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WHO May Soon Order Global Production of Swine Flu Vaccine
Date:5/7/2009

Expert panel to meet, advise agency next week on wisdom of such a move

THURSDAY, May 7 (HealthDay News) -- The World Health Organization could decide as early as next week to call for international production of an influenza A H1N1 swine flu vaccine.

The head of the agency's initiative for vaccine research told the Canadian Press that such a decision could force some vaccine manufacturers to make some lots that do not include a vaccine against influenza B viruses.

"I would be really, really very surprised that it would not be large-scale," Dr. Marie-Paule Kieny said Wednesday when asked whether widespread swine flu vaccine production would be recommended by the agency.

If so, a number of countries with pandemic vaccine contracts would probably activate their purchase orders, she said, triggering a major switch to production of a new vaccine.

The CP also reported that an expert panel will meet May 14 to review the available science on the swine flu and advise WHO Director General Margaret Chan on whether to call on vaccine manufacturers to make a vaccine to protect against the new H1N1 virus.

Meanwhile, U.S. health officials reported Wednesday that while the large majority of U.S. cases of swine flu continue to be mild, those who are hospitalized with more severe disease appear to be atypically young.

The median age of hospitalized individuals with swine flu is 15, which is younger than occurs with regular seasonal flu, Dr. Richard Besser, acting director of the U.S. Centers for Disease Control and Prevention, said during a Wednesday news conference.

"We are seeing the same distribution in hospitalized patients as we are in milder cases in the community, and that's younger than what you would see in seasonal flu," Besser said. "In seasonal flu, you tend to see a predominance of burden of disease in the elderly and in the very young, and here we are seeing it more in the younger population."

"That is something we are keeping our eye on. That is something that raises concern," he added.

Overall, the age spread for hospitalized patients ranges from 8 months to 53 years of age, Besser said. Why the more severe cases are skewing young remains unclear, he said, but it could be that younger people are getting sicker sooner, or that older people may have some kind of built-in immunity.

In any case, the U.S. outbreak of H1N1 swine flu is continuing and, although most cases are still mild, more deaths are expected, Besser said. "We remain concerned," he said. "We are seeing continued spread around the country. We are seeing increases in numbers of patients."

The death earlier this week of a woman in Texas, the first U.S. resident to die from the swine flu, "reminds us that influenza can be a very serious infection, and it's one we need to continue to take very seriously," Besser added.

According to the Associated Press, Texas health officials have not said that the death of 33-year-old schoolteacher Judy Trunnell was directly caused by the H1N1 flu, noting that she also had unspecified "chronic underlying conditions."

Late Tuesday, reports surfaced that the government would ask Americans to get three vaccinations for the upcoming flu season -- one for the seasonal flu and two for this new strain of H1N1. However, on Wednesday Besser said that it was premature to make that decision.

"Before a vaccine is administered, there are a series of studies that need to be taken. These are under the direction of the National Institutes of Health and approved by the Food and Drug Administration. They need to do studies to determine how much of the antigen needs to be in the vaccine to stimulate protection," he said.

"They will also need to see -- do you get sufficient immunity from one dose, do you need more than one dose," Besser said. "With each vaccine it's different, with different age groups it's different. It's really early to say how many vaccines someone is going to need until those studies are done," he said. "Hopefully, we will be able to find a vaccine that worked with one dose."

Besser said that, as of Wednesday, the CDC was reporting 1,487 probable and confirmed cases in 44 states. "That's an increase of around 400 from yesterday. There are around 850 probable cases and 642 confirmed cases. The confirmed cases are in 41 states," he said.

In addition, there are 35 confirmed hospitalizations from the flu and an additional 17 probably caused by flu, Besser said. Much of the increase in cases is due to catching up on testing, but there is also a real increase in disease, he said.

Besser noted that in Mexico, the outbreak's epicenter, the flu is disappearing in some areas and popping up in others, which is probably what will be seen in the United States as well.

"When you see a large outbreak or epidemic, it is frequently made up of a series of smaller outbreaks and epidemics. What they are seeing in Mexico is parts of the country where they are seeing increases in disease and in parts of the country they are seeing decreases in disease. When you add that all up it may show some leveling off, but it doesn't give a sense of how dynamic the situation is," he said.

The World Health Organization is now reporting almost 1,900 cases of swine flu in 23 countries, with Canada, Spain and the United Kingdom having the most cases outside of Mexico and the United States.

Last week, a 23-month-old boy from Mexico, who also had underlying health problems, died from the swine flu illness in a Houston hospital. He was the first fatality in the United States from the current swine flu outbreak.

On Tuesday, U.S. health officials said the outbreak of swine flu appears similar to the seasonal flu in its severity, so schools across the nation should remain open and any schools that did close should reopen.

This announcement marked a change from the previous guidance, which recommended that affected schools close for at least two weeks. Students who are sick with flu-like symptoms should stay home for at least a week, officials cautioned.

In Mexico City, the government has now allowed all businesses to reopen, according to the Associated Press. This includes sports arenas, movie theaters and restaurants. However, businesses must screen for those who might be sick and surgical masks will still be mandatory for workers and customers, the AP said.

High schools and universities reopened Thursday after a two-week closure intended to limit infections. Younger children returned to school on Monday, the news service said.

What U.S. health experts don't know is whether the never-before-seen virus will return, perhaps in a more dangerous form, when the regular flu season begins again late this year. Because the pathogen is a genetic mix of pig, bird and human flu strains, health officials are worried that humans may have no natural immunity to it.

As with the previously tested strains of the swine flu virus, new testing has found that the pathogen remains susceptible to the two common antiviral drugs Tamiflu and Relenza, according to the CDC.

On Wednesday, the U.S. Food and Drug Administration said it had approved a new manufacturing facility to be used to produce influenza vaccines. The facility is approved for seasonal flu vaccine production and could be used to produce vaccine against the new H1N1 swine flu strain.

The facility, located in the United States, is owned and operated by Sanofi Pasteur, and will greatly increase the company's production capability, the FDA said in a news release.

U.S. Human Cases of H1N1 Flu Infection
(As of May 6, 2009, 11:00 AM ET)
States # of
laboratory
confirmed
cases
Deaths
Alabama 4  
Arizona 48  
California 67  
Colorado 17  
Connecticut 4  
Delaware 33  
Florida 5  
Georgia 3  
Hawaii 3  
Idaho 1  
Illinois 122  
Indiana 15  
Iowa 1  
Kansas 2  
Kentucky* 2  
Louisiana 7  
Maine 1  
Maryland 4  
Massachusetts 45  
Michigan 8  
Minnesota 1  
Missouri 2  
Nebraska 4  
Nevada 5  
New Hampshire 2  
New Jersey 7  
New Mexico 3  
New York 97  
North Carolina 7  
Ohio 5  
Oklahoma 1  
Oregon 15  
Pennsylvania 1  
Rhode Island 2  
South Carolina
16
 
Tennessee
2
 
Texas
61
2
Utah 1  
Virginia
3
 
Washington
9
 
Wisconsin
6
 
TOTAL (41) 642 cases 2 deaths
*Case is resident of Ky. but currently hospitalized in Ga.
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: May 6, 2009, teleconference with Richard Besser, M.D., acting director of the U.S. Centers for Disease Control and Prevention; May 6, 2009, news release, U.S. Food and Drug Administration; May 5, 2009, teleconference with Kathleen Sebelius, secretary, U.S. Department of Health & Human Services, and Richard Besser, M.D., acting director of the U.S. Centers for Disease Control and Prevention; Associated Press; Washington Post


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