MedImmune Ramps Up H1N1 Vaccine

http://www.washingtonpost.com/wp-dyn/content/article/2009/07/31/AR2009073103418.html

By Terri Rupar
Washington Post Staff Writer
Saturday, August 1, 2009

MedImmune said it is producing more vaccine for the H1N1 flu virus than it originally predicted and expects to have more than 200 million doses by the end of the year.

MedImmune, part of global drugmaker AstraZeneca, is one of five companies with a contract to sell a vaccine for the H1N1 virus, originally known as swine flu, to the federal government. MedImmune's flu vaccine differs from the others in two major ways: It is delivered via nasal spray instead of an injection and is made with a live but weakened virus instead of a dead one.

Bernardus N.M. Machielse, Gaithersburg-based MedImmune's executive vice president for operations, said the company is getting more doses out of each egg used to grow the vaccine than companies using inactive vaccine.

"We can ramp it up much more quickly than the inactive vaccine guys now," he said.

Machielse said the company expects to have 45 million to 50 million doses filled by March 31.

One effect of the faster-than-expected production, however, is a lack of enough sprayers used to deliver the vaccine. The company is in talks with the Food and Drug Administration on approval for the vaccine to be delivered using a nasal dropper instead, Machielse said.


The Department of Health and Human Services has agreed to pay $151 million for 12.8 million doses of H1N1 vaccine from MedImmune. Machielse said the company expects the federal government to buy all of its doses eventually.

"We hope to receive more orders relatively soon," he said.

Sri Edupuganti, an assistant professor at Emory University and a principal investigator for H1N1 vaccine clinical trials, said MedImmune's production could help allay worries about low vaccine yields.

"This is good that they think they can make more," she said.

Bill Hall, an HHS spokesman, said that other companies' vaccine yields have also picked up but that MedImmune's "high production yield is very encouraging news."

He said the department plans to purchase more vaccine in the coming months.

HHS hopes to have vaccine ready for distribution as soon as mid-October, but the timing depends on clinical studies for the vaccines. One issue to be determined is whether people should receive one or two doses.

MedImmune also hopes that the use of its H1N1 vaccine will give a boost to sales of its seasonal flu vaccine, known as FluMist. Sales of FluMist were limited after its launch in 2003, because it was approved only for people between the ages of 5 and 49. But in 2007 it won approval for children as young as 2.

"We are now on a gradual but definite upslope with the seasonal vaccine," Machielse said.