A mother wants more done to figure out why thousands of children had adverse reactions to the HPV vaccine Gardasil.
The vaccine guards against four types of the human papillomavirus. Two of those strains are linked to causing cancer. More than half of all Americans will contract the HPV virus.
Gardasil’s “One Less” campaign prompted Tracie Moorman to get her then 15-year-old daughter Maddie vaccinated.
After the first dose of the vaccine, Maddie started having unexplained pain and fatigue. After the second dose, the pain and fatigue worsened to the point Maddie could not attend school.
At first, the family didn’t suspect the vaccine. Doctors couldn’t explain her reaction either. However, when the family mapped out her absences from school, they realized they started and intensified in the days after receiving the vaccine.
“There's a big difference between correlation and causation and I understand that. But it seemed very clear at that point,” Tracie said.
Doctors told Tracie that reactions to the vaccine do happen. The family filed a report with the FDA’s Vaccine Adverse Event Reaction System (VAERS).
The database keeps track of reactions reported by doctors and patients. Researchers then use these records to look for patterns that may indicate problems with vaccines.
According to the VAERS database, the agency has received adverse reaction reports from more than 31,000 people who received the Gardasil vaccine. More than 134 million doses of the drug have been administered to date.
The side effects are described as autoimmune reactions like the Moormans believe Maddie had after the vaccine was administered. They also include reports of seizures, paralysis, and in at least 43 cases of death. However, the FDA cannot prove the vaccine caused these reactions.
They only know these reactions were reported in people who received the vaccine.
In 2009, the Journal of the American Medical Association published a study where researchers analyzed the VAERS database looking for patterns. Those researches reported the reactions were small in comparison to the number of doses administered and no different than any other vaccine.
Of the people reporting adverse reactions, they found 94 percent of those reactions in their opinion were not serious.
Tracie questions that research. She said she has never been contacted about her report.
When contacted about Tracie’s concerns, an FDA spokesperson released this statement:
When evaluating whether an adverse event might be caused by a vaccine, the FDA applies several approaches. After a vaccine is approved for use in the United States, the FDA and CDC use the Vaccine Adverse Event Reporting System (VAERS) to monitor vaccine safety. Each day, the FDA medical officers review all serious adverse events, which for regulatory purposes are defined as those reported as fatal, disabling, life-threatening, requiring hospital admission, prolonging a hospital stay, resulting in a congenital anomaly, or requiring medical intervention to prevent such an outcome. When available, medical records, clinic notes, and autopsy reports are also reviewed. VAERS data may be used to detect new or rare adverse events, monitor known reactions, perform vaccine lot surveillance, identify risk factors, and evaluate the safety of newly licensed vaccines.
Several other questions were posed to the FDA about the Gardasil vaccine. You can find their complete response here.
Dr. Evelyn Reynolds, an oncology gynecologist at the University of Kansas Hospital, said the CDC does an excellent job in monitoring vaccines. She also does not find any patterns to link the vaccine to patient reactions.
As a doctor who treats people with cancer caused by HPV, she believes the benefits of the vaccine far outweigh the risks.
“I think people need to trust the evidence and the results we're already getting with the vaccine,” Reynolds said.
A spokesperson for Merck, the manufacturer of Gardasil, issued the following statement when asked about concerns:
Nothing is more important to Merck than the safety of our medicines and vaccines. Merck employees, and our families, use our vaccines, too.
We are confident in the safety profile of GARDASIL. The safety and efficacy of GARDASIL was established in clinical trials involving more than 25,000 females and males. Safety has continued to be evaluated in several large post-licensure surveillance studies in more than 500,000 people following administration of more than a million doses of vaccine. And while difficult to determine number of doses administered, more than 134 million doses of GARDASIL have been distributed globally since 2006.
People should understand the extensive data supporting the safety profile of GARDASIL, and we encourage them to look to CDC and FDA, and to the advice of their own physicians, to make an informed choice about something as important as a vaccine to help prevent cervical cancer.
While no vaccine or medicine is completely without risk, leading international health organizations
throughout the world including the World Health Organization (WHO), the U.S. CDC, Health Canada, the European Medicines Agency, and the Australia Therapeutic Goods Administration (TGA), among others, continue to recommend the use of GARDASIL. The U.S. CDC has stated that post-licensure safety monitoring from June 2006 through March 2013 continues to show no new HPV vaccine safety concerns, and the WHO’s Global Advisory Committee on Vaccine Safety reviewed updated safety information on HPV vaccines and stated in June that data from all sources continue to be reassuring about the safety profile of HPV vaccines.
Merck was asked several other questions about the vaccine. You can read the answers here.
The patient information label for Gardasil recommends people with allergies to yeast, aluminum, and polysorbate 80 (a thickening agent found in many foods and vaccines) not receive the vaccine.
Tracie said doctors never verbally told her about those and her daughter has never been tested for possible reactions to those chemicals.
She believes doctors should do a better job informing parents about this vaccine.
“If I ever could have a do-over, it absolutely would be this situation,” Tracie said.