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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Influenza (flu)
H1N1 virus
Types
Vaccines
Treatment
Pandemics
Outbreaks
See also

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.