Flu Vaccines

Every year there is a huge push for everyone to get the flu vaccine.  But does the flu shot work?  There has been substantial research done on this question and the overwhelming result is that the flu shot is woefully ineffective.

In this 2014-15 flu season, the strain causing most of the cases of influenza (type A, subtype H3N2) had mutated and is therefore not in this year's flu vaccine.  Therefore this year's flu vaccine offers no protection against the virus causing most of the cases of influenza.  http://www.naturalnews.com/047955_flu_shot_CDC_vaccine_industry.html#ixzz3Lbvp2GeN

A recent University of Minnesota study found that the flu vaccine is "substantially lower than for most routine recommended vaccines and is suboptimal."  The three year study found the injectable trivalent inactivated influenza vaccine protects adults at a rate of about 59 percent and didn't offer much protection to children or seniors.

The study also found that the nasal spray live attenuated influenza vaccine offered protection 83 percent of the time for children six months to seven years old and showed little evidence of protection for seniorshttp://www.kare11.com/news/article/994888/391/U-of-M-study-challenges-effectiveness-of-flu-vaccine

For more information on the effectiveness of flu vaccines, see the Influenza section under Diseases.

Listed below are the product inserts for two of the influenza vaccines.  This information directly from the vaccine manufacturer gives you an idea of some of the risks involved with this vaccine.

Fluzone

Fluzone – trivalent inactivated influenza vaccine (TIV) – Sanofi Pasteur – Package Insert

http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM305089.pdf        

Fluzone is a vaccine indicated for active immunization in persons 6 months of age and older against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine. (Page 1)

“If Guillain-Barré syndrome (GBS) has occurred within 6 weeks of previous influenza vaccination, the decision to give Fluzone should be based on careful consideration of the potential benefits and risks.” (Page 1)

“Most common (>10%) local reactions were soreness at injection site, tenderness, pain, and swelling.  Most common (>10%) systemic events were malaise, headache, and myalgia.” (Page 1)

“Safety and effectiveness of Fluzone have not been established in pregnant women or nursing mothers or children <6 months of age.” (Page 1)

“A severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine including egg protein or to a previous dose of any influenza vaccine is a contraindication to administration of Fluzone.” (Page 4)

The 1976 swine influenza vaccine was associated with an elevated risk of Guillain-Barré syndrome (GBS). Evidence for a causal relation of GBS with other influenza vaccines is inconclusive; if an excess risk exists, it is probably slightly more than 1 additional case per 1 million persons vaccinated.  If GBS has occurred within 6 weeks following previous influenza vaccination, the decision to give Fluzone should be based on careful consideration of the potential benefits and risks. (Page 4)

Post-marketing adverse reactions: See pages 10-11.

“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.” (Page 11)

“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.” (Page 11)

Fluzone Ingredients: formaldehyde, octylphenol ethoxylate (Triton X-100), gelatin (standard trivalent formulation only), thimerosal (multi-dose vial only), egg protein, phosphate buffers, sucrose 
http://www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/B/excipient-table-2.pdf
 

FluMist

FluMist – live attenuated influenza vaccine (LAIV) – MedImmune – Product Insert
http://www.medimmune.com/pdf/products/flumist_pi.pdf

FluMist is a vaccine indicated for the active immunization of individuals 2-49 years of age against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine. (Page 1)

Children not previously vaccinated with an influenza vaccine required 2 doses at least one month apart in the first year.

If Guillain-Barré syndrome has occurred with any prior influenza vaccination, the decision to give FluMist should be based on careful consideration of the potential benefits and risks. (Page 1)

Most common adverse reactions (≥ 10% in FluMist and at least 5% greater than in control) are runny nose or nasal congestion in all ages, fever >100°F in children 2-6 years of age, and sore throat in adults. (Page 1)

“Safety and effectiveness of FluMist have not been studied in pregnant women or nursing mothers.” (Page 1)

In a placebo controlled safety study conducted in 9689 children 1-17 years of age an increase in asthma events was observed in children less than 5 years of age. (Page 2 – Adverse Reactions in Clinical Trials)

In a separate placebo controlled trial in children 9-17 years of age, abdominal pain was reported in 12% of FluMist recipients compared to 4% of placebo recipients. (Page 2 - Adverse Reactions in Clinical Trials)

“Animal reproduction studies have not been conducted with FluMist. It is not known whether FluMist can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.” (Page 3)

“It is not known whether FluMist is excreted in human milk. Therefore, as some viruses are excreted in human milk and additionally, because of the possibility of shedding of vaccine virus and the close proximity of a nursing infant and mother, caution should be exercised if FluMist is administered to nursing mothers.” (Page 3)

“FluMist has not been evaluated for its carcinogenic or mutagenic potential or tis potential to impair fertility.” (Page 4)

“Immune mechanisms conferring protection against influenza following receipt of FluMist vaccine are not fully understood; serum antibodies, mucosal antibodies and influenza-specific T cells may play a role.” (Page 4)

FluMist Ingredients: ethylene diamine tetraacetic acid (EDTA), monosodium glutamate, hydrolyzed porcine gelatin, arginine, sucrose, dibasic potassium phosphate, monobasic potassium phosphate, gentamicin sulfate, egg protein 
http://www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/B/excipient-table-2.pdf
 

 
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