‘Girls were in tears in the corridors and everyone was in shock...They never told us that there was any danger in these jabs.
I didn’t know you could get sick or die from them.”
The words were Charmaine Dunn-Myria’s, a 15-year-old schoolgirl in the same year at the Blue Coat Church of England school in Coventry as Natalie Morton, who died on Monday just hours after receiving the cervical cancer vaccine. Read more..
Showing posts with label Gardasil. Show all posts
Showing posts with label Gardasil. Show all posts
10.05.2009
1.26.2008
1.18.2008
GSK Announces Trial To Compare Effectiveness Of Gardasil And Cervarix
GlaxoSmithKline has revealed that it will be conducting a clinical trial to determine whether its human papilloma virus vaccine Cervarix is more effective than rival Merck's HPV vaccine Gardasil, according to Philadelphia Inquirer.
GSK said that it will be focusing on the effectiveness of both the drugs on HPV strains 16, 18, 31 and 45. Brian Lortie, GSK's vice president for Cervarix operations, said his company is confident that Cervarix will prove to be the more effective vaccine among the two.
"We're quite confident Cervarix has a stronger immune response and broader protection than Gardasil", he said. Reacting to the news of the trial, officials at Merck released a statement saying that the study is limited to only immune response which can never reveal the true efficacy data of a drug.
The trial can further dent Gardasil's reputation, which due to its high cost ($360 for three doses) has not been widely prescribed. Gardasil is the most expensive vaccine on CDC's list of recommended childhood vaccines which has seen many of the private insurance companies not making adequate reimbursement to cover physicians' costs to purchase, store and administer the vaccine.
Merck has already said that it will be offering the vaccine for free to low-income women aged between 19 to 26 years and are not insured. New Hampshire and South Dakota are also thinking of offering the vaccine at no cost to women who are under 18 years of age.
Independent clinical trials have proved that both Gardasil and Cervarix are 100 percent effective in preventing the infection of strains 16 and 18 of HPV, which cause around 70 percent of known cervical cancer cases. Gardasil was approved by the Food and Drug Administration (FDA) last year with CDC's Advisory Committee on Immunization Practices saying that girls aged 11 and 12 should be given the vaccine.
A study published in the April 2006 online edition of the Lancet said that Cervarix successfully prevented the infection of HPV strains 31 and 45. Strains 16 and 18 along with 31 and 45 account for nearly 80 percent of cervical cancer cases. Meanwhile Merck has claimed that Gardasil is 99 percent effective in preventing strains 6 and 11, which when combined with strains 16 and 18 are responsible for 90 percent of genital wart cases.
http://www.vaccinerx.com/news/cervical-cancer/gsk-announces-trial-to-compare-effectiveness-of-gardasil-and-cervarix-20070124-62-56.html
GSK said that it will be focusing on the effectiveness of both the drugs on HPV strains 16, 18, 31 and 45. Brian Lortie, GSK's vice president for Cervarix operations, said his company is confident that Cervarix will prove to be the more effective vaccine among the two.
"We're quite confident Cervarix has a stronger immune response and broader protection than Gardasil", he said. Reacting to the news of the trial, officials at Merck released a statement saying that the study is limited to only immune response which can never reveal the true efficacy data of a drug.
The trial can further dent Gardasil's reputation, which due to its high cost ($360 for three doses) has not been widely prescribed. Gardasil is the most expensive vaccine on CDC's list of recommended childhood vaccines which has seen many of the private insurance companies not making adequate reimbursement to cover physicians' costs to purchase, store and administer the vaccine.
Merck has already said that it will be offering the vaccine for free to low-income women aged between 19 to 26 years and are not insured. New Hampshire and South Dakota are also thinking of offering the vaccine at no cost to women who are under 18 years of age.
Independent clinical trials have proved that both Gardasil and Cervarix are 100 percent effective in preventing the infection of strains 16 and 18 of HPV, which cause around 70 percent of known cervical cancer cases. Gardasil was approved by the Food and Drug Administration (FDA) last year with CDC's Advisory Committee on Immunization Practices saying that girls aged 11 and 12 should be given the vaccine.
A study published in the April 2006 online edition of the Lancet said that Cervarix successfully prevented the infection of HPV strains 31 and 45. Strains 16 and 18 along with 31 and 45 account for nearly 80 percent of cervical cancer cases. Meanwhile Merck has claimed that Gardasil is 99 percent effective in preventing strains 6 and 11, which when combined with strains 16 and 18 are responsible for 90 percent of genital wart cases.
http://www.vaccinerx.com/news/cervical-cancer/gsk-announces-trial-to-compare-effectiveness-of-gardasil-and-cervarix-20070124-62-56.html
Merck's Cervical Cancer Vaccine, Gardasil®, Added To The Cdc Vaccines For Children Contract
Merck & Co., Inc. today announced that the U.S. Centers for Disease Control and Prevention (CDC) has added Merck's cervical cancer vaccine, GARDASIL® [Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine] to the CDC's Vaccines for Children (VFC) contract for girls and women aged 9 to 18. GARDASIL was approved on June 8 by the Food and Drug Administration (FDA) for use in girls and women ages 9 to 26 years. GARDASIL is the world's first and only vaccine available for the prevention of HPV types 16- and 18-related cervical cancer, cervical pre-cancers (CIN 2/3 and AIS), vulvar pre-cancers (VIN 2/3) and vaginal pre-cancers (VaIN 2/3) and for the prevention of genital warts and low-grade cervical lesions (CIN 1) caused by HPV types 6, 11, 16 and 18.
"The addition of GARDASIL to the VFC program is a very positive step towards protecting the future health of girls and young women in this country against cervical cancer caused by HPV types 16 and 18," said Mark Feinberg, M.D., Ph.D., vice president, Policy, Public Health and Medical Affairs in the Merck Vaccine Division. "Inclusion of GARDASIL in the VFC program, coupled with private insurance coverage and Merck's Vaccine Patient Assistance Program, represent important means to facilitate broad and equitable access to GARDASIL."
Health insurers covering approximately 94 percent of privately insured lives in the US (currently more than 95 insurance plans) have decided to reimburse GARDASIL. Many lives not covered by Managed Care will now be covered under the VFC Program. Merck has also initiated a new patient assistance program for vaccines. Through this new program, currently available in private physicians' offices, Merck is making available, free of charge, GARDASIL and other Merck vaccines indicated for use in individuals aged 19 and older who are uninsured and who are unable to afford vaccines.
Since 1994, the VFC program has provided vaccines to children through age 18 who are Medicaid-eligible, uninsured, underinsured or Native American. After the CDC's Advisory Committee for Immunization Practices (ACIP) has made a recommendation for the use of a given vaccine, the ACIP votes on whether the vaccine should be included in the VFC program. At the June 2006 meeting of the ACIP, the committee voted unanimously to recommend GARDASIL to the VFC program. Eligible adolescents may receive recommended vaccines through VFC once the CDC contracts for the purchase of the vaccine, a process that is now complete. Read more..
http://www.medicalnewstoday.com/articles/55737.php
"The addition of GARDASIL to the VFC program is a very positive step towards protecting the future health of girls and young women in this country against cervical cancer caused by HPV types 16 and 18," said Mark Feinberg, M.D., Ph.D., vice president, Policy, Public Health and Medical Affairs in the Merck Vaccine Division. "Inclusion of GARDASIL in the VFC program, coupled with private insurance coverage and Merck's Vaccine Patient Assistance Program, represent important means to facilitate broad and equitable access to GARDASIL."
Health insurers covering approximately 94 percent of privately insured lives in the US (currently more than 95 insurance plans) have decided to reimburse GARDASIL. Many lives not covered by Managed Care will now be covered under the VFC Program. Merck has also initiated a new patient assistance program for vaccines. Through this new program, currently available in private physicians' offices, Merck is making available, free of charge, GARDASIL and other Merck vaccines indicated for use in individuals aged 19 and older who are uninsured and who are unable to afford vaccines.
Since 1994, the VFC program has provided vaccines to children through age 18 who are Medicaid-eligible, uninsured, underinsured or Native American. After the CDC's Advisory Committee for Immunization Practices (ACIP) has made a recommendation for the use of a given vaccine, the ACIP votes on whether the vaccine should be included in the VFC program. At the June 2006 meeting of the ACIP, the committee voted unanimously to recommend GARDASIL to the VFC program. Eligible adolescents may receive recommended vaccines through VFC once the CDC contracts for the purchase of the vaccine, a process that is now complete. Read more..
http://www.medicalnewstoday.com/articles/55737.php
CDC Purchasing 10 Million Doses of Gardasil
The Centers for Disease Control and Prevention’s (CDC) latest round of acquisitions under its Vaccines for Children program includes the purchase of 10 million doses of Merck’s human papillomavirus (HPV) vaccine Gardasil, according to CDC solicitation documents.
The agency’s planned purchase is the same as its 2007 procurement.
Merck is the only FDA-approved manufacturer of quadrivalent HPV, which is called for in the procurement specifications. Gardasil (HPV quadrivalent [types 6, 11, 16 and 18] vaccine, recombinant) protects against four different strains of the virus, unlike GlaxoSmithKline’s (GSK) Cervarix (HPV, AS04 adjuvant-adsorbed).
Cervarix, approved in Europe, provides 100 percent protection against strains 16 and 18 only, according to the company. Although GSK has indicated that the product provides broader protection against cancer-causing HPV strains, the firm’s marketing authorization from the European Medicines Agency only references strains 16 and 18.
The FDA recently issued a complete response letter for Cervarix, requesting more information about the product. Results from a head-to-head trial comparing Cervarix with Gardasil could be available later this year.
The anticipated performance period of the contract starts April 1 and continues through March 31, 2009. Only measles, mumps and rubella and Hib vaccines are subject to statutory price ceilings. Bids close Jan. 28. The solicitation can be accessed at fs1.fbo.gov/EPSData/HHS/Synopses/2965/2008-N-19196/VFC2008Solicitation.doc.
http://www.fdanews.com/newsletter/article?artueId=11210icleId=103084&iss
The agency’s planned purchase is the same as its 2007 procurement.
Merck is the only FDA-approved manufacturer of quadrivalent HPV, which is called for in the procurement specifications. Gardasil (HPV quadrivalent [types 6, 11, 16 and 18] vaccine, recombinant) protects against four different strains of the virus, unlike GlaxoSmithKline’s (GSK) Cervarix (HPV, AS04 adjuvant-adsorbed).
Cervarix, approved in Europe, provides 100 percent protection against strains 16 and 18 only, according to the company. Although GSK has indicated that the product provides broader protection against cancer-causing HPV strains, the firm’s marketing authorization from the European Medicines Agency only references strains 16 and 18.
The FDA recently issued a complete response letter for Cervarix, requesting more information about the product. Results from a head-to-head trial comparing Cervarix with Gardasil could be available later this year.
The anticipated performance period of the contract starts April 1 and continues through March 31, 2009. Only measles, mumps and rubella and Hib vaccines are subject to statutory price ceilings. Bids close Jan. 28. The solicitation can be accessed at fs1.fbo.gov/EPSData/HHS/Synopses/2965/2008-N-19196/VFC2008Solicitation.doc.
http://www.fdanews.com/newsletter/article?artueId=11210icleId=103084&iss
1.17.2008
FDA and HPV -- when did they know the truth?
What I have done is read all 68 pages of this document. What I am going to show you is that the FDA knew back in 2003 that a HPV is not the actual cause of cervical cancer. The actual cause is a "persistent HPV infection that may act as a tumor promoter in cancer induction [8-11]. Read more....
http://www.renewamerica.us/columns/janak/071212
http://www.renewamerica.us/columns/janak/071212
1.03.2008
Gardasil Causing Pain and Fainting?
Health officials have touted the Gardasil vaccine as an important new protection against a cancer-causing sexually transmitted virus. In recent months, they've also noted reports of pain and fainting from the shot.
During its first year of use, reports of girls fainting from vaccinations climbed, but it's not clear whether the pain of the cervical cancer vaccine was the reason for the reaction.
Officials at Merck & Co., which makes the vaccine, acknowledge the sting. They attribute it partly to the virus-like particles in the shot. Pre-marketing studies showed more reports of pain from Gardasil than from dummy shots, and patients reported more pain when given shots with more of the particles.
Meanwhile, U.S. health officials have noticed a rise in reports of vaccine-associated fainting in girls. From 2002-2004 there were about 50 reports of fainting; from 2005 until last July, there were about 230. About 180 of those cases followed a shot of Gardasil, which came on the market in 2006.
But it's not clear that Gardasil's sting is related to the fainting increase, said Dr. Barbara Slade, an immunization safety specialist at the U.S. Centers for Disease Control and Prevention.
http://news.yahoo.com/s/ap/20080103/ap_on_he_me/painful_shot
During its first year of use, reports of girls fainting from vaccinations climbed, but it's not clear whether the pain of the cervical cancer vaccine was the reason for the reaction.
Officials at Merck & Co., which makes the vaccine, acknowledge the sting. They attribute it partly to the virus-like particles in the shot. Pre-marketing studies showed more reports of pain from Gardasil than from dummy shots, and patients reported more pain when given shots with more of the particles.
Meanwhile, U.S. health officials have noticed a rise in reports of vaccine-associated fainting in girls. From 2002-2004 there were about 50 reports of fainting; from 2005 until last July, there were about 230. About 180 of those cases followed a shot of Gardasil, which came on the market in 2006.
But it's not clear that Gardasil's sting is related to the fainting increase, said Dr. Barbara Slade, an immunization safety specialist at the U.S. Centers for Disease Control and Prevention.
http://news.yahoo.com/s/ap/20080103/ap_on_he_me/painful_shot
12.04.2007
Cervical cancer vaccine Gardasil sparks reactions in Australia
Have we not heard enough about the affects of Gardasil to take it off the market? What is the life expectancy of these children that are being over vaccinated? Follow the money trail. It is sickening.
ALMOST 500 girls have had adverse reactions such as seizures, rashes and paralysis after taking cervical cancer vaccine Gardasil in Australia since it was released in April.
Of those, almost 200 Victorian schoolgirls were affected and 10 girls were admitted to hospital after fainting or collapsing following the jabs.
But leading experts defended the benefits of Gardasil and dismissed controversial reports of overseas deaths as unrelated and fictitious.
http://www.news.com.au/heraldsun/story/0%2C21985%2C22864043-2862%2C00.html
ALMOST 500 girls have had adverse reactions such as seizures, rashes and paralysis after taking cervical cancer vaccine Gardasil in Australia since it was released in April.
Of those, almost 200 Victorian schoolgirls were affected and 10 girls were admitted to hospital after fainting or collapsing following the jabs.
But leading experts defended the benefits of Gardasil and dismissed controversial reports of overseas deaths as unrelated and fictitious.
http://www.news.com.au/heraldsun/story/0%2C21985%2C22864043-2862%2C00.html
12.03.2007
FDA: 28 Miscarriages No Reason to Reexamine Gardasil
(CNSNews.com) - Since June 2006, when the HPV vaccine Gardasil was approved by the Food and Drug Administration, there have been 28 reported cases in which pregnant women miscarried after receiving the vaccine.
Nonetheless, based on the clinical trials done prior to approval of the drug - which indicated that miscarriages among pregnant women given Gardasil were statistically consistent with miscarriages among women given placebos and in the general population - the FDA remains convinced the vaccine is safe and is not further investigating its effect on pregnant women.
http://www.cnsnews.com/ViewCulture.asp?Page=/Culture/archive/200712/CUL20071206a.html
Nonetheless, based on the clinical trials done prior to approval of the drug - which indicated that miscarriages among pregnant women given Gardasil were statistically consistent with miscarriages among women given placebos and in the general population - the FDA remains convinced the vaccine is safe and is not further investigating its effect on pregnant women.
http://www.cnsnews.com/ViewCulture.asp?Page=/Culture/archive/200712/CUL20071206a.html
11.25.2007
Deaths Associated with HPV Vaccine Start Rolling In, Over 3500 Adverse Affects Reported
TORONTO, September 20, 2007 (LifeSiteNews.com) - As Canada, in large part due to aggressive behind the scenes lobbying, rolls out the not-comprehensively-tested Merck HPV vaccine for girls as young as nine, a look at developments on the vaccine south of the border should cause Canadians serious concern. In the United States a similar lobby campaign by the same company launched the mass HPV vaccination of girls beginning in June last year.
In just little over a year, the HPV vaccine has been associated with at least five deaths, not to mention thousands of reports of adverse effects, hundreds deemed serious, and many that required hospitalization.
Judicial Watch, a U.S. government watchdog, became concerned while noting large donations to key politicians originating from Merck. A freedom of information request from the group in May of this year discovered that during the period from June 8, 2006 - when the vaccines received approval from the U.S. Food and Drug Administration (FDA) - to May 2007 there were 1,637 reports of adverse reactions to the HPV vaccine reported to the FDA.
http://www.lifesite.net/ldn/2007/sep/07092004.html
In just little over a year, the HPV vaccine has been associated with at least five deaths, not to mention thousands of reports of adverse effects, hundreds deemed serious, and many that required hospitalization.
Judicial Watch, a U.S. government watchdog, became concerned while noting large donations to key politicians originating from Merck. A freedom of information request from the group in May of this year discovered that during the period from June 8, 2006 - when the vaccines received approval from the U.S. Food and Drug Administration (FDA) - to May 2007 there were 1,637 reports of adverse reactions to the HPV vaccine reported to the FDA.
http://www.lifesite.net/ldn/2007/sep/07092004.html
UK To Mandate HPV Vaccinations For Schoolgirls
British Department of Health (DoH) approved the mandatory vaccination of schoolgirls against Human Papilloma Virus (HPV) which is supposedly responsible for causing cervical cancer. The series of three vaccinations are required for girls aged 12 to 13 years old beginning in 2008 with an additional catch-up program for women up to 18 years old to start later.
Gardasil, jointly developed by Merck of the United States and Sanofi Pasteur of France, is the first European Union approved vaccine. A rival vaccine, Cervarix, made by the UK group GlaxoSmithKline is waiting approval. Studies are being conducted to see if these vaccines should also be given to young boys.
The potential sales income from Gardasil could be Merck’s biggest money earner with estimated sales of at least 2 million USD. This is income badly needed by Merck to make up for the Vioxx scandals. In order for Merck to reap this income, Gardisil vaccination would have to be a requirement to attend school.
http://www.newstarget.com/022262.html
Gardasil, jointly developed by Merck of the United States and Sanofi Pasteur of France, is the first European Union approved vaccine. A rival vaccine, Cervarix, made by the UK group GlaxoSmithKline is waiting approval. Studies are being conducted to see if these vaccines should also be given to young boys.
The potential sales income from Gardasil could be Merck’s biggest money earner with estimated sales of at least 2 million USD. This is income badly needed by Merck to make up for the Vioxx scandals. In order for Merck to reap this income, Gardisil vaccination would have to be a requirement to attend school.
http://www.newstarget.com/022262.html
Gardasil Follow-Up Report: Medical Alert
I went back to the MedAlert.org web site and clicked on the link to the “National Vaccine Information Center”. This site provides the public with the resource to research different vaccines.
This time I found 2207 reports of adverse reactions to Gardasil. This is an increase of 2125 new reports in 5 ½ months since my last article on February 6th, 2007, where I reported only 82 reports.
http://www.therant.us/guest/c_janak/08042007.htm
This time I found 2207 reports of adverse reactions to Gardasil. This is an increase of 2125 new reports in 5 ½ months since my last article on February 6th, 2007, where I reported only 82 reports.
http://www.therant.us/guest/c_janak/08042007.htm
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