Companies starting work on H1N1 vaccine: CDC

By Julie Steenhuysen

CHICAGO (Reuters) - Companies are starting preliminary work on a vaccine for the new H1N1 flu and should begin clinical trials in the coming months, but the new vaccine would not be ready for widespread use until October, U.S. health officials said on Thursday.

Although new to humans, they said, the H1N1 strain appears to be behaving very much like a seasonal H1N1 flu in striking more children and young people.

So far, there have been 8,585 probable and confirmed U.S. cases of the new H1N1 strain, commonly called swine flu, with 12 deaths and 507 hospitalizations, Dr. Anne Schuchat of the U.S. Centers for Disease Control and Prevention said in a telephone briefing.

She said the CDC shipped virus samples for making vaccines to different manufacturers several days ago.

The strains were made using traditional vaccine methods, which involve live vaccines made in chicken eggs, and a new, proprietary reverse genetics method that allows companies to make non-live vaccines, avoiding working with potentially highly infectious pandemic strains.

AstraZeneca's MedImmune unit owns the reverse genetics method, which it has licensed to a number of companies approved to sell flu shots in the United States including Sanofi-Aventis SA, Novartis AG and GlaxoSmithKline Plc.

Schuchat said in coming weeks companies will start making "candidate lots" of vaccine which will be used for clinical trials. "Those will happen over the summer months," she said.

Clinical trials will need to answer a number of questions, Schuchat said, including whether one or two injections will be needed, whether vaccinating different age groups yields different results and whether an immune system booster called an adjuvant would be needed to get a good response.