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NEW Gardasil vs. Menactra Risk Report (February 2009)

An Analysis by the National Vaccine Information Center of
Gardasil & Menactra Adverse Event Reports to the
Vaccine Adverse Events Reporting System (VAERS)
February 2009

 

The centralized federal Vaccine Adverse Events Reporting System (VAERS) was created under the National Childhood Vaccine Injury Act of 1986 and became operational in 1990. Although there was a mandate in the 1986 law for vaccine providers to report serious health problems, hospitalizations, injuries and deaths to VAERS, there were no sanctions for failure to report.

It is estimated that only between 1 and 10 percent of all adverse health outcomes which occur following vaccination are reported to VAERS. The following information was produced from analyzing VAERS data published by CDC and FDA and made available on the www.NVIC.org website through the MedAlerts searchable VAERS database at www.MedAlerts.org

 

Gardasil vs. Menactra VAERS Reports
(through November 30, 2008)

Menactra (meningococcal) vaccine was licensed by the FDA on January 14, 2005 for children and adults aged 11 to 55 years. One dose is recommended by the CDC for boys and girls 11-12 years old and many high schools and colleges are requiring it for attendance. Menactra is routinely administered by pediatricians and family practice physicians to grade school, high school and college students. Between 1,000 and 2,600 cases of meningococcal disease occurs in the U.S. every year and Menactra contains four of the most common strains of meningococcal.

Gardasil (Human Papillomavirus Quadrivalent) vaccine was licensed by the FDA on June 8, 2006 for girls and women aged 9 to 26 years. Three doses are recommended by the CDC for universal use in girls 11-12 years old and Gardasil is routinely administered by pediatricians, obstetrician/gynecologists and family practice physicians to grade school, high school and college students. Chronic human papillamovirus infection is associated with the development of cervical cancer and Gardasil contains four HPV types associated with this sexually transmitted infection.

What follows is a comparison of some of the more serious Gardasil and Menactra adverse event reports submitted to VAERS. 

SUMMARY STATISTICS

Gardasil (HPV)
Reports

Comment on Gardasil Reports

Menactra
Reports

Comment on Menactra Reports

Total Reports

10,151

 

4,436

 

Life Threatening

152

 

57

(18 with HPV)

Emergency Room

5,021

 

1,667

 

Hospitalization

458

 

268

 

Did Not Recover

2,017

 

393

 

Disabled

261

 

29

(13 with HPV)

Died

29

(25 HPV alone)

6

(none with HPV)

 

SYMPTOM STATISTICS

 

 

 

 

Alopecia

51

(41 HPV alone)

12

(8 with HPV)

Arrhythmia

18

(14 HPV alone)

4

(1 with HPV)

Arthralgia

276

 

119

 

Arthritis

68

(57 HPV alone)

18

(6 with HPV)

Blindness

36

(31 HPV alone)

10

(2 with HPV)

Blood clot

23

(all HPV alone)

0

 

Cardiac arrest

9

(all HPV alone)

2

(none with HPV)

Chest pain

123

 

63

(16 with HPV)

Collapse

44

(29 HPV alone)

18

(7 with HPV)

Deafness

17

(11 HPV alone)

5

(4 with HPV)

Demyelination  

12

(10 HPV alone)

10

(1 with HPV)

Dizziness

1,320

 

589

 

Encephalomyelitis

8

(5 HPV alone)

9

(1 with HPV)

Fainting

278

 

41

(28 with HPV)

Hair Loss

36

(30 HPV alone)

8

(5 with HPV)

Hemorrhage

9

(7 HPV alone)

2

(2 with HPV)

Joint pain

126

 

37

(7 with HPV)

Lupus 

28

(27 HPV alone)

6

(1 with HPV)

Migraine

159

 

36

(9 with HPV)

Multiple sclerosis

16

(12 HPV alone)

7

(2 with HPV)

Numbness

351

 

149

 

Pain

2,422

 

1,320

 

Paralysis

70

(54 HPV alone)

26

(6 with HPV)

Rash

963

 

473

 

Rheumatoid arthritis

31

(25 HPV alone)

6

(4 with HPV)

Seizures

544

 

158

(73 with HPV)

Stroke

16

(all HPV alone)

1

(none with HPV)

Syncope

1,643

 

427

 

Thrombosis

34

(all HPV alone)

1

(none with HPV)

Tingling

278

 

132

 

Vasculitis

11

(all HPV alone)

2

(none with HPV)

Rechallenge

275

 

8

(7 with HPV)

 

Red Flags:

VAERS is a sentinel reporting system, designed to raise “red flags” for unusual numbers of serious adverse events following receipt of a newly licensed vaccine. In 2005, the FDA responsibly issued a public advisory to physicians and parents after five (5) cases of Guillain Barre Syndrome (GBS) following receipt of Menactra by 17 and 18 year old girls occurred.   A rough comparison of Gardasil and Menactra adverse event reports to VAERS through November 30, 2008 reveals that:

  • Compared to Menactra, receipt of Gardasil is associated with at least twice as many Emergency Room visit reports; 4 times more Death reports; 5 times more “Did Not Recover” reports; and 7 times more “Disabled” reports.
  • Compared to Menactra, receipt of Gardasil is associated with all of the reports of Blood Clots. All 23 reports of Blood Clots following Gardasil occurred when Gardasil was given alone without any other vaccines.
  • Compared to Menactra, receipt of Gardasil is associated with at least 4 times as many Cardiac Arrest reports. All 9 reports of Cardiac Arrest following Gardasil occurred when Gardasil was given alone without any other vaccines.
  • Compared to Menactra, receipt of Gardasil is associated with at least 6 times as many Fainting reports and at least 3 times as many Syncope reports.
  • Compared to Menactra, receipt of Gardasil is associated with at least 4 times as many Lupus reports. 27 reports of Lupus following Gardasil occurred when Gardasil was given alone
  • Compared to Menactra, receipt of Gardasil is associated with at least 15 times as many Stroke reports. 16 reports of Stroke following Gardasil occurred when Gardasil was given alone.
  • Compared to Menactra, receipt of Gardasil is associated with at least 3 times as many Syncope reports.
  • Compared to Menactra, receipt of Gardasil is associated with at least 33 times as many Thrombosis reports. 34 reports of Thrombosis following Gardasil occurred when Gardasil was given alone.
  • Compared to Menactra, receipt of Gardasil is associated with at least 5 times as many Vasculitis reports. 11 reports of Vasculitis following Gardasil occurred when Gardasiil was given alone.
  • Compared to Menactra, receipt of Gardasil is associated with at least 30 times as many Rechallenge reports, which involve a worsening of symptoms experienced after previous receipt of Gardasil.  

 

Conclusion:

   In 2007, the National Vaccine Information Center issued three analyses of VAERS reports following receipt of Gardasil. In these reports, we warned that Gardasil appeared to be associated with an unusually high number of reports of atypical collapse (fainting and syncope) and other symptoms of brain and immune system dysfunction.

A rough analysis of adverse events reported to VAERS following receipt of Gardasil and/or Menactra vaccines through November 30, 2008 indicate that Gardasil is involved in a much higher number of serious adverse health events than Menactra.

Although Gardasil is given in a three- shot series and only one dose of Menactra is given, Menactra is given to both boys and girls while Gardasil is given only to girls. It is unusual for there to be such a big discrepancy between two vaccines used in similar populations involving serious and relatively rare life threatening adverse events and autoimmune disorders such as death, blood clots, cardiac arrest, lupus, thrombosis, stroke, and vasculitis.

Fainting, which has been attributed by doctors and health officials as “fear” of needles in teenage girls is reported six times as often (and Syncope is reported three times as often) after receipt of Gardasil than Menactra even though Menactra is also given to girls in the same age group.

In pre-licensure clinical trials, Gardasil was only tested in fewer than 1200 girls 16 years and younger. Through November 30, 2008, in girls 16 or younger, there were reports of 9 deaths; 3 blood clots; 4 cardiac arrests; 9 cases of lupus; 6 strokes; and 2 cases of vasculitis developing after receipt of Gardasil.

This VAERS analysis gives compelling evidence for the need for action to be taken by the FDA, CDC and Congress:

  • the FDA should further investigate reports of serious health problems and deaths following Gardasil vaccination; review the accuracy of information about adverse events contained in product manufacturer inserts; and inform physicians and parents about all serious health problems that have been reported to VAERS after Gardasil vaccination;
  • the CDC should re-investigate VAERS reports of serious health problems and deaths after Gardasil vaccination; consider the need to withdraw the recommendation that all girls between the ages of 9 and 26 should receive Gardasil vaccine; and issue a warning that, when a serious adverse event occurs after Gardasil vaccination, no further Gardasil shots should be given;
  • physicians in the fields of pediatrics and obstetrics/gynecology should  fully inform patients and parents about all reported Gardasil adverse events and refrain from re-vaccinating those who experience serious health problems following Gardasil vaccination;
  • Merck and the NIH should separately conduct studies into the biological mechanisms for Gardasil vaccine injury and death and define them for physicians and the public so: (a) biological high risk factors can be identified to facilitate informed medical decisionmaking ; (b) pathological profiles can be developed to confirm Gardasil- induced brain and immune system dysfunction and death; (c) healing therapies to moderate Gardasil- induced brain and immune system dysfunction can be developed; and (d) Merck can improve the safety of Gardasil;
  • Congress should investigate the fast- tracking of Gardasil vaccine without adequate long- term safety studies in American pre-adolescent and teenage girls between ages 9 and16 and the safety and effectiveness of Gardasil vaccine in all age groups.

Vaccines which are licensed and recommended by the government for universal use by children and young adults, should adhere to the highest standards with regard to proof of safety and efficacy. In October 2008, the government issued a report maintaining that receipt of Gardasil is not associated with more serious health problems, hospitalizations, injuries and deaths among young girls and women than are experienced by those young girls and women who do not receive Gardasil.   This analysis comparing adverse events reports to VAERS following receipt of Gardasil and Menactra appears to contradict that assertion.

Immediate action should be taken now by federal health agencies to protect recipients of Gardasil from injury and death.

 

References:


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