Issue: August 2011
August 01, 2011
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No substantial link noted between recent pandemic flu vaccine and GBS

Dieleman J. BMJ. 2011; 343:d3908 doi: 10.1136/bmj.d3908.

DeStefano F. BMJ. 2011; 343: d4159.

Issue: August 2011
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The adjuvanted vaccines used during the 2009 influenza pandemic did not likely increase recipients' risk of Guillain-Barré syndrome, but European researchers could not definitively rule out a link, according to study results published online this week.

Officials with the European Centre for Disease Prevention and Control funded a consortium of European researchers to examine data on influenza immunizations given during the 2009 H1N1 influenza pandemic from a population of 50 million people from five European countries. The researchers matched 104 GBS patients with one or more controls.

The researchers noted that the adjusted odds ratio for GBS in those who were vaccinated was 1.0, indicating no higher risk, but because the 95% confidence interval was somewhat wide, 0.3 to 2.7, they could not exclude the possiblity altogether.

Based on the study results, the researchers estimated this risk to be less than three excess cases of GBS for every million individuals protected by the vaccination, which they called “reassuring.” They added that larger studies, using different techniques to minimize bias, are currently underway that will give a clearer picture of the data.

This view was supported in an accompanying editorial by US researchers, Frank Destefano, MD, and colleagues from the CDC, who said the risk of GBS, if any, is considerably smaller than that seen with the 1976 swine influenza vaccines. In 1976, almost one extra GBS case was reported for every 100,000 vaccinations. The editorial pointed out that safety findings on adjuvanted influenza vaccines are important if such vaccines become more common in future, whether in seasonal influenza vaccines or for the next pandemic.

Disclosures: The researchers reported no relevant conflicts of interest.

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