MedImmune, the company that has successfully sold flu vaccines to healthy adults in the age range of 5 to 49 is now poised on the edge of another victory. The U.S Food and Drug Administration is now about to approve the sale of FluMist targeting children younger than 5 years.
This announcement comes at a time when the company is planning to self itself to UK's AstraZeneca for 15.6 billion dollars. AstraZeneca was behind MedImmune because it did not have its own flu vaccine business. Once the deal closes, MedImmune becomes a wholly owned subsidiary of AstraZeneca.
The vaccine FluMist has had more than its share of hurdles, such as the preliminary safety concerns, being deemed unfit for young kids, and then storage problems as most pharmacies refused the drug as it needed to be stored in the freezer. This was overcome recently by a FDA-approved refrigerator safe version.
The newer version of MedImmune 's FluMist appears effective for children younger than 5 years old, although safety data on the influenza vaccine is still under examination.
MedImmune sought FDA approval to market the spray for children ages 1 to 5 without a history of wheezing or asthma.
According to FDA documents, four studies conducted by MedImmune found the drug was effective against Type A and B influenza viruses, including one trial that showed the vaccine was about 90 percent effective.
Reviewers for the FDA also said one company study of the nasal spray vaccine did not signal any widespread safety problems, but results from other studies are still being reviewed. Those findings will be presented to the panel on Wednesday.
Though children who received FluMist experienced more wheezing than those who were given an inactive vaccine, "the difference between treatment groups is quite small," one reviewer said.
Other side effects included pneumonia, among other problems. Previously known side effects with FluMist include nasal congestion, runny nose, sore throat and cough.
In a separate document, MedImmune claimed the vaccine's safety and efficacy were proven in children 24 to 59 months old and "that the risk-benefit profile for children 12 (to) 23 months of age without a history of wheeze or asthma warrants use of FluMist in this population as well."
It also said it would continue to monitor the drug in younger patients if approved.
FluMist competes with injectable flu vaccines made by GlaxoSmithKline Plc, Sanofi-Aventis' Sanofi Pasteur unit, and Chiron, which was recently acquired by Novartis AG.