Medicine:Live attenuated influenza vaccine

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Short description: Nasal influenza vaccine
Live attenuated influenza vaccine
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Nurse administering the FluMist product
Vaccine description
Target diseaseInfluenza
TypeAttenuated virus
Clinical data
Trade namesFlumist Quadrivalent, Fluenz Tetra
AHFS/Drugs.comMonograph
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administration		Intranasal
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Live attenuated influenza vaccine (LAIV) is a type of influenza vaccine in the form of a nasal spray that is recommended for the prevention of influenza.[5]

It is an attenuated live vaccine, unlike other influenza vaccines, which are inactivated vaccines. Live attenuated influenza vaccine is administered intranasally,[6] while inactivated vaccines are administered by intramuscular injection. Live attenuated influenza vaccine is sold under the brand name FluMist Quadrivalent in the United States and the brand name Fluenz Tetra in the European Union.[7][4] FluMist was first introduced in 2003 by MedImmune.[8][9][10]

Medical uses

The live attenuated influenza vaccine is used to provide protection against the flu caused by infection with influenza viruses.[11][12][13]

Contraindications

The use of the live attenuated influenza vaccine is contraindicated, and should therefore not be used, in the following populations:

  • children <24 months of age, due to increased risk of wheezing[14]
  • individuals with a history of hypersensitivity to previous influenza vaccination.[14]
  • individuals with a history of hypersensitivity, especially anaphylactic reactions, to eggs, egg proteins, gentamicin, gelatin, or arginine or to any other ingredient in the formulation [14]
  • People with a medical condition that places them at high risk for complications from influenza, including those with chronic heart or lung disease, such as asthma or reactive airways disease[15]
  • People with medical conditions such as diabetes or kidney failure or people with illnesses that weaken the immune system, or who take medications that can weaken the immune system[15]
  • Children less than 5 years old with a history of recurrent wheezing[15]
  • Children or adolescents receiving aspirin[15]
  • People with a history of Guillain–Barré syndrome, a rare disorder of the nervous system[15]
  • Pregnant women[15]
  • People who have a severe allergy to chicken eggs or who are allergic to any of the nasal spray vaccine components[15]

Production

The live attenuated vaccine is based on a flu strain that does not cause disease, that replicates well at relatively cold temperatures (about 25 °C, for incubation purposes), and replicates poorly at body temperature (which minimizes risk to humans). Genes that code for surface proteins (targeted antigens) are combined with this host using genetic reassortment from strains that are projected to be circulating widely in the coming months. The resulting viruses are then incubated in chicken eggs and chick kidney cells. To make the refrigerated version, the virus is purified in centrifuges through a sucrose gradient, then packaged with sucrose, phosphate, glutamate, arginine, and gelatin made from pigs that has been hydrolyzed with acid.[16]

Risks

Even though the virus in the live attenuated influenza vaccine is attenuated (low in virulence), it is still a living virus, and may cause an infection with complications in people with weakened immune systems or other underlying medical conditions. The live attenuated influenza vaccine is recommended only for people 2–49 years of age, and people who have a weakened immune system, pregnant women, and people with certain chronic diseases may not be eligible to receive live attenuated influenza vaccine.[17] In contrast, inactivated virus vaccines contain no living virus, and cannot cause a live infection. Persons receiving the live attenuated influenza vaccine may shed small amounts of the vaccine virus during the first week. People coming in contact with the vaccinated person are not considered to be at risk, unless their immune systems are severely weakened (for example, bone marrow transplant recipients) and possible recombination with other (wild or live vaccine) flu strains.[5]

History

The live attenuated influenza vaccine was developed by the University of Michigan School of Public Health in Ann Arbor, Michigan and later by Aviron, in Mountain View, California, under the sponsorship of the National Institutes of Health (NIH) in the 1990s. MedImmune, Inc. purchased Aviron in 2002, and the US Food and Drug Administration (FDA) approved the live attenuated influenza vaccine in June 2003.[18][10]

The FDA initially approved the live attenuated influenza vaccine only for healthy people aged 5 to 49 because of concerns over possible side effects. The live attenuated influenza vaccine is approved and recommended for healthy children 24 months of age and older. The FDA approved the unfrozen refrigerated version for the same age group (ages 5–49) in August 2006, following completion of phase III clinical trials.[19]

The cold-adapted influenza vaccine version of the vaccine is called CAIV-T, and is stable for storage in a refrigerator, rather than requiring freezer storage as did the originally-approved formulation. Approved for the 2007-2008 flu season,[10] the refrigerated formulation can be distributed more economically, so that the price differential with shots (which had hampered sales of the original frozen version of FluMist) is now largely eliminated. FluMist was initially priced higher than the injectable vaccines, but sold only 500,000 of the four million doses it produced its first year on the market, despite a comparative shortage of flu vaccine in fall 2004.[20] The price was sharply lowered the next year, and the company reported distributing 1.6 million doses in 2005.[21] Because of the price drop, despite selling almost three times as many doses in 2005, the company reported $21 million in FluMist sales, compared to $48 million the previous year.[22]

Society and culture

MedImmune is one company that manufactures the live attenuated influenza vaccine, which it sells under the brand name FluMist in the United States and the brand name Fluenz Tetra[4] in the European Union. For the 2010–2011 flu season, FluMist was the only live attenuated influenza vaccine approved by the FDA for use in the US.[23][24] All other FDA-approved lots were inactivated virus vaccines.[citation needed] In September 2009, a live attenuated influenza vaccine for the novel H1N1 influenza virus was approved[25] and the seasonal intranasal vaccine was approved by the European Medicines Agency (EMA) for use in the European Union in 2011.[3] The quadrivalent version was approved for use in the European Union in 2013.[4]

(As of 2007), the only other company holding live attenuated influenza vaccine rights is BioDiem of Australia.[26] BioDiem licensed rights to private production of the vaccine in China to Changchun BCHT Biotechnology, which also holds public rights for production in China sublicensed from the World Health Organization.[27]

It was the first and, (As of 2007), the only live attenuated vaccine for influenza available outside of Europe.[28] In September 2009, a live attenuated influenza vaccine for the novel H1N1 influenza virus was approved.[25] In 2011, the vaccine was approved by the European Medicines Agency (EMA) for use in the European Union under the brand name Fluenz.[3][29]

AstraZeneca acquired MedImmune and retired the MedImmune name.[30][31]

Research

The live attenuated influenza vaccine is designed to be quickly modifiable to present the surface antigens of seasonal flu. The modifiability could also allow it to be quickly customized as a vaccine against a pandemic influenza if one were to emerge. In light of the global spread of H5N1, ways of reducing human mortality in the event of an H5N1 pandemic have been investigated. Modifying FluMist to serve as a specific human H5N1 vaccine is among the measures studied.[32]

In June 2006, the National Institutes of Health (NIH) began enrolling participants in a Phase I H5N1 study of an intranasal influenza vaccine candidate based on MedImmune's live, attenuated vaccine technology.[33]

In September 2006, the National Institute of Allergy and Infectious Diseases (NIAID) reported that inoculation with a live attenuated influenza vaccine modified to present the surface antigens of certain H5N1 variants provided broad protection against other H5N1 variants in the mouse and ferret models.[34] Attenuated live viruses were found protective against H5N1 in mice and chickens in a 2009 study.[35]

"Several trials have reported that live attenuated influenza vaccines can boost virus-specific CTLs as well as mucosal and serum antibodies and provide broad cross-protection against heterologous human influenza A viruses." (58, 59)[36] "[V]accine formulas inducing heterosubtypic T cell–mediated immunity may confer broad protection against avian and human influenza A viruses."[36]

References

  1. ↑ "Prescription medicines: registration of new chemical entities in Australia, 2016". 21 June 2022. https://www.tga.gov.au/prescription-medicines-registration-new-chemical-entities-australia-2016. 
  2. ↑ "FluMist Quadrivalent (Influenza Vaccine Live, Intranasal) Intranasal Spray 2021-2022 Formula Initial U.S. Approval: 2003". 2 August 2021. https://dailymed.nlm.nih.gov/dailymed/archives/fdaDrugInfo.cfm?archiveid=637868. 
  3. ↑ 3.0 3.1 3.2 "Fluenz EPAR". 17 September 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/fluenz. 
  4. ↑ 4.0 4.1 4.2 4.3 "Fluenz Tetra EPAR". 17 September 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/fluenz-tetra. 
  5. ↑ 5.0 5.1 "Shedding and immunogenicity of live attenuated influenza vaccine virus in subjects 5-49 years of age". Vaccine 26 (38): 4940–4946. September 2008. doi:10.1016/j.vaccine.2008.07.013. PMID 18662737. 
  6. ↑ "Live attenuated versus inactivated influenza vaccine in infants and young children". The New England Journal of Medicine 356 (7): 685–696. February 2007. doi:10.1056/NEJMoa065368. PMID 17301299. 
  7. ↑ "FluMist Quadrivalent". 15 November 2019. https://www.fda.gov/vaccines-blood-biologics/vaccines/flumist-quadrivalent. 
  8. ↑ "FDA Information Regarding FluMist Quadrivalent Vaccine". 16 January 2018. https://www.fda.gov/vaccines-blood-biologics/vaccines/fda-information-regarding-flumist-quadrivalent-vaccine. 
  9. ↑ "CBER Approval Letter, Influenza Virus Vaccine, Live, Intranasal (FluMist)". U.S. Food and Drug Administration (FDA). 17 July 2003. https://www.fda.gov/cber/approvltr/inflmed061703L.htm. 
  10. ↑ 10.0 10.1 10.2 "FluMist". https://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm094047.htm. 
  11. ↑ "Live Intranasal Influenza Vaccine Information Statement". August 2021. https://www.cdc.gov/vaccines/hcp/vis/vis-statements/flulive.html. 
  12. ↑ "Live Attenuated Influenza Vaccine. The Nasal Spray Flu Vaccine". 15 October 2021. https://www.cdc.gov/flu/prevent/nasalspray.htm. 
  13. ↑ "FluMist". 17 April 2019. https://www.fda.gov/vaccines-blood-biologics/vaccines/flumist. 
  14. ↑ 14.0 14.1 14.2 AstraZeneca Inc. (2013). Product Monograph: FluMist. AstraZeneca Inc.. http://webprod5.hc-sc.gc.ca/dpd-bdpp/item-iteme.do?pm-mp=00021215. Retrieved 27 August 2013. 
  15. ↑ 15.0 15.1 15.2 15.3 15.4 15.5 15.6 "The Nasal-Spray Flu Vaccine (Live Attenuated Influenza Vaccine [LAIV])". National Center for Immunization and Respiratory Diseases. 22 January 2008. https://www.cdc.gov/flu/about/qa/nasalspray.htm. 
  16. ↑ FDA Vaccines and Related Biological Products Advisory Committee (April 2007). "FluMist Live, Attenuated Influenza Vaccine Briefing Document". https://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4292B1-02.pdf. 
  17. ↑ "Facts and Myths about FluMist". AstraZeneca. September 2020. https://www.flumistquadrivalent.com/flu-vaccine-resources/flu-vaccine-myths-vs-facts.html. 
  18. ↑ "Nasal FluMist overcomes obstacles to reach public". USA Today. 7 January 2004. https://www.usatoday.com/news/health/2004-01-07-flumist_x.htm. 
  19. ↑ "MedImmune begins shipping live intranasal flu vaccine for 2006-2007 after U.S. FDA release". Lab Law Weekly. 25 August 2006. http://www.newsrx.com/newsletters/Lab-Law-Weekly/2006-08-25/08212006333927LL.html. 
  20. ↑ "FluMist Sales Falling Short, Survey Finds". The Washington Post: p. E05. 6 January 2005. https://www.washingtonpost.com/ac2/wp-dyn/A51955-2005Jan5. [|permanent dead link|dead link}}]
  21. ↑ "MedImmune reports revenues of $1.2 billion". Pharma Business Week. 27 February 2006. http://www.newsrx.com/issue_article/Pharma-Business-Week/2006-02-27/02272006333154PB.html. 
  22. ↑ "Sales of MedImmune's Flu Vaccine Drop Sharply". The Washington Post: p. D04. 3 February 2006. https://www.washingtonpost.com/wp-dyn/content/article/2006/02/02/AR2006020202320.html. 
  23. ↑ "2010-2011 Influenza Season Vaccine Questions and Answers". https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Post-MarketActivities/LotReleases/ucm220649.htm. 
  24. ↑ "Influenza Virus Vaccine for the 2010-2011 Season". https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Post-MarketActivities/LotReleases/ucm202750.htm. 
  25. ↑ 25.0 25.1 "Update on Influenza A (H1N1) 2009 Monovalent Vaccines". 9 October 2009. http://www.cdc.gov/mmwr/pdf/wk/mm5839.pdf. 
  26. ↑ "MedImmune takeover holds promise for BioDiem". BioTechnologyNews. 26 April 2007. http://www.biotechnologynews.net/storyview.asp?StoryID=97712. 
  27. ↑ "BioDiem licenses LAIV technology to Changchun BCHT". ResearchInChina. 10 February 2012. http://www.researchinchina.com/Htmls/News/201202/30360.html. 
  28. ↑ "Using live, attenuated influenza vaccine for prevention and control of influenza: supplemental recommendations of the Advisory Committee on Immunization Practices (ACIP)". MMWR. Recommendations and Reports 52 (RR-13): 1–8. September 2003. PMID 14557799. https://www.cdc.gov/mmwr/preview/mmwrhtml/rr5213a1.htm. Retrieved 9 September 2017. 
  29. ↑ "European Commission approves nasal spray vaccine Fluenz for the prevention of seasonal influenza in children". AstraZeneca (Press release). 1 February 2011. Archived from the original on 13 June 2022. Retrieved 29 August 2022.
  30. ↑ "AstraZeneca Ships FluMist Quadrivalent Vaccine in the US for 2020-2021 Flu Season" (Press release). AstraZeneca. 13 August 2020. Archived from the original on 9 July 2021. Retrieved 8 July 2021 – via Business Wire.
  31. ↑ "AstraZeneca retires Medimmune name amid sales turnaround". 14 February 2019. https://www.biopharmadive.com/news/astrazeneca-retires-medimmune-name-amid-sales-turnaround/548489/. 
  32. ↑ "Vaccines for pandemic influenza". Emerging Infectious Diseases 12 (1): 66–72. January 2006. doi:10.3201/eid1201.051147. PMID 16494720. PMC 3291408. https://wwwnc.cdc.gov/eid/article/12/1/pdfs/05-1147.pdf. Retrieved 23 June 2022. 
  33. ↑ "MedImmune and National Institutes of Health Begin Clinical Testing of a Live, Attenuated Intranasal Vaccine Against an H5N1 Avian Influenza Virus". phx.corporate-ir.net (Press release). 15 June 2006. Archived from the original on 9 January 2016. Retrieved 22 June 2022.
  34. ↑ "Live, attenuated influenza A H5N1 candidate vaccines provide broad cross-protection in mice and ferrets". PLOS Medicine 3 (9): e360. September 2006. doi:10.1371/journal.pmed.0030360. PMID 16968127.  open access
  35. ↑ "Live attenuated influenza viruses containing NS1 truncations as vaccine candidates against H5N1 highly pathogenic avian influenza". Journal of Virology 83 (4): 1742–1753. February 2009. doi:10.1128/JVI.01920-08. PMID 19073731. 
  36. ↑ 36.0 36.1 "Memory T cells established by seasonal human influenza A infection cross-react with avian influenza A (H5N1) in healthy individuals". The Journal of Clinical Investigation 118 (10): 3478–3490. October 2008. doi:10.1172/JCI32460. PMID 18802496. 




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