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FDA Okays four H1N1 flu vaccines

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By David Liu

The Food and Drug Administration on Sept 15 approved four H1N1 flu vaccines which are expected to be available in next four weeks.

CSL Limited,  Novartis Vaccines and Diagnostics Limited, and sanofi Pasteur Inc manufacture inject-able influenza A/H1N1 monovalent vaccine while MedImmune LLC produces intranasal influenza A (H1N1) monovalent vaccine.

The H1N1 vaccine by CSL Limited is indicated for persons ages 18 years of  age and older against pandemic H1N1 2009 virus.

This H1N1 vaccine comes in two forms, one with 0.5 ml preservative free, single-dose prefilled syringe and the other with 5 ml mult-dose vial containing ten doses. Each vaccine shot (0.5 ml) in the latter form contains 24.5 micrograms of mercury or thimerosal, a mercury derivative used as a preservative.

The H1N1 vaccine ingredients for this thimerosal-free product include "sodium chloride (4.1 mg), monobasic sodium phosphate (80 mcg), dibasic sodium phosphate (300 mcg), monobasic potassium phosphate (20 mcg), potassium chloride (20 mcg), and calcium chloride (1.5 mcg)."

CSL says "From the manufacturing process, each dose may also contain residual amounts of sodium taurodeoxycholate (≤ 10 ppm), ovalbumin (≤ 1 mcg), neomycin sulfate (≤ 0.2 picograms [pg]), polymyxin B (≤ 0.03 pg), and beta-propiolactone (< 25 nanograms)".

The common side effects or adverse reactions include tenderness, pain, redness, and swelling on the injection site. Other adverse effects include headaches, malaise, and muscle aches.

CSL Limited warns in the package insert that careful consideration of the potential benefits and risks should be given to those who have developed Guillain-Barre Syndrome within 6 weeks of previous influenza vaccination. Immunocompromised persons may have a diminished immune response to the vaccine.

The drug company acknowledges that its vaccine does not work in all individuals.

The H1N1 vaccine by Novartis Vaccines and diagnostic Limited is indicated for active immunization of persons 4 years of age and older.  For children 4 to 9 years of age, two shots are injected 30 days apart. Children 10 to 17 years of age and adults ages 18 and older needs a single injection.

The vaccine also comes in two versions, the one with prefilled single dose syringe contains less than or equal to 1 micro-gram of mercury while another contains 25 mcg mercury per 0.5-ml dose (one shot).

The drug companies say in the package insert that the side effects of the product is similar to those observed with seasonal trivalent influenza virus vaccine made by Novartis.

The H1N1 vaccine by Sanofi Pasteur Inc is indicated for active immunization of persons 6 months of age and older against flu illness by pandemic h1n1 2009 virus.

With this vaccine, children 6 months to 35 months of age need two 0.25 ml doses. Children 36 months to 9 years of age need two 0.5 ml doses.  Two shots should be given one month apart.  For persons 10 years of age and older, a single injection is needed.

The H1N1 vaccine comes in four forms, but only the multi-dose 5-ml vial contains 250 mcg mercury.

The H1N1 vaccine delivered through nasal spraying in indicated for persons 2 to 49 years.  It is made by MedImmune LLC.  Children 2 to 9 years of age need two doses (0.2 ml each). and other individuals need 1 dose (0.2 ml).

The company warns that this nasal spray H1N1 vaccine should not be given to children younger than 24 moths because of increased risk of hospitalization and wheezing. It should not be given to individuals with asthma or children younger than 5 years of age with recurrent wheezing. 

FDA says on its website that the H1N1 vaccine induces a robust immune response in most healthy adults eight to 10 days after a single dose.  But the agency does not  say what may happen to those who have a health condition and are actually more likely to be victims of H1N1 flu.

The optimal dose for children has not yet been determined as clinical trails have not been completed, FDA says.

FDA warns "as with any medical product, unexpected or rare serious adverse events  may occur.




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