U.S. to make swine flu vaccine for 20 million people

WASHINGTON — The federal government has asked three drug companies to make enough swine flu vaccine to immunize at least 20 million people in key positions in health care, national security and emergency services, officials said Friday.

The order, announced by Health and Human Services Secretary Kathleen Sebelius, is part of a $1-billion investment in immediate production and testing of vaccine against the newly emerged strain of H1N1 flu virus. Further orders for potentially hundreds of millions of doses of vaccine are expected.

"This is really to reserve our place in line," Sebelius said at a news conference at the agency's day care center.

Although questions remain unanswered about the effectiveness of a swine flu vaccine, how many doses it will take to protect a person, and who should get it, Sebelius said "we can't wait" for the answers before putting the manufacturing machinery in motion.

The order is for bulk quantities of a killed version of the virus and two different "adjuvants," chemical additives that boost the immune system's response and allow a lower dose of vaccine to be used, which in turn stretches the supply.

The money will also pay for testing pilot lots of the vaccine in human volunteers.

The vaccine ingredients would not be combined and "finished" into useable vaccine until late summer. Special permission from the Food and Drug Administration will be needed for the adjuvants to be used, as neither one is currently approved for use in this country.

The government's pandemic preparedness plan divides the U.S. population into five tiers of priority for getting the vaccine. The first tier, which comprises about 24 million people, includes deployed armed forces, critical health-care workers, fire, police and ambulance workers, pregnant women and small children.

HHS has contracts with five companies to make pandemic vaccine. The department has activated the ones with Sanofi Pasteur, Novartis and GlaxoSmithKline. It is still negotiating with the two others, MedImmune and CSL, an Australian company.

Sebelius was at the HHS day care center with Elmo, the Sesame Street character who appears in a new television public service announcement showing children how to properly cough, sneeze and wash one's hands in during a flu outbreak. A large, fidgety red character, Elmo initially covered his cough with his hands. He was gently corrected by Sebelius, who demonstrated that the crook of the elbow is the proper body part to use.

Also Friday, an official of the World Health Organization said that agency has begun reviewing its pandemic threat alert system to see if its definition of a full-scale pandemic should be revised.