More Countries Move Ahead With H1N1 Vaccine Testing

The race to develop a H1N1 (swine flu) vaccine before the fall flu season ramped up Wednesday, after Australia launched the first human trials of the H1N1 vaccine and scientists from the U.S., China and Britain announced plans for human trials of an H1N1 vaccine in coming weeks, AFP/France24.com reports (7/23).

On Wednesday, the U.S. federal government announced the trials of the experimental H1N1 vaccine will begin next month, likely as early as August 10, Reuters reports. “The first round of tests will be in adults, but will quickly move to children, said Dr. Karen Kotloff of the University of Maryland, who will be leading one of the trials,” the news service writes.

The first trials of healthy adults will test two different doses of H1N1 vaccine needed to protect against the H1N1 virus as well as “the safety and immune response in healthy adult and elderly volunteers who are given the seasonal flu vaccine” in combination with the H1N1 vaccine (Fox, 7/22). The government is seeking thousands of volunteers for the trial, the AP/Philadelphia Inquirer reports (Neergaard, 7/23).

“If early information from those trials indicates that these vaccines are safe, similar trials in healthy children (aged 6 months to 17 years old) will begin,” according to a written statement by the National Institute of Allergy and Infectious Diseases (NIAID), who will be overseeing the H1N1 trials (NIH release, 7/22). Trials of pregnant women, who are known to be at higher risk of H1N1, may come at a later date, the New York Times reports.

The newspaper writes that the trials – which will include about 2,400 volunteers – “are being conducted ‘in a compressed time frame in a race against the possible autumn resurgence’ of the swine flu, possibly at the same time as the regular seasonal flu, said Dr. Anthony S. Fauci, director of [NIAID]. Only after the trials are done, which is estimated to take about two months, can health officials recommend a [voluntary] vaccination program,” that “would have to be rolled out in stages because not nearly enough doses for all Americans will be ready in the fall even if there are no testing or production problems” (McNeil, 7/22).

The AP/Philadelphia Inquirer adds that in the U.S., “[i]t promises to be a confusing fall, as doctors struggle to administer vaccine against the regular winter flu and tell patients to stay tuned for when and if they can later return for another shot or two of swine flu vaccine” (7/23).

“Health authorities in other countries are looking to the U.S. studies … as they make their own plans,” the AP/Washington Post writes in an article that examines the drug manufacturers’ race against the clock to produce an H1N1 vaccine, in light of an FDA meeting scheduled for Thursday that will offer “the first in-depth public progress report since U.S. scientists delivered the novel virus to manufacturers and asked them to turn it into usable vaccine” (Neergaard [2], 7/23 ).

CNN reports that drugmaker GlaxoSmithKline (GSK) on Wednesday announced how the company’s antiviral drug Relenza experienced a major sales boost as “governments around the world stockpiled in preparation for a swine flu pandemic … Glaxo also said that by the end of the year, it expects to have an annual production capacity for Relenza of 190 million treatment courses, more than a threefold increase to its previously announced maximum capacity,” CNN writes (7/23).

The Globe and Mail reports on GSK’s announcement Wednesday that the company plans to donate 20 percent of production from its Canadian manufacturing site to developing countries. “The decision to donate was made by the company, not the federal government,” the newspaper writes, adding “[n]either Health Canada nor the Public Health Agency of Canada was willing to comment Wednesday on GSK’s commitment” (Alphonso/Galloway, 7/22).

Arab Health Ministers Ban Children, Elderly, Patients With Chronic Medical Conditions From Hajj In Attempt To Stop H1N1 Spread

In related news, “Arab health ministers decided in a late night meeting Thursday to ban children, the elderly and those with chronic medical conditions from attending the annual Muslim pilgrimage to Saudi Arabia this year in effort to slow the spread of swine flu,” however they “stopped short of calling for the cancellation this year of the hajj — a duty for all Muslims in their lifetime — which attracts about 3 million people every year to the holy cities of Mecca and Medina,” AP/Google.com reports (Michael, 7/23).

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