CDC Statement on Discontinued Use of Pandemrix Influenza Vaccine in Europe

Released: September 1, 2010

The Centers for Disease Control and Prevention (CDC) has become aware of recommendations made by the Finland National Institute for Health and Welfare (THL) to discontinue vaccination with Pandemrix, an adjuvanted  H1N1 influenza vaccine, while an investigation is conducted looking into the observed rise in cases of narcolepsy among children and adolescents, mainly in Sweden and Finland.  This vaccine was developed specifically for pandemic 2009 H1N1 influenza (this past flu season).  A different influenza vaccine will be used in Europe during the upcoming influenza season. Narcolepsy is a chronic neurological disorder caused by the brain’s inability to regulate sleep-wake cycles normally.

Pandemrix is not licensed for use in the United States. No adjuvanted influenza vaccines are licensed in the United States. The European Medicines Agency has launched a review of Pandemrix to investigate whether there is a link between cases of narcolepsy and vaccination with Pandemrix. This vaccine has been used in at least 30.8 million Europeans.

In response to these recent cases in Europe, CDC has reviewed information from the U.S. Vaccine Adverse Event Reporting System (VAERS) and found no signals or concerns suggesting an association between U.S.-licensed H1N1 or seasonal influenza vaccines and narcolepsy in the United States. CDC has enhanced its surveillance for cases of narcolepsy occurring after 2010-11 seasonal influenza vaccine and will continue to monitor the situation and take appropriate action as needed.

CDC recommendations for influenza vaccine during the 2010-2011 season are in place and can be found at: Prevention and Control of Influenza with Vaccines Recommendations of the Advisory Committee on Immunization Practices (ACIP), 2010, MMWR August 6, 2010 / Vol. 59 / No. RR-8.