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Canada to buy unadjuvanted vaccine for pregnant women, health officer says

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By Helen Branswell Medical Reporter (CP)

 

TORONTO - Canada will purchase supplies of unadjuvanted swine flu vaccine to

offer to pregnant women who might otherwise choose not to be vaccinated, the

country's chief public health officer has revealed.

 

Dr. David Butler-Jones told The Canadian Press that Canada will buy 1.2

million doses of unadjuvanted pandemic vaccine which will be reserved for

pregnant women, who are at significantly greater risk of becoming severely

ill and dying if they contract the virus.

 

"I'm anticipating for pregnant women we will have an option," he said in an

interview.

 

The vaccine will be supplied by GlaxoSmithKline, Canada's pandemic vaccine

manufacturer, and is expected to be available at the same time as the

country's other supplies of vaccine.

 

Adjuvants are compounds that boost the immune system's response to vaccine,

allowing smaller doses to be used per person. Canada is buying adjuvanted

pandemic vaccine partly in response to a call from the World Health

Organization for affluent countries to use "antigen (vaccine) sparing"

techniques so that limited global supplies can be stretched as far as

possible.

 

While some European countries have used adjuvanted flu vaccines for a number

of years, none of the currently licensed flu vaccines in Canada contains an

adjuvant.

 

And there are no data on the use of adjuvanted flu vaccine in pregnant

women - a fact that may add to the already high degree of reluctance many

pregnant women feel about taking any medication or therapy.

 

"What is absolutely clear is that there is much more of a safety data base

in pregnant woman with non-adjuvanted vaccine," said Dr. Marie-Paule Kieny,

head of the WHO's vaccine research initiative, the division overseeing

pandemic vaccine issues.

 

"Does it mean that it (adjuvanted vaccine) will be unsafe? No. It means that

there is no hard evidence that it will be (safe)."

 

The lack of evidence led a panel of experts that advises the WHO on vaccine

issues to recommend unadjuvanted vaccine be offered to pregnant women if

that option is available.

 

Butler-Jones said some pregnant women may prefer an adjuvanted formulation,

because it's likely to protect more broadly against mutated strains of the

virus if and when they arise, and because it can be taken in smaller doses.

 

Another plus, he said, is that one dose of adjuvanted vaccine might suffice,

meaning pregnant women could be protected faster than if they had to get two

doses of an unadjuvanted vaccine. (Dose requirements for swine flu vaccines

are still being determined.)

 

But the decision to buy unadjuvanted vaccine for pregnant women - something

the Public Health Agency of Canada had earlier said it would not do -

reflects the very real fear of public health officials that pregnant women

may shun this vaccine.

 

"I think that it is possible that a good chunk of the (pregnant) patients

may just say: 'You know what? No thanks.' And that's obviously a problem,"

said Dr. Richard Beigi, an academic obstetrician from Pittsburgh who

recently published results of a survey suggesting few pregnant women would

agree to take a pandemic flu shot.

 

"I think it is going to be challenging, " Kris Sheedy, head of the H1N1

vaccine communications team at the U.S. Centers for Disease Control, said of

the effort to convince pregnant women they should get a pandemic flu shot.

 

It is well known that in previous pandemics pregnant women were the hardest

hit group in terms of deaths. And this time around, there have been many

reports already of miscarriages, emergency deliveries and deaths in pregnant

women who caught swine flu.

 

Pregnant women are also at greater risk of complications from catching

seasonal flu. Yet their willingness to be vaccinated against it remains low,

despite government recommendations that they should get flu shots.

 

Sheedy said in the U.S., around 15 per cent of pregnant women get vaccinated

most years. Dr. Jeff Kwong, a University of Toronto researcher who studies

flu shot rates, said he doesn't know of a corresponding national figure for

Canada. But a small study in Toronto during the 2003-04 flu season showed 14

per cent of women got a flu shot during their pregnancy.

 

Beigi's survey asked nearly 400 pregnant women if they would agree to be

vaccinated with an avian influenza vaccine during a pandemic caused by that

virus.

 

The survey was conducted before swine flu broke out and was done in the

context of fears that the H5N1 virus - which kills roughly 60 per cent of

the people who catch it - might cause the next pandemic.

 

Despite the high fatality rate of the H5 virus, only 15.4 per cent of the

pregnant women surveyed said they'd take a shot if a bird flu pandemic

erupted. And half the office staff of the obstetrical practices where the

survey was conducted said they would not recommend the pregnant women in

their care get pandemic vaccine.

 

"I was relatively shocked at the responses," said Beigi, who teaches in the

department of obstetrics, gynecology and reproductive sciences at the

University of Pittsburgh Medical Center.

 

Sheedy said the CDC plans to work with obstetricians, hoping to persuade

them to make the case for pandemic vaccination to their patients. Studies

have shown, she said, that pregnant women value highly the advice they get

from their obstetricians.

 

"I'm empathetic," she said, noting she has a two year old and a five year

old, and remembers well the concerns of pregnancy.

 

"I understand that some (pregnant women) are going to choose not to

vaccinate, but I do hope that if we're able to get information out there

about what we're seeing with this virus and its impact on these women, that

many of them will at least ... consider it."

 

-Follow Canadian Press Medical Writer Helen Branswell's flu updates on

Twitter at CP-Branswell

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