Efficacy of FluMist(R) in Children Highlighted at Pediatric Academic Societies Meeting

Tuesday, May 6, 2008 General News
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HONOLULU, May 5 Data from two new studies presented at theannual meeting of the Pediatric Academic Societies (PAS) demonstrate thatFluMist(R) (Influenza Virus Vaccine Live, Intranasal) may offer children bothdurable protection against influenza, as well as significant protection forpreviously unvaccinated children who receive the recommended two-dose regimenapproximately four weeks apart. In the efficacy trial evaluating one and twodoses in previously unvaccinated children, protection was also observed amongpreviously unvaccinated children who received only one dose of FluMist.

(Photo: http://www.newscom.com/cgi-bin/prnh/20080505/NEM076 )

"These data add to the growing body of evidence that FluMist offers goodprotection against influenza for children eligible to receive it," commentedChris Ambrose, M.D., director, medical affairs. "We hope that this data willhelp support public health efforts to encourage parents to vaccinate theirchildren each year as soon as vaccine is available and follow dosingrecommendations to optimally protect children against this infectiousdisease."

FluMist is different from the flu shot in that it uses live, attenuated --or weakened -- viruses within the vaccine to help stimulate an immune responsethat is designed to closely resemble the body's natural response to aninfluenza infection.

Efficacy of FluMist Among Previously Unvaccinated Children

In a study involving 3,200 previously unvaccinated children between theages of six (1) and 36 months, the efficacy of one dose of FluMist wascompared to the recommended two doses. The study showed that for childrenreceiving one dose of FluMist, efficacy against matched strains was 58percent, and efficacy increased to 74 percent for those receiving two doses.In the second season of the study, both groups received a single dose ofFluMist (per recommendations) and no difference in efficacy was seen(efficacies of 65 percent and 74 percent, respectively). Runny nose/nasalcongestion and cough were the most frequently reported events. No events weresignificantly increased in FluMist recipients; cough was significantlydecreased. This double-blind, placebo controlled study, led by Drs. Braccoand Farhat of the Federal University of San Paulo, Brazil, was conducted at 35sites in the Southern Hemisphere during the 2001 and 2002 influenza seasons.

Dr. Ambrose stated: "Previously unvaccinated children under nine years ofage are recommended to receive two doses of influenza vaccine, but studieshave shown that less than 50 percent of these children actually receive thesecond dose. Our trial shows clear evidence that receiving the second dose ofFluMist provides more robust protection. However, we are also encouraged thatthere was still protection for those that received one dose."

Duration of Influenza Protection Using Nasal Spray Flu Vaccine

In a second study, researchers at MedImmune examined data from fourprevious clinical trials of children between six months (1) and 18 years ofage and found that children who were given FluMist had a comparable level ofprotection through 12 months after vaccination.

"The data on FluMist's duration of protection provide comfort forproviders and parents who wish to vaccinate children in late summer or earlyfall," said Ambrose.

About FluMist

FluMist is a live attenuated influenza virus vaccine indicated for activeimmunization of individuals two to 49 years of age against influenza diseasecaused by influenza virus subtypes A and type B contained in the vaccine.

FluMist is contraindicated in individuals with history of hypersensitivityto eggs, egg proteins, gentamicin, gelatin or arginine or withlife-threatening reactions to previous influenza vaccinations, and in childrenand adolescents receiving concomitant aspirin or aspirin-containing therapy.

Do not administer F


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