FDA Gardasil Decision DelayedJun 17, 2010 | Parker Waichman LLP
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.
Approved in 2006, 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. The vaccine is approved for use in girls and young women, ages 9 to 26. Last year, the FDA approved Gardasil’s use in males 9 to 26 years old to prevent genital warts caused by HPV.
Merck has been seeking approval to market Gardasil to older women for more than two years. But according to The Wall Street Journal, 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.
The FDA would not comment on the delay, the Journal said.
Since its approval in 2006, Gardasil has been the subject of controversy, some of which centered around safety concerns. As of June 2009, 15 million girls had received Gardasil, with more than 14,000 recipients reporting adverse reactions. The complaints included reports of dizziness numbness, and blood clots. Health regulators are also looking at 43 reports of fatalities that occurred following Gardasil administration.
Last June, the FDA announced that the Gardasil label had been updated to include more prominent warnings about fainting that can occur following administration of the vaccine. According to the agency, some Gardasil fainting victims have suffered from tonic-clonic (jerking) movements and seizure-like activity, and some have fallen resulting in traumatic injuries. According to the agency, roughly 13% of Gardasil side effects reported to its Vaccine Adverse Event Reporting System (VAERS) describe fainting.
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.