Research supports safety of HPV vaccine
Your next patient is an adolescent female who has requested immunization with the vaccine for human papillomavirus (HPV). When she asks specifically about the vaccine's safety, what can you tell her?
Research continues to support the safety of the HPV vaccine, according to a recent review of material by the World Health Organization's (WHO) Global Advisory Committee on Vaccine Safety.1 The group examined pre- and post-licensure data from the United States for the HPV vaccine (Gardasil, Merck & Co.; Whitehouse Station, NJ). The vaccine's safety profile is similar to that found in the pre-licensure trials, the group noted.1 The group also looked at safety data from other countries and concluded that Gardasil is a safe vaccine, says Martin Myers, MD, director and editor of the National Network for Immunization Information, a service provided by Immunizations for Public Health, a Galveston, TX-based nonprofit corporation that provides current, science-based information to health care professionals, the media, and the public. The WHO committee is calling for increased attention to building capacity for post-marketing surveillance in those countries where introduction is being planned, since many countries only recently have introduced HPV vaccines at the national level.2
Newly published research adds to the database on the safety of the vaccine. In one study analyzing use of the vaccine in Australian teenagers ages 12-18, researchers report that hypersensitivity reactions to the quadrivalent vaccine are uncommon and that most girls in this age range can tolerate subsequent doses.3 Scientists based their findings on results of clinical evaluations, skin tests, and examination of vaccine challenges in 25 schoolgirls with suspected hypersensitivity to the vaccine after more than 380,000 doses were administered in schools in Victoria and South Australia.
Another study released prior to the American Academy of Neurology's 61st Annual Meeting in Seattle looked at reports of use of the vaccine and Guillain-Barré syndrome, a rare disorder that causes muscle weakness.4 Results indicate that Guillain-Barré is not occurring more often after HPV vaccination than it does in the general population.
To perform the analysis, researchers examined data from the Vaccine Adverse Event Reporting System. They noted 36 cases of Guillain-Barré reported after HPV vaccination in the United States from 2006 to 2008; the disorder occurred within six weeks after vaccination in 75% of the people. In 60% of those with the disorder, the HPV vaccine was the only immunization they received at the time, while the remaining 40% received the HPV vaccine along with other vaccines.4
Watch for fainting
From the time Gardasil was approved by the Food and Drug Administration (FDA) in June 2006 until August 2008, more than 20 million doses of HPV vaccine were distributed in the United States. A total of 10,326 adverse events following immunization were reported in that time period to the Vaccine Adverse Events Reporting System, with the most commonly reported adverse events noted as fainting and dizziness.5 However, studies suggest that increased fainting occurs among females 13 years and older after receiving any vaccine.6
It is important for clinicians to take the precaution to have patients sit for 15 minutes following immunization, says Myers, who also serves as professor of pediatrics and preventive medicine and community health at the University of Texas Medical Branch in Galveston. The package labeling for the HPV vaccine now reads "Syncope has been reported following vaccination with Gardasil and may result in falling with injury; observation for 15 minutes after administration is recommended."7 [Editor's note: Use a FDA Consumer Health Information Sheet, "Addressing Questions on Gardasil," to help answer patient questions. Access the sheet by going to the FDA web site, www.fda.gov, and under "Consumers," select "Consumer Health Information." Select "All Consumer Updates," "Vaccines," and "Addressing Questions on Gardasil." Also use a fact sheet, "Questions and Answers about HPV Vaccine Safety," prepared by the Centers for Disease Control and Prevention (CDC). Go to the Vaccine Safety section of the CDC web site, www.cdc.gov/vaccinesafety. Under "Featured Items," select "Human Papillomavirus (HPV) Vaccine Safety." Under "HPV Vaccine Safety," select "Questions and Answers about HPV Vaccine Safety." There is a printer-friendly version available.]
References
- World Health Organization. Global Advisory Committee on Vaccine Safety, 17-18 December 2008. Weekly Epid Rec 2009; 5:37-40.
- Kang LW, Crawford N, Tang ML, et al. Hypersensitivity reactions to human papillomavirus vaccine in Australian schoolgirls: Retrospective cohort study. Br Med J 2008; 337: a2642.
- National Network for Immunization Information. HPV Vaccines. Safety of Human Papillomavirus Vaccine. Accessed at www.immunizationinfo.org.
- Michas-Martin P, Krivitskaya N, Khan H, et al. Guillain-Barré syndrome after vaccination with Gardasil in United States. A report from the CDC/FDA Vaccine Adverse Event Reporting System. Presented at the American Academy of Neurology conference. Seattle; April 2009.
- Calugar A. 2008. Vaccine Safety Update. Presentation to the Advisory Committee on Immunization Practices, Oct. 22, 2008. Accessed at www.cdc.gov/vaccines.
- Centers for Disease Control and Prevention (CDC). Syncope after vaccination — United States, January 2005 — July 2007. MMWR 2008; 57:457-460.
- Merck & Co. Patient Information about GARDASIL. Accessed at www.gardasil.com.
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