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News of the Day ... In Perspective8/27/2007
Guillain Barr� syndrome reported after human papillomavirus vaccine
As of May 31, there have been 13 cases of Guillain Barr� syndrome (GBS) in association with human papillomavirus (HPV) vaccine (Gardasil) reported to the Vaccine Adverse Event Reporting System (VAERS). The Centers for Disease Control and Prevention (CDC) notes that six of the patients had received Gardasil alone, and six had also received meningococcal vaccine (Menactra). Since the end of May, an additional two cases have been reported.
The CDC states that studies are planned concerning the concomitant administration of Gardasil and Menactra. So far, the combination of Gardasil and hepatitis B vaccine is the only one that has been studied, although one or more other vaccines are frequently given to Gardasil recipients.
An analysis of VAERS data by the National Vaccine Information Center (NVIC) concludes that the risk of serious adverse reactions such as GBS is increased by concomitant administration of other vaccines. In patients who made a report to VAERS, the risk of GBS is more than 10 times greater for Gardasil given with Menactra compared to Gardasil given alone (P<.0001). A causal relationship with vaccine administration has not been proved. The background incidence of GBS in persons in the second decade of life is 1-2/100,000.
According to an NVIC press release, one of the patients who reported a reaction to VAERS was an 18-year-old athlete who ran 6 miles/day before receiving Gardasil, Menactra, and Varivax on the same day. She did not need a ventilator but was hospitalized for 22 days with weakness of all limbs. Now receiving physical therapy, she hopes at least to be able to play the guitar, draw, and smile again.
The second most commonly reported adverse event is syncope, with 239 reports. Sometimes this has resulted in serious injury, including fractures and subdural hematomas. It is suggested that vaccines be administered with the patient supine and be followed with at least 10 minutes of observation. Syncope has, however, occurred after a longer delay.
Gardasil is now involved in 15�20 percent of all VAERS reports that are filed.
In May, Lawrence Gostin, J.D., of the Georgetown Law Center and Catherine DeAngelis, M.D., M.P.H., Editor in Chief of JAMA, wrote of �important concerns about mandatory HPV vaccination� that are �not moral,� including cost, parental concerns about safety, and potential compensation for injury. They advocated taking a �deliberative approach� rather than mandating the vaccine for school entry at the present time.
�Legislation to make HPV vaccine mandatory has undermined public confidence and created a backlash among parents,� they write. �There is nothing more important to the success of public health policies than to ensure community acceptability. In the absence of an immediate risk of serous harm, it is preferable to adopt voluntary measures, making state compulsion a last resort� (Gostin LO, DeAngelis CD. Mandatory HPV vaccination: public health vs private wealth. JAMA 2007;297:1921-1923).
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