Up to Twelve-Month Efficacy Against Influenza Observed;
Good Protection Demonstrated in Trial Evaluating the Benefit of the
Recommended Two Doses for Previously Unvaccinated Children
HONOLULU, May 5 /PRNewswire/ -- Data from two new studies presented at the
annual meeting of the Pediatric Academic Societies (PAS) demonstrate that
FluMist(R) (Influenza Virus Vaccine Live, Intranasal) may offer children both
durable protection against influenza, as well as significant protection for
previously unvaccinated children who receive the recommended two-dose regimen
approximately four weeks apart. In the efficacy trial evaluating one and two
doses in previously unvaccinated children, protection was also observed among
previously 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 good
protection against influenza for children eligible to receive it," commented
Chris Ambrose, M.D., director, medical affairs. "We hope that this data will
help support public health efforts to encourage parents to vaccinate their
children each year as soon as vaccine is available and follow dosing
recommendations to optimally protect children against this infectious
FluMist is different from the flu shot in that it uses live, attenuated --
or weakened -- viruses within the vaccine to help stimulate an immune response
that is designed to closely resemble the body's natural response to an
Efficacy of FluMist Among Previously Unvaccinated Children
In a study involving 3,200 previously unvaccinated children between the
ages of six (1) and 36 months, the efficacy of one dose of FluMist was
compared to the recommended two doses. The study showed that for children
receiving one dose of FluMist, efficacy against matched strains was 58
percent, and efficacy increased to 74 percent for those receiving two doses.
In the second season of the study, both groups received a single dose of
FluMist (per recommendations) and no difference in efficacy was seen
(efficacies of 65 percent and 74 percent, respectively). Runny nose/nasal
congestion and cough were the most frequently reported events. No events were
significantly increased in FluMist recipients; cough was significantly
decreased. This double-blind, placebo controlled study, led by Drs. Bracco
and Farhat of the Federal University of San Paulo, Brazil, was conducted at 35
sites in the Southern Hemisphere during the 2001 and 2002 influenza seasons.
Dr. Ambrose stated: "Previously unvaccinated children under nine years of
age are recommended to receive two doses of influenza vaccine, but studies
have shown that less than 50 percent of these children actually receive the
second dose. Our trial shows clear evidence that receiving the second dose of
FluMist provides more robust protection. However, we are also encouraged that
there 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 four
previous clinical trials of children between six months (1) and 18 years of
age and found that children who were given FluMist had a comparable level of
protection through 12 months after vaccination.
"The data on FluMist's duration of protection provide comfort for
providers and parents who wish to vaccinate children in late summer or early
fall," said Ambrose.
FluMist is a live attenuated influenza virus vaccine indicated for active
immunization of individuals two to 49 years of age against influenza disease
caused by influenza virus subtypes A and type B contained in the vaccine.
FluMist is contraindicated in individuals with history of hypersensitivity
to eggs, egg proteins, gentamicin, gelatin or arginine or with
life-threatening reactions to previous influenza vaccinations, and in children
and adolescents receiving concomitant aspirin or aspirin-containing therapy.
Do not administer FluMist to children less than two years of age due to an
increased risk of hospitalization and wheezing that was observed in clinical
trials. FluMist should not be administered to any individual with asthma and
to children less than five years of age with recurrent wheezing unless the
potential benefit outweighs the potential risk. Do not administer FluMist to
individuals with severe asthma or active wheezing.
If Guillain-Barre syndrome has occurred with prior influenza vaccination
or if an individual is immunocompromised, the decision to give FluMist should
be based on careful consideration of the potential benefits and risks.
FluMist should not be administered to individuals with underlying medical
conditions predisposing them to wild-type influenza infection complications
unless the potential benefit outweighs the potential risk. FluMist should be
given to a pregnant woman only if clearly needed.
Most common adverse reactions (occurring in 10 percent or more of
individuals receiving FluMist and at a rate at least five percent higher than
in those receiving placebo) are runny nose or nasal congestion in recipients
of all ages, fever more than 100 degree F in children two to six years of age,
and sore throat in adults.
FluMist may not protect all individuals receiving the vaccine. FluMist is
for intranasal administration only.
Please see complete Prescribing Information for FluMist, call
1-877-FLUMIST (1-877-358-6478) or visit
http://www.flumist.com/prescribing-information.aspx for additional
MedImmune strives to provide better medicines to patients, new medical
options for physicians and rewarding careers to employees. Dedicated to
advancing science and medicine to help people live better lives, the company
is focused on infection, oncology, respiratory disease and inflammation,
cardiovascular/gastrointestinal disease, and neuroscience. With approximately
3,000 employees worldwide and headquarters in Maryland, MedImmune is wholly
owned by AstraZeneca plc (LSE: AZN.L, NYSE: AZN). For more information, visit
MedImmune's website at http://www.medimmune.com.
(1) Do not administer FluMist to children less than two years of age due
to an increased risk of hospitalization and wheezing observed in
CONTACT: Media, Karen Lancaster, +1-301-398-5864, or Investors, Peter
Vozzo, +1-301-398-4358, both of MedImmune