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Is Gardasil Safe? – Updated

Question: Is Gardasil Safe?

Recent news reports have suggested that Gardasil, the HPV vaccine, may be causing serious side effects. Is this something parents should worry about, or is it all just media hype? Just because an adverse reaction is reported to the vaccine adverse event reporting system (VAERS), it doesn’t mean it’s related to the vaccine. With less than 8000 reported adverse events outof 12 million distributed doses, Gardasil is one of the safer vaccines on the market. Still, my heart goes out to the young women who have had serious side effects near the time they got the HPV vaccine, even if they had nothing to do with the shot.

Answer:

Careful review of the data suggests that Gardasil is probably as safe as any other vaccine. In fact, it may be even safer, as the reporting rate for adverse events is approximately half that for most vaccines.

Out of more than 67 million doses of the Gardasil vaccine distributed between June 2006 and March 2014, there have been only slightly more than 25,000  reported adverse events, and the vast majority (92.4 percent) of those reports to VAERS were for minor conditions, such as injection site pain, which are common to many vaccines. There have, however, been reports of other, more serious, adverse events.

According to the CDC, of 47 confirmed deaths reported to the VAERS as potentially linked to HPV vaccination during that time period, none were clearly linked to vaccination. There was also no consistency in cause of death that would imply vaccination was the cause. Similarly, with respect to the reports of Guillain-Barre Syndrome (GBS),  the number of GBS is not inconsistent with the rate of disease seen in the general population. No significant increase in risk has been found with vaccination. Therefore, these cases can not be linked definitively to use of Gardasil. Safety data for Cervarix appears similar but based on a smaller population of people who have been vaccinated

It is important to remember that there are limits to the vaccine adverse events reporting system. In order for researchers to be able to learn about those side effects that are actually related to vaccine use, they must collect every possible bit of data — and a lot of the reported events will have nothing to do with the vaccine. People get sick, sometimes very sick, and sometimes they get a vaccine in the week or two before they would have been struck down by a serious illness anyway. The only way to figure out which events are related to vaccine use, and which aren’t, is careful investigation. So far, that investigation suggests that Gardasil is nothing to worry about. At this point, the potential benefits in reducing deaths and sickness from cervical cancer and discomfort from genital warts more than outweigh the still primarily theoretical risks.

Sources:
The CDC GARDASIL VAERS Report for 2008

Markowitz LE, Dunne EF, Saraiya M, Chesson HW, Curtis CR, Gee J, Bocchini JA Jr, Unger ER; Centers for Disease Control and Prevention (CDC). Human papillomavirus vaccination: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2014 Aug 29;63(RR-05):1-30. Erratum in: MMWR Recomm Rep. 2014 Dec 12;63(49):1182. PubMed PMID: 25167164