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FDA doesn’t okay Merck’s Gardasil used for older women 6-25-08
The Food and Drug Administration denied Merck & Co Inc. request to market the
multi-billion selling cervical cancer vaccine Gardasil to women age 27 to 45
because the agency did not have enough time to address the issues related to the
drug and license application.
Gardasil has already been approved for females age 9 to 26 for prevention of
cervical cancer induced by a couple of Human papillomavirus (HPV) strains. The
vaccine, demonstrated in trials involving a small number of young girls, showed
it effectively protects against development of precancerous lesions caused by
strains 6,11,16 and 18.
The vaccine is targeted at the young females who do not get infected with HPV.
But critics said the trials were not adequate because only a small number of
young girls were involved and the outcomes used to evaluate the efficacy of the
vaccine were pre-cancerous lesions, not cervical cancer, suggesting that the
real efficacy remains unknown.
Furthermore, critics pointed out the long term effect of Gardasil against
precancerous lesions remains unknown because no long-term trials have been
conducted, meaning that whether or not a boost shot is needed remains unclear.
Gardasil works in those who have not been infected at the time they receive the
vaccine. Many women at the age 27 to 45 may have acquired HPV rendering the
vaccine useless. This means when they opt to get three shots of Gardasil
vaccine, they might want to have a test done whether or not they have been
infected.
The vaccine come in three shots and costs $360 per person. It earns Merck an
estimated 1.5 billion dollars even without states mandating universal
immunization of school girls with this vaccine.
Early, Merck was vigorously engaged in pushing states to mandate a universal
inoculation of Gardasil and some states yielded to Merck's lobbying and required
young school girls to get shots if they want to enter public schools.
The FDA said Merck can't claim Gardasil protects from certain viral strains and
approval of a new request for claim that the vaccine protects against vulvar and
vaginal cancers is on hold because of some manufacturing issue.
The FDA move is reviewed as negative and Merck's shares dropped 1% to 36.68,
according to CNNmoney.com. Merck is expected to respond in July, media reports.
Comments:
This is a good move but it would be better to revoke this useless and dangerous vaccine. There is not enough proof that cervical cancer is caused by this virus. The Human papillomavirus causes all warts even genital warts. There is a small disproportion in woman with cervical cancer and those with genital warts. This is the anecdotal evidence used to perpetuate this vaccine's necessity.
Gardasil Ingredients:
amorphous aluminum hydroxyphosphate sulfate, sodium chloride, L-histidine,
polysorbate
80, sodium borate, and water for injection. inactive proteins that come from HPV
Types 6, 11, 16, and 18.
You can view this and all other vaccines on our vaccine ingredients page.