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U.S. Asks Firms to Make Swine Flu Vaccine

By David Brown and Rob Stein
Washington Post Staff Writers
Saturday, May 23, 2009

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 yesterday.

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 the 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.

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 during a flu outbreak. 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.

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 that "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 usable 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, of about 24 million people, includes deployed armed forces members; 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.

Also yesterday, 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.

The WHO's pandemic threat level is currently set at Phase 5, the next-to-highest level. The WHO's current system calls for raising the alert to Phase 5 when a new influenza virus is spreading in more than one country in one region of the world. The WHO raised the alert to Phase 5 on April 29, when it determined the new H1N1 virus was causing outbreaks in both Mexico and the United States.

Under the current system, the alert will be raised to Phase 6 if the virus is spreading through the population in two regions. Although the H1N1 virus has caused outbreaks in other parts of world, such as Spain and Japan, the situation does not yet meet the criteria for a Phase 6, because it remains unclear whether the virus is spreading widely in populations outside North America, officials said.

The situation has raised questions about the current system, because so far the H1N1 virus does not seem to be causing illness as severe as when the outbreak began in Mexico, or as severe as is caused by the avian flu officials have been watching for several years.

During the World Health Assembly, which ended yesterday, member nations urged the WHO not to raise the threat level to Phase 6 and called for the organization to consider revising the system.

"What the countries have said is that we are in this mixed situation, and we are concerned that if we go to a Phase 6, the message to our populations will be, 'You should be very afraid,' when in fact we think it indicates the virus is spreading out but the level of fear should not go up," Keiji Fukuda told reporters.

In addition, WHO officials say they think that all the necessary precautionary steps are being taken.

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