Pregnant women will get a shot of Aussie H1N1 vaccine
October 27, 2009
Joanna Smith
OTTAWA BUREAU
OTTAWA–Pregnant women will be able to get an alternative version of the H1N1 vaccine by early next week.
The federal government is importing 200,000 doses of the alternative vaccine from Australia so that expectant mothers will not have to wait for the Canadian version to make its way through the regulatory approval process.
The Australian imports do not contain adjuvant – a substance added to the vaccine to stretch supply and boost immunity.
Pregnant women have been advised to use an adjuvant-free vaccine because there is a lack of data on the effects the additive could have on a pregnancy.
"We have heard the concerns of pregnant women about having to wait for an unadjuvanted vaccine and we have been working very hard on providing it earlier given they have always been considered a priority group," Health Minister Leona Aglukkaq told a news conference Monday.
Canada paid $2.55 million for the vaccine produced by CSL Ltd., which is approved for use in the United States and Australia, where it has already been administered to about 600,000 people.
Pregnant women will only need to get one dose of the Australian vaccine to be immunized from the pandemic strain of influenza that has killed 86 people across Canada so far.
Immunization began Monday for priority groups in most provinces and territories but the dose being given to those people contains an adjuvant.
The adjuvant used in most of the 50.4 million doses being produced by GlaxoSmithKline Inc. at its plant in Ste. Foy, Que., is a mixture of squalene (derived from fish oil), tocopherol (containing vitamin E) and an emulsifier called polysorbate.
The additive serves two purposes: It stretches the supply of the vaccine, requiring the use of less antigen per dose, and, clinical trials have shown, boosts the response of the immune system. There are also signs that if the virus mutates, the adjuvant will help the vaccine adapt to cope with new strain.
While the adjuvant has been tested on more than 40,000 people worldwide, there are virtually no clinical data when it comes to the effects it has on pregnancy, so the World Health Organization recommended this summer that versions of the H1N1 vaccine without adjuvant should be made available for pregnant women.
Canada ordered 1.8 million doses of adjuvant-free vaccine from GlaxoSmithKline but it requires a separate licence and would not be available until after priority groups are vaccinated this week and next.
Pregnant women are a priority to receive the vaccine because research has shown that while they are not at greater risk of catching the virus than anyone else, they are about four times as likely to develop severe complications – including the loss of their baby – if they do.
That is why Public Health Agency of Canada has recommended that pregnant women who have reached the 20-week gestation mark, have underlying medical conditions, or are at risk of getting sick with H1N1 from those around them get the vaccine without waiting for the adjuvant-free option.
Aglukkaq signed an interim order allowing the use of the supplementary vaccine from Australia so that pregnant women will not have to wait as long for the second choice.
Chief Public Health Officer David Butler-Jones said that health officials would monitor the vaccine for safety and effectiveness, but using a vaccine from Australia means a lot of data are already available.
"While we in the northern part of the world were dealing with H1N1 over the summer in small amounts, the southern hemisphere was in the midst of its winter flu season," Butler-Jones told MPs on the Commons health committee Monday.
Toronto Star
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