Swine Flu Vaccine Should Not Be Given to Children in Schools

Posted: 7/22/2009 12:05:11 AM | with 60 comments

by Barbara Loe Fisher

On April 26, a national public health emergency was declared by officials in the U.S. Departments of Health and Homeland Security. 1,2 We were told it was necessary to declare a national emergency because people were getting sick from a new swine flu virus that began in Mexico and might cause a deadly influenza pandemic.

So far, the vast majority of people who get sick with swine flu have symptoms that are no worse than the regular flu and recover completely. 3,4,5, 6

Three Week Testing of Swine Flu Vaccines
The declaration of a national public health emergency last spring set a chain of events in motion: some schools were closed, 7 some people were quarantined 8, 9 and drug companies were given billons of tax dollars to create experimental swine flu vaccines. 10 These new vaccines are being fast tracked by the FDA. We are being told they will only be tested for a few weeks on a few hundred children and adults 11 before being given to children in schools in October.

Liability Protection for Vaccine Injuries & Deaths
Under federal legislation passed by Congress since 2001, an Emergency Use Authorization (EUA) 12,13,14 allows drug companies, health officials and anyone who gives experimental vaccines to Americans during a declared public health emergency, to be protected from liability if people get hurt.

Safety and Informed Consent At Risk in Schools

The National Vaccine Information Center has been a vaccine safety watchdog since 1982. We are questioning the need to turn schools into medical clinics this fall where swine flu vaccines being rushed to market will be given to children first. We are calling on the Obama Administration and state Governors to provide solid evidence to parents that it is necessary to give children experimental swine flu vaccines in schools.

Are the states prepared to obey vaccine safety provisions in the 1986 National Childhood Vaccine Injury Act,15 which include:

1. Giving parents written information about vaccine benefits and risks before children are vaccinated; 16

2. Keeping a record of which vaccines the children get, including the manufacturer’s name and lot number;

3. Recording which vaccines were given in the child’s medical record;

4. Recording serious health problems that develop after vaccination in the child’s medical record and immediately making a report to the federal Vaccine Adverse Event Reporting System (VAERS) 17

Will States Compensate Vaccine Injured Children?
And there are more questions that need to be answered: Are the states prepared to provide financial compensation to children harmed by swine flu vaccines given in schools? Are parents going to be given complete, truthful information about swine flu vaccine risks and have the right to say “YES” or “NO” before their children are lined up and vaccinated in the school setting?

Vaccines are pharmaceutical products that carry a risk of injury or death and those risks are greater for some than others. 1 in 6 children in America is learning disabled18. 1 in 9 has asthma 1 in 150 develops autism. 1 in 450 has diabetes and millions more suffer with allergies and autoimmune disorders. Will the swine flu vaccine be safe for them?

Although it is a good idea for health officials to prepare for a worst case scenario and stockpile vaccines, it is a bad idea to turn schools into medical clinics and basically test experimental swine flu vaccines on children first. Especially when nobody has any liability. That has the potential to hurt children instead of keeping them well.

NVIC Oct. 2-4 Conference Addresses Vaccine Risks
This Oct. 2-4, 2009 in Washington, D.C., parents concerned about the lack of vaccine safety and informed consent protections in the vaccination system will gather with doctors, scientists, bioethicists, legal experts, journalists, and consumer advocates at the Fourth International Public Conference on Vaccination to talk about the science, policy, law and ethics of vaccination.

Register now

– Special Early Bird registration ends on July 31.

Click here for more information about swine flu, swine flu vaccines, public health laws that govern you and you family, and how you can be better prepared to make well informed decisions during the declared national public health emergency.

Endnotes:

1 U.S. Department of Homeland Security. Press Briefing on Swine Influenza with Dept. of Homeland Security, Centers for Disease Control and White House. April 26, 2009.

2 U.S. Department of Health & Human Services. Determination That A Public Health Emergency Exists. April 26, 2009.

3 Gale J. Bloomberg News. Swine Flu May Be Less Lethal Than Earlier Estimated, Study Says. July 6, 2009.

4 Schmid RE. The Seattle Times. Study: New flu inefficient in attacking people. July 2, 2009.

5 Centers for Disease Control. FluView. 2008-2009 Influenza Season Week 27 Ending July 11, 2009.

6 Food and Drug Administration, Center for Biologics Evaluation and Research, Office of Vaccine Research and Review. Regulatory Considerations Regarding the Use of Novel Influenza A (H1N1) Virus Vaccines. July 23, 2009.

7 US Department of Education. H1N1 Flu & U.S. Schools: Answers to Frequently Asked Questions. May 5, 2009.

8 NBC. Marine Tests Positive for Swine Flu. April 29, 2009.

9 CBS. DHS Sets Guidelines for Possible Swine Flu Quarantines. April 28, 2009.

10 The Independent. Obama earmarks emergency funding to fight swine flu. July 16, 2009.

11 Food and Drug Administration, Center for Biologics Evaluation and Research, Office of Vaccine Research and Review. Regulatory Considerations Regarding the Use of Novel Influenza A (H1N1) Virus Vaccines. July 23, 2009.

12 Project Bioshield Act of 2004 (PL 108-276)

13 The Pandemic and All Hazards Preparedness Act of 2006 (PL 109-417).

14 Nightingale SL, Prasher JM, Simonson S. Emergency Use Authorization (EUA) to Enable Use of Needed Products in Civilian and Military Emergencies, United States. Emerging Infectious Diseases Vo. 13, No.7: July 2007

15 National Childhood Vaccine Injury Act of 1986 (PL99-660)

16 CDC. Fact Sheet for Vaccine Information Statements.

17 MedAlerts. Online Access to the U.S. VAERS Database.

18 Fisher BL. Vaccine Safety Research Priorities: Engaging the Public. National Vaccine Advisory Committee. April 11, 2008.



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Preventing Gardasil Vaccine Injuries & Deaths

Posted: 7/14/2009 9:00:00 PM | with 67 comments

by Barbara Loe Fisher

She is just 16: the intelligent, lively pretty girl from Kansas, who was a high school gymnast and cheerleader and got straight A’s until, in 2008, three Gardasil shots changed her life and she became one more Gardasil reaction statistic.1

Today, Gabrielle never knows when she will be back in the hospital emergency room. Diagnosed with inflammation in the brain and body, the brain seizures won’t stop. She has had strokes. The right side of her body is weakened. She is in almost constant pain.  Gabi has developed lupus now. Her doctor says she could die.

Fast-Tracked Vaccine

Gardasil vaccine was fast tracked to licensure by the Food and Drug Administration in 2006.2 It contains genetically engineered virus-like protein particles (VLPs) and aluminum, 3,4,5 which affect immune function. 6,7,8  The exact mechanism of protection is unknown and the vaccine has not been evaluated for the potential to cause cancer or be toxic to the genes.10

It is a vaccine that, by the summer of 2009, already caused more than 15,000 thousand reports of vaccine reactions, including more than 3,000 injuries and 48 deaths.11 14 of the girls who died after getting Gardasil were under age 16 just like Gabrielle.

At the National Vaccine Information, we issued our first press release in the summer of 2006 warning parents that Gardasil had not been adequately tested in young girls before government health officials recommended that all 11 and 12 year old girls get three doses of the vaccine.12  Merck only studied Gardasil in fewer than 1200 girls under age 16 and followed them up for about two years before lobbyists tried, unsuccessfully in 2007, to get the vaccine mandated for all sixth grade girls in every state.13

Expanding Multi-Billion Dollar Market: Boys Are Next

Even though Gardasil was only tested on about a thousand young girls before licensure in 2006, CDC officials told doctors to give three doses of the vaccine to millions of little girls at a cost averaging $165 per dose.14 Because Merck did not test Gardasil in pre-licensure clinical trials in combination with all other vaccines routinely given to pre-teen and teenage girls, the CDC suggested that safety could be assumed and directed that Gardasil be given simultaneously with other vaccines.15

Now Merck is asking the FDA to license Gardasil for young boys,16 an action that will expand Merck’s market by tens of millions of dollars.17 In 2008, the global sales from Gardasil topped $2 billion dollars.18

HPV Virus Naturally Cleared From Bodies of Most People


But what is Gardasil vaccine supposed to protect our children against? It is supposed to prevent a sexually transmitted virus called HPV. Most people, who have been sexually active, have been exposed to HPV and clear the virus from their bodies within two years without any problems and are left with permanent, lifelong immunity to the HPV strains that caused infection.19,20,21 The small minority of women, who do not clear the HPV virus, can develop cervical cancer and die IF they do not get regular Pap test screening and immediate treatment of pre-cancerous cervical lesions.

Routine Pap Screening Prevents Cervical Cancer & Death

After routine Pap tests became a standard part of health care for American women in the 1960’s, deaths from cervical cancer dropped by more than 70 percent.22  In fact, cervical cancer represents less than two percent of all cancers diagnosed in the U.S. every year and is not among the top ten causes of cancer deaths in American women today.23,24,25 About 11,000 American women are diagnosed with cervical cancer every year and about 4,000 women die.

Plus Merck, government officials and doctors do not know how long three shots of Gardasil will protect against HPV infection.26,27,28  The vaccine only contains several of the many HPV strains associated with cervical cancer and hasn’t been on the market long enough to know how well it works.

Unknown If Gardasil Prevents HPV Infection Long-Term

 
In fact, girls are still supposed to get Pap tests even if they have been vaccinated because nobody really knows if Gardasil will prevent HPV infection for a long time without booster shots.

So here’s the bottom line: Gardasil vaccine is supposed to prevent a sexually transmitted infection that is naturally cleared from the body within two years by the vast majority of people.  Getting regular Pap tests can help prevent almost all cases of cervical cancer and death.

Treating Gabrielle’s serious Gardasil vaccine injury has cost her family and insurance company tens of thousands of dollars. 

Most Vaccine Reactions Not Reported

How many more Gabrielle’s are out there? We don’t know, even though there have been many similar Gardasil reaction reports from doctors and parents in the U.S. and other countries like Spain and Australia.29,30,31,32,33

Fewer than 10 percent, perhaps only one percent of all serious health problems following vaccination are ever reported to U.S. federal health agencies.34,35 This means that - instead of the more than 15,000 bad health outcomes following Gardasil vaccination that have already been reported in America – actually there could have been between 150,000 and 1.5 million adverse health events following Gardasil shots which have never been counted.

Government & Doctors Say: “It’s All A Coincidence!”

Why? Because many doctors write off Gardasil related hospitalizations, injuries and deaths as just a “coincidence” and do not report.  Labeling bad things that happen after vaccination as a “coincidence” minimizes the risks of vaccination.36,37

Officials at the CDC and FDA have dismissed what happened to Gabrielle after she got her Gardasil shots as a coincidence.

In fact, they have only admitted that Gardasil can cause a sudden loss of consciousness and warn that “FDA and the CDC continue to receive reports of traumatic injuries of individuals fainting and falling after receiving Gardasil. Some who have fainted have had serious injuries from falling, which have often occurred while still in the healthcare provider’s office, and other fainting episodes resulted in motor vehicle accidents.”38  (This fact makes it dangerous for girls to drive alone to and from doctor’s offices where Gardasil shots are given).

But government health officials have told doctors and the American public that ALL of the other serious Gardasil reaction reports, including seizures, paralysis, brain inflammation, rheumatoid arthritis, lupus, heart attacks, blood clots, strokes and deaths in young girls and women, are just a coincidence.39,40,41

All of them.

How unscientific, illogical and irresponsible. We expect a lot more from doctors in charge of making sure vaccines are safe.

What if all of the injuries and deaths associated with Vioxx had been allowed to be written off as a “coincidence” after that dangerous drug had been on the market for years?42,43

Pharmaceutical Products Carry Risks Greater for Some

Every pharmaceutical product, including every vaccine, carries a risk of injury or death. That risk can be greater for some than others.

At the not-for-profit National Vaccine Information Center, we have been operating a Vaccine Reaction Registry for nearly three decades.44 The most tragic cases of vaccine injury we see are when doctors revaccinate babies, children, teenagers and adults over and over again and ignore the fact that symptoms are getting worse and worse after each dose of vaccine.

Know Gardasil Reaction Symptoms

It is so important to know how to recognize Gardasil vaccine reaction symptoms like:

fainting
seizures
numbness & tingling
pain & weakness
hair loss
rashes
extreme fatigue
other health problems

Report Vaccine Reactions to NVIC

If you or a loved one has suffered a health problem after a Gardasil shot or another vaccine, after a report has been made to the federal Vaccine Adverse Event Reporting System (VAERS),45  go to http://www.nvic.org/Forms/CivilianReactionPage.aspx and file a report. We won’t dismiss your report as just a coincidence. We will treat it seriously and with the respect it deserves.

On the NVIC website, you can sign learn more about HPV and Gardasil Vaccine. You can sign the “Investigate Gardasil Risks Now” petition to Congress and the Obama Administration.46

You can sign up for this NVIC Vaccine E-newsletter and register for the Fourth International Public Conference on Vaccination being held this Oct. 2-4, 2009 in Washington, D.C., where you can learn from vaccine experts and network with other families in your state to protect vaccine choices.47
 
Empower yourself with information and take action now so we can stop girls like Gabrielle from becoming one more vaccine reaction statistic.

References: 

1  NVIC. “Gardasil & The Damage Done - Gabrielle”

2 VRBPAC. Background Document: Gardasil HPV Quadrivalent Vaccine. May 18, 2006.

3  BIOPHARMA: Biopharmaceutical Products in the U.S. and European Markets: HPV Vaccine, rDNA/Merck.

4  FDA. Gardasil (Human Papillomavirus Vaccine) Questions & Answers: What Is A Recombinant Vaccine?

5  Ruiz W, McClements WL et al. Kinetics and isotype profile of antibody responses in rhesus macaques induced following vaccination with HPV 6, 11, 16 and 18 L1-virus-like particles formulated with or without Merck aluminum adjuvant. J Immune Based Ther Vaccines. 2005; 3: 2.

6 Gherardi M et al. 2001. Macrophagaic myofastitis lesions assess long-term persistence of vaccine-derived aluminum hydroxide in muscle. Brain, Vol 124, No. 9, 1821-1831.

7  Shingde M et al. 2005. Macrophagic myofastitis associated with vaccine derived aluminum. MJA, 183 (03):145-146.

8  Lenz P,Day PM et al. Papillomavirus-Like Particles Induce Acute Activation of Dendritic Cells.The Journal of Immunology, 2001, 166: 5346-5355.

10 Merck & Co., Inc. 2006, 2008. Gardasil Quadrivalent Human Papillomavirus Types 6,11,16,18) Recombinant Vaccine product insert

11 MedAlerts: U.S. Government VAERS Database. HPV4Vaccine.

12 NVIC. June 27, 2006 Press Release: Merck’s Gardasil Not Proven Safe for Little Girls.

13 Pettypiece S, Zimm A. Merck Stops Campaign to Mandate Gardasil Vaccine Use (Update 3). Bloomberg News. Feb. 20, 2007.

14 Shots, Etc.

15 CDC. Quadrivalent Human Papillomavirus Vaccine: Recommendations of the Advisory Committee on Immunization Practices (ACIP): Concomitant Administration of HPV Vaccine with Other Vaccines; Simultaneous Administration with Other Vaccines. MMWR. Mar. 12, 2007/56; 1-24.

16 Medical News Today. Gardasil Debate Shifts as Merck Pushes for Use in Boys. Mar.  27, 2009.

17 CBS News. Cervical Cancer Vaccine – For Boys? Drugmaker Merck Seeks to Expand Market for Anti-SD Injection Gardasil. Jan. 6, 2009.

18 Reports-Research.com. Datamonitor: Merck & Co. – Gardasil shows promise in older women. June 15, 2009.

19 CDC. Genital HPV Infection Fact Sheet.

20 Rousseau MC, Franco EL et al. A cumulative case-control study of risk factor profiles for oncogenic and non-oncogenic cervical human papillomavirus infections. Cancer Epidemiology Biomarkers & Prevention. Vol. 9; 469-476. May 2000.

21 Rutgers University. HPV: Diagnosis & Treatment of Genital Human Papillomavirus Infection.

22 Saskow D, Runowicz CD et al. American Cancer Society Guidelines for the Early Detection of Cervical Neoplasia and Cancer. CA Cancer J Clin 2002; 52:342

23 Hill, M. More than 650,000 Cancer Deaths Avoided. WebMD Health News. May 27, 2009.

24 CDC. Cervical Center Statistics.

25 American Cancer Society. Cancer Facts & Figures. 2005.

26 Springen K. The Fast Track. Newsweek. August 20, 2008.

27 Merck & Co., Inc. 2006, 2008. Gardasil Quadrivalent Human Papillomavirus Types 6,11,16,18) Recombinant Vaccine] product insert

28 National Cancer Institute, NIH. HPV Vaccines: Questions & Answers (#9: How long do the [HPV] vaccines protect against infection?)

29 Laino C.. Gardasil Linked to Nerve Disorder: Cervical Cancer Vaccines May Raise Risk of Guillain-Barre Syndrome. WebMD. April 30, 2009.

30 Kotz D. CDC Takes Closer Look at Gardasil and Paralysis. U.S. News & World Report. March 20, 2009.

31 Sutton I, Lahoria R et al. CNS demyelination and quadrivalent HPV vaccination. Mult Scler. 2009 Jan; 15(1): 116-9.

32 Reuters. Update 1- Spain halts batch of Merck’s Gardasil. Feb. 10, 2009. and
TypicallySpanish.com. Valencia vaccine girls rushed back into intensive care. March 15, 2009.

33 Yahoo 7 News – Australia. Today Tonight: Gardasil side effects controversy. Dec. 7, 2007.
 
34 Rosenthal S, Chen R. The reporting sensitivities of two passive surveillance systems for vaccine adverse events.. Am J Public Health 1995; 85:1706-9.

35 Braun M. Vaccine adverse event reporting system (VAERS): usefulness and limitations. John’s Hopkins Bloomberg School of Public Health.

36 Myers MG, Orenstein WA, Marcuse EK. Countering Vaccine Misinformation (Transcript). American Academy of Pediatrics. 2009.

37 Fagone J. Will This Doctor Hurt Your Baby? Philadelphia Magazine. June 1, 2009.

38 FDA. Information Pertaining to Labeling Revisions for Gardasil (Reminder to Health Care Providers: 15 Minute Observation Needed After Vaccination). June 9, 2009.
  
39 CDC. Reports of Health Concerns Following HPV Vaccination. June 10, 2009.

40 Attkisson S. New Worries About Gardasil Safety: Vaccine Safety Group Study Shows Higher Incidence of Medical Side-Effects Than Another Vaccine. CBS Evening News. Feb. 6, 2009

41 Fisher BL, Debold V. An Analysis by the National Vaccine Information Center of Gardasil & Menactra Adverse Events Reports to the Vaccine Adverse Events Reporting System (VAERS). NVIC. February 2009.

42 ConsumerAffairs.com. “FDA Estimates Vioxx Causes 27,785 Deaths.” Nov. 4, 2004.
  and “Researchers Claim Vioxx Safety Study Was Actually Marketing Plan. Aug. 19, 2008.

43 Loudon M. The FDA Exposed: And Interview with Dr. David Graham, The Vioxx Whistleblower. MrGreen.Biz.com. August 30, 2005.

44 NVIC Vaccine Reaction Registry. Civilian Reaction Reporting Form.

45 VAERS.

46 NVIC “Investigate Gardasil Risks Now!” Petition.

47 Fourth International Public Conference on Vaccination Oct. 2-4, 2009.


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