Finland, Sweden and the UK will cease to give the flu vaccine Pandemrix to young people after it was linked to an increased chance of narcolepsy, as further investigations into the drug continue across Europe.
The jab was commonly used in member states during the last swine flu scare in 2009 but was linked last week to the rare sleeping disorder by a report from the European Medicine Agency's committee for medicinal products for human use (CHMP).
The report said that Pandemrix should only be given to children and teenagers at risk of H1N1 flu if other jabs – such as seasonal vaccines devised to head off flu – are unavailable.
The CHMP's investigation followed reports from Finland, Sweden, Iceland and the UK of children and adolescents suffering from narcolepsy, which causes people to fall asleep suddenly and unexpectedly. It said studies had shown a six to 13-fold increased risk of narcolepsy in children and adolescents vaccinated with Pandemrix compared to unvaccinated children.
Ongoing investigations over Pandemrix
In a statement, the CHMP said it had "noted that the vaccine is likely to have interacted with genetic or environmental factors which might raise the risk of narcolepsy, and that other factors may have contributed to the results". Several initiatives are being developed to "further investigate the association," according to the CHMP.
In the UK – where more than six million doses of the vaccine have been given out – Pandemrix was the most widely used vaccine during the 2009 pandemic. But a spokesman for the Department of Health confirmed to EURACTIV that it is no longer in use, and will not be used for children any more.
Spokesmen for the Finnish and Swedish health ministries also confirmed that Pandemrix will no longer be used to immunise those younger than 20.
Seasonal flu vaccine to be used
The Finnish spokesman said that inoculations for the 2011-2012 season will be based on last year's seasonal flu vaccine, so there are likely to be plentiful supplies and additional vaccines such as Pandemrix would not be needed anyway.
Scientists in Finland studying the association of narcolepsy with the Pandemrix vaccine will publish a final report in August.
Overall, Pandemrix has been given to more than 31m people worldwide.
In a statement, manufacturers GlaxoSmithKline said it had received reports of 335 cases of narcolepsy in people vaccinated with Pandemrix by the start of July.
The company added: "GSK is committed to patient safety and will continue to work closely with the CHMP and other national regulatory organisations in the best interest of patients."
Meanwhile, the World Health Organsiation said that its global advisory committee on vaccine safety is currently reviewing the evidence presented and will provide its own conclusions shortly.
The European Medicines Agency (EMEA) expert committee on new drugs gave the go-ahead for the first H1N1 swine flu vaccines from GlaxoSmithKline and Novartis, called Pandemrix and Focetria, in September 2009.
The shots were then approved by the European Commission, in an accelerated process designed to regulate pandemic vaccines.
A third vaccine from Baxter, which had also been submitted under a fast-track procedure, was not given the green light.
Manufacturers and governments were scrambling for vaccines to target the new H1N1 flu strain, which had been declared a pandemic in June of that year.
The World Health Organisation (WHO) warned that drug makers would only be able to produce enough H1N1 vaccine each year for half the planet – around three billion doses per year – meaning governments would have to decide who should get the limited supplies.
- Summer 2011: investigations by European Medicines Agency to continue, World Health Organisation to give opinion on Pandemrix
EU official documents
- European CommissionNotes on pandemic response preparedness
- Wolrd Health OrgansationPandemic (H1N1) 2009
- European Medicine Agency Committee for Medicinal Products for Human UseReport on Pandemrix
EU Actors positions
- European Centre for Disease Prevention and Controlhttp://ecdc.europa.eu/en/Pages/home.aspx