The Food and Drug Administration approved MedImmune?s FluMist vaccine for children as young as 2, the Gaithersburg company announced Wednesday.
Business is looking up for MedImmune, which was acquired by AstraZeneca in June. Also this year, it won approval for a FluMist formula that doesn?t need to be frozen.
“The combination of having the refrigerated formulation and the availability to children under 5 does mean we have the opportunity to broaden the availability of FluMist,” spokeswoman Jamie Lacey said.
In 2006, MedImmune ? the largest biotech company in Maryland ? took in $1.3 billion in product sales, Lacey said. The company has more than 3,000 employees worldwide, with more than half of them in Maryland.
FluMist is a nasal-spray vaccine containing live, weakened viruses of influenza types A and B. According to a research article published in the New England Journal of Medicine in February, FluMist proved somewhat effective against other flu types and more effective than existing injected vaccines using dead viral bodies.
FluMist was previously licensed by the FDA for ages 5 to 49.
MedImmune anticipates shipping FluMist with the expanded label directions to health care providers in the coming days so that vaccinations may be offered to eligible individuals ahead of and throughout the upcoming influenza season.
Each year, up to 60 million Americans get the flu, according the U.S. Centers for Disease Control and Prevention. Resulting complications cause more than 200,000 hospitalizations and approximately 36,000 deaths in the U.S. annually.
Children aged 2 to 17 are twice as likely to catch influenza than adults, including the elderly, the CDC reports. During a widespread outbreak, the rate of flu infections can exceed 30 percent in school-age children.
“As a company dedicated to innovative advancements in pediatric medicine, MedImmune is delighted to be able to offer FluMist as an option for children as young as 2 years old to help protect them from influenza,” Dr. James F. Young, president of research and development, said in a statement. “It is an exciting time for FluMist.”
