Would you give your baby the flu vaccine?

People keep asking me what I think about the annual flu vaccine and about the H1N1 flu vaccine.

More important than what I think is what you think.

Please ask yourself the below questions:

How many babies would need to be studied to convince you that the flu vaccine is safe enough to give to your baby?

How many children should be observed for side effects, and for how long would you want them observed, before you would trust that the vaccine was safe?

How many children would you want studied to feel confident that the flu vaccine was effective in reducing your baby’s chances of getting the flu?

How effective should the vaccine be to be worth the risks?

Lastly, if you (or your wife) were pregnant, what kind of research would you want to prove the safety and efficacy of the flu vaccine on you (your wife) and your unborn fetus?

Now read below and realize that all information was taken directly from the package insert on Fluzone, which is the seasonal flu vaccine used for children >6months through adulthood. This is the only vaccine that has been approved for children less than 4 years old in the US.  Also note that the studies quoted are the only studies that the package insert refers to regarding these specific issues.

The information can be found at the below website:

http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm112854.htm

How many babies would need to be studied for you to be convinced that the flu vaccine is safe enough to give to your baby?

8.4. Pediatric Use

Safety and effectiveness of Fluzone vaccine in children below the age of 6 months have not been established. The immune response and safety of Fluzone vaccine was evaluated in 31 children between the ages of 6-26 months. [See Adverse Reactions (6.1), Clinical Studies (14)]

As a pediatrician, I would have expected thousands to have been studied.  I am shocked that they are basing any scientific data on only 31 children.

How many children would you want observed for side effects, and for how long would you want them observed, before you could trust that the flu vaccine was safe?

Children The 2003-2004 formulation of Fluzone vaccine was studied in 19 children 6 to 23 months of age and in 12 children 24 to 36 months of age, given in 2 doses one month apart. Local reactions and systemic events were solicited for 3 days after each dose. Most local and systemic reactions were mild. The proportions of local and systemic reactions in children were similar to the proportions in adults. No reported local or systemic reaction required a therapeutic intervention other than analgesics. (3)

19 children in this study were only observed for 3 days.  What if 1 in 100 children have a bad reaction? What if the vaccine causes inflammation that affects the child in 1 week?  Why were asthmatic children, who were given the flu vaccine, found to be three times more likely to need hospitalization than other children with asthma who were unvaccinated?

How many children would you want studied to feel confident that the flu vaccine was effective in reducing your baby’s chances of getting the flu?

14.2. Immunogenicity in Children

In a study using 2 doses of Fluzone vaccine (2003-2004) in 31 healthy children 6–36 months of age (3 Black, 23 Caucasian, 2 Hispanic, and 3 other; 15 were male and 16 were female), the following immunogenicity results were obtained on day 0 before vaccination and approximately 14 days after dose number 2. (See Table 2.)

Again, only 31 children studied!

How effective should the vaccine be to be worth the risks?

I couldn’t copy table 2 referred to above, however, it clearly shows that, after 2 vaccines, only 52% of babies, ages 6-36 months, had sufficiently elevated titers to Influenza A and only 27% had elevated titers to influenza B.  What does this mean?  It means that the vaccine will at best protect 52% of babies against the strains included in the vaccine, and only those 3 strains included in the vaccine.

In past years (for example, in 2008), the “experts” predicted the wrong vaccine strains and the flu vaccine offered virtually no protection at all.  Furthermore, these are only titers – no actual data showing that these children did or did not get the flu.  But, with only 31 kids studied, this data would mean nothing anyway.

Lastly, if you (or your wife) were pregnant, what kind of research would you want to prove the safety and efficacy of the flu vaccine on you (your wife) and your unborn fetus?

8.1. Pregnancy

Pregnancy Category C: Animal reproduction studies have not been conducted with Fluzone vaccine. It is also not known whether Fluzone vaccine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Fluzone vaccine should be given to a pregnant woman only if clearly needed.

They haven’t even tested pregnant animals!  Either that or they have and don’t want to share the data.  The unborn fetus is incredibly sensitive to toxins and stressors.  How can the authorities tell us that the vaccine is safe for our unborn babies when they don’t know because they haven’t done ANY testing?  Why are they using humans as guinea pigs?

8.3. Nursing Mothers

It is not known whether Fluzone vaccine is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Fluzone vaccine is administered to a nursing woman.

Note that all other flu vaccines inserts contain the same statement about cautioned use in pregnant women and nursing mothers.

All the above information was with regards to the commonly used ANNUAL flu vaccine currently given to babies, children and adults.

Realizing that the H1N1 vaccine is a newer vaccine, has been tested far LESS than the annual flu vaccine, and has been found to be associated with an increased risk of Guillian Barre, Bell’s Palsy and thrombocytopeniawould you give it to your family?

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