HPV shot safety affirmed in teens, young women
New data confirms the safety of the quadrivalent human papilloma virus (HPV4) vaccine.1 Results of the large study indicate that immunization was associated only with same-day syncope and skin infections in the two weeks after vaccination, similar to previous findings.2
"I think there are two important findings in this study," says Kevin Ault, MD, professor of gynecology and obstetrics at Emory University in Atlanta. "It is a post marketing study, so it is a 'real world' report of vaccine safety after widespread use of the HPV4 vaccine, [and] it is reassuring, as other HPV4 vaccine safety reports have been."
The study was conducted within the Northern and Southern California Kaiser Permanente integrated healthcare delivery systems. It included 189,629 females who received one or more doses of the vaccine between August 2006 and March 2008. More than 99% of the females were between ages 9-26 when they received the first shot, with approximately half between the ages of 9-15 at first dose.1 Investigators designed the study to compare the risk of emergency department visits and hospitalizations during post-vaccination intervals of 1-60 days, 1-14 days, and day 0 (day of vaccination), with control intervals ranging from 60 days for those who received one dose of the quadrivalent vaccine to 180 days for those who received three doses.
What were the outcomes?
"Taking into account all the analyses, subanalyses and relevant medical record reviews, an independent safety committee noted that there may be an association between HPV4 vaccination and same-day syncope, as well as skin infections during the two weeks after immunization," says lead author Nicola Klein, MD, PhD, co-director and research scientist at the Kaiser Permanente Vaccine Study Center in Oakland, CA.
The association between the quadrivalent vaccine (Gardasil, Merck & Co., West Point, PA) and syncope was not unexpected, investigators state. Immunization and injections in general have a known association with syncope, particularly in young women.
The study also detected an association between the vaccine and skin infections in the two weeks following shot administration. "Medical record review suggested that some cases may have been local injection site reactions; however, females who received HPV4 sought increased clinical care for skin conditions following vaccination," the investigators note.
That the study detected two potentially expected outcomes provides reasonable reassurance that it was a valid approach to uncovering HPV4-associated safety signals, Klein notes. The findings substantiate the overall safety of the HPV4 vaccine in women and girls following routine administration, she states.
As noted in the current research, prior data suggests that increased fainting occurs among females 13 years and older after receiving any vaccine.3 To avoid serious injury related to a syncopal episode, vaccine providers should consider observing patients for 15 minutes after they are vaccinated.4
The 15-minute time period is suggested by the Centers for Disease Control and Prevention (CDC) for all vaccines, notes Ault. Clinicians should make patients wait 15 minutes after they have received any vaccine to leave the office, Ault states.
Who gets the shot?
Be sure your office is identifying potential candidates for HPV vaccination. The Food and Drug Administration approved the quadrivalent HPV vaccine in 2006 for females between ages 9-26 for prevention of a range of diseases attributed to HPV. The vaccine later was approved to protect boys and men against the HPV types that cause most genital warts and anal cancers.
The CDC recommends the HPV vaccine for all boys ages 11 or 12 and for males through age 21 who have not already received all three doses. It also is recommended for gay and bisexual men (or any man who has sex with men) and men with compromised immune systems (including HIV) through age 26, if they did not receive full vaccination at a younger age. The vaccine is safe for all men through age 26, but it is most effective when given at younger ages, according to the CDC.
The Advisory Committee on Immunization Practices voted in 2011 to recommend that males be routinely vaccinated against HPV, a move many public health officials hailed as a potential boost for use of the shot.
References
- Klein NP, Hansen J, Chao C, et al. Safety of quadrivalent human papillomavirus vaccine administered routinely to females. Arch Pediatr Adolesc Med 2012. Doi:10.1001/archpediatrics.2012.1451.
- Slade BA, Leidel L, Vellozzi C, et al. Postlicensure safety surveillance for quadrivalent human papillomavirus recombinant vaccine. JAMA 2009; 302(7):750-757.
- Centers for Disease Control and Prevention (CDC). Syncope after vaccination -- United States, January 2005-July 2007. MMWR 2008; 57:457-460.
- Centers for Disease Control and Prevention (CDC). FDA licensure of bivalent human papillomavirus vaccine (HPV2, Cervarix) for use in females and updated HPV vaccination recommendations from the Advisory Committee on Immunization Practices (ACIP). MMWR 2010; 59:626-629.
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