Posted: Sun Sep 06, 2009 6:00 pm Post subject: Vax Dilemma of Speed Versus Safety
MONTREAL: Doctors who've seen how desperately sick some swine flu patients become are pressing authorities to further fast-track vaccine approval. But a large portion of the public appears reluctant to take the vaccine, a situation that could worsen if fast-tracking deepens suspicions about the product's safety.
Individuals and organizations concerned about global equity are urging countries with vaccine contracts to stretch supplies by using boosting compounds called adjuvants so developing countries can also get some serum. But the decision to use an adjuvant is being blamed -- unfairly, federal officials say -- for the fact Canada may not start vaccinating until a month after the U.S. and Britain.
Dr. Ross Upshur, director of the University of Toronto's Joint Centre for Bioethics, sums up the dilemma that federal authorities managing the pandemic vaccine file face.
"They're going to get enough vaccine for everybody to have it; nobody's going to want it, and any sequence that they can come up with of who gets it first isn't going to satisfy anybody because somebody has to go second for a vaccine that they don't want to get," Upshur says.
"They can't win," agrees Dr. Marie-Paule Kieny, head of the World Health Organization's vaccine research initiative.
The WHO had asked countries with first access to pandemic shots to employ vaccine sparing approaches, such as the use of adjuvants, so that there will be more to go around. Without frugal use in wealthy countries, the vast majority of nations will have limited access, at best, to vaccine against the novel H1N1 virus.
If the strain drifts - which we don't know, but may well be the case - then with adjuvant would be preferable," she says. "I think it was a sensible decision to make.
U.S. authorities have made it clear they will only use adjuvanted vaccine if their supplies won't meet American needs. They will not use the boosting compounds to stretch supplies for the developing world.
In a commentary published in the New England Journal of Medicine, Dr. Tachi Yamada said it would be inexcusable for people in poorer countries to die because richer countries use up most of the limited vaccine supplies. And he specifically pointed to the reluctance to use adjuvanted vaccines, currently licensed in parts of Europe but not in North America.
"Under a global health crisis where millions could die we have to really think hard whether we play by the rules we establish for normal times, or we think much more aggressively and take greater risks," he said in an interview last month.
But people in this country who fear Canada's supplies will arrive too late to prevent a possible surge in severe cases in the early fall contend the inclusion of an adjuvant is dragging out the approval process.
In an editorial published last week, the Canadian Medical Association Journal called on the federal government to offer unadjuvanted vaccine to people at high risk of having life-threatening bouts of flu, and to make it available sooner.
Editor-in-chief Dr. Paul Hebert, who signed the editorial, is an intensive care physician in Ottawa. He admits his experience treating gravely ill swine flu patients is framing his position on the issue.
But conflicting views even within the journal illustrate the dilemma federal officials face.
By the end of one day-long discussion, 49% of the participants favoured a "moderate effort" approach to vaccine roll out and 30% preferred a "go slow" approach.
Only 21% supported going "full throttle" on pandemic vacccine.
Posted: Fri Sep 11, 2009 11:01 am Post subject: Is this the answer to all the problems?
Studies: 1 dose of swine flu vaccine works
(AP) -- Good news in the world's flu fight: One dose of the new swine flu vaccine looks strong enough to protect adults - and can spark protection within 10 days of the shot, Australian and U.S. researchers said Thursday.
Australian shot maker CSL Ltd. published results of a study that found between 75 percent and 96 percent of vaccinated people should be protected with one dose - remarkable considering scientists thought it would take two doses.
One dose means tight supplies of H1N1 vaccine won't be stretched so badly after all. The U.S. has ordered 195 million doses, based on the hope that 15 micrograms was indeed the right dose. Had it taken twice that dose, or two shots apiece, half as many people could have received the vaccine.
A separate report in Thursday's New England Journal suggested European manufacturers might get away with an even smaller dose. Novartis Vaccines added what's called an adjuvant, or immune-boosting chemical, to its version of the swine flu shot and found a 7.5-microgram dose was effective. It did, however, spark more of those reactions like injection-site pain.
Numerous countries allow flu vaccines with adjuvants to sell every year, but the U.S. has never approved an adjuvant-containing flu shot.
The winter flu vaccine is widely available now, and U.S. health authorities urged people Thursday to get it out of the way now before swine flu shots start arriving in mid-October.
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