MedImmune Plans to Begin Shipping Seasonal Vaccine to Health Care
Providers in August
GAITHERSBURG, Md., June 1 /PRNewswire/ -- MedImmune announced today that
the U.S. Department of Health and Human Services (HHS) has awarded the company
a contract to manufacture monovalent (single-strain) live attenuated influenza
vaccine for Novel Influenza A (H1N1) to vaccinate priority populations
identified by HHS in the National Strategy for Pandemic Influenza. An initial
order of $90 million of vaccine has been placed, with the potential for
additional orders. This project has been funded in whole or in part with the
Federal funds from HHS/ASPR/BARDA, under Contract No. HHSO100200900002I.
MedImmune scientists have identified several promising vaccine candidates
against the Novel Influenza A (H1N1) strain, and are currently evaluating
their growth properties and antigenicity (i.e., their ability to stimulate
antibodies) for mass production as part of the vaccine manufacturing process.
"MedImmune is pleased to be able to contribute our scientific expertise in
influenza vaccine development and manufacturing to help combat this
unpredictable public health threat," said Ben Machielse, Drs., executive vice
president of operations, MedImmune. "We are confident that our vaccine
technology has several attributes that may be useful in protecting people with
limited exposure to influenza against the Novel Influenza A (H1N1) strain."
MedImmune's live attenuated influenza vaccine (LAIV) technology may be
particularly well-suited for vaccinating against emerging influenza strains.
LAIV is different from the injectable influenza vaccine ("flu shot") in that
it is a gentle mist sprayed into the nose, where the influenza virus usually
enters the body. It contains live vaccine virus strains that are weakened so
as not to cause the flu, but prompt the body to mount an immune response after
the first dose. Because it is live and stimulates a broad range of immune
responses, LAIV may offer some cross-protection against circulating flu
strains that are "drifted" - meaning they are very closely-related but not
perfectly matched to the flu strains in the vaccine.
As a needle-free nasal spray, LAIV is well suited to facilitate mass
vaccination, and has been widely used for school-based vaccinations and to
help protect active-duty military personnel.
While MedImmune is committed to supporting global efforts to help protect
individuals against the Novel Influenza A (H1N1) virus, its vaccine technology
is currently only licensed in the United States. MedImmune is willing to make
additional vaccine available to other governments if any capacity remains
after fulfilling obligations to the U.S. government, assuming that necessary
regulatory approval can be obtained.
Seasonal FluMist(R) on Track to Begin Shipping in August
MedImmune believes that the best way to help protect all eligible age
groups against seasonal influenza is to vaccinate prior to and during the
back-to-school period. The CDC's Advisory Committee on Immunization Practices
(ACIP) recommends influenza vaccination for all age groups as soon as seasonal
vaccine is available each year. MedImmune plans to begin shipping the first
of approximately 10 million doses of seasonal FluMist(R) (Influenza Virus
Vaccine Live, Intranasal) to health care providers in August. This early
availability of vaccine significantly widens the window of opportunity to
vaccinate more eligible individuals and improve seasonal influenza vaccination
rates, as patients seeing their providers for routine office visits can be
vaccinated without waiting for the rush of fall vaccination clinics.
About Seasonal FluMist
FluMist(R) (Influenza Virus Vaccine Live, Intranasal) is a 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 degrees 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, the worldwide biologics business for AstraZeneca PLC (LSE:
AZN.L, NYSE: AZN), has approximately 3,100 employees worldwide and is
headquartered in Gaithersburg, Maryland. With an advancing pipeline of
promising candidates, we aim to be the next revolutionary force in
biotechnology by delivering life-changing products, industry-leading
performance, and a tireless commitment to improving patient health. For more
information, visit MedImmune's website at www.medimmune.com.
The opinions expressed herein do not represent opinions or statements made
or expressed by the U.S. Department of Health and Human Services.
CONTACT: Karen Lancaster of MedImmune, +1-301-398-5864