Vaccine Watch: Gardasil Side-Effects?

Sharyl Attkisson is an investigative correspondent for CBS News.

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Yesterday I spoke to the families of young women who believe the Gardasil HPV vaccine may have – or did in fact – cause their child's serious illness. One of the cases involves a now 18-year old young woman named Amanda.

Amanda's parents say she developed a serious reaction to Gardasil after her first dose last summer. It began with soreness where she received the injection. The soreness eventually travelled down her arm, her legs, and led to a horrible autoimmune myofasciitis that is so painful Amanda had to go on morphine for the pain.

She was transformed, through the illness, from a high school varsity sport athlete to a chronically ill person who takes a handful of pills a day just to keep her illness tolerable. When she goes off the medicine, the excruciating pain and other debilitating symptoms return.

One thing that's different about Amanda's case than some of the others is that both of her parents medical doctors who didn't think twice about having their daughter get the shot – but are now second-guessing themselves. They call their daughter's illness after Gardasil "a very sobering experience." Amanda's dad says, "as the father of three girls, I've had to ask myself why I let my eldest one get an unproven vaccine against a few strains of a nonlethal virus that can be dealt with in many more effective ways. It's not like they are at high risk. It was the regrettable acceptance of the vaccine party line that [mis]led me."

Merck, which makes the vaccine, the CDC and the FDA all say it is safe, effective, and important. Speaking of more than 8,000 adverse event reports and more than a dozen deaths, the CDC told CBS News, "we have found no connection between these deaths" and Gardasil. "We still recommend the vaccine and feel it is an important vaccine for the health of women. There are about 20 million people currently infected with HPV. Women have an 80 percent chance of developing HPV by the time they are 50. HPV is most common in people in their late teens and early 20s. Because the vaccine is a preventative and not a cure, it is important that the vaccine be given prior to beginning sexual activity. About 11,000 women will be diagnosed with cervical cancer and 3,600 will die. This vaccine prevents four viruses that account for about 70 percent of cervical cancers."

The CDC says it is conducting its own analysis of Adverse Event Reports on Gardasil. Of 7,802 reports after Gardasil vaccination in the U.S. as of April 20, 2008, "Less than 7 percent reported adverse events were considered serious, about half of the average for vaccines overall. Again, a report to (the Vaccine Adverse Event Reporting System) does not mean there is a connection between the vaccine and the report. It means the event took place following vaccination."

The CDC has acknowledged fainting problems after Gardasil vaccination and has recommended that doctors keep vaccinated patients in the office for 15 minutes following the injection. You can see the CDC's HPV VAERS reports here.

The FDA agrees with the CDC and sent CBS News an email with some "important points" including:

We are not surprised by the number and type of reported adverse event cases following Gardasil administration since it was approved.

We are monitoring the safety of the HPV vaccine very carefully, and the only safety signal identified to date is syncope, or fainting. (A safety signal refers to a concern about an excess of adverse events compared to what would be expected to be associated with a product's use.)

Syncope, or fainting, is a common event occurring with needle injections and vaccinations, especially in adolescents. Some vaccinees who fainted were injured when they fell. On October 1, 2007, FDA approved a revised label that added a "Post-marketing Reports" section that included syncope, dizziness, nausea, vomiting and hypersensitivity reactions.

Deaths and serious reports (operationally defined as an event that resulted in life-threatening illness, hospitalization, prolongation of hospitalization, persistent or significant disability, and congenital anomaly/birth defect) are followed up by telephone to obtain additional information about the event and the patient's prior medical history.

Most adverse events (94 percent) reported to VAERS for Gardasil were not serious and included reports of syncope, pain, headache, nausea and fever.

Passive surveillance systems such as VAERS are subject to many limitations. True associations will inevitably be underreported, to an unknown extent. Other adverse events might be expected to occur coincidentally after vaccination. It is problematic that temporal associations will be reported, often with little data to evaluate any causal connection with the vaccine. This inability to obtain precise numerators coupled with inadequate denominator data means that incidence rates cannot be determined. Although the number of doses distributed is available to the FDA we do not know the number of doses actually administered or the demographic distribution of those receiving the vaccine. Reporting of unconfirmed diagnoses is common, and on follow-up initially reported diagnoses are not uncommonly found to be inaccurate. For purposes of evaluating the possible causal relationship between an event and a vaccination, a particularly important limitation is the lack of a direct and unbiased comparison group from which to determine the incidence of the same type of adverse events among people who have not been vaccinated.

There is likely still a lot to be learned about the ultimate benefits and risks of this relatively new vaccine. Since the test subjects are young, it will be decades before a large group of them reaches the age at which women typically get cervical cancer. Which means it may be a long time before we know the vaccine's true real world effectiveness when it comes to preventing cervical cancer. In the meantime, public health officials say they will closely monitor any emerging side effect trends. Hopefully, this vaccine will prove to be the lifesaver everyone would like for it to be.