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Is Gardasil Safe?

Fretting about whether to get your daughter vaccinated against cervical cancer? Or perhaps about getting Gardasil yourself? The federal government has new data that officials say should help calm fears about the safety of the controversial shots.

The analysis of data collected from about 190,000 women and girls who got at least one Gardasil shot found no evidence that the vaccine increased the risk for any serious complications, according to the federal Centers for Disease Control and Prevention in Atlanta.

The CDC and other major medical groups recommend girls get the vaccine before they become sexually active to minimize the chances of getting cervical cancer later in life. The vaccine protects against strains of the human papilloma virus (HPV) that can cause cervical cancer.

But many parents have been reluctant to get their daughters vaccinated. Part of the reluctance is worries that vaccinating girls against a sexually transmitted virus might encourage sexually activity, and part of it is concerns about safety. Vaccine critics cite thousands of reports that the CDC has received about complications among people who got the vaccine, including strokes, blood clots, seizures and even some deaths.

The CDC and the Food and Drug Administration have looked into this before and concluded that it's not surprising that serious problems may have been reported among some recipients, given that doctors have administered more than 20 million doses of the vaccine. There's no convincing evidence that the major complications that have been reported have been actually caused by the vaccine, the agencies said.

To try to explore that further, however, CDC researchers analyzed preliminary data collected by another system specifically set up to better monitor adverse reactions from vaccines known as the Vaccine Safety Datalink. The system collects detailed medical information from seven large health maintenance organizations around the country.

Scientists compared the rate of adverse reactions among girls or young women who received some 375,000 doses of the vaccine in the last two years with that among those who did not get the vaccine or got other vaccines. None of eight serious complications, including seizures, blood clots, strokes or the neurological condition Guillain-Barre syndrome, occurred more frequently among those vaccinated than those who went without it, the CDC reported yesterday to a panel of experts that monitors vaccines for the agency.

The agency said it also carefully analyzed the 27 deaths that have been reported, and found no common pattern that would indicate they were caused by the vaccine.

The shots do cause minor reactions, such as sore arms, dizziness, nausea and mild headaches, and a lot of fainting. But so far that seems to be the worst problems.

Given the level of passion surrounding Gardasil, the new data are unlikely to settle the debate. While CDC officials say they hope the new information will help reassure those who have gotten the vaccine or are considering it, critics say they remain unconvinced.

By Rob Stein  |  October 23, 2008; 7:00 AM ET
Categories:  Family Health , Teens , Women's Health  
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Comments

Concerns about vaccinating with Gardasil because it protects against a sexually transmitted infection are ridiculous.

We vaccinate infants and older against Hep B, a virus that can be spread through sexual contact and I hear nary a peep about that.

Do critics really think that genital warts and/or an incompetent cervix (infertility) and/or cancer is an appropriate punishment for poor sexual behavior?

I have a 6-month-old daughter and she will be vaccinated once she is old enough. I cannot imagine thinking that preserving her virginity or preserving some set of expectations about her sexual behavior would be more important to me than protecting her from genital warts, infertility and/or cancer.

Posted by: Melissa | October 23, 2008 8:50 AM | Report abuse

As a medical professional and a mother I would warn others against rushing to add yet another vaccination to the growing list we currently administer to our children. Also, I am not sure I have ever administered a Hep B vaccine to an infant. One thing about this vaccine is that it only protects against one strain of the virus that can cause cervical cancer in women...there are many others. Multitudes of young girls are damaged PERMENANTLY by this vaccine and it has not been tested throughly enough..for instance there are no long term studies (30 year longitudinal) that have been conducted on this vaccine...how does anyone know what the future reprecussions could be? I would strongly advise Melissa to do more independent research before deciding to inject a virus into her child's body.

Posted by: chynna12169 | October 23, 2008 2:46 PM | Report abuse

Hep B vaccine is routine and recommended for infants, and has been for many years. I don't know what "permanent damage" from Gardasil you are referring to - I'd love to see a citation if possible. As for future repercussions, it's a valid concern for this vaccine and any other vaccine or medication, but it's also simply impractical. If we waited for 30 year longitudinal studies for every new vaccine, we would still have polio in this country.

Posted by: lom123 | October 23, 2008 3:01 PM | Report abuse

Also, the Gardasil vaccine is not "injecting a virus" - the vaccine is composed of recombinant (ie. synthetic) proteins designed to stimulate the immune system. It is not in any way a live virus.

Posted by: lom123 | October 23, 2008 3:11 PM | Report abuse

What is it Stein -- there is "no" evidence, or there is no "convincing" evidence?

The fact that serious problems have been reported among some recipients, including death, as admitted by you, is EVIDENCE.

Is it really so hard for the Post to write stories honestly and accurately, without biased spin?

The bigger question is whether you are a hack for the pharmaceutical industry that is pushing this, or whether you are a hack for pro-teen sex groups that are also pushing this?

Posted by: ooyah32 | October 23, 2008 3:41 PM | Report abuse

Gardasil is yet another poorly thought out and inadequately vaccination campaign that will most likely be more detrimental to society then helpful.

There are still no long term studies showing the safety and effectiveness of this study. It will not reduce the expenses to the population as a whole because you will still need to be screened for the cancers. Will this vaccine increase the chances of getting other cancers or illnesses because of the elimination of HPV? This question is unknown. Is this vaccine like the chickenpox vaccine in that it reduced societies overall immune response to HPV and increased the likelihood of cervical cancers to those that are not immunized? Also unknown. Is Gardasil like antibiotics in that its use will create super strains of HPV that will be treatment resistant? Also unknown. Only limited numbers of women are currently vaccinated, but men also carry and transmit HPV. Herd immunity cannot possibly be achieved if significantly less then 50% of the population receives the vaccine.

A less then half-hearted attempt by the medical community for a vaccine with very real questionable problems.

Posted by: cakkallen@rstarmail.com | October 24, 2008 9:46 AM | Report abuse

Post hoc, ergo propter hoc. Most of you suffer from this affliction. Look it up. Learn it. Live it.

Posted by: rlalumiere | October 25, 2008 8:19 AM | Report abuse

"Post hoc, ergo propter hoc." isn't applicable to all the statements here. I think a better term would be:

Caveat emptor.

Learn it. Live by it.

Posted by: cakkallen@rstarmail.com | October 25, 2008 7:46 PM | Report abuse

It's really sad that we live in a time where people believe they have to vaccinated against everything. And still the cancer, diabetes and every major disease in on the rise. I would never vaccinate my child with something that just came out. 27 deaths!!!! They will never say it was the vaccines fault. Yet there are thousands more that had serious side affects such as paralysis and acute pancreatic attacks. How many more will suffer... The best way to protect yourself from any disease is to eat a sound diet. Unfortunately that is food that doesn't come from conventional grocery stores. Pleases quit feeding your children chemicals and dyes and processed foods!!!!

Posted by: acmalone | October 29, 2008 11:11 AM | Report abuse

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