FluMist
1073824
223883657
2008-07-06T09:33:07Z
Mendaliv
200402
{{expert-subject|Medicine|date=July 2008}}
{{expert-subject|Medicine|date=July 2008}}
'''FluMist''' is the product name of a [[nasal spray]] [[influenza vaccine]] manufactured by [[MedImmune]], Inc. first introduced in 2003.<ref name="approval">{{cite web|url=http://www.fda.gov/cber/approvltr/inflmed061703L.htm|title=CBER Approval Letter, Influenza Virus Vaccine, Live, Intranasal (FluMist)|last=Midthun|first=Karen|coauthors=Steven Masiello|date=[[2003]]-[[07-17]]|publisher=[[U.S. Food and Drug Administration]]|accessdate=2008-07-06}}</ref> It was the first and (as of 2007) the only live attenuated vaccine for influenza available outside of Europe, and is also called '''Live Attenuated Influenza Vaccine''' (LAIV).<ref name="QandA">{{cite web|url=http://www.cdc.gov/flu/about/qa/nasalspray.htm|title=The Nasal-Spray Flu Vaccine (Live Attenuated Influenza Vaccine <nowiki>[LAIV]</nowiki>)|date=[[2008]]-[[01-22]]|publisher=[[National Center for Immunization and Respiratory Diseases]]|accessdate=2008-07-06}}</ref>
==History==
FluMist was originally developed by Hunein "John" Maassab, Professor of Epidemiology at the [[University of Michigan]] School of Public Health in [[Ann Arbor]], [[Michigan]] and later by [[Aviron]] under the sponsorship of [[NIH]] in the mid-1990s. [[MedImmune]], Inc. purchased Aviron in 2002, and the FDA approved FluMist in June of 2003.<ref>{{cite news|url=http://www.usatoday.com/news/health/2004-01-07-flumist_x.htm|title=Nasal FluMist overcomes obstacles to reach public|last=Appleby|first=Julie|date=[[2004]]-[[01-07]]|work=USA Today|accessdate=2008-07-06}}</ref> FluMist was first made available in September 2003.
The [[Food and Drug Administration]] ([[FDA]]) initially approved FluMist only for healthy people ages 5 to 49 because of concerns over possible side effects. Now Flumist is approved and recommended for healthy children 24 months of age and older. The FDA approved the current unfrozen refrigerated version for the same age group (ages 5-49) in August 2006 following completion of phase 3 clinical trials.<ref name="Drug Week">{{cite news|url=http://www.newsrx.com/newsletters/Lab-Law-Weekly/2006-08-25/08212006333927LL.html|title=MedImmune begins shipping live intranasal flu vaccine for 2006-2007 after U.S. FDA release|date=[[2006]]-[[08-25]]|work=Lab Law Weekly|accessdate=2008-07-06}}</ref>
CAIV-T has been approved by the [[FDA]] and is the version offered on the market beginning in fall of 2007.
The current 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, 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 4 million doses it produced its first year on the market, despite a comparative shortage of flu vaccine in fall 2004.<ref>{{cite news|url=http://www.washingtonpost.com/ac2/wp-dyn/A51955-2005Jan5|title=FluMist Sales Falling Short, Survey Finds|last=Rosenwald|first=Michael|date=[[2005]]-[[01-06]]|work=[[The Washington Post]]|page=E05|accessdate=2008-07-06}}</ref> The price was sharply lowered the next year, and the company reports distributing 1.6 million doses in 2005.<ref>{{cite news|url=http://www.newsrx.com/issue_article/Pharma-Business-Week/2006-02-27/02272006333154PB.html|title=MedImmune reports revenues of $1.2 billion|date=[[2006]]-[[02-27]]|work=Pharma Business Week|accessdate=2008-07-06}}</ref> 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.<ref>{{cite news|url=http://www.washingtonpost.com/wp-dyn/content/article/2006/02/02/AR2006020202320.html|title=Sales of MedImmune's Flu Vaccine Drop Sharply|last=Rosenwald|first=Michael|date=[[2006]]-[[02-03]]|work=[[The Washington Post]]|page=D04|accessdate=2008-07-06}}</ref> Further cuts in pricing had to await [[FDA]] approval of a refrigerator-cooled FluMist formulation, as the initial formulation required freezer storage and thawing on demand before administration. Although it is positioned as a premium product, the remaining price premium for FluMist over the cost of needle-injected vaccine is small.
==Groups for whom Flumist is recommended==
Vaccination is a cost-effective counter-measure to the threat of seasonal or pandemic outbreaks of [[influenza]].<ref>{{cite web|url=http://www.cdc.gov/flu/professionals/acip/efficacycomparison.htm|title=Comparisons of LAIV and TAIV Efficacy|date=[[2007]]-[[10-26]]|publisher=[[National Center for Immunization and Respiratory Diseases]]|accessdate=2008-07-06|quote=Neither the comparative advantages of Flumist in the first study nor the apparent advantages of needle-injected vaccine in the second rose to statistical significance.}}</ref><ref>{{cite journal|last=Bright|first=Rick|coauthors=Donald Carter, Corey Crevar, Franklin Toapanta, Jonathan Steckbeck, Kelly Cole, Niranjan Kumar, Peter Pushko, Gale Smith, Terrence Tumpey and Ted Ross|date=January 2008|title=Cross-Clade Protective Immune Responses to Influenza Viruses with H5N1 HA and NA Elicited by an Influenza Virus-Like Particle|journal=[[PLoS ONE]]|publisher=[[Public Library of Science]]|volume=3|issue=1|page=e1501|accessdate=2008-07-06|doi=10.1371/journal.pone.0001501|url=http://dx.doi.org/10.1371%2Fjournal.pone.0001501}}</ref> In February, 2008, the U.S. [[Centers for Disease Control and Prevention| CDC's]] [[Advisory Committee on Immunization Practices]] (ACIP), recommended vaccination for all children and teenagers between six months and 18 years of age.<ref name="CTV">{{cite news|url=http://www.ctv.ca/servlet/ArticleNews/story/CTVNews/20080227/flu_shot_080226/20080227|title=U.S. panel recommends all kids get the flu shot|date=[[2008]]-[[02-27]]|publisher=CTV.ca|accessdate=2008-07-06}}</ref> In Canada, the National Advisory Committee on Immunization (NACI), the group that advises the Public Health Agency of Canada, currently recommends that everyone aged 2 to 64 years be encouraged to receive annual influenza vaccination, and that children between the age of six and 24 months, and their household contacts, should be considered a high priority for the flu vaccine.<ref name="CTV" />
Flumist is a vaccine of demonstrated effectiveness against seasonal influenza.<ref name="QandA" />
In 2007, FluMist received additional [[FDA]] approval extending the age groups it is approved for, to include healthy children two years old and onward.<ref>http://www.fda.gov/bbs/topics/NEWS/2007/NEW01705.html FDA Approves Nasal Influenza Vaccine for Use in Younger Children</ref> And the [[Centers for Disease Control and
Prevention]]'s (CDC's) [[Advisory Committee on Immunization Practices]] (ACIP), endorsed the needle-free vaccine as a good option for healthy (non-asthmatic) children aged 2 through 4 years.<ref>[http://www.cidrap.umn.edu/cidrap/content/influenza/general/news/oct2507acip.html CIDRAP >> ACIP endorses FluMist for 2-, 3-, and 4-year-olds</ref> This extended approval supplemented approvals for children over four years of age that were already effective. The sum of these approvals is that Flumist is approved and recommended from the child's 25th month through the adult's 49th year of age.
Flumist is currently recommended for all healthy persons at least two years old and under 50 years of age wishing to protect themselves from [[influenza]] and its complications, or to avoid spreading the flu to members of certain vulnerable groups:
"All healthy, non-pregnant persons age 49 yrs and younger who want to reduce the likelihood of becoming ill with influenza, or of spreading it to others who meet any of the criteria listed below:
<blockquote>-Working or living with at-risk people as listed in the section above. </blockquote>
<blockquote>-Healthcare personnel or other persons who provide direct care to at-risk people (except persons in close contact with severely immunosuppressed persons). </blockquote>
<blockquote>-Household contacts and out-of-home caregivers of children age 0–59m. </blockquote>
<blockquote>-Travelers who may be among people from areas of the world where there is current influenza activity (e.g., on organized tours). </blockquote>
<blockquote>-Students or other persons in institutional settings (e.g., dormitory residents)." <ref>http://www.immunize.org/catg.d/p2011.pdf Summary of Recommendations for Adult Immunization linked from CDC website http://www.cdc.gov/vaccines/recs/schedules/adult-schedule.htm#print</ref>
</blockquote>
For comparison, only [[Sanofi-Aventis]]'s injectable influenza vaccine is approved for children 7 months of age and older; flumist is approved after the second year, and other injectable vaccines from four years of age onward. Injectable influenza vaccine approvals have no upper age limit, while Flumist has not yet been tested or presented for [[FDA]] approval for use by persons 50 or older.
Within the age groups they are approved for, injectable vaccines do occasionally present mild side effects such as soreness, redness, swelling, fever, and aches, and Flumist sometimes causes brief and mild symptoms such as a runny nose, all of which are in balance far less than the effects of the flu.
Tests against injected (killed virus) vaccinations have shown that FluMist is more effective than needle shots in preventing influenza, especially in children aged 6 to 17<ref name ="MedicalNews"> [http://www.cidrap.umn.edu/cidrap/content/influenza/general/news/nov1706asthma.html FluMist More Effective Than Injections For Small Children And Babies]. ''Medical News Today''. 1 May 2006.</ref><ref name="R&D Focus Drug News">'FluMist MedImmune clinical data (phase III) (influenza).' R&D Focus Drug News 30 January 2006.</ref>
but one smaller study in adults showed lower effectiveness against influenza B viruses in adults.<ref name="cbs"> [http://www.cbsnews.com/stories/2006/12/13/ap/health/mainD8M07HM80.shtml Study: Flu Shots Better Than FluMist]. cbsnews.com. 13 December 2006.</ref>
In past years when flu vaccine has been in short supply, healthy people were requested to abstain from vaccination early in the season, to leave the limited supply for the most vulnerable groups. Flu vaccine supplies are now abundant, and since healthy people benefit from vaccination they are now encouraged to protect themselves and others by being vaccinated.
The 2007 recommendations by the US [[Advisory Committee on Immunization Practices]] (ACIP) include six principal changes or updates. These stress that all persons who want to reduce the risk of becoming ill with influenza or of transmitting influenza to others should be vaccinated, and that young children not previously vaccinated should be vaccinated twice, and include these specific recommendations:
<blockquote>ACIP reiterates a previous recommendation that all persons, including school-aged children, who want to reduce the risk of becoming ill with influenza or of transmitting influenza to others should be vaccinated (see Box and Recommendations for Using TIV and LAIV During the 2007--08 Influenza Season).</blockquote>
<blockquote>ACIP emphasizes that immunization providers should offer influenza vaccine and schedule immunization clinics throughout the influenza season (see Timing of Vaccination).</blockquote>
<blockquote>ACIP recommends that health-care administrators consider the level of vaccination coverage among health-care personnel (HCP) to be one measure of a patient safety quality program and implement policies to encourage HCP vaccination (e.g., obtaining signed statements from HCP who decline influenza vaccination) (see Additional Information Regarding Vaccination of Specific Populations).<ref> Primary Changes and Updates in the Recommendations (2007) http://www.cdc.gov/MMWR/preview/mmwrhtml/rr5606a1.htm</ref></blockquote>
</blockquote>
==Groups for whom Flumist is not recommended==
Who should not be vaccinated with the nasal-spray flu vaccine LAIV (FluMist)?
People less than 2 years of age<ref name="QandA" />
People 50 years of age and over<ref name="QandA" />
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;
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.
Children <5 years old with a history of recurrent wheezing
Children or adolescents receiving aspirin
People with a history of Guillain-Barré syndrome, a rare disorder of the nervous system
Pregnant women
People who have a severe allergy to chicken eggs or who are allergic to any of the nasal spray vaccine components.<ref name="QandA" />
==Testing pandemic Flumist variants==
Flumist 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]] advance preparation to reduce [[Human mortality from H5N1|human mortality in the event of an H5N1 pandemic]] has begun. Modifying Flumist to serve as a specific human H5N1 vaccine is among the measures studied.<ref>See, e.g., http://www.cdc.gov/ncidod/EID/vol12no01/05-1147-G.htm | Volume 12, Number 1, January 2006
Vaccines for Pandemic Influenza
Catherine J. Luke* and Kanta Subbarao*
*National Institutes of Health, Bethesda, Maryland, USA</ref>
In June 2006, the [[National Institutes of Health]] (NIH) began enrolling participants in a [[H5N1 clinical trials|Phase 1 H5N1 study]] of an intranasal [[influenza vaccine]] candidate based on [[MedImmune]]'s live, attenuated vaccine technology.<ref> [http://phx.corporate-ir.net/phoenix.zhtml?c=83037&p=irol-newsArticle_Print&ID=872852&highlight= MedImmune] Press release ''MedImmune and National Institutes of Health Begin Clinical Testing of a Live, Attenuated Intranasal Vaccine Against an H5N1 Avian Influenza Virus'' published June 15, 2006</ref>
In September 2006 the [[NIH]] [[NIAID]] reported that inoculation with a Flumist vaccine modified to present the surface antigens of certain H5N1 variants provided broad protection against other H5N1 variants in the mouse and ferret models.<ref>
Live, Attenuated Influenza A H5N1 Candidate Vaccines Provide Broad Cross-Protection in Mice and Ferrets
Suguitan Jr. AL, McAuliffe J, Mills KL, Jin H, Duke G, et al. (2006)
PLoS Med 3(9): e360 doi:10.1371/journal.pmed.0030360
http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371%2Fjournal.pmed.0030360&ct=1&SESSID=07d78e87981cd554b16f65daeff7d78d
Received: April 25, 2006; Accepted: August 1, 2006; Published: September 12, 2006 </ref>
Although early work is focusing on the looming H5N1 threat, the [[CDC]] team led by Kanta Subbarao and others intends to eventually prepare and store surface antigens for all known strains of influenza, ready to be grafted onto the base attenuated Flumist core virus whenever a pandemic threat might emerge.
==References==
{{reflist}}
==External links==
* [http://www.flumist.com/ Flumist nasal flu vaccine - Official website]
* [http://www.sph.umich.edu/news_events/flumist/ FluMist information on University of Michigan, School of Public Health website]
* [http://www.who.int/entity/vaccine_research/diseases/influenza/Roudenko.pdf Live Attenuated Vaccine in Russia] presentation on Russian live influenza vaccines since 1961
* [http://www.cdc.gov/MMWR/preview/mmwrhtml/rr5213a1.htm Using Live, Attenuated Influenza Vaccine for Prevention and Control of Influenza] Supplemental Recommendations of the Advisory Committee on Immunization Practices (ACIP) MMWR 52 RR13 (2003)
[[Category:Vaccines]]
[[Category:Influenza vaccines]]