U.S. Releases $1B For H1N1 Vaccine Testing, Production

The U.S. government on Friday announced it had placed orders for enough H1N1 (swine flu) vaccines to immunize 20 million people, the Washington Post reports (Brown/Stein, Washington Post, 5/23). The HHS also said that $1 billion taken from existing pandemic flu and preparedness federal funds will help fund the production and testing of an H1N1 vaccine, the Wall Street Journal reports (McKay, Wall Street Journal, 5/23).

HHS has contracts with five vaccine makers to make a pandemic vaccine and has placed orders with Sanofi Pasteur, Novartis and GlaxoSmithKline, and remains in negotiation with two other companies. Additional orders for “potentially hundreds of millions of doses of vaccine are expected” to follow, the Washington Post writes.

“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 newspaper writes. “This is really to reserve our place in line,” Sebelius said during a news conference (Washington Post, 5/23).

“Novartis AG will receive $289 million, Sanofi Aventis SA will receive $191 million, and GlaxoSmithKline PLC will be given $181 million to produce H1N1 vaccine ingredients,” and $150 million will fund clinical trials to test the safety, dose and effectiveness of a H1N1 vaccine, according to the Wall Street Journal.

CDC scientists are finishing the analysis of two candidate viruses that could be used in an H1N1 vaccine and are expected to “send one or both to manufacturers by the end of next week,” the Wall Street Journal writes (Wall Street Journal, 5/23). The companies will be able to begin vaccine production as early as next month (AP/Google.com, 5/26).

A vaccine would need to be tested and receive special approval from the FDA – steps that will take until at least late summer. The first people eligible to receive the new H1N1 vaccine as designated by the U.S. government’s pandemic preparedness plan would be “deployed armed forces members; critical health-care workers; fire, police and ambulance workers; pregnant women and small children” – about 24 million people (Washington Post, 5/23).

H1N1 Cases, Deaths Increase; WHO To Revise Criteria for Pandemic Alert System

The WHO on Tuesday reported that 46 countries have officially confirmed 12,954 cases of H1N1 infection, including 92 deaths. A full list of country cases and deaths is available here (WHO Influenza A(H1N1) – update 39, 5/26). 

In closing at the World Health Assembly (WHA) on Friday WHO Director-General Margaret Chan defended the WHO’s decision to hold off on raising the pandemic alert to Phase 6 – indicating the swine flu outbreak to be a pandemic, but urged developing countries to remain on alert for swine flu to reach the southern hemisphere, where populations are most vulnerable, VOA News reports (Schlein, VOA News, 5/22). “This is a subtle, sneaky virus,” Chan said. “We have clues, many clues, but very few firm conclusions” (MacInnis/Nebehay, Reuters/Vancouver Sun, 5/22). 

Also on Friday, after international governments last week pleaded with the WHO to reevaluate its pandemic alert system, U.N. flu chief Keiji Fukada on Friday announced the WHO’s pandemic alert scale would be revised to include how harmful a virus is, not just how rapidly it spreads, before declaring a pandemic, AP/Google.com reports (AP/Google.com, 5/23). The revisions to the pandemic alert system mean “the swine flu virus circling the globe will probably never be declared a full-fledged pandemic,” the New York Times writes.

Although Fukada told the news conference “he could not predict exactly what the new rules would be but that criteria would include a ‘substantial risk of harm to people,’ not just the geographic spread of a relatively benign virus,” the newspaper writes (McNeil, New York Times, 5/23). “The bottom line here is we are trying to walk a very fine line between not raising panic, but also not becoming complacent,” Fukuda said (Reuters/Vancouver Sun, 5/22).

The WHA ended Friday without countries finalizing a deal on virus sharing, the AP/Atlanta Journal-Constitution reports. The countries instead concluded that Chan “find a solution by early next year,” the newspaper writes. The U.S. and E.U. did not support this decision, calling instead “for samples to be shared without restriction, arguing that this was in the best interest of science and global efforts to combat disease” (Jordans, AP/Atlanta Journal-Constitution, 5/22).

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