January 21

FDA Vaccine Safety Notice: Post-Vaccine Seizures in Infants

Public concerns about vaccine safety are well-founded in reality.

The FDA has just issued a Flu Vaccine Safety notice indicating that there have been 36 confirmed reports of seizures this flu season in children ages 6 months through 2 years within one day after being vaccinated with Fluozone, the flu shot recommended in the US for infants.

The fact is, US courts have long classified vaccines as "unavoidably unsafe." Contrary to public pronouncements, vaccines have not undergone rigorous, placebo-controlled clinical trials.

Indeed, as West’s Encyclopedia of American Law states:

"Vaccines are never entirely safe. Side effects range from mild to serious — from swelling and fever to brain damage and death. These dangers were recognized early on. Between 1961 and 1963, federal agencies noted occasional serious side effects from polio vaccines. By 1964, the Surgeon General’s Special Advisory Committee on Oral Poliomyelitis Vaccine found that fifty- three cases of polio could apparently be linked to the three types of the vaccine.

 "Public health authorities have nevertheless consistently urged the continuation of vaccine programs, arguing that the extremely minor incidence of adverse side effects is far outweighed by the health and lives they preserve. The Centers for Disease Control estimates, for example, that 1 in 310,000 children is adversely affected by the diphtheria, pertussis, and tetanus (DPT) vaccine. According to the American Medical Association, one in 3.2 million doses of polio vaccine will cause paralysis, and one in 1 million doses of measles vaccine will cause brain damage." http://www.answers.com/topic/immunization-programs

 In an effort to further shield vaccine manufacturers from liability litigation, Congress used a similar iability standard when it passed the National Childhood Vaccine Injury Act. 1986, establishing a federal no-fault compensation program for victims. Families alleging injury or death due to a child’s compulsory inoculation could file suit in the federal Claims Court–rather than sue the manufacturer.

 So, parents who are fearful of vaccinating their young children have evidence-based reason to be wary and distrustful.

An OpEd piece in today’s New York Times, Why Parents Fear the Needle , provides a historic background, noting that the Times had once dismissed parents opposed to vaccinating their children as "benighted and deranged” and “hopeless cranks.”  

Vaccine safety will continue to be a very contentious debate unless an honest dialogue will commence.

Not all vaccines pose the same risks of harm. Children who suffer vaccine-induced brain damage cannot be dismissed as collateral damage for the protection of herd immunity!

The furor about vaccines won’t subside until the safety evidence for each of the required vaccines that children are exposed to, is openly and honestly examined by independent scientists and lay people–not by stakeholders in the vaccine business.

Vera Hassner Sharav




Jan 20,2011

Feds checking post-vaccine seizures in young kids

By MIKE STOBBE, AP Medical Writer

 ATLANTA – Government officials are investigating an apparent increase in fever-related seizures in young children after they got a flu shot.

 The U.S. Food and Drug Administration on Thursday said there have been 36 confirmed reports of seizures this flu season in children ages 6 months through 2 years. The seizures occurred within one day after they were vaccinated with Fluzone, the only flu shot recommended in the United States for infants and very young children. Ten of the children were hospitalized, but all recovered.

 The FDA said it is investigating to see if there is any connection between the vaccine and the seizures, or if something else caused the convulsions. The agency said recommendations for using the vaccine have not changed, nor has there been any change in flu vaccine guidance.

 In the U.S., vaccination is recommended for everyone except infants under 6 months.

 The vaccine’s manufacturer, Sanofi Pasteur, issued a statement emphasizing that no clear link has been established between the flu shot and the seizures and that the cases may be coincidental.

 Thursday’s announcement comes at a time when the FDA has been working on disclosing more information about potential safety problems with drugs and devices after they’ve been approved.

 The government uses a national reporting system to monitor possible side effects following vaccination. Doctors, nurses, parents and vaccine manufacturers all can file reports.

 "It’s meant to cast a wide net" to look for problems, but is only regarded as preliminary information that must be checked out, said Shelly Burgess, an FDA spokeswoman.

 FDA officials said they’ve been paying special attention to seizure reports because of an unexplained higher rate of fevers and seizures in young children in Australia and New Zealand who got a specific flu vaccine earlier this year.

 In August, a U.S. vaccines advisory panel said doctors should avoid using that vaccine, made by CSL Biotherapies, in children ages 6 months through 8 years.

 It’s possible the Australia cases sparked increased reports this fall, said Dr. Andrea Sutherland, an official in the FDA’s Center for Biologics Evaluation and Research.

 The fever-related seizures — called febrile seizures — are convulsions brought on by a fever in infants or small children. A child often loses consciousness and shakes. Most seizures last a minute or two, and often children quickly recover.

 Such seizures may occur with any common childhood illnesses that may cause fever, such as ear infections, colds, influenza and other viral infections.

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