On December 18, 2009 some lots of the H1N1 vaccine were recalled. An faq is available at the CDC, but the gist is that the recall is due to a loss of efficacy of certain lots of the H1N1 vaccine produced by Sanofi Pasteur for children aged 6-35 months. The CDC advice to parents is that if your child got vaccinated using a vial from these recalled lots your child will be adequately immunized. This is true even if both shots were from the recalled lots since the efficacy was just barely below the desired threshold. Having worked closely with quality control in the past, I believe this conclusion. Control thresholds such as efficacy are defined with a margin so that the true efficacy threshold is much lower than the control threshold. It does remind me though that my daughter got her first H1N1 vaccine and it has been 28 days since her first so she is eligible to get her second. On a slightly different note, I'm disappointed by the lack of immediate information on the Sanofi Pasteur website relating to the recall. Under press releases on the homepage, I see a press release from Dec 16 and the next from Dec 23, neither relating to the recall. I would expect a company that is providing vaccine to the US population to be very upfront about a recall.

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02 January 2010