1st Trimester

Data on flu vaccine safety issue (hopefully helpful info)

After reading the debate in the post below about flu shot safety, I decided to take a look at the available safety information for the flu vaccines that are being used this season, to help me in making my own decision on what I am going to do.  I'm not attempting to further the debate or advocate getting v. not-getting the shot.  You all can believe whatever you want, but here's the actual safety data available on the vaccines being used this season. 

All information below is readily available for your own review in the package insert information for each of the vaccine manufacturers on the FDA website at http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm094045.htm

Here's a summary of what I found:

There are 6 "brands" of the injectible flu vaccine being used this year (I did not bother reading the info about Flu Mist, which is a 7th variety available but generally NOT recommended by docs for pregnant women because it contains the active virus). 

All warn in their product information that they should be given to pregnant women only if "clearly necessary".  I assume this language was developed by their legal departments to limit liability risks, since they all say the same thing and nobody bothers to define what "clearly necessary" actually means.

Of those 6 brands approved for use this season, only 3 of them have actually done animal testing on their product (some on rats, some on rabbits, so put whatever degree of faith in that you believe appropriate) to determine possible risks to pregnant women and their fetuses.  Those 3 are all rated Pregnancy Category B (i.e., no human testing done, but animal testing shows no negative effects). 

The three brands that are rated Category B are:

Agriflu (manufactured by Novartis) --  contains no thimerosol preservative

Fluarix (manufactured by GlaxoSmithKline) --  contains no thimerosol preservative

Flulaval (manufactured by ID Biomedical) --  this one does contain thimerosol preservative

The other three brands are rated Pregnancy Category C, because they did not do any animal testing (although, arguably, they are all containing the same virus strains this year, so likely would get the same results if they bothered to do the testing). 

The three brands rated Category C* are:

Afluria (manufactured by CSL Limited) -- makes a single dose version with no thimerosol, and a multi-dose version that does contain thimerosol

Fluvirin (manufactured by Novartis --- same manufacturer as the Class B Agriflu) -- single dose vials made with no thimerosol, multi-dose vials with thimerosol

Fluzon (manufactured by Sanofi Pasteur) -- it was not clear based on the safety sheet whether this one contains thimerosol or not, and there appear to be three different versions of the shot.  *In the interest of full disclosure, also note, there appears to be an intra-dermal version of Fluzon (as opposed to intra-muscular like all of the other vaccine shots) that is rated Category B instead of C.  It is not clear to whom the intra-dermal shot is available, since I believe pharmacies usually offer only the flu mist and the intra-muscular versions.

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Re: Data on flu vaccine safety issue (hopefully helpful info)

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