Feds juggling speed, safety of pandemic vaccine

[Guest guest]

Feds juggling speed, safety of pandemic vaccine

Updated Sun. Sep. 6 2009 2:02 PM ET

The Canadian Press

MONTREAL -- In the race to get pandemic vaccine into Canadian arms, public

health and vaccine regulatory authorities in this country find themselves the

reluctant filling in a rock-and-a-hard-place sandwich, knowledgeable observers

say.

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-e 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.

Kieny, who is based in Geneva, has watched the Canadian debate unfold from afar.

" They have thought it would be better to have with adjuvant and they could well

be right, " she says. Kieny notes that with an adjuvant, the vaccine should

protect against not only the current viruses, but those that are expected to

start to circulate as the virus evolves or " drifts " as that process is called in

flu science.

" 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. "

In the United States where the 1976 swine flu incident is looming large over the

response to this perplexing pandemic, authorities have opted for caution. In

1976, a feared pandemic with a swine flu virus didn't materialize. But elevated

rates of the sometimes fatal Guillain-Barre syndrome emerged among the more than

40 million vaccinees.

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.

That position has also drawn fire, including by the head of the Gates

Foundation's global health program.

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. 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.

Earlier in the summer Dr. Amir Attaran, the journal's associate editor for

editorials, co-authored an editorial arguing that pandemic vaccine must be

shared equitably globally.

Attaran, who is taking a break from the editorial team until the end of the

year, says if he'd been there he would have argued against the call to use

unadjuvanted vaccine.

" We're in this domain where there can be disagreements among well-intentioned,

knowledgeable people sharing the same goal, and yet it is not possible to say

who is right or wrong, " he says.

Federal officials, who have faced a barrage of questions about why Canada's

program would start later than those of other countries, have tried for days to

shake the perception that adjuvant is the enemy of speed.

" Whether it's adjuvanted or unadjuvanted, it doesn't matter. It did not delay

the process at all, " insists Dr. Bulter-, the country's chief public

health officer.

He says there are ways to bring the program forward, but they involve doing less

study of the safety and effectiveness of the vaccine.

Those compromises might be warranted if flu activity starts earlier than the

typical seasonal pattern, where the worst of the illness comes after Christmas,

or if the proportion of severe cases starts to mount, - says.

But they might come at a cost in terms of public acceptance of the vaccine. The

vaccine skeptics have the pandemic flu shots firmly in their sights.

" There's definitely anxiety and concern, " says Keelan, a public health

researcher at the University of Toronto who studies trends in vaccine acceptance

and monitors the Internet's heated discourse on vaccines.

" People keep talking about the rapid deployment of this vaccine.... 'Why are we

hastening when it's not 100 per cent clear what the actual risks are from this

infection? " '

The U.S. vaccine resistance group the National Vaccine Information Center, for

instance, says it's now obvious swine flu is no more serious than garden variety

flu and it argues " fast-tracked " and " experimental " swine flu vaccines will end

up being riskier for children than catching the virus.

Keelan, who says American and Canadian attitudes on pandemic vaccine seem

closely aligned, notes a recent public consultation process undertaken by the

U.S. Centers for Disease Control found participants were concerned about the use

of the preservative thimerosol, the possible use of adjuvants and the adequacy

of testing.

By the end of one day-long discussion, 49 per cent of the participants favoured

a " moderate effort " approach to vaccine roll out and 30 per cent preferred a " go

slow " approach.

Only 21 per cent supported going " full throttle " on pandemic vacccine.

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