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H5N1 vaccine

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

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

Vaccination of poultry against the avian H5N1 influenza epizootic is widespread in certain countries.[6][7] Some vaccines also exist for use in humans, and others are in testing. As of July 2024 these include Aflunov, Celldemic and Seqirus/Audenz.[8][9]

The hemagglutinin protein is the main viral antigen of influenza A viruses, including the H5N1 subtype. Vaccination can induce antibodies that block the functions of the H5 hemagglutinin and neutralize virus infectivity.[10]

The influenza virus is highly variable - the H5N1 virus now infecting cattle in the USA[a] is different from the H5N1 viruses that first showed up in poultry in 1997 and subsequently spread through wild bird populations in all continents except Australia. Scott Hensley, Professor of Microbiology at Perelman School of Medicine, has stated “If this H5 causes a pandemic, it likely is not going to be identical to whatever is circulating in cows [currently].” This means that any vaccine developed in anticipation of a human pandemic is unlikely to be an exact match to the pandemic strain.[11] However licensed vaccines can be updated in a process similar to that used for updating seasonal influenza vaccines.[12]

Timeline

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In December 2024 the UK government announced the purchase of five million doses of human H5 influenza vaccine to boost the country’s resilience in the event of a possible H5 influenza pandemic. The vaccine will be manufactured by CSL Seqirus UK Limited.[13] The vaccine is based on the A/H5N8/Astrakhan/3212/2020 clade 2.3.4.4b strain of influenza.[14] If needed, the H5 vaccine could be used while a pandemic-specific vaccine is developed and produced.[15]

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.[16]

In May 2024, CSL Seqirus was selected by the US government to supply 4.8 million doses of an H5 vaccine to the National Pre-Pandemic Influenza Vaccine Stockpile program. The vaccine is well matched to the H5N1 strains currently circulating in wild birds and cattle.[17]

In January 2020, the U.S. Food and Drug Administration (FDA) approved Audenz, an adjuvanted influenza A (H5N1) monovalent vaccine.[2][18] Audenz is a vaccine indicated for active immunization for the prevention of disease caused by the influenza strain which is contained in the vaccine (currently A/turkey/Turkey/1/2005 NIBRG-23).[19] In the event of an outbreak of the disease in humans, the strain could be updated in a process similar to that used for updating seasonal vaccines.[2][12]

In November 2013, the U.S. Food and Drug Administration (FDA) approved an experimental H5N1 bird flu vaccine to be held in stockpiles.[20][21] 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.[22]

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,[23][24]
  • GlaxoSmithKline's vaccine Prepandrix approved by the European Union in May 2008, with reactive AS03 (containing squalene) adjuvant,[25] 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.[26] Adjupanrix contains the flu strain A/VietNam/1194/2004 NIBRG 14 (H5N1).[26]
  • Foclivia, approved for medical use in the European Union in October 2009.[27] Foclivia contains the flu strain A/Vietnam/1194/2004 (H5N1).[27]
  • Aflunov, approved for medical use in the European Union in November 2010.[28] Aflunov contains the flu strain A/turkey/Turkey/1/2005 (H5N1)-like strain (NIBRG-23) (clade 2.2.1).[28]
  • Pumarix, approved for medical use in the European Union in March 2011.[29]

Vaccine Production

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Main article: Vaccine § Production

H5N1 continually mutates, meaning vaccines based on current samples of avian H5N1 cannot be depended upon to work in the case of a future pandemic of H5N1. While there can be some cross-protection against related flu strains, the best protection would be from a vaccine specifically produced for any future pandemic flu virus strain. Daniel R. Lucey, co-director of the Biohazardous Threats and Emerging Diseases graduate program at Georgetown University, has made this point, "There is no H5N1 pandemic so there can be no pandemic vaccine."[30] However, "pre-pandemic vaccines" have been created; are being refined and tested; and do have some promise both in furthering research and preparedness for the next pandemic.[31] Vaccine manufacturing companies are being funded to increase flexible capacity so that if a pandemic vaccine is needed, facilities will be available for rapid production of large amounts of a vaccine specific to a new pandemic strain.[32]

Notes

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  1. ^ As of December 2024

References

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  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. ^ "Bird flu vaccination policies by country". Reuters. 17 February 2023. Retrieved 30 July 2024.
  7. ^ "Vaccination of poultry against highly pathogenic avian influenza – Available vaccines and vaccination strategies". efsa.europa.eu. 10 October 2023. Retrieved 9 May 2024.
  8. ^ "Vaccines for pandemic influenza". European Medicines Agency. Retrieved 30 July 2024.
  9. ^ "Audenz". U.S. Food and Drug Administration (FDA). 31 January 2020. STN: 125692. Archived from the original on 6 August 2020. Retrieved 5 February 2020. Public Domain This article incorporates text from this source, which is in the public domain.
  10. ^ Xiong X, Corti D, Liu J, Pinna D, Foglierini M, Calder LJ, et al. (July 2015). "Structures of complexes formed by H5 influenza hemagglutinin with a potent broadly neutralizing human monoclonal antibody". Proceedings of the National Academy of Sciences of the United States of America. 112 (30): 9430–9435. Bibcode:2015PNAS..112.9430X. doi:10.1073/pnas.1510816112. PMC 4522749. PMID 26170284.{{cite journal}}: CS1 maint: overridden setting (link)
  11. ^ Fox M. "We May Not Have Enough Bird Flu Vaccines when We Need Them". Scientific American. Retrieved 12 December 2024.
  12. ^ a b "FDA Briefing Document - Vaccines and Related Biological Products Advisory Committee Meeting". Food and Drug Administration. 10 October 2024. Retrieved 12 December 2024.
  13. ^ "UK secures H5 influenza vaccine to boost pandemic preparedness". GOV.UK. Retrieved 12 December 2024.
  14. ^ "CSL Seqirus Announces New Pandemic Preparedness Award from the UK Government". www.cslseqirus.co.uk. Retrieved 12 December 2024.
  15. ^ "UK orders H5 avian flu vaccine for pandemic preparedness | CIDRAP". www.cidrap.umn.edu. 3 December 2024. Retrieved 12 December 2024.
  16. ^ "Commission secures access for Member States to 665,000 doses of zoonotic influenza vaccines to prevent avian flu". European Commission. 11 June 2024.
  17. ^ "CSL Seqirus Announces US Government Award in Response to Avian Influenza". CSL Seqirus. 30 May 2024. Retrieved 13 December 2024.
  18. ^ Keown A (4 February 2020). "FDA Approves Seqirus' Audenz as Vaccine Against Potential Flu Pandemic". BioSpace. Retrieved 5 February 2020.
  19. ^ "Package Insert - AUDENZ". US Food and Drug Administration. October 2023. Retrieved 12 December 2024.
  20. ^ "Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, manufactured". U.S. Food and Drug Administration (FDA). 22 November 2013. Retrieved 5 February 2020.
  21. ^ "Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted". U.S. Food and Drug Administration (FDA). 23 April 2019. STN#: 125419. Retrieved 5 February 2020.
  22. ^ Lowes R (22 November 2013). "FDA Approves First Adjuvanted Vaccine for H5N1 Bird Flu". Medscape. Retrieved 16 March 2015.
  23. ^ "H5N1 Influenza Virus Vaccine Questions and Answers". U.S. Food and Drug Administration (FDA). 17 April 2007. Retrieved 5 February 2020.
  24. ^ "Diagnostic Targets and Potential Vaccine Against H5n1 Avian Influenza". U.S. Food and Drug Administration (FDA). 11 September 2019. Retrieved 5 February 2020.
  25. ^ "EU licenses first pre-pandemic bird flu vaccine LONDON". Reuters. 19 May 2008.
  26. ^ a b "Adjupanrix EPAR". European Medicines Agency (EMA). 17 September 2018. Retrieved 13 January 2021.
  27. ^ a b "Foclivia EPAR". European Medicines Agency. 17 September 2018. Retrieved 13 January 2021.
  28. ^ a b "Aflunov EPAR". European Medicines Agency (EMA). 17 September 2018. Retrieved 13 January 2021.
  29. ^ "Pumarix EPAR". European Medicines Agency (EMA). 17 September 2018. Retrieved 13 January 2021.
  30. ^ "H5N1 Influenza Pandemic Threat (Avian Flu) | Sino Biological". www.sinobiological.com. Archived from the original on 12 September 2024. Retrieved 13 December 2024.
  31. ^ "Vaccines for pandemic influenza | European Medicines Agency (EMA)". www.ema.europa.eu. Retrieved 13 December 2024.
  32. ^ McElwee F, Newall A (July 2024). "The Value of Flexible Vaccine Manufacturing Capacity: Value Drivers, Estimation Methods, and Approaches to Value Recognition in Health Technology Assessment". PharmacoEconomics. 42 (Suppl 2): 187–197. doi:10.1007/s40273-024-01396-6. PMC 11230966. PMID 38819720.

Further reading

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