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September 15, 2009

MedImmune Says Swine Flu Vaccine Ready End of September

By Maggie Fox
WASHINGTON (Reuters) Sep 10 - MedImmune's inhaled vaccine against the pandemic H1N1 virus could be ready to start shipping to the U.S. government by the end of September, a company official said on Thursday.
MedImmune's Dr. Raburn Mallory said the company, a unit of AstraZeneca, has submitted safety data for its nasal spray swine flu vaccine to the U.S. Food and Drug Administration.
"There are no red flags there. We think we can have 5 million doses ready to distribute at the end of September," Dr. Mallory said in an interview. U.S. officials had not expected vaccination to begin until mid-October.
The United States hopes to vaccinate 160 million Americans by the beginning of December.
The company has 5 million doses in spray devices now, a company spokeswoman said, adding that a more conservative estimate would be that 3.5 million doses could be sent out by the end of September.
Dr. Mallory said the company was preparing details on how well the vaccine works.
Last week vaccine makers Novartis and China's Sinovac reported their vaccines elicited protective immune responses in patients with one dose. Infectious disease experts had feared people would need two doses to get full immunity against the virus because it is a new strain.
Earlier on Thursday, Thomas Lonngren, executive director of the European Medicines Agency, said early clinical trial results show swine flu vaccines being rushed through development produce a strong immune response.
Dr. Mallory said he did not know if MedImmune's vaccine would work with a single dose. He noted that the company uses a weakened live virus, compared to the killed viruses used by other flu vaccine makers. Tests have shown MedImmune's live virus seasonal vaccine produces a stronger immune response than killed virus vaccines.
MedImmune has said it can produce about 200 million doses of its needle-free vaccine in bulk. But it can only deliver about 40 million doses of its product because it lacks the sprayers to squirt the vaccine into the nose.
Dr. Mallory said company officials were working with the FDA to perfect a device to drip vaccines into the nose -- technology that has been used with other vaccines.
Other pharmaceutical companies like Sanofi Aventis, GlaxoSmithKline and CSL are also racing to develop H1N1 vaccine as governments scramble to secure supplies.

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