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Home HPV Vaccines HPV Vaccines Interview with Dr. Kevin Ault on Vaccine Safety

Interview with Dr. Kevin Ault on Vaccine Safety

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HPV News chatted with Kevin Ault, M.D., an Associate Professor in the Division ofDr. Kevin Ault Gynecologic Oncology at the Emory University School of Medicine in Atlanta, about media reports on concerns over possible health complications being linked to Gardasil®, the HPV/cervical vaccine that hit the market in 2006. Dr. Ault, whose research focuses on women’s health and infectious diseases, was lead investigator with one of the clinical trials that looked at the effectiveness of Gardasil® in preventing cervical diseases related to the two “high risk” HPV types found with the majority of cervical cancers.

HPV News: Is it common in general for vaccines to have a number of adverse events associated with them?
Kevin Ault: I think the number of adverse advents reported with Gardasil® is about the same as what’s seen with other vaccines that are out there; it might be a slightly higher but certainly not out of the norm.

Recent news reports have examined claims about neurological disorders, and even a few deaths, observed in females who have received Gardasil®. Have any of the serious adverse events allegedly associated with the vaccine actually been proven?
The one that gets the most press is probably the possible association with Guillain-Barré Syndrome (GBS, an autoimmune disorder that can lead to paralysis). The bottom line is that many autoimmune diseases have a pretty high background rate to begin with, and the rate with GBS and other autoimmune diseases is 1 to 10 cases per 100,000 individuals each year among the group for which Gardasil® is approved, 9-26 year old adolescents and young women. CDC’s press release on this subject indicates there have been 16 million doses of Gardasil® given, so potentially there could be dozens and dozens of kids in the vaccine group who develop diseases like GBS that is related by pure chance. But what have we seen? Very few cases.  GBS is something that happens to kids in that age group regardless. There is nothing that supports a cause and effect relationship with the vaccine.

What about reports that some teens have fainted after receiving the injections?

That’s very common in young people, so we’re discussing a group of people who faint frequently from any vaccine, not just Gardasil®. That’s the nature of giving vaccines to adolescents. During the clinical trials, we had women stick around for half an hour after their injections, and we had no problems with fainting. I’m not sure that protocol gets followed so strictly in doctor’s offices!

Some of the reporting on this topic has been alarmist, it seems. How much has this fueled the hype?
I’m not sure that good news always gets publicized the way the bad does, and this is true beyond vaccines and the medical community, to be sure. I talked with one major news outlet for a long time about this, but my comments didn’t make the evening news like the negative stuff did. One story that showed up online was especially concerning, because it mentioned miscarriages and blood clots and all kinds of things that are clearly not related to the vaccine, and nobody ever thought they were in the first place! When you start throwing in everything except the kitchen sink, it’s a concern.

What is the bottom line here, if parents have concerns about vaccinating their daughters? What do we tell them?
I think the safety record of Gardasil® is overall good. The rate of serious adverse events related to this vaccine is 2 per 100,000 doses.  If you really think about it, we know hundreds of thousands of women in the U.S. each year get genital warts or premalignant changes detected on their Pap tests, so the risk and benefit is clearly in favor of the vaccine.