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Influenza Vaccine Package Inserts

Adult influenza vaccine injury claims are now the leading claim submitted to the federal Vaccine Injury Compensation Program so it is important to understand risks associated with influenza vaccines. Below are current links for the influenza vaccine manufacturer's package inserts that have been licensed for use in the U.S.  NVIC encourages consumers read this information carefully prior to receiving a vaccine. These links will lead you to the U.S. Food & Drug Administration's website, which makes vaccine package inserts and licensing information from available to the public.  Inserts contain important information regarding drug interactions, contraindications, adverse reactions, warnings and precautions.     

Influenza vaccines are classified by the FDA as Category B and C drugs. A Category B designation means that animal studies do not demonstrate a risk to the fetus and that there are no adequate and well-controlled studies in pregnant woman. Many vaccine manufacturers product inserts go on to state that animal studies do not always predict the response humans may have to these vaccines.

Category C designation means there are no adequate and well-controlled studies in pregnant women and no animal data, which means that animal reproduction studies have not been conducted and it is not known whether these vaccines can cause fetal harm when administered to a pregnant woman or if they can affect reproduction capacity. 

Many influenza vaccines in the U.S. also contain the mercury preservative, Thimerosal, in amounts above federal safety guidelines. Thimerosal free influenza vaccine is also licensed in the U.S. and it is advisable to request these vaccines in advance from your healthcare provider, if your preference is the Thimerosal free version.  Click here to determine which vaccines are Thimerosal free.

Quadrivalent Vaccines - Nasal
Quadrivalent Vaccines - Injected
Trivalent Vaccines - Injected

A live-virus nasal flu vaccine, FluMist, was approved for use in June 2003 and its approved use was limited to healthy people between the ages of 5 and 49. It was subsequently approved by the FDA for use in children as young as two years of age but with precautions.

FluMist is prepared by introducing influenza viruses into eggs where they are allowed to multiply. Fluid from the eggs is processed and sucrose, potassium phosphate and monosodium glutamate (MSG) are added as stabilizers. The antibiotic Gentamicin is also added during the manufacturing process. FluMist is a live virus vaccine and does not contain any preservatives.

Flu Mist vaccine is a Category B drug, and the product insert states:

"A developmental and reproductive toxicity study has been performed in female rats administered FluMist Quadrivalent either three times (during the period of organogenesis) or six times (prior to gestation and during the period of organogenesis), 200 microliter/rat/occasion (approximately 150 human dose equivalents), by intranasal instillation and has revealed no evidence of impaired fertility or harm to the fetus due to FluMist Quadrivalent. There are however, 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."

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