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First Batch of Swine Flu Vaccine Already Here: Company
Date:6/12/2009

Announcement comes a day after WHO declared H1N1 a pandemic

FRIDAY, June 12 (HealthDay News) -- European drug maker Novartis AG announced Friday that it has successfully produced the first batch of H1N1 swine flu vaccine, weeks earlier than had been expected.

The shortened production schedule was made possible because the vaccine was produced in cells, rather than the egg-based method typically used for vaccines, the company said.

The announcement comes a day after the World Health Organization declared the first flu pandemic since 1968, triggered by the rapid spread of the H1N1 virus across North America, Australia, South America, Europe and regions beyond.

According to the Associated Press, Novartis says it is using this first batch for evaluation and testing, prior to its use in people, and it is also being considered for use in clinical trials. Millions of doses of the vaccine might be produced weekly, the company said. The U.S. Department of Health and Human Services had already placed a $289 million order for swine flu vaccine with Novartis in May, the AP said.

On Thursday, WHO director Dr. Margaret Chan made the much-anticipated announcement that swine flu had now reached pandemic status. She did so immediately after an emergency teleconference with flu experts from a number of countries.

"The world is moving into the early days of its first influenza pandemic in the 21st century," Chan said in Geneva, according to the Associated Press. "The [swine flu] virus is now unstoppable."

The declaration pushes the WHO alert status on the outbreak from phase 5, where it had remained for weeks, to the highest level, phase 6, as the number of swine flu cases hit close to 30,000 in the United States, Europe, South America and Australia.

The rapid spread of cases in Australia, where they rose by more than 1,000 on Monday, appeared to fit a key criteria for declaring a global pandemic -- if at least two regions of the world are hit.

On Thursday, WHO said 74 countries have now reported 28,774 cases of swine flu, including 144 deaths, the AP reported.

U.S. health officials on Thursday were not surprised by the pandemic announcement. "It's based on the data," CDC director Dr. Thomas R. Frieden said during an afternoon press conference.

But, he added, "this does not mean there is any difference in the severity of the flu. There has been no change in the virus."

"Here in the United States, we have been responding as if it were a pandemic already," Dr. Anne Schuchat, director of the CDC's National Center for Immunization and Respiratory Disease, added.

What the pandemic declaration means, she said, is that "for countries that were not seeing the flu we have seen here, they need to dust off their pandemic plans."

In a separate statement in response to the WHO announcement, U.S. Department of Health and Human Services Secretary Kathleen Sebelius said, "What this declaration does do is remind the world that flu viruses like H1N1 need to be taken seriously. Although we have not seen large numbers of severe cases in this country so far, things could possibly be very different in the fall, especially if things change in the Southern Hemisphere, and we need to start preparing now in order to be ready for a possible H1N1 immunization campaign, starting in late September."

And U.S. Department of Homeland Security Secretary Janet Napolitano added, "This decision comes as no surprise. We acted aggressively to stay ahead of the virus as it spread across the country. Now our challenge is to prepare for a possible return in the fall."

"The Obama Administration has been working together across the government, and will continue to do so over the weeks and months ahead to keep the American people safe," she said.

According to WHO statistics, the last pandemic -- the Hong Kong flu of 1968 -- killed about 1 million people. By comparison, ordinary flu kills about 250,000 to 500,000 people each year.

Other experts also cautioned that the new declaration does not mean that the swine flu has gotten more severe.

"A World Health Organization level 6, which in effect states that H1N1 infections are now worldwide in distribution, is simply a declaration of the extent of geographic spread, and not a statement of severity of the clinical disease," Dr. Pascal James Imperato, a former New York City health commissioner and dean of public health at the State University of New York's Downstate Medical Center, said in a statement. "The disease remains relatively mild in most people. A positive consequence of this declaration is that it empowers countries to move forward with vaccine production."

Chan on Thursday also characterized the H1N1 virus as "moderate," and WHO officials said they would be now urging flu vaccine makers to start producing swine flu vaccine.

Since the outbreak started in April, health officials in the United States have also said that infections have been mild for the most part, and most people recover fairly quickly. Testing has found that the H1N1 virus remains susceptible to two common antiviral drugs, Tamiflu and Relenza.

During the next few months, CDC scientists will be looking to see if the swine flu virus mutates or becomes resistant to antiviral medications or is more easily spread among people.

U.S. health officials have said there's no way to tell now if the H1N1 virus will be more virulent when -- and if -- it returns to the Northern Hemisphere with the approach of winter.

U.S. Human Cases of H1N1 Flu Infection
(As of June 5, 2009, 11:00 AM ET)
States and Territories* # of
confirmed and
probable cases
Deaths
Alabama
94
 
Alaska
3
 
Arkansas
9
 
Arizona
547
4 deaths
California
973
 
Colorado
75
 
Connecticut
395
1 death
Delaware
142
 
Florida
247
 
Georgia
33
 
Hawaii
115
 
Idaho
16
 
Illinois
1357
5
Indiana
173
 
Iowa
92
 
Kansas
92
 
Kentucky
96
 
Louisiana
134
 
Maine
17
 
Maryland
89
 
Massachusetts
787
 
Michigan
298
1 death
Minnesota
82
 
Mississippi
40
 
Missouri
46
1 death
Montana
15
 
Nebraska
60
 
Nevada
128
 
New Hampshire
64
 
New Jersey
148
 
New Mexico
108
 
New York
858
8 deaths
North Carolina
30
 
North Dakota
23
 
Ohio
35
 
Oklahoma
93
 
Oregon
167
 
Pennsylvania
299
 
Rhode Island
18
 
South Carolina
60
 
South Dakota
10
 
Tennessee
104
 
Texas
1670
3 deaths
Utah
461
2 deaths
Vermont
9
 
Virginia
55
1 death
Washington
577
1 death
Washington, D.C.
24
 
West Virginia
6
 
Wisconsin
2217
 
Wyoming
25
 
Territories
Puerto Rico
1 case
 
TOTAL*(52)
13,217 cases
27 deaths
*includes the District of Columbia and Puerto Rico

Source: U.S. Centers for Disease Control and Prevention

More information

For more on swine flu, visit the U.S. Centers for Disease Control and Prevention.



SOURCES: June 11, 2009, teleconference with Thomas R. Frieden, M.D., director, U.S. Centers for Disease Control and Prevention, and Anne Schuchat, M.D., director, CDC National Center for Immunization and Respiratory Disease; June 11, 2009, statements, U.S. Department of Health and Human Services and U.S. Department of Homeland Security; Pascal James Imperato, M.D., M.P.H., dean, Graduate Program in Public Health, State University of New York Downstate Medical Center, New York City; Associated Press


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