Friday, October 23, 2009

First thoughts

I have 2 inserts from Sanofi Pasteur for Influenza Virus Vaccine (FLUZONE) and Influenza A ( H1N1) 2009 Monovalent Vaccine.

Neither give me a list of ingredients. I guess I was expecting something like on the back of every food item in the pantry. I wonder if they assumed someone would try to whip up their own batch if the ingredients were listed.

In section 14 of the H1N1 pamphlet, "Sanofi Pasteur's [the manu] influenza A (H1N1) 2009 Monovalent vaccine and trivalent influenza virus vaccine (Fluzone vaccine) are manufactured by the same process. Data in this section were obtained in clinical studies with Fluzone vaccine."

Nice. They didn't even test the actual vaccine.

As for the "Immunogenicity in the adult and geriatric population," (remember this is for the FLUZONE, not H1N1) 121 people were tested: "2 asian, 11 black, 106 caucasian, and 2 other, no gender data were available." Seems like it would matter if it was a 120lb woman or a 180lb man.... and 121 people? really?

Dosage and Administration:
Children 6 - 35 months (0.25 mL dose through intramuscular injection) / Two 0.25 mL doses approx. one month apart (2.2)
36 months - 9 years (0.5 mL dose through intramuscular injection) / Two 0.5 mL doses approx. one month apart (2.2)
10 years - and older (a single 0.5 mL dose through intramuscular injection) (2.2)
Adults (a single 0.5 mL dose through intramuscular injection) (2.2)

Dosage Forms and Strengths: 
Influenza A ( H1N1) 2009 Monovalent Vaccine, a sterile suspension for intramuscular injection, is supplied in four presentations:
  1. Prefilled Syringe, 0.25 mL, no preservative, distinguished by a pink syringe plunger rod (3) 
  2. Prefilled Syringe, 0.5 mL, no preservative (3) 
  3. Single-dose vial, 0.5 mL, no preservative (3) 
  4. Multi-dose vial, 5mL, contains thimerosal, a mercury derivative, added as a preservative. Each 0.5 mL dose contains 25 mcg mercury. (3,11)
I am less concerned with the mercury than likely any other ingredient. After a lecture by Meg Ryan and Robert Kennedy Jr. 5 years ago at UCF, we are apparently doomed to consume mounds and mounds of mercury... and clearly already have and haven't died. But you can eat a whole tree of bananas and be fine, try injecting ANY potassium into your blood and see how fast your heart stops. There is a reason we don't like needles.

So Sanofi basically copied their Influenza insert and slapped on a "H1N1" label. Well, sign me up!

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