GSK European regulatory update on Pandemrix™

Issued London UK

GlaxoSmithKline (GSK) announced today that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended changes to the product label for Pandemrix. The amendment includes prescribing advice based on information on a potential increased risk of narcolepsy in children or adolescents. This is based onpreliminary results from epidemiological studies on the risk of narcolepsy from Finland, Sweden and France. This does not apply to adults where to date no data support such a change. The EMA state that this is an interim measure pending the outcome of the European review expected to conclude in July 2011.

The label will advise health professionals to perform an individual benefit-risk assessment taking the narcolepsy information into account when considering the use of Pandemrix in children and adolescents.

In recent months data from a number of different countries that have administered Pandemrix indicate a large variability in the number of cases of narcolepsy being reported. The CHMP stated that preliminary results from epidemiological studies from Sweden and France strengthened the signal in children and adolescents although the data had methodological limitations. In other EU and non-EU countries the same signal of an increase in the number of reports of narcolepsy following Pandemrix is not seen. This may indicate the influence of other unknown factors impacting some countries and t his requires further investigation in order to fully understand any potential link.

GSK maintains that further information must be gathered on a potential likelihood of a causal relationship between Pandemrix and narcolepsy before any conclusions can be drawn. It is important to wait for the results of the ongoing European investigation, which includes an epidemiological study of narcolepsy and pandemic vaccines across a network of research and public health institutions (VAESCO) in nine European Union Member States. Preliminary results of the VAESCO study and of the epidemiological study in Canada being conducted by GSK are expected by July 2011.  

GSK is committed to patient safety. The company will continue to work closely with EMA and other national regulatory organisations while the broader, European investigation continues.

Over 31 million doses of Pandemrix have been administered worldwide in 47 countries. A total of 247 cases of narcolepsy in people vaccinated with Pandemrix have been reported to GSK as of 5th April 2011.  

Notes for Editors

Expected wording in section 4.4 to the product information:

Preliminary reports form epidemiological studies in two countries (Sweden and Finland) have indicated a  4-9-fold risk increase of narcolepsy in vaccinated as compared with unvaccinated children/adolescents, corresponding to an absolute risk increase of about three-four additional cases in 100 000 vaccinated subjects. This risk increase has not been found in adults (older than 20 years). Similar epidemiological studies have not yet been conducted in other countries.

The relationship between Pandemrix and narcolepsy is still under investigation.

When considering the use of Pandemrix in children and adolescents, an individual benefit risk assessment should be performed taking this information into account.

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