Gardasil: A false sense of immunity?

Abstract

e13023 Background: Gardasil, a quadrivalent vaccine for human papilloma virus (HPV), is recommended to women aged 9 to 26 to prevent cervical cancer. Over 26 million doses of Gardasil have been administered since its approval by the FDA in June 2006. The vaccine, which protects women from infection by four types of HPV, has been implicated in Guillain-Barre Syndrome (GBS), a rare paralytic disorder. Methods: We conducted a search of the Vaccine Adverse Event Reporting System (VAERS). Our analysis included reports from June 2006 and Aug 2009 of women ages 9 to 26 who had received Gardasil and no other vaccines (concurrent or recent) and presented with either confirmed or suspected GBS. Results: We found 42 incidences of Gardasil-related GBS (reported mainly by medical personnel), including pts receiving Gardasil alone (N=27; age 10-26 yrs; mean 16.67 for the 18 subjects for which age was reported). Of the 27 incidences, 33% were complete reports, with 10 reports after the first dose and 4 reports after the third dose. Initial symptoms averaged 30 days post-Gardasil injection for these 11 cases. GBS was confirmed as final diagnosis in 20 reports, and was highly suspected in 7 reports. Conclusions: A majority of the VAERS data was incomplete: missing pt age, Gardasil dose, or date of GBS onset. Serious adverse events such as GBS require improved efforts at obtaining complete information. Prospective studies are needed to evaluate the link between GBS and Gardasil. Date reported to VAERS (N=none) Age Gardasil dose Onset of symptoms (days) Confirmed diagnosis (Y=yes, S=suspected) 9/7/06 16 1 14 Y 9/14/06 15 1 50 Y 12/3/06 13 N/A 9 Y 4/6/07 N/A N/A N/A Y 5/3/07 18 1 1 Y 5/14/07 13 N/A N/A Y 8/2/07 N/A N/A N/A S 10/12/07 19 1 N/A Y 11/26/07 14 1 1 Y 10/15/07 N/A N/A N/A S 10/15/07 23 N/A N/A Y 1/16/08 18 N/A 15 Y 3/17/08 N/A 1 N/A Y 3/17/08 19 1 150 Y 5/19/08 14 N/A N/A Y 6/19/08 N/A 3 N/A S 6/19/08 N/A 3 N/A S 8/18/08 N/A N/A N/A S 9/17/08 11 N/A N/A S 9/17/08 15 1 75 Y 12/9/08 11 N/A N/A Y 12/22/08 24 3 1 Y 2/10/09 10 1 13 Y 2/18/09 26 1 1 Y 3/16/09 N/A N/A N/A S 4/8/09 N/A N/A N/A Y 4/17/09 21 3 N/A Y No significant financial relationships to disclose.