Statement of Global Advisory Committee on Vaccine Safety (GACVS) on Pandemrix® vaccine and narcolepsy
The National Institute of Health and Welfare of Finland issued a statement on 1 February 2011, indicating an increased risk of narcolepsy observed among children and adolescents vaccinated with Pandemrix®, an adjuvanted vaccine against pandemic influenza A(H1N1) 2009 manufactured by GlaxoSmithKline.
WHO’s Global Advisory Committee on Vaccine Safety (GACVS) reviewed the data on 4 February 2011. In a statement on 8 February, GACVS agreed that further investigation is warranted concerning narcolepsy and vaccination with Pandemrix® and other vaccines. GACVS noted, however, that an increased risk of narcolepsy has not previously been observed in association with the use of any vaccines.
On the basis of the risk assessment provided by GACVS and considering that the regulatory authority of record for WHO prequalification, the European Medicines Agency, has not taken any regulatory action, WHO is not changing its current position on the use of pandemic influenza vaccines. Countries should continue vaccinating against pandemic influenza A(H1N1) 2009 to immunize people at risk of severe disease, using monovalent vaccines, including Pandemrix®, if trivalent seasonal vaccine is not available.
GACVS will continue to monitor the situation closely, and WHO will provide updates as further information becomes available and is assessed.