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Are Vaccines Safe?
CDC says vaccines are safe
Bad things do happen after vaccines
   Vaccine Adverse Events Reporting System
   National Vaccine Injury Compensation Program
   Pharmaceutical firms disclose serious adverse events occur after vaccination
      Simultaneous administration
      Size of clinical trials
      Erring on the side of caution

CDC Says Vaccines Are Safe

Many parents are going online to read about vaccine safety.  Our national childhood immunization program reports to the Centers for Disease Control and Prevention.  If you read the website of this government agency, you will find a lot of very reassuring information about the importance of monitoring safety and the ways vaccines are tested and monitored.



If you continue your research, however, there's a lot more to discover about vaccine safety.

Bad Things Do Happen After Vaccines

Vaccine Adverse Events Reporting System.

VAERS is the primary method of post-licensure surveillance used by the government and industry to determine whether the vaccines, deemed safe by the FDA, recommended by the CDC, endorsed by the American Academy of Pediatrics and manufactured by vaccine makers, are performing according to expectations.  The FDA offers information about VAERS as does the U.S. Department of Health & Human Services.

Since the inception of VAERS in 1990, nearly 300,000 adverse events have been reported (see basic summary).  If you'd like to perform your own search using the VAERS database, you can search by vaccine, lot number, injury, location and many other variables, click HERE.



There are many problems with VAERS.  Physicians are required to report adverse events but compliance is not enforced.  Physicians typically do not report to VAERS for a wide variety of reasons which include disbelief that it was a vaccine-related event and the feeling that it was not important or they were too busy to take the time. Research studies have been performed which document that only 1 to 10% of adverse events are ever reported.  Gross-underreporting by VAERS will understate and underestimate the magnitude of any vaccine safety issue, resulting in slower than ideal responsiveness to potential safety and protocol problems.

Consumers are not generally aware that they are permitted to self-report to VAERS.  NVIC describes the possible symptoms of vaccine injury and makes it easy for people to report a vaccine reaction.  You can also find the printable form, web form, snail mail address and other information HERE.

National Vaccine Injury Compensation Program

The government will occasionally provide compensation when someone is killed or injured by vaccines. Our federal government website describes the Vaccine Injury Compensation Program.  Here's the official vaccine injury table which highlights the vaccines that typically cause injury, the nature of the injury and the time interval the injury must have been sustained in order to be eligible to receive compensation.  The most recent table in PDF format is dated November 2008. 



Pharmaceutical firms approached Congress in the early 1980s and expressed concern that vaccine injury lawsuits might result in their inability to ensure a cost-effective, stable supply of vaccines.  They asked for and were granted liability protection.  In 1988, Congress passed the National Childhood Vaccine Injury Act of 1986 (Public Law 99-660).   As a result, the families of those harmed or killed by their vaccines are unable to obtain recourse through our legal system and must instead file a claim with the VICP.  

Compensation is paid out of a Trust Fund, funded by a $0.75 excise tax on each dose of vaccine purchased. In the case of the trivalent measles, mumps and rubella (MMR) vaccine, the excise tax imposed is $2.25 because it targets three diseases.  The eligible and taxable vaccines are those recommended by the CDC for routine administration to children.  Awards for vaccine-related death are limited to $250,000.  Awards to individuals with an injury judged to be vaccine-related have averaged just over $1 million.

The VICP was meant to be an expedited alternative with a lower burden of proof threshold.  Instead, families are finding that the process is neither expedited nor just.  The process imposes the most stringent state of limitations, three years.  Instead of a bona fide judge, Special Masters with varying degrees of experience and background are assigned to adjudicate the cases.

Our federal government has approved or recommended seven news studies relating to vaccines and autism.  It has contracted with the Institute of Medicine to review evidence regarding the adverse events associated with some of the vaccines on the childhood vaccine schedule.  These reports will include varicella (chicken pox), influenza, hepatitis B and the human papillomavirus vaccines.  The website reveals that other vaccines could be added if additional funding is secured.  A few observations are in order: 

  1. If the vaccines are so safe, why are more studies needed?
  2. Our government and private industry together spend many billions of dollars promoting vaccines. Surely some portion of this money could be allocated toward funding this important study for all vaccines on the schedule. 
  3. These reports should have been issued before the vaccines were added to the schedule.  Hepatitis B vaccine was introduced in 1991, varicella in 1995, influenza in 2004 and HPV in 2007.  This project was initiated in 2008.  

In my opinion, the system created by the 1986 law is a failed experiment. Legal recourse is acknowledged to be the most important motivation for industry to create and continuously seek to invent safer  products. Removal of this natural "check and balance" within the system has unfairly and inappropriately removed the burden of proof of safety from the manufacturer and onto the victim.  There has been another unintended and unfortunate consequence of this law. Because we have conferred liability protection for every vaccine on the federally-recommended schedule, industry has been powerfully motivated to obtain CDC-endorsement of every new licensed vaccine for children.  Of the sixteen different vaccines currently on the CDC schedule,  nine of them, over half  of all the vaccines on the schedule, were added after the law was passed in 1988. They include haemophilus influenzae type b (Hib), hepatitis B, varicella, rotavirus, pneumococcal conjugate, trivalent influenza, hepatits A, meningococcal conjugate and polysaccharide, and human papillomavirus vaccines.

Pharmaceutical Firms Disclose Serious Adverse Events Occur After Vaccination

Most people are not sufficiently motivated to read the vaccine package inserts or to dive into the Physician's Desk Reference.  If you are, click HERE and dig in.  Here's some of what I found:



 If you continuing reading, you'll learn a lot more.  Highlights include:

Simultaneous Administration

  • Is it safe to give our children all these shots at the same time?  How many of us have asked this very question of our children's pediatricians?  Read page 9 of Merck's MMR-II package insert: 

Routine administration of DTP (diphtheria, tetanus, pertussis) and/or oral polio vaccine (OPV) conccurently with measles, mumps and rubella vaccines is not recommended because there are limited data relating to the simultaneous administration of these antigens. 

Wow.  Limited data.  It hasn't been adequately studied.  Who knew? 

Size of Clinical Trials

  • How large would you think the clinicals trials should be for a vaccine given to babies within hours of birth?  Read page 7 of Merck's Recombivax HB (hepatitis B vaccine) package insert:

In three clinical studies, 434 doses were administered to 147 healthy infants and children (up to 10 years of age) who were monitored for 5 days after each dose.

They tested only 147 children, pre-screened for good health.  They tested children up to ten years of age for a vaccine given to newborns.  And the children were followed for only five days even though not all injuries and disorders will present with symptoms after just five days.  

Erring on the Side of Caution

  • Depending on what they find, will vaccine makers err on the side of caution?  Read page 3 of Sanofi Pasteur's IPOL (polio vaccine inactivated) package insert:
Although no causal relationship between IPOL vaccine and Guillain-Barre Syndrome (GBS) has been established, GBS has been temporally related to administration of another inactivated polio vaccine.  Deaths have been reported in temporal association with the administration of IPV.

People are dying and developing severe autoimmune disease.  It's certainly understandable from the perspective of corporate self-interest that the manufacturer will distance itself by stating that causation has never been proven.  The better question might be: who should be responsible for taking the time and incurring the expense to thoroughly evaluate safety and causation?  Industry is motivated to get product to market and make money.  The FDA performs no independent safety testing. and yet, the consuming public assumes the studies have been done.  It appears there's an important job vacancy.
  • At the very least, we surely have determined that vaccines are not contributing to the dramatic increase in pediatric and adult cancer we have been experiencing, right?  Check out any vaccine package, search "carcinogenic" and see what you come up with.  I offer you the inserts from two combination vaccines, Pentacel and Pediarix as examples and you can do the same with any of the above package insert links:
PEDIARIX has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.

No studies have been performed with Pentacel vaccine to evaluate carcinogenicity, mutagenic potential or impairment of fertility.

Thanks for the heads up, guys.  Don't say they never told us.

 

 
    
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