Ottawa got last-minute warning of shortfall in H1N1 vaccine

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Canada's vaccine manufacturer did not inform federal health officials until Thursday that the number of H1N1 doses available to Canadians next week would shrink by much more than half - prompting provinces to suspend the rollout of the vaccine to the general public for at least a couple of weeks.

GlaxoSmithKline is forecast to ship 436,000 doses to provinces and territories, far less than the roughly two million anticipated, because it had to interrupt production at its Ste-Foy, Que., plant to make a version of the vaccine for pregnant women.

The last-minute admission of a shortfall is the latest and largest blow in a week marked by anxiety, confusion and mounting frustration. Problems with vaccine supply and underestimation in pandemic planning now threaten to undermine Canada's largest-ever inoculation campaign.

What's gone wrong?

It's a story of slower-than-expected vaccine production, a resurgent virus targeting the young, and a once-skeptical public suddenly rushing to get the shot.

As flu clinics prepared to open this week, rising anti-vaccination sentiment persuaded health officials that uptake would be low, prompting them to step up their campaign to persuade Canadians to be immunized.

What they didn't count on was the far more compelling effect of real-world events - the deaths of two seemingly healthy young Canadians. Panicked, parents hurried children of all ages to flu-shot clinics; healthy adults went too, ignoring the carefully planned protocol that the most vulnerable should come first.

And now this: the shortage that David Butler-Jones, Canada's Chief Public Health Officer, said the government only learned the extent of late Thursday. He said federal officials had an earlier hint there might be a problem, but the situation has been rapidly changing.

"What I know today is not what I knew yesterday morning. And tomorrow I may find out something new," Dr. Butler-Jones said yesterday. "We have been transparent about that. We've been working closely with the provinces."

It's a far different message than the one Canadians have been hearing in recent days: that the country secured 50 million doses, enough to vaccinate all. Six million have been delivered so far. Now, as public health officials brace for a new week of crushing demand for a product in limited supply, the problems are being traced back to the manufacturing facility.

Canada decided to use an immune-boosting adjuvant in its H1N1 vaccine, a decision made largely because adjuvants allow less active ingredient to be used, meaning manufacturers can make large quantities of vaccine quickly. But since there is no data on the safety of adjuvants in pregnant women, the federal government decided to also purchase 1.8 million doses of unadjuvanted vaccine to be used on that high-risk group.

What they didn't foresee is the huge shortfall precipitated by GSK halting production in mid-October of the adjuvanted vaccine, in order to complete the unadjuvanted version. Although both vaccines contain the same active ingredient, or antigen, the unadjuvanted version requires far more, which mean GSK had to shift its production focus entirely to meet the demand.

Last night, GSK avoided addressing the vaccine shortage directly, and issued a statement saying it had "delivered on its agreement" with the federal government. The company said output will "vary to some degree" because of the complex nature of vaccine production. The company has completed the order and is now producing adjuvanted vaccine again, but the delay comes at the worst possible time.

Flu clinics in Ontario will begin turning away healthy individuals on Monday, and it will be several weeks before the province receives enough vaccine to roll out its pandemic plan to the general public.

Nova Scotia has changed its strategy mid-stream: Healthy individuals move to the back of the line, in favour of vaccinating pregnant women, young children and those in remote communities.

Perry Kendall, British Columbia's public health officer, said his best guess is all will run smoothly again in two, perhaps even three weeks as the manufacturing plant ramps up vaccine production to millions of doses a week.

That will do little to calm public fears, which hit a crescendo this week following the two children's deaths, fatalities that are rare with H1N1 but a tragic reminder of how swiftly the disease can kill.

Before the tragedies, no one had expected such large crowds to come out. Those who worked on Ontario's pandemic plan, which serves as a model for the rest of the country, had foreseen worst-case scenarios involving illness, not inoculations. Pandemic planners considered situations in which the entire health-care system would become overwhelmed with sick people, and how hospitals and clinics would cope with the workload.

But vaccines? They didn't see people rushing for those.

"When something so many of us as parents can identify with [what happens] it just makes it very real and it does make all of us want to huddle around and protect our own," said Allison Stuart, an assistant deputy health minister in Ontario.

But the nationwide shortage has raised fears that more people might become sick before they get the vaccine, now that the country has seen a resurgence of the virus.

"Is this just a glitch, a momentary glitch because of a switch, or is this going to be an ongoing issue?" asked Kumanan Wilson, Canada Research Chair in public-health policy at the Ottawa Hospital Research Institute. "That's obviously a point of concern because there's no point vaccinating everybody after the virus has spread to the population."