Safety of Tdap vaccine in pregnant women: an observational study

Petousis-Harris, Helen; Walls, Tony; Watson, Donna; Paynter, Janine; Graham, Patricia; Turner, Nikki

The women in our group were older (32 vs 29.2 years) and more likely to be of NZ European ethnicity (73.5% vs 49.5%) than the general NZ maternal population. This is most likely a reflection of the health-seeking behaviour associated with these demographics. While pregnancy complications increase with age, in contrast, NZ European ethnicity is associated with lower risk pregnancies. 22 The reactogenicity of acellular pertussis-containing vaccines in adults was reviewed in 2012. 23 Data on the reactogenicity of Tdap are derived from clinical trials and prospective studies; however, the results are not presented in a standardised way that allows for comparison. There is insufficient information in the study manuscripts to determine in more detail how events are measured or classified. However, severe local pain ranges from less than 1% to 30%, and severe local redness or swelling (≥50 mm) ranges from 2% to 18%. [24] [25] [26] [27] [28] [29] [30] Although most of these studies were published after 2007 when definitions were published by the Brighton Collaboration, none have provided information about induration.