The National Vaccine Information Center (NVIC) 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.