U.S. Prescribing Information for GARDASIL Updated; Indication Not Granted for Use in Adult Women
To Expand or Not Expand – That is the Question….Will FDA Approve Merck’s 4th Request to Expand Gardasil to 26 – 45 year old Women? That Was The Question!
S.A.N.E. Vax, Inc. Asks FDA to Rescind Approval of Gardasil™: Inappropriate Endpoint and Unreliable HPV Genotyping Methods Used for Vaccine’s Efficacy Evaluation
Latest Press Releases From “SaneVax, Inc.”
Scientific triumph: Important ruling in the U.S. against the vaccine Gardasil (HPV) from Merck laboratories
April 8, 2011 : Google Translation
Merck loses market share while attempting to expand the marketing of Gardasil ® for the mature woman . Press SANE Vax Inc. Declares Victory in the campaign to raise awareness about the dangers of Gardasil ” : In a long awaited decision (1), the U.S. FDA ruled against the request to obtain a license Merk Supplemental Biological Applications, supplemental biologics license application (sBLA) – and the drug may not indicate the use of GARDASIL ® [virus vaccine recombinant quadrivalent human papillomavirus (types 6, 11, 16 and 18)] for women aged 27 to 45 years . This was the fourth rejected Merck’s request to expand the use of Gardasil to a broader population of women.
SANE Vax, Inc. welcomes the decision by the FDA . According to Norma Erickson, President of the organization, “This decision marks a major victory for consumers of medical products worldwide. I would like to personally thank the team SaneVax and each of the medical professionals, scientific researchers and educators who helped get the truth behind the development, testing, approval and marketing of this vaccine to the public. ” “The work of SANE team Vax, Inc. has prompted consumers to say enough is enough!” If it is not safe, affordable, necessary or effective, not the need! “
Leslie Carol Botha, Vice President of Public Relations for SANE Vax, Inc. stated that “it is obvious that the awareness campaign Vax SANE against Gardasil has been effective. We have communicated our concerns to the FDA on several occasions showing peer-reviewed scientific evidence and analysis. At the same time we have written and distributed hundreds of press releases and articles that document not only research, but the harm that Gardasil has caused previously healthy adolescents. We can proudly say that both medical consumers and doctors, as well as the government are paying attention to our concerns. ”
This entry was written by , posted on April 11, 2011 at 10:48 am, filed under Cervical Cancer, Gardasil / Silgard, HPV Vac. Adverse Reacts., HPV VACCINES, Human Papillomavirus,Pharmaceuticals, SANE Vax Press Releases, The Government, The Politics and tagged Autoimmune Diseases, Cervarix, Cervical Cancer, Endocrine, Gardasil/Silgard, GlaxoSmithKline, HPV, HPV VACCINES,Human Papillomavirus, Merck, Sane Vax, Vaccinations, Vaccine Adverse Reactions. Bookmark thepermalink. Follow any comments here with the RSS feed for this post. Post a comment or leave a trackback: Trackback URL.
Merck & Co. said the Food and Drug Administration failed to widen the indication of its Gardasil vaccine to prevent cancers linked to human papillomavirus in women over age 26.
Winning a wider market for Gardasil is key for the vaccine, once expected to be a blockbuster for Merck. Sales in Gardasil have weakened because the pool of users has shrunk as more are immunized and because of competition from GlaxoSmithKline PLC's Cervarix. In Merck's latest quarterly results, sales of Gardasil fell 20%.
Rather than widen the indication of Gardasil for women aged 27 to 45, Gardasil's listing of limitation of use and effectiveness was updated to say the drug hasn't been shown to prevent cervical dysplasia or worse ailments in women in that age range.
End of study data from the clinical study evaluating the use of the vaccine in this age group was also added to the prescribing information.
In the U.S., Gardasil is approved for girls and women ages nine through 26 to prevent cervical, vulvar, vaginal and anal cancers, as well as genital warts and lesions, caused by HPV. Boys and men in the same age range can get the vaccine for the prevention of anal cancer and lesions and genital warts.
A Hamilton toddler who was mistakenly injected with a vaccine to prevent cervical cancer when he was just six weeks old has developed a rare form of leukaemia.
Chace Topperwien began chemotherapy for the M7 strand of acute myeloid leukaemia on his second birthday last month, but doctors cannot tell them whether the Gardasil vaccine he was injected with in May 2009 caused the cancer.
His parents, Ryan and Keri Topperwien, are devastated at the diagnosis after they were reassured at the time of the incident that their baby would not suffer any adverse reactions.
"I had thought in the very back of my mind that the absolute worst thing they could say is leukaemia," Mrs Topperwien said. "When they said that he had it, it blindsided both of us."
The couple, both 27, were horrified when at six weeks old their son was given the vaccination meant for teenage girls instead of one to prevent meningitis.
Gardasil targets the human papillomavirus, which causes warts on the hands, feet and genitals and is responsible for 99 per cent of cervical cancers.
Since the cancer diagnosis, Chace has been undergoing an aggressive course of chemotherapy treatment for up to 10 hours a day in Starship hospital in Auckland.
The little boy is due to start a second course of chemotherapy on Tuesday but doctors are waiting for his white blood cell levels to increase.
Until then the once energetic and outdoor-loving preschooler is confined to his bedroom 23 hours a day while his immune system recovers – a simple cold or bug could be disastrous.
The couple said their only child was taking the illness in his stride and, other than a nasogastric tube in his nose for feeding, looked deceivingly well.
"He's still smiling and laughing. Other than not being allowed out of his room he's still happy. But he knows that he's not well."
Mr Topperwien has taken indefinite leave from his job as a ceiling installer and Mrs Topperwien has put her PhD studies on hold so they can be at their son's bedside.
The pair, who are sleeping at Ronald McDonald House and take turns spending the night with Chace, have taken a three-month "mortgage holiday" to keep financial pressures at bay.
But they are worried about what will happen when that ends and said if Chace's chemotherapy was not successful they might need to look at further treatment overseas.
To help the family, friends have started three Facebook pages to raise money and so far fundraising events have netted more than $4000. A head-shaving fundraiser planned for tonight in Hamilton had attracted up to 20 participants, Mr Topperwien said.
He and his wife had already shaved their own hair to show Chace, whose hair had begun falling out, that it was okay to have it shaved off.
Meanwhile they want their concerns about a possible link between the Gardasil vaccination mistake and Chace's leukaemia acknowledged. "It's not a crazy theory," Mrs Topperwien said.
"We feel the development of his immune system has been interrupted and when he was diagnosed doctors said that the mutation of his cells had come about through a different pathway to the way leukaemia normally develops."
Waikato District Health Board medical officer of health Dr Felicity Dumble said she did not believe there would be a link between Gardasil and leukaemia.
However, she said it was important cases such as Chace's be monitored and researched to establish if there was a possible association.
To help raise money for the family donate at any ASB branch to the Chace Topperwien Fundraising account, number: 12 3217 0163111 00 or you can visit his Facebook pages by searching Chace Topperwien.