Swine flu vaccine testing in new, exciting and potentially dangerous ways
This is my site Written by Alex on August 26, 2009 – 8:32 am   

Swine flu – or the H1N1 influenza pandemic – is THE story in clinical trials and in medicine right now. It looks to continue to be the object of intense focus and fascination until at least the winter, when the flu is expected to either impact millions of people or be blunted by the distribution of a vaccine. It is the vaccine, of course, that is now under clinical trials testing. However, the trials are being conducted in an interesting way that involves first producing the vaccine and filling the vials for shipment before the trials are finished. This poses significant risks yet also carries the possibility for great success in stemming the spread of the flu, depending on how things go.

The story below is a good overview of things right now. I will keep updating events as they move forward. Let me know what you think.

latimes.com

Swine flu could hospitalize 2 million in U.S. this winter

As many as 300,000 could clog intensive care units in heavily affected regions, a new report says. But the CDC director notes that the H1N1 outbreak also could be much milder.

By Thomas H. Maugh II

Reporting from Atlanta

Nearly 2 million Americans could be hospitalized during this winter’s novel H1N1 influenza pandemic, with as many as 300,000 clogging intensive care units in heavily affected regions, according to a report released Monday by the President’s Council of Advisors on Science and Technology.

Overall, 20% to 40% of the population could develop symptoms of the strain commonly known as swine flu, and 30,000 to 90,000 could die, according to the report. During a normal flu season, the virus kills about 35,000 Americans.

The difference this year is that pandemic H1N1 is killing middle-aged adults and adolescents, whereas seasonal flu kills primarily the elderly.

The numbers confirm those previously released by the Centers for Disease Control and Prevention, said CDC director Dr. Thomas R. Frieden, but he emphasized the great unpredictability of flu outbreaks and cautioned that this winter’s could be much milder.

The figures are not a prediction but a possibility, said epidemiologist Marc Lipsitch of the Harvard School of Public Health, who helped prepare the 86-page report that is available on the White House website.

Researchers expect the high incidence of infections because the new flu is dramatically different from strains that have been circulating in recent years, so that the bulk of the population has no residual immunity.

“This isn’t the flu that we are used to,” said Kathleen Sebelius, secretary of the Department of Health and Human Services, at a news conference at the CDC headquarters in Atlanta. “We won’t know until we are in the middle of the flu season how serious the threat will be.”

The report also made several recommendations, including:

* A senior member of the White House staff should be responsible for coordination of all decision-making about the pandemic. The most likely candidate would be the president’s homeland security advisor.

* The CDC’s surveillance systems should be expanded to improve the chances of detecting new variants of the virus.

* The government should accelerate production of vaccines to have them become available in the middle of September rather than the middle of October, as currently planned. That would allow an initial immunization of 40 million of the most vulnerable people, including pregnant women, health workers and children.

To achieve that goal, vaccine manufacturers should be allowed to fill vaccine vials and prepare them for shipping while they await results from the clinical trials, a process known as “fill and finish.” The process normally takes a month, and waiting for results from clinical trials before beginning it would significantly delay distribution.

Sebelius said that manufacturers have been given such permission.

She also noted that no final decision had been made about using the vaccine. But, she said, “we are anticipating moving ahead with vaccination” if the clinical trials show that it works and do not raise any questions about safety.

Experts still think that two doses will be necessary to stimulate immunity because of the lack of previous exposure to the strain.

“By Thanksgiving, we should have a large group of people immunized,” she said.

thomas.maugh@latimes.com

Copyright © 2009, The Los Angeles Times

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