Pandemrix

Pandemrix
Vaccine description
TargetPandemic H1N1/09 virus
Vaccine typeInactivated
Clinical data
Routes of
administration
Intramuscular injection
ATC code
Legal status
Legal status
Identifiers
CAS Number
ChemSpider
  • none
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Pandemrix is an influenza vaccine for influenza pandemics, such as the 2009 flu pandemic. The vaccine was developed by GlaxoSmithKline (GSK)[2] and patented in September 2006.[3]

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).[4] 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).[4] The vaccine was initially developed as a pandemic mock-up vaccine using an H5N1 strain.[5]

Pandemrix was found to be associated with an increased risk of narcolepsy[6] following investigations by Swedish and Finnish health authorities[7] and had higher rates of adverse events than other vaccines for H1N1.[8] This resulted in several legal cases.[9] Stanford University studies suggested that narcolepsy is an autoimmune disease[10] and that it appears to be triggered by upper airway respiratory infections.[11]

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.[12]

  1. ^ "Pandemrix EPAR". European Medicines Agency. Retrieved 14 June 2022.
  2. ^ "Pandemic (H1N1) 2009 Influenza Update: GSK's H1N1 'Pandemrix' vaccine receives positive opinion from European Regulators" (Press release). GlaxoSmithKline. 25 September 2009. Archived from the original on 29 September 2009. Retrieved 2009-11-07.
  3. ^ WO 2006100109, Hanon, Emmanuel Jules & Stephenne, Jean, "Use of an influenza virus an oil-in-water emulsion adjuvant to induce CD4 T-cell and/or improved B-memory cell response", published 2006-09-28, assigned to Glaxosmithkline Biolog SA 
  4. ^ a b "EMEA Pandemrix page". Emea.europa.eu. Archived from the original on 8 October 2009. Retrieved 8 September 2018.
  5. ^ "Assessment report for the mock-up H5N1 vaccine" (PDF). EMEA. Archived from the original (PDF) on September 2, 2009. Retrieved 2009-11-07.
  6. ^ Cite error: The named reference :0 was invoked but never defined (see the help page).
  7. ^ "The MPA investigates reports of narcolepsy in patients vaccinated with Pandemrix". The Swedish Medical Products Agency. 2010-08-18. Archived from the original on 17 February 2011. Retrieved 2010-08-19.
  8. ^ Cite error: The named reference :1 was invoked but never defined (see the help page).
  9. ^ Cite error: The named reference :2 was invoked but never defined (see the help page).
  10. ^ Cite error: The named reference Stanford_narcolepsy_autoimmune was invoked but never defined (see the help page).
  11. ^ Cite error: The named reference Stanford_narcolepsy_flu was invoked but never defined (see the help page).
  12. ^ "Narcolepsy Following 2009 Pandemrix Influenza Vaccination in Europe | Vaccine Safety | CDC". www.cdc.gov. 2020-08-20. Retrieved 2023-01-16.