), the FDA staff stated that> > Merck clinical trial data indicated there may be "the potential for GARDASIL> > to enhance cervical disease in subjects who had evidence of persistent> > infection with vaccine-relevant HPV types prior to vaccination. " [2] Girls> > and women now being vaccinated with GARDASIL are not routinely being tested> > for active HPV infection before vaccination.> > > > > > > > The FDA staff also questioned whether the "HPV types not contained in the> > vaccine might offset the overall clinical effectiveness of the vaccine."> > There are more than 15 types of HPV associated with cervical cancer but> > GARDASIL only contains HPV types 16 and 18. It is unknown whether> > non-vaccine HPV types will become more dominant in the future. However,> > there are indications this could occur because some of the seven strains of> > pneumococcal contained in Wyeth's PREVNAR vaccine, which was recommended by> > the CDC for universal use in all babies in 2000, have been replaced by some> > of the more than 80 other pneumococcal strains not contained in the vaccine.> > [4] [5] [6]> > > > > > > > VAERS is a passive surveillance system and depends upon voluntary reporting> > of serious health problems following vaccination, even though safety> > provisions in the National Childhood Vaccine Injury Act of 1986 mandated> > that health care providers report vaccine adverse events. There have been> > estimates that fewer than 10 percent, even as low as 1 to 4 percent, of> > adverse events which occur after prescription drug or vaccine use are ever> > reported to government adverse event reporting systems. [7] [8] [9] [10]> > > > > > > > "If only 1 to 4 percent of all adverse events associated with GARDASIL> > vaccination are being reported to VAERS, there could have been up to 38,000> > health problems after GARDASIL vaccination in 2006 which were never> > reported," said Fisher. "How many girls are really having short-term health> > problems associated with getting this vaccine that could turn into long-term> > neurological or immune system disorders? And how many will go on to develop> > fertility problems, cancer or damage to their genes, all of which Merck> > admits in its product insert that it has not studied at all? We just don't> > know enough to be mandating GARDASIL for anyone, much less vulnerable 11 to> > 12 year old girls entering puberty."> > > > > > > > For a copy of NVIC's Report on VAERS and GARDASIL, references for this> > statement and information about how to report a vaccine reaction to VAERS,> > go to www.nvic.org <http://www.nvic. org/> <http://www.nvic. org/> .> > > > ____________ _________ _________ _________ _________ __> >

[Guest guest]

I think parents consenting to this vax for a three month old is, just as in the discussion on your ODD list, simple ignorance. It's the cause or case in much of the vax considerations.

As my sons' step-mother said to them... "I'll do whatever the doctor tells me". Uhm, what about educating yourself and being not only 'part' of the team, but leader of the team? Oy. LOL What's sad is she isn't the exception.

Challis

For those interested.. . -- more info on HPV vaccine> > > > > > > > HPV is Human Papilloma Virus, predominantly a sexually transmitted disease.> > The vaccine is given to males and females, between the ages of 3 months and> > 77 years. VAERS reports involving this vaccine are now 15 to 20 percent of> > all VAERS reports filed (VAERS = Vaccine Adverse Events Reporting Service).> > More information on this vaccine can be found at NVIC's (National Vaccine> >

Information Center's) site, given at the end of the article.> > > > > > > > ~~> > > > for immediate release> > February 21, 2007> > > > > > > > VACCINE SAFETY GROUP RELEASES GARDASIL REACTION REPORT> > Calls on FDA and CDC to Warn Doctors and Parents to Report to VAERS> > > > > > > > Washington, D.C. - The National Vaccine Information Center (NVIC) today> > released a new analysis of the federal Vaccine Adverse Event Reporting> > System (VAERS) reports of serious health problems following HPV vaccination> > (Merck's GARDASIL) during the last six months of 2006. Out of the 385> > individual GARDASIL adverse event reports made to VAERS, two-thirds required> > additional medical care and about one-third of all reports were for children> >

16-years-old and under, with nearly 25 percent of those children having> > received simultaneously one or more of the 18 vaccines that Merck did not> > study in combination with GARDASIL. NVIC is calling on the FDA and CDC to> > warn parents and doctors that GARDASIL should not be combined with other> > vaccines and that young girls should be monitored for at least 24 hours for> > syncopal (collapse/fainting) episodes that can be accompanied by seizure> > activity, as well as symptoms of tingling, numbness and loss of sensation in> > the fingers and limbs, all of which should be reported to VAERS immediately.> > > > > > > > "Because Merck only studied GARDASIL in fewer than 1200 girls under age 16> > in pre-licensure trials, it is critical that doctors and parents be made> > aware of the nature of the initial adverse event

reports coming into VAERS> > and that they report serious health problems after vaccination when they> > occur," said NVIC President Barbara Loe Fisher. "There are twice as many> > children collapsing and four times as many children experiencing tingling,> > numbness and loss of sensation after getting a GARDASIL vaccination compared> > to those getting a Tdap (tetanus-diphtheria -acellular pertussis)> > vaccination. There have been reports of facial paralysis and Guillain-Barre> > Syndrome. And doctors who give GARDASIL in combination with other vaccines> > are basically conducting an experiment on their young patients because Merck> > has not published any safety data for simultaneous vaccination with any> > vaccine except hepatitis B vaccine."> > > > > > > > According to NVIC's report, a majority of GARDASIL

adverse event reports to> > VAERS involved those who suffered fever, nausea, headache or pain; 14> > percent were for syncopal episodes with or without neurological signs; and 8> > percent experienced tingling, numbness and loss of sensation, facial> > paralysis or Guillain-Barre Syndrome.> > > > > > > > Although adverse event reports to VAERS do not prove causation, they can> > provide an early warning sign that a new vaccine may be causing health> > problems that could be important. For example, reports to VAERS of bowel> > blockage (intussusception) in babies following receipt of Merck's Rota Teq> > (rotavirus) vaccine prompted the FDA to issue a public warning to doctors> > and consumers on Feb. 13. [1> > <http://www.909shot. com/Diseases/ HPV/www.fda. gov/cber/ safety/phnrota02 1307.h> > tm>

]> > > > > > > > "About 4 reports per day were filed with VAERS in December 2006 for the HPV> > vaccine," said NVIC Health Policy Analyst Vicky Debold, RN, Ph.D. "Some of> > these girls are being injured when they collapse after getting the vaccine> > and others are complaining of neurological symptoms that should not be> > ignored. Doctors and nurses should take note of the patient safety issues> > related to giving this vaccine. Giving GARDASIL simultaneously with any of> > the 18 vaccines Merck did not study in combination is not an evidence-based> > guideline and should involve informed consent and a signed patient release.> > To avoid unnecessary injuries, teenage girls should be vaccinated laying> > down, not be left unattended and probably should not walk or drive> > themselves home from the doctor's office

after they get vaccinated."> > > > > > > > NVIC also found that there were several VAERS reports of HPV infection,> > genital warts and cervical lesions after GARDASIL vaccination. It is unknown> > if the girls were infected with HPV before being vaccinated or if GARDASIL> > failed to protect them. One case of HPV infection occurred in a 22-year-old> > girl who had participated in a Merck GARDASIL trial in 2003 when she had> > shown "strong conversion to all 4 vaccine types" but "tested positive for> > high risk HPV" in 2006, according to the VAERS report.> > > > > > > > In a May 18, 2006 Background Document for the FDA Vaccines and Related> > Biological Products Advisory Committee (VRPBAC), the FDA staff stated that> > Merck clinical trial data indicated there may be "the potential for

GARDASIL> > to enhance cervical disease in subjects who had evidence of persistent> > infection with vaccine-relevant HPV types prior to vaccination. " [2] Girls> > and women now being vaccinated with GARDASIL are not routinely being tested> > for active HPV infection before vaccination.> > > > > > > > The FDA staff also questioned whether the "HPV types not contained in the> > vaccine might offset the overall clinical effectiveness of the vaccine."> > There are more than 15 types of HPV associated with cervical cancer but> > GARDASIL only contains HPV types 16 and 18. It is unknown whether> > non-vaccine HPV types will become more dominant in the future. However,> > there are indications this could occur because some of the seven strains of> > pneumococcal contained in Wyeth's PREVNAR vaccine, which was recommended

by> > the CDC for universal use in all babies in 2000, have been replaced by some> > of the more than 80 other pneumococcal strains not contained in the vaccine.> > [4] [5] [6]> > > > > > > > VAERS is a passive surveillance system and depends upon voluntary reporting> > of serious health problems following vaccination, even though safety> > provisions in the National Childhood Vaccine Injury Act of 1986 mandated> > that health care providers report vaccine adverse events. There have been> > estimates that fewer than 10 percent, even as low as 1 to 4 percent, of> > adverse events which occur after prescription drug or vaccine use are ever> > reported to government adverse event reporting systems. [7] [8] [9] [10]> > > > > > > > "If only 1 to 4 percent of all adverse events associated

with GARDASIL> > vaccination are being reported to VAERS, there could have been up to 38,000> > health problems after GARDASIL vaccination in 2006 which were never> > reported," said Fisher. "How many girls are really having short-term health> > problems associated with getting this vaccine that could turn into long-term> > neurological or immune system disorders? And how many will go on to develop> > fertility problems, cancer or damage to their genes, all of which Merck> > admits in its product insert that it has not studied at all? We just don't> > know enough to be mandating GARDASIL for anyone, much less vulnerable 11 to> > 12 year old girls entering puberty."> > > > > > > > For a copy of NVIC's Report on VAERS and GARDASIL, references for this> > statement and information about how to report a vaccine reaction

to VAERS,> > go to www.nvic.org <http://www.nvic. org/> <http://www.nvic. org/> .> > > > ____________ _________ _________ _________ _________ __> >