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FDA Holds Off on Gardasil for Older Women

The Food & Drug Administration (FDA) has put off a decision on whether or not it should approve the expanded use of the Gardasil vaccine to older women, ages 27 to 45. The FDA’s decision, which was expected sometime next week, will not come until later this year.

The FDA delayed its approval because it wanted longer-term data on Gardasil’s efficacy, after four years of follow-up. Merck & Co., the maker of Gardasil, provided that information last year. The efficacy rate after four years of follow up was 88.7 percent compared with 91 percent after two years.

Meanwhile, though it is still considered a blockbuster, Gardasil sales dropped 11 percent to $232.6 million in the first quarter this year. A study just released earlier this month found only about a third of girls are getting the vaccine.

Blood Clots, Other Reactions Linked to Gardasil

As of June 2009, 15 million girls had received Gardasil vaccines and some also reported suffering from adverse reactions that have included dizziness, numbness, and blood clots, among other dangerous, and sometimes even deadly, reactions.

Reports of side effects following vaccinations are compiled by the Vaccine Adverse Event Reporting System (VAERS), which is jointly managed by the FDA and the U.S. Centers for Disease Control and Prevention (CDC). While reports remain unconfirmed and there is no direct tie to the Gardasil vaccination, data indicates that over 23 million Gardasil doses were administered between 2006 and 2008. Of these, said the Washington Post, 12,424 complaints were filed and included “pain and redness at the injection site, dizziness, nausea, headaches, and fainting.”

Of note, six percent of the reports were very serious and included “blood clots and Guillain-Barré syndrome,” as well as 32 reports of death. Guillain-Barré is a neurological disorder that causes weakness in the muscles, as well as tingling, which can lead to paralysis, said the Washington Post. Because of the differing symptoms involved, there is yet to be a confirmed link to the vaccine.

Immigrants Won’t Need Gardasil to Get a Green Card

Effective Dec. 14,Gardasil or other HPV vaccination will no longer be a requirement for immigrant girls and women seeking a green card.

The requirement to receive at least the first dose of the HPV vaccine, which is administered in three doses, was implemented by the CDC for female immigrants between the ages of 11 and 26 in July 2008.

“More than half of the immigrants who come to the U.S. seeking opportunity are women,” said Silvia Henriquez, executive director of the National Latina Institute for Reproductive Health, in a statement, quoted the AP. “We thank the CDC for restoring their dignity and reproductive justice.”

There are currently two HPV vaccines approved for use in the U.S. Gardasil prevents four strains of HPV, two of which cause 70 percent of all cervical cancers. The other two HPV strains are responsible for about 90 percent of genital warts. Cervarix, approved by the Food & Drug Administration (FDA) just last month, protects against two strains of HPV that cause more than 70 percent of cases of cervical cancer in women.

Gardasil Probed for ALS Connection

Gardasil may have played a role in two fatal cases of amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease, according to researchers from the ALS Center at the University of California San Francisco Medical Center.

ALS is a rapidly progressive, fatal disease. According to WebMD, the cases documented by the ALS Center involved two young women, ages 17 and 20. The story of one, 17-year-old Jenny Tetlock, has been reported on this blog before. Both young began showing symptoms of ALS just months after receiving a Gardasil shot. In Jenny Tetlock’s case, she had received her third and final vaccine in March 2007. The second victim, a 20-year-old, developed problems within four months of her fist Gardasil injection. According to WebMD, the disease progressed similarly in both young women before it took their lives. Jenny Tetlock died in March 2009, while the other young woman died 28 months after receiving Gardasil.

The ALS Center researchers concede that the development of ALS in both young women so soon after Gardasil vaccination could be a coincidence. But according to WebMD, they are concerned by a couple of factors. For one thing, the disease progressed more quickly than is usual for young ALS patients. Autopsies revealed the spinal cord of both victims was severely inflamed, something the researchers said is not typically seen with ALS. According to WebMD, the researchers believe these factors “all support a temporal association between [the illness] and vaccination.”

FDA Panel Says Yes to Gardasil for Boys

A Food & Drug Administration (FDA) advisory panel has recommended that Gardasil be approved for boys and young men aged 9 to 26 for protection against genital warts caused by HPV.

According to CNN, at yesterday’s advisory panel meeting, Merck presented data from three clinical trials that the company claims supports broadening the distribution of the vaccine to include males. According to Merck, the trials saw a 90 percent reduction in genital warts and pre-cancerous lesions caused by HPV in men, and an 89 percent reduction in genital warts incidence. Merck also claimed that no serious adverse events related to the vaccine were reported , and that side effects – such as fever and pain at the injection site – were mild.

According to the Associated Press, the advisory panel voted unanimously with one abstention that the vaccine is effective for preventing HPV, in males ages 9 to 26. The panel voted 7-1 that the vaccine is safe for those patients.

The FDA is not required to follow the recommendations of its advisory panels, but it usually does so.