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 seniors.  https://www.mprnews.org/story/2011/10/25/university-of-minnesota-flu-vaccine-study

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 – Quadrivalent inactivated influenza vaccine (IIV4) – 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)

“Do not administer Fluzone Quadrivalent to anyone with a history of 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.” (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 14-15.

"There are however [aside from a rabbit study] no adequate and well controlled studies in pregnant women.  Because animal studies are not always predictive of human response Fluzone Quadrivalent should be administered during pregnancy only if clearly needed." (Page 15)

“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 16)

Fluzone Ingredients:  octylphenol ethoxylate (Triton X-100) sodium phosphate-buffered isotonic sodium chloride solution, thimerosal (multi-dose vial only), egg protein, sucrose 
http://www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/B/excipient-table-2.pdf
 

FluMist

FluMist Quadrivalent– live attenuated influenza vaccine (LAIV4) – MedImmune – Package Insert 

https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm294307.pdf

* Due to it's ineffectiveness, FluMist Quadrivalent was not recommended for the 2016-17 flu season

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 clinical trials, in children 6 through 23 months of age, FluMist was associated with an increased risk of hospitalization and wheezing. (Page 1)

Children younger than 5 years of age with recurrent wheezing and persons of any age with asthma may be at increased risk of wheezing following administration of FluMist Quadravalent.  FluMist Quadravalent has not been studied in persons with severe asthma or active wheezing.  (page 4)

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 5 – 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 7 - Adverse Reactions in Clinical Trials)

"There are however [aside from a rat study] no adequate and well controlled studies in pregnant women.  Because animal studies are not always predictive of human response FluMist Quadrivalent should be administered during pregnancy only if clearly needed." (page 11)

“It is not known whether FluMist is excreted in human milk. Because some viruses are excreted in human milk, caution should be exercised if FluMist Quadriivalent is administered to nursing woman.” (Page 11)

“FluMist Quadrivalent has not been evaluated for its carcinogenic or mutagenic potential or tis potential to impair fertility.” (Page 16)

Shedding studies found that 89% of infants 6-23 months shed virus following injection with FluMist Quadrivalent for up to 28 days. (page 14)

“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 13)

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
 

 
© 2011 - • VaccineDecision.info