MedImmune, Inc.
(Nasdaq: MEDI) announced today that the U.S. Food and Drug Administration
(FDA) has approved the company's supplemental biologics license application
(sBLA) to use reverse genetics technology to construct new vaccine strains
to produce seasonal influenza vaccines, including FluMist (Influenza Virus
Vaccine Live, Intranasal) and the next-generation, refrigerator-stable
formulation, CAIV-T (cold adapted intranasal vaccine -- trivalent).
Creation of new vaccine strains is the first step (and often a
production-limiting one) in the influenza vaccine manufacturing process.
Use of reverse genetics (also known as "plasmid rescue") technology
enhances the safety, specificity, reliability and efficiency with which new
vaccine strains can be produced.
"Reverse genetics represents an important breakthrough in commercial
influenza vaccine processes by improving the efficiency of producing new
influenza vaccine strains on an annual basis," said George W. Kemble,
Ph.D., vice president, research and development, vaccines. "This technology
enables scientists to replace cumbersome seasonal vaccine strain
development methods that were created in the 1960s with modern techniques,
which should allow us to accelerate the availability of influenza vaccines
to the public.
"For producing pandemic influenza vaccine seeds, reverse genetics has
the added benefit of allowing scientists to remove potentially pathogenic
portions of the virus, thereby creating a safer production process for the
vaccines," Dr. Kemble commented further.
Toward this end, MedImmune has already begun applying its plasmid
rescue technology to pandemic research efforts. Last month, the National
Institutes of Health (NIH) began enrolling participants in a Phase 1 study
of an intranasal H5N1 influenza vaccine candidate based on MedImmune's
live, attenuated vaccine technology, which also utilized reverse genetics
technology. Investigators at MedImmune and Johns Hopkins Bloomberg School
of Public Health Center for Immunization Research, where the study is being
conducted, are hopeful that a live, attenuated intranasal influenza vaccine
would be as effective against potential pandemic A strains as it has been
shown to be against seasonal matched and mismatched A strains of influenza.
Most influenza vaccine manufacturing companies and governmental
agencies are now using reverse genetics technology in their development of
pandemic vaccine candidates because it allows them to avoid working
directly with the infectious, circulating pandemic strains. As the owner or
exclusive licensee of the key patent estates for use of the reverse
genetics technology in human influenza vaccines, MedImmune remains
committed to making sure that the technology is accessible to government
institutions and industry manufacturers. As such, the company has offered
other influenza vaccine manufacturers non-exclusive licenses to this
intellectual property estate for use in manufacturing seasonal or pandemic
vaccines.
MedImmune's Commitment to Delivering Influenza Vaccines to the Public
As the manufacturer of FluMist, the first major innovation in influenza
vaccine technology in more than 50 years, MedImmune continues to expand
upon its commitment to ensure the nation is adequately protected against
seasonal and pandemic influenza by using the latest in scientific and
medical advancements. In addition to the activities described above, the
company also recently received a $170-million contract from the U.S. Health
and Human Services Department to expedite the development of cell
culture-based production of its influenza vaccine. Further, the company
also recently submitted its first lots of commercial FluMist for the
2006-2007 influenza season to the FDA for approval and release. The company
expects to have all lots approved and released for commercial sale by the
first week in September. Should all things continue on track, MedImmune
anticipates shipping its first doses of FluMist for the upcoming season to
customers by the end of July 2006.
About FluMist
FluMist is indicated for active immunization for the prevention of
disease caused by influenza A and B viruses in healthy children and
adolescents, 5 to 17 years of age, and healthy adults, 18 to 49 years of
age. There are risks associated with all vaccines, including FluMist. Like
any vaccine, FluMist does not protect 100 percent of individuals
vaccinated. In studies of people between the ages of 5 and 49 years, runny
nose was the most commonly reported side effect. Other common side effects
included various cold-like symptoms, such as headache, cough, sore throat,
tiredness/weakness, irritability, and muscle aches.
FluMist should not be used, under any circumstances, in anyone with an
allergy to any part of the vaccine, including eggs; in children and
adolescents receiving aspirin therapy; in people who have a history of
Guillain-Barre syndrome; and in people with known or suspected immune
system problems. Pregnant women and people with certain medical conditions,
asthma, or reactive airways disease should not get FluMist.
About CAIV-T
CAIV-T is an investigational intranasal, cold-adapted trivalent
influenza vaccine. It is the next-generation, refrigerator-stable
formulation of FluMist, which is a frozen, live attenuated cold-adapted
trivalent influenza vaccine. To date, the safety, tolerability and efficacy
of CAIV-T has been studied in both healthy and at-risk populations between
the ages of 6 weeks and 98 years.
On May 1, 2006 at the Pediatric Academic Societies' annual meeting,
MedImmune presented its pivotal Phase 3 study for CAIV-T, entitled,
"Comparison of the Efficacy and Safety of Cold-Adapted Influenza Vaccine,
Trivalent With Trivalent Inactivated Influenza Vaccine in Young Children 5
to 59 Months of Age." The study included 8,475 children at 249 sites in 16
countries in North America, Europe, the Middle East and Asia. Study
participants were randomized one-to-one to receive either CAIV-T or the flu
shot during the 2004-2005 influenza season. Each participant also received
a placebo nasal spray or placebo injection to preserve the double-blind
design of the study. Participants were followed through the influenza
season and evaluated to identify illnesses caused by influenza virus. The
trial included more than 6,300 previously unvaccinated children with nearly
50 percent of those children less than 2 years of age.
The results of this trial showed that CAIV-T was 55 percent more
effective than the trivalent injectable inactivated influenza vaccine (TIV)
in reducing influenza illness caused by any influenza strain in children 6
months to 59 months of age, including both matched and mismatched strains.
The influenza attack rate was 8.6 percent for study participants receiving
the flu shot compared to 3.9 percent for those who received CAIV-T (P
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