The Food and Drug Administration yesterday issued a warning to Gaithersburg biotechnology company MedImmune Inc. about contamination affecting the company’s flu vaccine, but the agency said the nation’s flu vaccine stock will not be disrupted.
The FDA’s concerns will slow Medimmune’s effort to gain approval for its nasal flu spray FluMist for children as young as 1. Currently it is approved for ages 5 to 49.
When inspecting a MedImmune manufacturing plant in Liverpool, England, in March, the FDA found bacteria and mold contamination at a very early stage of vaccine production. Specifically, federal inspectors said MedImmune failed to take steps to control microorganisms in hen eggs used to make the flu vaccine.
In addition, the FDA said the company had not taken steps to ensure that its workers used proper methods to keep the facility sterile.
“Operators were observed wearing safety glasses allowing for skin to be exposed and, therefore, increasing the opportunity for contamination,” the FDA said in the warning letter.
MedImmune is allowed to continue to manufacture FluMist while it takes steps to comply with the FDA’s safety rules. The contamination findings should not be enough to hinder production of FluMist for the 2007-2008 flu season.
“Our concern is not that there was an affect on the safety, purity or potency of the product itself,” said Mary Malarkey, head of compliance at the FDA’s Center for Biologics Evaluation and Research. “However, we were concerned around the investigation.”
MedImmune is a major player in the region’s biotech industry. Following disappointing sales of FluMist after the federal approval’s age limitations, MedImmune put itself up for sale this year and found a buyer in AstraZeneca for $15 billion.
In 2004, the nation’s flu-shot supply was slashed dramatically when British regulators shut down a Chiron Corp. factory because of contamination concerns. However, the FDA stressed its concerns with MedImmune will not have a similar effect.
“It is different from Chiron in that we do not have a product failure at this point,” Dr. Malarkey said.
The warning means the FDA will delay approving FluMist for use in children as young as 1 until MedImmune develops a plan to correct the problems. Earlier this month, a federal advisory committee approved FluMist for children under the age of 5 after the company presented new data showing its effectiveness and some decrease in side effects that led to age limits when it was first approved in 2004.
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