Thursday, January 17, 2013

Flu Vaccine and Safety in Pregnancy. A breakdown of the study that says it is.

I'm sure you'll be hearing about, or have already heard, the new study that says the flu vaccine is safe for pregnant women. Here is a breakdown of the actual study they are basing this on.

1) It is a data survey study that looked at H1N1 vaccinated pregnant women in Norway in 2009 and it showed from their study that there was a decrease incidence of fetal deaths in the vaccinated population. That's it. Now, you look closer here's the discrepencies.

A) First, their only parameter for safety is of fetal death. No statistics or information about birth defects, APGAR scores, mental status, autism, etc. - you know the drill. Basically, while fetal death is important, it is not the only thing that makes a vaccine safe or not safe (and I use the word 'safe' loosely)

B) Second, it makes no mention of or decision to look into the socioeconomic factors that may effect the data - lower socioeconomic status usually means less access to healthcare which can translate to less vaccines but also more ways to effect fetal mortality. Again, they are making broad assumptions that fetal deaths are only correlated to vaccinated vs. non-vaccinated along with flu exposure.

C) Third, the vaccine that they were following, Pandemrix is (a) influenza-based but only supposed to be using in cases of pandemic H1N1 (a situation we're not currently in in the US), and, most importantly (b) is not licensed for usage in the US, so it's not a vaccine any of our patients, or any US citizen, is likely to ever be innoculated with, so even if the study was actually valid, it's not one that just translates to our current flu vaccines being 'safe'. (FYI, Pandemrix contains thimerosal,squalene, formaldehyde and polysorbate 80 and is thought to cause narcolepsy in children and adolescents)
 
D) Fourth, the actual percentage difference in fetal deaths between the vaccinated and non-vaccinated population was, by my own calculations, a .17% difference.

D) Fifth, the conclusion in the paper only actually states there is a decrease in fetal deaths (which I still think is a big leap in stating so, but whatever) but the media has taken it and extrapolated that to say it's plain old safe. 
E) One last thing, while it made sure to include pregnant women with an influenza diagnosis, it makes an unverified leap that those that had a fetal death, were indeed caused by their flu So there's the real info. Here's the link to the study if you need as well:
http://www.nejm.org/doi/full/10.1056/NEJMoa1207210?query=featured_home

Thanks to my fellow colleague Dr. Jason Pape for the breakdown.