Wikipedia

List of seasonal influenza vaccines

Seasonal influenza vaccine brands include Fluzone/Fluzone Quadrivalent[1] and Vaxigrip/VaxigripTetra,[2] Influvac and Optaflu.

AstraZeneca

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Fluenz, Flumist and their quadrivalent formulations are nasal attenuated vaccines by AstraZeneca.

  • Fluenz[3]
  • Fluenz Tetra[4]
  • Flumist[5]
  • Flumist Quadrivalent[6]

GlaxoSmithKline

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Fluarix, Flulaval and their quadrivalent formulations are split virus inactivated vaccines by GlaxoSmithKline.[7]

  • Fluarix
  • Flulaval
  • Fluarix Tetra[8]

Mylan/Viatris

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Influvac and its quadrivalent formulation are surface antigen subunit vaccines marketed by Mylan.

  • Influvac
  • Influvac Tetra[8]

They contain inactivated purified surface fragments (subunits) from the three different strains of the influenza virus (A/H1N1, A/H3N2, and Influenza B virus) that are selected and distributed by the World Health Organization, on the basis of their latest recommendations. Previously, they were produced and marketed by Abbott Laboratories[9]

In February 2010, Abbott acquired the vaccines subunit from Solvay Pharmaceuticals included in its $6.2 billion purchase[10] and the subunit influenza vaccine — Influvac has been commercially available on the market since the early nineteen-eighties.[9] With the acquisition of Solvay, Abbott retained access to the Eastern European, Middle Eastern & Latin American markets. Approximately $850 million of sales revenue from vaccines was reported by Solvay Pharmaceuticals in 2009.[10]

In February 2015, Mylan Laboratories completed the deal with Abbott to purchase Abbott's generic drugs business in developed markets, which includes Influvac.[11][12]

In some countries, Influvac is marketed by Viatris after Upjohn merged with Mylan to create Viatris.[13][14]

Novartis

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In April 2007, Novartis received a positive opinion supporting European Union approval of Optaflu. It is the first influenza vaccine made in a mammalian cell line, rather than chicken eggs.[15] The plan was to manufacture the vaccine in Holly Springs, North Carolina. The United States government provided $500 million in construction costs and guaranteed vaccine purchases.[16]

Novartis' flu vaccine unit was sold to CSL Limited in 2014, and was placed under CSL subsidiary, bioCSL (Seqirus).[17] bioCSL as marketing authorization holder decided to discontinue the usage of Optaflu brand in 2017 due to commercial reasons[18]

Sanofi-Aventis

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Vaxigrip Tetra and Fluquadri are quadrivalent split virus inactivated vaccines by Sanofi-Aventis.

  • Vaxigrip Tetra[8]
  • Fluquadri[8]

Sanofi Pasteur

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Sanofi Pasteur produces the following vaccines:

Fluzone

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A 5cc vial of Fluzone

Fluzone and its quadrivalent formulation are split virus inactivated vaccines distributed by Sanofi Pasteur mainly in the United States.

Dosage and storage

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Fluzone is typically administered in a single dose by intramuscular injection;[20] an intradermal injection is also available.[21] It is presented as a 0.25 ml syringe for pediatric use, as a 0.5 ml syringe for adults and children, as a 0.5 ml vial for adults and children, and as a 5 ml vial for adults and children.[20] Fluzone must be refrigerated under temperatures from 2 to 8 °C (36 to 46 °F) and is inactivated by freezing. Fluzone was initially approved in 1980 by the FDA.[20]

Adverse effects

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The following adverse effects have been reported:[20]

High-dose vaccine

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A high-dose vaccine (Fluzone High-Dose) four times the strength of standard flu vaccine was approved by the FDA in 2009.[22][23][24] This vaccine is intended for people 65 and over, who typically have weakened immune response due to normal aging. The vaccine produces a greater immune response than standard vaccine. According to the CDC,[1] "a study published in the New England Journal of Medicine[25] [in August, 2014] indicated that the high-dose vaccine was 24.2% more effective in preventing flu in adults 65 years of age and older relative to a standard-dose vaccine." The CDC recommends the high-dose vaccine for people 65 and over but expresses no preference between it and standard vaccine. Further studies were underway as of 2014.[citation needed]

Vaxigrip/Vaxigrip Tetra

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Vaxigrip and its quadrivalent formulation Vaxigrip Tetra are split virus inactivated vaccines made by Sanofi Pasteur in Europe.[2][26] Vaxigrip provides immune responses to three influenza strains and VaxigripTetra adds another B strain. VaxigripTetra was approved in Europe in 2016 except for infants younger than three years old.[2]

Flublok/Flublok Quadrivalent

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Flublok and its quadrivalent formulation are recombinant subunit vaccines prepared in cell cultures. Recombinant influenza vaccines are produced using recombinant virus technology. This method does not require an egg-grown vaccine virus and does not use chicken eggs in the production process.[27][28][19] The DNA for the hemagglutinin antigen of influenza virus is added to a baculovirus. This recombinant virus is then used to infect cultured insect cells (of the moth Spodoptera frugiperda), which subsequently produce the hemagglutinin protein. The protein is harvested and purified. This is done for four different types of influenza hemagglutinin to create the Flublok Quadrivalent vaccine.[29]

Seqirus

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Afluria and its quadrivalent formulation are a split virus inactivated vaccines. Fluad and its quadrivalent formulations are adjuvanted surface antigen inactivated vaccines. Flucelvax and its quadrivalent formulations are surface antigen inactivated vaccines prepared in cell cultures.

Novartis developed the first influenza vaccine, which did not need to be grown in chicken eggs, a cell-based vaccine.[30] In 2014, CSL Limited obtained Novartis' flu vaccine unit, and transferred it to CSL Subsidiary, bioCSL, named Seqirus.[17]

The following are list of bioCSL flu vaccine brands:[31]

  • Trivalent
    • Afluria, also marketed as Enzira, Fluvax, and Nilgrip in various different markets
    • Agrippal, also marketed as Begripal, Fluazur, Sandovac, Agriflu, and Chiroflu in various different markets
    • Fluad,[32][1][33]
    • Fluad Pediatric, a pediatric vaccine
    • Flucelvax[34][35]
  • Quadrivalent
    • Afluria Quadrivalent,[1] also marketed as Afluria Quad[8] and Afluria Tetra in various different markets
    • Fluad Quad[36][8]
    • Fluad Quadrivalent[37]
    • Fluad Tetra[38]
    • Flucelvax Quad[39][8]
    • Flucelvax Quadrivalent[1]
    • Flucelvax Tetra[40]

See also

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References

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  1. ^ a b c d e f "Influenza vaccines — United States, 2019–20 influenza season*". U.S. Centers for Disease Control and Prevention (CDC). 22 August 2019. Retrieved 27 January 2020.
  2. ^ a b c d Gresset-Bourgeois V, Leventhal PS, Pepin S, Hollingsworth R, Kazek-Duret MP, De Bruijn I, et al. (27 November 2017). "Quadrivalent inactivated influenza vaccine (VaxigripTetra)". Expert Review of Vaccines. 17 (1): 1–11. doi:10.1080/14760584.2018.1407650. PMID 29157068. S2CID 23761150.
  3. ^ "Fluenz EPAR". European Medicines Agency (EMA). 17 December 2013. Retrieved 6 August 2020.
  4. ^ "Fluenz Tetra EPAR". European Medicines Agency (EMA). 17 December 2013. Retrieved 6 August 2020.
  5. ^ "Flumist". U.S. Food and Drug Administration. 9 July 2020. Retrieved 6 August 2020.
  6. ^ "Flumist Quadrivalent". U.S. Food and Drug Administration. 9 July 2020. Retrieved 6 August 2020.
  7. ^ "GSK ships 2019-20 seasonal influenza vaccines for US market". GlaxoSmithKline. 15 July 2019. Retrieved 27 January 2020.
  8. ^ a b c d e f g "2021 seasonal influenza vaccines". Therapeutic Goods Administration (TGA). 13 April 2021. Retrieved 15 April 2021.
  9. ^ a b Giezeman KM, Nauta J, de Bruijn IA, Palache AM (April 2009). "Trivalent inactivated subunit influenza vaccine Influvac: 25-Year experience of safety and immunogenicity". Vaccine. 27 (18): 2414–7. doi:10.1016/j.vaccine.2009.02.008. PMID 19368782.
  10. ^ a b "Abbott Halts Influvac Sale". Drug Discovery & Development.
  11. ^ Pierson R (14 July 2014). "Mylan to buy Abbott generics, cut taxes, in $5.3 billion deal". reuters. Retrieved 27 January 2020.
  12. ^ Tascarella P (27 February 2015). "Mylan inversion deal completed". Pittsburgh Business Times. Retrieved 27 January 2020.
  13. ^ "Pfizer Completes Transaction to Combine Its Upjohn Business with Mylan". Pfizer. 16 November 2020. Retrieved 17 June 2024 – via Business Wire.
  14. ^ "Brands". Viatris. 16 November 2020. Retrieved 17 June 2024.
  15. ^ "Optaflu, the Novartis cell culture-derived influenza vaccine, receives positive opinion supporting European Union regulatory approval" (Press release). Novartis. Archived from the original on 21 November 2008. Retrieved 29 April 2009.
  16. ^ Pollack A (28 April 2009). "Swine Flu Vaccine May Be Months Away, Experts Say". The New York Times. Archived from the original on 24 January 2020. Retrieved 29 April 2009. But Novartis is building a cell culture flu vaccine factory in Holly Springs, N.C., which might be ready for use in 2010 or 2011. The federal government is providing nearly $500 million in construction costs and guaranteed vaccine purchases.
  17. ^ a b "Australia's CSL buys Novartis flu vaccine unit for $275 mln". Reuters. 27 October 2014. Retrieved 27 January 2020.
  18. ^ "Optaflu - Expiry of the marketing authorisation in the European Union" (PDF). European Medicine Agency. 22 June 2017. Retrieved 27 January 2020.
  19. ^ a b "Recombinant Influenza (Flu) Vaccine". Center for Disease Control and Prevention. Retrieved 4 February 2020.
  20. ^ a b c d "Fluzone Prescribing Information" Archived 10 June 2015 at the Wayback Machine. Sanofi Pasteur. June 2012.
  21. ^ "Fluzone intradermal vaccine website". Sanofi Pasteur.
  22. ^ "FDA Approves A High Dose Seasonal Influenza Vaccine Specifically Intended for People Ages 65 and Older" (Press release). U.S. Food and Drug Administration (FDA). 23 December 2009. Archived from the original on 31 December 2009.
  23. ^ Centers for Disease Control and Prevention (CDC) (April 2010). "Licensure of a high-dose inactivated influenza vaccine for persons aged >or=65 years (Fluzone High-Dose) and guidance for use - United States, 2010" (PDF). MMWR. Morbidity and Mortality Weekly Report. 59 (16): 485–6. PMID 20431524.
  24. ^ "Fluzone High-Dose Quadrivalent". U.S. Food and Drug Administration (FDA). 14 November 2019. Archived from the original on 1 December 2019. Retrieved 30 November 2019.   This article incorporates text from this source, which is in the public domain.
  25. ^ DiazGranados CA, Dunning AJ, Kimmel M, Kirby D, Treanor J, Collins A, et al. (August 2014). "Efficacy of high-dose versus standard-dose influenza vaccine in older adults". N. Engl. J. Med. 371 (7): 635–45. doi:10.1056/NEJMoa1315727. PMID 25119609.
  26. ^ Haugh M, Gresset-Bourgeois V, Macabeo B, Woods A, Samson SI (June 2017). "A trivalent, inactivated influenza vaccine (Vaxigrip): summary of almost 50 years of experience and more than 1.8 billion doses distributed in over 120 countries". Expert Rev Vaccines. 16 (6): 545–564. doi:10.1080/14760584.2017.1324302. PMID 28460594. S2CID 3353358.
  27. ^ "Flublok". U.S. Food and Drug Administration (FDA). 26 February 2018. STN 125285. Archived from the original on 14 October 2019. Retrieved 14 October 2019.   This article incorporates text from this source, which is in the public domain.
  28. ^ "Flublok Quadrivalent". U.S. Food and Drug Administration (FDA). 2 August 2019. STN 125285. Archived from the original on 14 October 2019. Retrieved 14 October 2019.   This article incorporates text from this source, which is in the public domain.
  29. ^ Nolletti C (11 July 2016). "FDA Clinical Review of Flublok Quadrivalent". Food and Drug Administration.
  30. ^ Alice Park (30 October 2014). "This Flu Shot Is Not Like the Others". Time. Retrieved 19 October 2021.
  31. ^ "CSL's product list". seqirus.com. Seqirus. Retrieved 27 January 2020.
  32. ^ "Fluad". U.S. Food and Drug Administration (FDA). 8 November 2019. STN 125510. Archived from the original on 2 December 2019. Retrieved 2 December 2019.   This article incorporates text from this source, which is in the public domain.
  33. ^ "Fluad EPAR". European Medicines Agency (EMA). 17 October 2024. Retrieved 19 October 2024.
  34. ^ "Flucelvax EPAR". European Medicines Agency (EMA). 17 October 2024. Retrieved 19 October 2024.
  35. ^ "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 October 2024". European Medicines Agency (EMA). 18 October 2024. Retrieved 21 October 2024.
  36. ^ "Fluad Quad Australian prescription medicine decision summary". Therapeutic Goods Administration (TGA). 13 December 2019. Retrieved 24 August 2020.
  37. ^ "Fluad Quadrivalent". U.S. Food and Drug Administration (FDA). 21 February 2020. Retrieved 29 May 2020.
  38. ^ "Fluad Tetra EPAR". European Medicines Agency (EMA). 24 March 2020. Retrieved 29 May 2020.
  39. ^ "Flucelvax Quad". Therapeutic Goods Administration (TGA). 9 September 2020. Retrieved 22 September 2020.
  40. ^ "Flucelvax Tetra EPAR". European Medicines Agency (EMA). 24 September 2018. Retrieved 31 March 2020.
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