The National Vaccine Information Center (NVIC) today released a new analysis of the federal Vaccine Adverse Event Reporting System (VAERS) reports of serious health problems following HPV vaccination (Merck's Gardasil) during the last six months of 2006.
Out of the 385 individual Gardasil adverse event reports made to VAERS, two-thirds required additional medical care and about one-third of all reports were for children 16-years-old and under, with nearly 25 percent of those children having received simultaneously one or more of the 18 vaccines that Merck did not study in combination with Gardasil. NVIC is calling on the FDA and CDC to warn parents and doctors that Gardasil should not be combined with other vaccines and that young girls should be monitored for at least 24 hours for syncopal (collapse/fainting) episodes that can be accompanied by seizure activity, as well as symptoms of tingling, numbness and loss of sensation in the fingers and limbs, all of which should be reported to VAERS immediately.
"Because Merck only studied Gardasil in fewer than 1200 girls under age 16 in pre-licensure trials, it is critical that doctors and parents be made aware of the nature of the initial adverse event reports coming into VAERS and that they report serious health problems after vaccination when they occur," said NVIC President Barbara Loe Fisher. "There are twice as many children collapsing and four times as many children experiencing tingling, numbness and loss of sensation after getting a Gardasil vaccination compared to those getting a Tdap (tetanus-diphtheria-acellular pertussis) vaccination. There have been reports of facial paralysis and Guillain-Barre Syndrome. And doctors who give Gardasil in combination with other vaccines are basically conducting an experiment on their young patients because Merck has not published any safety data for simultaneous vaccination with any vaccine except hepatitis B vaccine."
According to NVIC's report, a majority of Gardasil adverse event reports to VAERS involved those who suffered fever, nausea, headache or pain; 14 percent were for syncopal episodes with or without neurological signs; and 8 percent experienced tingling, numbness and loss of sensation, facial paralysis or Guillain-Barre Syndrome. Although adverse event reports to VAERS do not prove causation, they can provide an early warning sign that a new vaccine may be causing health problems that could be important. For example, reports to VAERS of bowel blockage (intussusception) in babies following receipt of Merck's Rota Teq (rotavirus) vaccine prompted the FDA to issue a public warning to doctors and consumers on Feb. 13.
"About 4 reports per day were filed with VAERS in December 2006 for the HPV vaccine," said NVIC Health Policy Analyst Vicky Debold, RN, Ph.D. "Some of these girls are being injured when they collapse after getting the vaccine and others are complaining of neurological symptoms that should not be ignored. Doctors and nurses should take note of the patient safety issues related to giving this vaccine. Giving Gardasil simultaneously with any of the 18 vaccines Merck did not study in combination is not an evidence-based guideline and should involve informed consent and a signed patient release. To avoid unnecessary injuries, teenage girls should be vaccinated laying down, not be left unattended and probably should not walk or drive themselves home from the doctor's office after they get vaccinated."
NVIC also found that there were several VAERS reports of HPV infection, genital warts and cervical lesions after Gardasil vaccination. It is unknown if the girls were infected with HPV before being vaccinated or if Gardasil failed to protect them. One case of HPV infection occurred in a 22-year-old girl who had participated in a Merck Gardasil trial in 2003 when she had shown "strong conversion to all 4 vaccine types" but "tested positive for high risk HPV" in 2006, according to the VAERS report.