Unfortunately, this was inevitable. The adverse events reports on the HPV vaccine are starting to flood in. Garadsil was just released on the market a few months ago and already 82 serious adverse events have been reported. It’s been estimated that the federal database only receives reports of anywhere from 1 in 10 serious reactions or deaths to 1 in a 100. (The former Commissioner of the FDA, Dr. David Kessler, said in 1993: “Only about one percent of serious events are reported.”) So we can safely assume that there have already been at least a thousand girls who have had severe reactions. Maybe more. Unfortunately, this is only the beginning.
This is what happens when a product is rushed on the market, expedited through an already capricious FDA approval process. The fact that a dozen or so state legislatures are considering mandating this shot for preteen girls before they attend school is truly breathtaking. Take a moment today and write your state representatives and senators. They are getting the message.
The following is from PR Newswire:
“GARDASIL safety appears to have been studied in fewer than 2,000 girls aged 9 to 15 years pre-licensure clinical trials and it is unclear how long they were followed up. VAERS is now receiving reports of loss of consciousness, seizures, arthritis and other neurological problems in young girls who have received the shot,” said NVIC President Barbara Loe Fisher. “At the same time, parents who take their daughters to private pediatricians are going to be shocked to find that they will be paying two to three times the widely publicized $360 cost for the three-dose series. The cost is going to break the pocketbooks of parents and break the banks of both insurance companies and taxpayers, when the reality is that almost all cases of HPV- associated cervical cancer can be prevented with annual pap screening of girls who are sexually active.”
Between July 2006 and January 2007, there have been 82 reports of adverse events filed with VAERS following receipt of GARDASIL by girls ranging in age from 11 to 27 years. Reaction reports have come from 21 states, including Virginia and the District of Columbia. All but three of the reports were for adverse events which occurred within one week of vaccination and more than 60 percent occurred within 24 hours of vaccination.
“The most frequent serious health events after GARDASIL shots are neurological symptoms,” said NVIC Health Policy Analyst Vicky Debold, RN, Ph.D. “These young girls are experiencing severe headaches, dizziness, temporary loss of vision, slurred speech, fainting, involuntary contraction of limbs (seizures), muscle weakness, tingling and numbness in the hands and feet and joint pain. Some of the girls have lost consciousness during what appears to be seizures.” Debold added “The manufacturer product insert should include mention of syncopal episodes, seizures and Guillain-Barre Syndrome so doctors and parents are aware these vaccine adverse responses have been associated with the vaccine.”
VAERS reports also indicate the doctors are administering GARDASIL to girls and women at the same with Tdap, DT, meningococcal (Menactra), hepatitis A, and other vaccines, even though the Merck product insert states that, with the exception of hepatitis B vaccine, “Co-administration of GARDASIL with other vaccines has not been studied.” There is no publicly available information about how many of the 9 to 15 year old girls in Merck’s pre- licensure clinical trials received GARDASIL simultaneously with hepatitis B vaccine.