by Playfuls Staff |
9th January 2007
MedImmune announced that the U.S. Food and Drug
Administration (FDA) has approved the company's new refrigerated formulation of
FluMist (Influenza Virus Vaccine Live, Intranasal) for use in helping to [more]
prevent influenza in healthy children and adults from 5 years to 49 years of
age.
"Large and well-controlled clinical trials have shown
FluMist to be an effective and well-tolerated option to help prevent influenza
disease in healthy children and adults," stated Frank M. Malinoski, M.D.,
Ph.D., senior vice president, medical and scientific affairs. "We are
confident that the approval of our refrigerated formulation for FluMist will
encourage more healthcare providers to offer FluMist to their customers and
patients. The new formulation can be conveniently stored in a standard
refrigerator rather than frozen, as previously required. We recognize that the
frozen storage presented difficulties for some physician practices as well as
for providers who administer vaccine in places like schools, pharmacies and
grocery stores, and we are confident that this improvement will enhance access
to this important vaccine."
FluMist has been marketed in a frozen formulation since its
original FDA approval in 2003, and millions of doses have been distributed and
administered. The newly approved formulation of FluMist, known in clinical
studies as CAIV-T (cold adapted influenza vaccine-trivalent), will be available
for the 2007-2008 influenza season. Both formulations are free of
preservatives, including thimerosal.
To date, 42 clinical trials involving approximately 60,000
individuals have been conducted, including children as young as 6 weeks of age
and adults up to 98 years of age. In a recently completed pivotal Phase 3 study
involving approximately 8,500 children between 6 months and 59 months of age,
FluMist demonstrated a statistically significant 55 percent relative reduction
in the incidence of influenza illness caused by any influenza strain including
both matched and mismatched strains when compared to the injectable influenza
vaccine (TIV). This study was conducted during the 2004-2005 influenza season
in the U.S., Europe and Asia and it was submitted in July 2006 to the FDA as
the basis of MedImmune's request to expand the age indication for FluMist to include
children as young as one year of age who do not have a history of wheezing or
asthma.
Pending the FDA's approval of an expanded age indication,
MedImmune plans to increase production of its new formulation of FluMist for
the 2007-2008 season. MedImmune anticipates shipping its first doses in 2007 in
time for physicians to start vaccinating patients as early as August.
