Pandemrix
Pandemrix is an influenza vaccine for influenza pandemics, such as the 2009 flu pandemic. The vaccine was developed by GlaxoSmithKline (GSK) and patented in September 2006.
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Target | Pandemic H1N1/09 virus |
Vaccine type | Inactivated |
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Routes of administration | Intramuscular injection |
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Influenza (flu) |
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The vaccine was one of the H1N1 vaccines approved for use by the European Commission in September 2009, upon the recommendations of the European Medicines Agency (EMEA). The vaccine is only approved for use when an H1N1 influenza pandemic has been officially declared by the World Health Organization (WHO) or European Union (EU). The vaccine was initially developed as a pandemic mock-up vaccine using an H5N1 strain.
Pandemrix was found to be associated with an increased risk of narcolepsy following investigations by Swedish and Finnish health authorities and had higher rates of adverse events than other vaccines for H1N1. This resulted in several legal cases. Stanford University studies suggested that narcolepsy is an autoimmune disease and that it appears to be triggered by upper airway respiratory infections.
In 2018, a study team including Centers for Disease Control and Prevention (CDC) scientists analyzed and published vaccine safety data on adjuvanted pH1N1 vaccines (arenaprix-AS03, Focetria-MF59, and Pandemrix-AS03) from 10 global study sites. Researchers did not detect any associations between the vaccines and narcolepsy.