EMA to assess GSK flu vaccine for narcolepsy link
pharmafile | September 1, 2010 | News story | Research and Development, Sales and Marketing | GlaxoSmithKline, Pandemrix, h1n1
The European Medicines Agency has launched a review of GlaxoSmithKline’s influenza vaccine Pandemrix.
The European Commission asked the EMA to establish whether there is a link between the brand and cases of narcolepsy, a rare disorder that causes a person to fall asleep suddenly.
On 24 August, Finland’s National Institute for Health and Welfare recommended Pandemrix jabs should stop until any potential link has been evaluated.
The single-dose drug was granted a fast-track authorisation and has been used since September 2009 against H1N1 influenza to deal with the flu pandemic declared by the World Health Organisation on 11 June last year.
Novartis, Sanofi-Pasteur and Baxter were the other companies providing A/H1N1 vaccines.
At least 30.8 million Europeans have received Pandemrix, and the EMA says a “limited number of cases” of narcolepsy have been reported, mainly in Sweden and Finland.
These have occurred around the same time as the use of Pandemrix, and causes of narcolepsy are thought to include a combination of genetic and environmental factors, including infections.
However, it is not known if the vaccine caused the disorder and the EMA’s Committee for Medicinal Products for Human Use (CHMP) has been tasked with looking at any evidence of a causal link, liaising with the European Centre for Disease Prevention and Control and the WHO.
Its work will take into account the number of cases that would normally be expected to be diagnosed and it will discuss the need for any provisional measures at its September meeting.
Pandemrix has been important for GSK, contributing to strong sales growth last year. When the UK’s swine flu vaccination programme began in October 2009, for example, the vast majority of people were offered Pandemrix.
But governments worldwide began limiting their H1N1 vaccines as cases of the virus declined – in April this year the UK government capped its order at 34.8 million doses after originally ordering 60 million.
The Department of Health agreed to spend the saved money on other GSK products: H5N1 bird flu vaccine Prepandrix and courses of the antiviral Relenza.
Adam Hill
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