MedImmune, Inc. has submitted to the US Food and Drug Administration (FDA) a supplemental Biologics License Application (sBLA) for use of CAIV-T (cold adapted influenza vaccine, trivalent) in children 12 months to 59 months of age, who do not have a history of wheezing or asthma.
CAIV-T is the refrigerator-stable formulation of FluMist (Influenza Virus Vaccine Live, Intranasal), a frozen vaccine approved in the US to prevent influenza in individuals 5 to 49 years of age, a company release stated.
"This is a very satisfying moment for MedImmune as it represents the culmination of multi-year clinical, manufacturing and regulatory efforts, to improve the profile of our influenza vaccine," said Edward M. Connor, Jr., MD, executive vice president and chief medical officer. "Pending FDA review and approval, we believe that our live, attenuated influenza vaccine will be an important new vaccine for many children currently recommended for annual influenza vaccination by the US Centres for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP)."
The sBLA consists of data from more than 30,000 subjects in 15 clinical studies, including MedImmune's pivotal phase 3 trial involving approximately 8,500 children between 6 months and 59 months of age. In this trial, efficacy of the vaccine was established across all age groups of children. Specifically, children vaccinated with CAIV-T had 55-per cent fewer overall confirmed cases of influenza compared to the injectable vaccine.
The study also showed that CAIV-T vaccination resulted in 89-percent fewer cases of matched H1N1 strains and 79-percent fewer cases of circulating mismatched H3N2 strains as compared to the flu shot. MedImmune's risk-benefit analysis of age subgroups of children within this trial indicated that CAIV-T is appropriate for use in children older than 12 months of age who do not have a history of wheezing or asthma.
"It is particularly important to vaccinate young children against influenza to help reduce hospitalizations and morbidity associated with influenza disease," said Kathryn Edwards, MD, Prof., paediatrics and vice chair, clinic research at Vanderbilt University Medical Centre. "Recognizing the need to help reduce the influenza disease burden in children, the ACIP recently recommended influenza immunization for children 6 months to 59 months of age."