Reported adverse effects, including death, have raised debate over the safety of the human papillomavirus (HPV) vaccine Gardasil, which was released in June 2006.
Judicial Watch, a public interest association, filed a request in May 2007 to retrieve reports on Gardasil from the Vaccine Adverse Events Reporting System (VAERS), a cooperative analysis program between the Food and Drug Administration (FDA) and the Centers for Disease Control (CDC). Of the 1,637 adverse reports, the FDA considered 136 of them serious. Thirteen instances of Guillain-Barré Syndrome, a disorder in which the body's immune system attacks part of the peripheral nervous system, surfaced amongst Gardasil recipients. Seven females were hospitalized, one suffered a seizure and another from brain hemorrhaging. Five patients received other vaccines simultaneously with Gardasil.
The FDA-approved Gardasil, created and distributed by Merck & Co., is marketed as a vaccine to reduce the prevalence of cervical cancer in the U.S. Every year, 11,000 people are diagnosed with cervical cancer and 3,700 people die. The traditional side effects of the vaccine are fainting and fever.
According to the CDC, four fatalities occurred near the time of the patients' Gardasil injections. One patient died three hours after receiving the Gardasil vaccination; blood clotting was listed as the cause of death.
A 12-year-old was co-vaccinated with Gardasil and a vaccine targeting Hepatitis A on March 1, 2007, and died six days later. The autopsy revealed myocarditis (inflammation of the heart muscle) as the cause of death. The girl had a prior history of complications in the aortic valve.
Merck's Web site states, "Co-administration of Gardasil with other vaccines has not been studied."
On March 6, a 14-year-old patient was hospitalized for pneumonia four days after receiving her second dose of Gardasil. The patient died of multi-organ system failure due to Influenza B.
A 19-year-old woman began convulsing while exercising on a playing field. She was vaccinated on March 12, 2007, and died on March 26, 2007, from a pulmonary embolism - a block in the lung from a blood clot. The woman took oral contraceptives in conjunction with receiving the Gardasil vaccinations.
According to Merck's Web site, "Use of hormonal contraceptives or lack of use of hormonal contraceptives among study participants did not alter vaccine efficacy."
VAERS also reported two non-fatal cases of Steven Johnson Syndrome (SJS), a potentially deadly skin disease typically resulting from a drug reaction or allergy, in the 9 through 11 age group.
Merck defended its vaccine against criticism related to these deaths.
"There is no direct correlation to the adverse events," said Kelly Dougherty, a spokeswoman for Merck, while commenting on Gardasil. "The database as of now only shows pain at the injection site."
Prior to FDA approval, Merck conducted testing for Gardasil on 20,000 women over a period of nearly six years, beginning in 2000. The results yielded close to 100 percent effectiveness in preventing HPV. Whether the vaccine requires a booster shot will not be known until 2011, five years after Gardasil was first released.
In response to why Gardasil was placed onto the market, Dougherty responded, "[Gardasil's] clinical program is comparable to all vaccines, same as with child immunizations."
The FDA requires drugs and vaccines to undergo three testing phases, usually lasting several years, before granting its approval. A fourth phase exists when the product is released to the general population, wherein adverse effects can be documented and studied. Gardasil is currently in this stage, giving rise to the prominence of these criticisms.
"Since the vaccine is new, more studies need to be done," the FDA Web site states.
Gardasil protects against four types of HPV. The FDA-approved vaccine is said to be 95 to 100 percent effective in preventing HPVs 6 and 11, pertaining to genital warts, and to HPVs 16 and 18, which cause 70 percent of cervical cancers. Gardasil does not treat HPV types 16 or 18 if women already have it, but rather it prevents the virus' effects, such as cervical cancer.
However, HPV does not treat other high-risk HPV types that cause cancer. The vaccine does not account for the 30 percent margin of other dangerous HPV types. The American Cancer Society states that more than 100 strains of HPV are in existence.
The American Cancer Society recognizes that more than 50 percent of college-aged women acquire HPV, a cause of 70 percent of cervical cancer, within four years after first having intercourse.
The ACS also states that most cases of HPV go away on their own because the immune system is strong enough to fight the virus. Cervical cancer is also declining by 4 percent annually.
Several states have attempted to encourage girls entering the sixth grade to receive the Gardasil vaccination in an effort to protect citizens' health. In February 2007, Illinois State Assembly introduced a bill requiring girls ages 11 and 12 to be vaccinated for the 2009 school year. Parents have the choice to exempt their daughters from the requirement, due to religious convictions for example, provided they go through educational programs about HPV.
Curtis Allen, CDC spokesman, explained vaccines are not cures, so the best time for vaccination is before girls become sexually active.
"We're not protecting for next week, we're protecting for down the road," Allen said. "We recommend vaccination at 11 to 12 years of age, permissive with recommendations of the doctor.
"We do not see any problems or links to the fatalities," Allen said. He said that the CDC is looking for a "background rate," which only measures coincidences, not causality. "The VAERS system has not really determined a cause and effect relationship."
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