H5N1 vaccine

H5N1 vaccine
Vaccine description
TargetH5N1
Vaccine typeInactivated
Clinical data
Trade namesAudenz, Aflunov
AHFS/Drugs.comMicromedex Detailed Consumer Information
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ATC code
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H5N1

A H5N1 vaccine is an influenza vaccine intended to provide immunization to influenza A virus subtype H5N1.

Vaccines have been formulated against several of the avian H5N1 influenza varieties. Vaccination of poultry against the H5N1 epizootic is widespread in certain countries. Some vaccines also exist for use in humans, and others are in testing, but none have been made available to civilian populations, however production could be scaled up to quantities sufficient to protect much of the Earth's population in the event of an H5N1 pandemic.[citation needed]

In January 2020, the U.S. Food and Drug Administration (FDA) approved Audenz, an adjuvanted influenza A (H5N1) monovalent vaccine.[2][6] Audenz is a vaccine indicated for active immunization for the prevention of disease caused by the influenza A virus H5N1 subtype contained in the vaccine. Audenz is approved for use in persons six months of age and older at increased risk of exposure to the influenza A virus H5N1 subtype contained in the vaccine.[2]

Some older, egg-based H5N1 vaccines for humans that have been licensed are:

  • Sanofi Pasteur's vaccine approved by the United States in April 2007,[7][8]
  • GlaxoSmithKline's vaccine Prepandrix approved by the European Union in May 2008, with reactive AS03 (containing squalene) adjuvant,[9] and
  • CSL Limited's vaccine Panvax approved by Australia in June 2008.

Other licensed H5N1 vaccines include:

  • Adjupanrix, approved for medical use in the European Union in October 2009.[10] Adjupanrix contains the flu strain A/VietNam/1194/2004 NIBRG 14 (H5N1).[10]
  • Foclivia, approved for medical use in the European Union in October 2009.[11] Foclivia contains the flu strain A/Vietnam/1194/2004 (H5N1).[11]
  • Aflunov, approved for medical use in the European Union in November 2010.[12] Aflunov contains the flu strain A/turkey/Turkey/1/2005 (H5N1)-like strain (NIBRG-23) (clade 2.2.1).[12]
  • Pumarix, approved for medical use in the European Union in March 2011.[13]

In November 2013, the U.S. Food and Drug Administration (FDA) approved an experimental H5N1 bird flu vaccine to be held in stockpiles.[14][15] In a clinical trial including 3,400 adults, 91% of people age 18-64 and 74% of people age 65 or older formed an immune response sufficient to provide protection. Reported adverse effects were generally mild, with pain at the injection site being the most common adverse effect.[16]

In June 2024, the European Commission signed a four-year contract with CSL Seqirus to secure 665,000 pre-pandemic vaccines with a provision for a further 40 million doses of avian flu vaccines for 15 member states.[17]

  1. ^ "Health product highlights 2021: Annexes of products approved in 2021". Health Canada. 3 August 2022. Retrieved 25 March 2024.
  2. ^ a b c "Audenz". U.S. Food and Drug Administration (FDA). 31 January 2020. STN: 125692. Retrieved 5 February 2020. Public Domain This article incorporates text from this source, which is in the public domain.
  3. ^ "Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted". U.S. Food and Drug Administration. 14 November 2019. Retrieved 21 September 2024.
  4. ^ "Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, manufactured". U.S. Food and Drug Administration. 22 November 2013. Retrieved 21 September 2024.
  5. ^ "Aflunov EPAR". European Medicines Agency (EMA). 29 November 2010. Retrieved 21 September 2024.
  6. ^ Keown A (4 February 2020). "FDA Approves Seqirus' Audenz as Vaccine Against Potential Flu Pandemic". BioSpace. Retrieved 5 February 2020.
  7. ^ "H5N1 Influenza Virus Vaccine Questions and Answers". U.S. Food and Drug Administration (FDA). 17 April 2007. Retrieved 5 February 2020.
  8. ^ "Diagnostic Targets and Potential Vaccine Against H5n1 Avian Influenza". U.S. Food and Drug Administration (FDA). 11 September 2019. Retrieved 5 February 2020.
  9. ^ "EU licenses first pre-pandemic bird flu vaccine LONDON". Reuters. 19 May 2008.
  10. ^ a b "Adjupanrix EPAR". European Medicines Agency (EMA). 17 September 2018. Retrieved 13 January 2021.
  11. ^ a b "Foclivia EPAR". European Medicines Agency. 17 September 2018. Retrieved 13 January 2021.
  12. ^ a b "Aflunov EPAR". European Medicines Agency (EMA). 17 September 2018. Retrieved 13 January 2021.
  13. ^ "Pumarix EPAR". European Medicines Agency (EMA). 17 September 2018. Retrieved 13 January 2021.
  14. ^ "Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, manufactured". U.S. Food and Drug Administration (FDA). 22 November 2013. Retrieved 5 February 2020.
  15. ^ "Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted". U.S. Food and Drug Administration (FDA). 23 April 2019. STN#: 125419. Retrieved 5 February 2020.
  16. ^ Lowes R (22 November 2013). "FDA Approves First Adjuvanted Vaccine for H5N1 Bird Flu". Medscape. Retrieved 16 March 2015.
  17. ^ "Commission secures access for Member States to 665,000 doses of zoonotic influenza vaccines to prevent avian flu". European Commission. 11 June 2024.