TDaP in every pregnancy has been a new recommendation (in the US) since February 2013. Now we are pushing this in Canada too, and if you ask me, this is being done BEFORE the evidence even exists that this is a safe and effective vaccine in pregnancy. Some evidence to this effect:
First off - Package insert -> Adacel and Boosterix both have the same statements, which say:
USE IN SPECIFIC POPULATIONS------------
-> Safety and effectiveness of Adacel vaccine have not been established in pregnant women. (8.1)
-> Pregnancy Surveillance Registry: contact Sanofi Pasteur Inc. at
1-800-822-2463 (1-800-VACCINE). (8.1)
https://www.vaccineshoppe.com/image.cfm?doc_id=10437&image_type=product_pdf
IMO - They they made this recommendation (to get a TDaP with every pregancy) in February of 2013 without any evidence, and are only now starting to test these theories. (Wreckless if you ask me...)
A current clinical trial testing the claim they are making about safety and efficacy in pregnancy. In this stufy, they are actively seeking volunteers who have had recent TDaP injections because they don't even know if TDaP every pregnancy is safe. http://clinicaltrials.gov/ct2/show/study/NCT02209623?term=TDaP+Pregnancy&rank=5
Here's another current clinical trial that has been ongoing since 2007! "The purpose of this study is to assess whether immunization against pertussis in the mid third trimester of pregnancy provides passive protection to the infant by transfer of IgG transplacentally and by transfer of secretory IgA (and possibly IgG) in breast milk, sufficient to protect the infant against pertussis disease in the critical neonatal period, without suppressing the infant's immune response to active immunization and disease" Again, they have no clue if vaccinating moms in pregancy has risks.
http://clinicaltrials.gov/ct2/show/NCT00553228?term=TDaP+Pregnancy&rank=4
There are a couple completed clinical trials as well, but shocker - one of them is nothing to do with safety and effecacy, but rather on TDaP and how to promote the vaccine to increase the likelihood that a mother will take them during pregnancy (WTFF??):http://clinicaltrials.gov/ct2/show/NCT01761799?term=TDaP+Pregnancy&rank=6
And this completed clinical trial, that compares pregnant woman receiving TDaP to non-pregnant woman receiving TDaP. http://clinicaltrials.gov/ct2/show/NCT00707148?term=TDaP+Pregnancy&rank=8
The thing that really rubs me the wrong way in this trial is the study design. They have 48 pregnant and 32 non-pregnant, 32 of the pregnant woman woman receive TDaP during pregnancy, and a saline placebo post pardum, and 16 pregnant woman receive the saline placebo in pregnancy and the TDaP post pardum. The 32 non-pregnant woman receive just the vaccine. So they are ALL getting the vaccine. The reserach paper from this stufy concludes "Further research is needed to provide definitive evidence of the safety and efficacy of Tdap immunization during pregnancy." http://www.ncbi.nlm.nih.gov/pubmed/24794369?dopt=Abstract
