NVIC Analysis Shows Greater Risk of GBS Reports

NVIC Analysis Shows Greater Risk of GBS Reports When
HPV Vaccine Is Given with Meningococcal and Other Vaccines

Washington, August 15, 2007 – The National Vaccine Information Center (NVIC) today issued a new report on HPV vaccine (Gardasil®) safety analyzing adverse event reports to the federal Vaccine Adverse Event Reporting System (VAERS). The analysis gives evidence for a reported association in VAERS between Gardasil and Guillain-Barre Syndrome (GBS), with a statistically significant increased risk of GBS and other serious adverse event reports when Gardasil is co-administered with other vaccines, especially meningococcal vaccine (Menactra®).

NVIC is calling on the Centers for Disease Control (CDC) to issue an Advisory and amend its March 12 policy by alerting the public that Gardasil has been associated with 15 cases of GBS and an increased risk of GBS and other serious adverse event reports made to VAERS when the vaccine is administered simultaneously with Menactra and other vaccines. “The precautionary principle dictates that good science should precede CDC vaccine policy recommendations,” said Barbara Loe Fisher, NVIC co-founder and president. “Parents have a right to expect proof of safety and not assumption of safety before new vaccines, like Gardasil, are given simultaneously with other vaccines to their children.

GBS is a disorder in which the body’s immune system attacks part of the peripheral nervous system, and can cause total paralysis. “Our analysis of Gardasil reports to VAERS indicates there was a two to 12 times greater likelihood that serious adverse events, such as GBS, were reported when Gardasil was given in combination with Menactra rather than given alone,” said Vicky Debold, PhD, RN, NVIC director of patient safety. “Accepted scientific standards indicate that these findings are statistically significant and cannot be dismissed as coincidence. In particular, the available VAERS data show there was a more than 1,000 percent increased risk of GBS reports following Gardasil administration when Menactra was given at the same time.”

Reported GBS and Other Serious Adverse Events

NVIC found that, as of May 31, there have been 2,227 Gardasil adverse events filed with VAERS, including 13 suspected or confirmed cases of GBS (two more GBS reports were made in June for a total of 15) and 239 cases of syncope (fainting with temporary loss of consciousness), many of which resulted in head injuries and fractures. Seven deaths have been reported after receipt of Gardasil. Nearly 10 percent of all Gardasil adverse event reports to VAERS involved avoidable medical errors.

A total of 1,930 reported Gardasil adverse events involved administration of Gardasil alone, and 135 adverse events involved co-administration of Gardasil with Menactra. NVIC’s comparative analysis of those two categories of VAERS reports indicates that when Gardasil was given simultaneously with Menactra rather than alone, there was a statistically significant increased risk of reported adverse events:

*respiratory problem reports increased by 114 percent;
*cardiac problems reports increased by 118 percent;
*neuromuscular and coordination problem reports increased by 234 percent;
*convulsions and central nervous system problem reports increased by 301 percent;
*reports of injuries from falls after unconsciousness increased by 674 percent; and
*GBS reports increased by 1,130 percent.

On February 21, NVIC expressed concern about the safety of administering Gardasil simultaneously with other vaccines because the manufacturer (Merck), the FDA and the CDC had not provided evidence to the public that co-administration was safe. (1) On March 12, the CDC published recommendations for Gardasil use in MMWR that acknowledged there is a lack of evidence that Gardasil can be safely administered with other vaccines, while encouraging physicians to co-administer Menactra and other vaccines with Gardasil based on assumption of safety. (2)

Adverse Event Reports to NVIC: Shannon Nelson

Nineteen Gardasil adverse event reports from 12 states have been made to NVIC’s Vaccine Reaction Registry involving unconsciousness and injury, convulsions, numbness, weakness and other neuromuscular and coordination problems and GBS.

Shannon Nelson, 18, a Chicago area athlete, musician and artist entering college reported to NVIC that she received HPV vaccine (Gardasil), meningococcal vaccine (Menactra) and chicken pox vaccine (Varivax ®) simultaneously on June 21. Symptoms of tingling, numbness and muscle weakness began within a week and progressively got worse. By July 3 she could barely walk or raise her arms. She was hospitalized, paralyzed with GBS on July 5, and spent 22 days in the hospital.

“Before the shots, I ran six miles a day,” said Nelson. “The doctors told me that I might have been put on a respirator if I hadn’t been in such good shape,” she said. “I am out of the hospital now and getting a lot of physical therapy. I just want to go to college and do the things I did before, like play the guitar and draw or even just be able to smile. My Mom and I wish we had known about HPV vaccine risks, especially what could happen if I got other vaccines at the same time.”


To view a copy of NVIC’s report on HPV vaccine (Gardasil) safety, go to http://www.nvic.org/Diseases/HPV/HPVHOME.htm. To report a vaccine reaction, go to https://www.nvic.org/report/reaction.htm

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Founded in 1982, the National Vaccine Information Center (NVIC) is a non-profit 501(C)3 organization working for child health, public education and consumer empowerment. NVIC is dedicated to preventing vaccine injuries and deaths through public education and defending the right to informed consent to vaccination. NVIC has operated a private Vaccine Reaction Registry for 25 years.

References:

1) Vaccine Safety Group Releases Gardasil Report: Calls on FDA and CDC to Warn Doctors and Parents to Report to VAERS, February 21, 2007 http://www.nvic.org/Diseases/HPV/pr022107HPV.htm.

2) Centers for Disease Control and Prevention. Quadrivalent Human Papillomavirus Vaccine: Recommendations of the Advisory Committee on Immunization Practices (ACIP). Morbidity and Mortality Weekly Report (MMWR) Early Release 2007; 56 March 12, 2007:1-24. http://www.cdc.gov/mmwr/preview/mmwrhtml/rr56e312a1.htm