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.

Always missing my Mommy (1954-2010) and Daddy (1943-2012)
TTC since 2009 ; BFP 9/13/10 = MC 10/21/10
DX = DOR/POA (AMH=1.1; AFC=4-5)
Surprise BFP 8/31/11 while waiting to cycle for IVF
Welcomed our little miracle 5/7/12
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Re: Data on flu vaccine safety issue (hopefully helpful info)

  • Thanks for posting this-- there are also people who are scared of the flu shot and it's helpful to get accurate information out there.

    ps. I grew up in Rockland!

    Lilypie Pregnancy tickers Lilypie Second Birthday tickers
  • Thanks for the info, did your post cut off at the end or did you really stop writing after the definition/description of Fluzon? Just wondering.
  • image mpayne:
    Thanks for the info, did your post cut off at the end or did you really stop writing after the definition/description of Fluzon? Just wondering.

    I stopped there.  As I said, I'm not attempting to tell anyone what conclusions to draw, just wanted to throw the info out there.

    Always missing my Mommy (1954-2010) and Daddy (1943-2012)
    TTC since 2009 ; BFP 9/13/10 = MC 10/21/10
    DX = DOR/POA (AMH=1.1; AFC=4-5)
    Surprise BFP 8/31/11 while waiting to cycle for IVF
    Welcomed our little miracle 5/7/12
    Baby Birthday Ticker Ticker

  • Sounds great. I just wanted to double check to make sure I read everything you posted. Thank you so much for the information.

  • I got my flu shot 2 weeks ago Smile Of course, I really had no choice. I work in a hospital and I wasn't about to wear a mask for 4 months.
    Lilypie Third Birthday tickers Lilypie First Birthday tickers
  • Thank you so much for the more informative post :)  I did get my flu shot last week.  I tend to get them and tend to support getting them just because I did get the flu one year and it was horrific.  I was out two full weeks, very high fever, severly dehydrated, even hallucinated.  I guess I will take the risk on the flu shot because had I been pregnant when I got that sick I probably would have miscarried.  It was scary.  I still don't really like putting something into my body while I am pregnant so I am very cautious.  Helps to be informed from all sides.  Thanks again for the post.

    Lilypie - (pbOJ)

    Lilypie Second Birthday tickers
  • 1) Thank you for this.  Facts are awesome.  Everyone should have them and weigh them for themselves.

    2) Something important to know about Class C drugs - many many many prescription prenatal vitamins contain a Class C drug.  The very popular stool softener Colace (ducosate sodium) is used commonly in prenatals and it is a Class C drug.  http://www.obfocus.com/reference/Formulary/Drugs in Pregnancy/Docusate.htm

    Curious that I don't see anyone come on here and claim that their prenatal vitamins could have caused their miscarriage . . . 

    ds #1 | our perfect miracle born 39w1d | 12.9.2009 loss #1 | natural m/c 7/2010 (~8w) loss #2 | chemical pregnancy 6/2011 (4w4d) loss #3 | chemical pregnancy 7/2011 (4w3d) loss #4 | natural m/c 11/2011 (10w1d) RPL Testing 12/2011. Results 100% normal. ds #2 | our 2nd perfect miracle born 36w3d | 12.31.2012
  • For those that are planning on getting the shot, hopefully this will be helpful (sorry if I'm repeating anyone). I did call my OB/GYN just now (I was thinking of getting one here at work and wanted to make sure it would be ok) and the nurse said just to make sure it is "Thimerosal free". That said, I just decided to get the shot AT my OB/GYN so I know I'm getting the right one.
  • Thank you, very timely!  My company is offering the shot, but it does contain thimerosol.  My ob/gyn also offers her pregnant patients thimerosol free shots, so I'm going to get one from her. 
    BabyFruit Ticker
  • My doctor told me I SHOULD get the shot, but that I will need to wait until I am 12 weeks or later.  That seemed to be their standard recommendation, I heard them telling another lady the same thing.  But I haven't heard of any other pregnant women's doctors telling them this, most of them just say go ahead and get the shot.  Has anyone else's doctor said anything like this?  I'm going to get the shot at 12 weeks like I was told, but I would have actually liked to get it already.  I work at the public library in a very high-traffic area and I come into contact with a lot of germy people during flu season! 
    BabyFruit Ticker
  • I got my flu shot the day before I got my BFP.  They recommend the preservative free shot if you are expecting but since I didn't know I got the one with preservatives.  So far, so good.
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