By Michael S. Rosenwald
Washington Post Staff Writer
Tuesday, June 2, 2009
Federal health officials, racing to respond to a potential swine flu pandemic that has already sickened thousands of people around the world, yesterday awarded a major contract for a vaccine to Gaithersburg-based MedImmune.
The $90 million deal comes less than two weeks after Department of Health and Human Services officials said they were setting aside about $1 billion to test and purchase vaccines for the national stockpile to fight the unusual virus strain, called swine-origin influenza A (H1N1).
Under the contract with HHS, MedImmune will continue to make its seasonal FluMist vaccine and also develop a vaccine targeted specifically at the H1N1 virus that has prompted world health officials to raise the pandemic alert level to the fifth of six stages.
Health officials say that H1N1 has sickened more than 15,000 people, killing 99, in 53 countries. MedImmune began working at hyper speed on a vaccine shortly after the outbreak grabbed world attention five weeks ago.
"For many people around here it's been quite an intense experience over the last five weeks," said Ben Machielse, MedImmune's executive vice president of operations.
However, MedImmune's vaccine differs from those companies' more traditional flu vaccines in that FluMist is a nasal spray instead of an injection. Another difference is that the vaccine is formulated using live but weakened virus strains. Flu shots use viruses that have been killed.
The differences in MedImmune's vaccine present some potential advantages. If the original virus the vaccine is targeting changes, MedImmune's vaccine shows some ability to protect against it. Also, a stronger immune response is likely with a live vaccine.
"There is no doubt that historically -- and this goes beyond influenza -- that a live attenuated vaccine more closely resembles natural infection and therefore in general induces a more robust immune response," said Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health.
However, like traditional flu vaccines, MedImmune's product must also be grown in eggs, an important part of a manufacturing process that takes several months. Because the strain is new, Machielse said it is unclear how well it would grow in the eggs, and therefore the firm was unsure of how much vaccine it would be able to make.
"This is still a big question for all manufacturers," Machielse said. "We just don't know yet."
MedImmune, which is the biotech unit of global drugmaker AstraZeneca, acquired FluMist by buying a company called Aviron for $1.5 billion in 2002. However, MedImmune officials struggled to win the product a wide following because it had to be kept frozen and wasn't approved for children under 5, a primary customer base looking to avoid injections.
The company has since won approval for a refrigerated version that can also be given to children older than 2. (Children with asthma cannot be given the vaccine because of potential side effects.) Last year, FluMist sales totaled $104 million compared with $54.8 million in 2007 and $36.4 million in 2006.
"I think we are slowly getting there," Machielse said.