H1N1 Package Insert Information


Below are the package inserts for the new H1N1 vaccines, whose “safety studies” are largely based on the seasonal flu vaccines. Please read the inserts carefully. In recent news the CDC suggested that  all pregnant women and children get this vaccine

Here is a summary of the H1N1 and seasonal vaccines according to the package inserts:

a.. The vaccines have not been tested for safety or effectiveness in pregnant women or nursing mothers (even though pregnant women are a priority target group for this vaccine. As stated: “It is not known whether these vaccines can cause fetal harm when administered to a pregnant woman or can affect reproductive capability. It is not known whether the H1N1 vaccine is excreted in human milk.”

b.. The vaccines have not been tested for mutagenic or carcinogenic potential.

c.. The multi-dose vaccines (Sanofi Pasteur) contain a full dose (25 mcg) of thimerosal/mercury (known neurotoxin).

d.. Other ingredients include: formaldehyde (carcinogen); hemagglutinin (glycoprotein that causes red blood cells to agglutinate/clump and attach to the respiratory tract to cause infection); gelatin (known allergen); polyethylene glycol p-isoctylphenyl ether (strong detergent).

e.. “Safety studies” of Fluzone/H1N1 vaccine included 19 CHILDREN (6-23 months) and 12 children (24-36 months) for 3 days.

f.. Some of the reported adverse events/side effects of the vaccines include: Thrombocytopenia (spontaneous bleeding); anaphylaxis (life threatening allergic reaction); lymphadenopathy (diseased lymph nodes); Guillain-Barre (paralysis); Bells Palsy (facial paralysis); convulsions; encephalomytis (brain inflammation/damage); optic neuropathy (optic nerve damage); syncope (loss of consciousness); Stevens Johnson Syndrome, vasculitis (inflammatory destruction of blood vessels).

g.. Warnings included in package insert: “The 1976 swine influenza vaccine was associated with an increased frequency of Guillain Barre Syndrome. Evidence for a causal relation with subsequent vaccines prepared from other influenza viruses is unclear.” Also…”Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of this vaccine.”

Here are the package inserts for both the injectable and intranasal H1N1 vaccines.


http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm181950.htm

Source: FDA

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