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OBGYNs back H1N1 vaccine for pregnant women
Last Updated: Thursday, October 22, 2009 | 4:25 PM ET
CBC News
Both forms of the H1N1 vaccine are safe for pregnant women, a group of Canadian doctors said Thursday.
On Wednesday, Health Minister Leona Aglukkaq announced the approval of the adjuvanted swine flu vaccine. An adjuvant is a substance that stimulates the body's immune response.
Canada has also ordered about 1.8 million doses of non-adjuvanted H1N1 vaccine, and regulatory approval of that version is expected in a week or two.
"Women should be provided with the option to receive either H1N1 vaccine based on facts, not fear about safety," Dr. Michel Fortier, president of the Society of Obstetricians and Gynaecologists of Canada, said in a statement Thursday.
"More important than the decision about which H1N1 vaccine a pregnant woman should take is the decision to get vaccinated, regardless of the vaccine type selected."
The adjuvant is a natural product made of fish oil, water and vitamin E.
While this is the first time an adjuvant has been used in an influenza vaccine in Canada, the adjuvant has been used in other vaccines for decades.
Non-adjuvanted vaccine available in November
The adjuvanted vaccine includes four times less viral material than the non-adjuvanted vaccine, the society noted.
A single dose of the adjuvanted vaccine is needed to achieve immunity in healthy adults. Clinical trials are underway to test how many doses of both types are needed to protect pregnant women, and it's possible that multiple doses of the non-adjuvanted vaccine may be needed.
The adjuvanted vaccine is also more likely to offer protection from mutations in the virus, the group said.
GlaxoSmithKline's adjuvant has been tested in about 45,000 people worldwide and was evaluated by Health Canada and other regulators as part of a review of the H5N1 avian flu vaccine before the H1N1 pandemic started in the spring, with no significant safety concerns raised.
In July, an expert committee at the World Health Organization recommended that pregnant women should receive non-adjuvanted vaccine where possible, but that the adjuvanted version could be used if necessary.
Likewise on Wednesday, Canada's chief public health officer, Dr. David-Butler-Jones, recommended giving pregnant women one dose of non-adjuvanted vaccine. If that is not available and H1N1 rates are high or increasing in their area, then women more than 20 weeks into their pregnancy may be offered the adjuvanted version.
Pregnant women with an underlying health condition should talk to their health-care provider about getting the adjuvanted form, Butler-Jones advised, rather than wait for the non-adjuvanted vaccine which may not be available until November.
The SOGC also backed Health Canada's earlier recommendation that pregnant women be given a prescription for antivirals to be used only if H1N1 symptoms appear. Antivirals should not be used for preventive purposes.
Women and their families should be aware of serious symptoms of H1N1, and seek emergency care if these occur.
According to the U.S. Centers for Disease Control and Prevention, emergency warning signs in children are:
http://www.cbc.ca/health/story/2009/10/22/h1n1-vaccine-pregnant-women-sogc.html
Last Updated: Thursday, October 22, 2009 | 4:25 PM ET
CBC News
Both forms of the H1N1 vaccine are safe for pregnant women, a group of Canadian doctors said Thursday.
On Wednesday, Health Minister Leona Aglukkaq announced the approval of the adjuvanted swine flu vaccine. An adjuvant is a substance that stimulates the body's immune response.
Canada has also ordered about 1.8 million doses of non-adjuvanted H1N1 vaccine, and regulatory approval of that version is expected in a week or two.
"Women should be provided with the option to receive either H1N1 vaccine based on facts, not fear about safety," Dr. Michel Fortier, president of the Society of Obstetricians and Gynaecologists of Canada, said in a statement Thursday.
"More important than the decision about which H1N1 vaccine a pregnant woman should take is the decision to get vaccinated, regardless of the vaccine type selected."
The adjuvant is a natural product made of fish oil, water and vitamin E.
While this is the first time an adjuvant has been used in an influenza vaccine in Canada, the adjuvant has been used in other vaccines for decades.
Non-adjuvanted vaccine available in November
The adjuvanted vaccine includes four times less viral material than the non-adjuvanted vaccine, the society noted.
A single dose of the adjuvanted vaccine is needed to achieve immunity in healthy adults. Clinical trials are underway to test how many doses of both types are needed to protect pregnant women, and it's possible that multiple doses of the non-adjuvanted vaccine may be needed.
The adjuvanted vaccine is also more likely to offer protection from mutations in the virus, the group said.
GlaxoSmithKline's adjuvant has been tested in about 45,000 people worldwide and was evaluated by Health Canada and other regulators as part of a review of the H5N1 avian flu vaccine before the H1N1 pandemic started in the spring, with no significant safety concerns raised.
In July, an expert committee at the World Health Organization recommended that pregnant women should receive non-adjuvanted vaccine where possible, but that the adjuvanted version could be used if necessary.
Likewise on Wednesday, Canada's chief public health officer, Dr. David-Butler-Jones, recommended giving pregnant women one dose of non-adjuvanted vaccine. If that is not available and H1N1 rates are high or increasing in their area, then women more than 20 weeks into their pregnancy may be offered the adjuvanted version.
Pregnant women with an underlying health condition should talk to their health-care provider about getting the adjuvanted form, Butler-Jones advised, rather than wait for the non-adjuvanted vaccine which may not be available until November.
The SOGC also backed Health Canada's earlier recommendation that pregnant women be given a prescription for antivirals to be used only if H1N1 symptoms appear. Antivirals should not be used for preventive purposes.
Women and their families should be aware of serious symptoms of H1N1, and seek emergency care if these occur.
According to the U.S. Centers for Disease Control and Prevention, emergency warning signs in children are:
- Fast breathing or trouble breathing.
- Bluish skin colour.
- Not drinking enough fluids.
- Not waking up or not interacting.
- Being so irritable that the child does not want to be held.
- Flu-like symptoms improve but then return with fever and worse cough.
- Fever with a rash.
- Difficulty breathing or shortness of breath.
- Pain or pressure in the chest or abdomen.
- Sudden dizziness.
- Confusion.
http://www.cbc.ca/health/story/2009/10/22/h1n1-vaccine-pregnant-women-sogc.html