Health Canada approves H1N1 flu vaccine

[Shiloh]

Source: http://www.ctv.ca/servlet/ArticleNe...1/vaccine_flu091021/20091021?hub=TopStoriesV2

Health Canada approves H1N1 swine flu vaccine
CTV.ca News Staff

Date: Wednesday Oct. 21, 2009 11:13 AM ET

CTV News has learned that Health Canada has approved the H1N1 vaccine, meaning the first Canadians to receive the shot could be vaccinated as early as the end of the week.

Two million doses of the vaccine have already been shipped to the provinces and territories, but health officials had to wait for regulatory approval before they were able to give the go-ahead.

All Canadians can access the vaccine, unlike in the United States, which so far has only about 40 million doses for a population of 300 million.

Federal officials in Canada meanwhile have ordered 50.4 million doses of the vaccine, which contains an adjuvant, a compound that will boost immune system response and that Canada has never approved before in a flu vaccine.

Another 1.8 million doses of the vaccine without the adjuvant are also on the way, though the timing of when that will be available remains unclear. That vaccine must be manufactured, packaged and shipped separately.

Canadian clinical trials of the vaccine are still underway, and the results won't be available until next year. So federal health authorities have relied on data from clinical trials done on the same vaccine in Europe. Those trials have found the vaccine safe.

The adjuvant used in Canada's swine flu vaccine, AS03, has also been tested in about 45,000 people around the world using a "mock" H5N1 vaccine. No significant safety concerns were detected, Health Canada reports.

The Canadian clinical trials are focused on determining the safety and effectiveness of the vaccine in select population groups, such as First Nations, people who are HIV positive, children and pregnant women.

Because some reactions from vaccines are so rare they arise in only one in a million cases, the final picture of the vaccine's safety won't be clear until after the immunization program is underway

Dr. David Butler-Jones, Canada's chief public health officer, says that while pregnant women are encouraged to receive the vaccine without the adjuvant, the vaccine with adjuvant is still considered safe for expectant mothers.

While there have been few studies of adjuvanted flu vaccine on pregnant women, the risks are only theoretical, whereas the risk of swine flu to pregnant women are real and significant, Butler-Jones has said.

"The risks to pregnant women from contracting H1N1 are much, much higher than any theoretical risk posed by adjuvanted vaccine," he said earlier this week.

About 4,700 people worldwide have died of H1N1 to date, including 83 deaths in Canada.

The Public Health Agency of Canada says everyone aged six months and older should get the vaccine, but those who will benefit most and those who care for them include:

* People under 65 with chronic health conditions
* Pregnant women
* Children aged six months to less than five years
* People in remote and isolated communities
* Health care workers involved in the delivery of essential health care services
* Household contacts and care providers of persons at high risk who cannot be immunized

The vaccine will be distributed by the provinces and available through flu clinics offered by local health units.

 

[Pathfinder]

Re: Health Canada approves H1N1 flu vaccine

Feds approve swine-flu vaccine, shots to begin in days

By: Steve Rennie, THE CANADIAN PRESS
21/10/2009 2:24 PM |

A tray of influenza vaccine is seen in the medical center for the Bayer Corporation's U.S. headquarters near Pittsburgh, Pa.

OTTAWA - Canada's largest-ever immunization campaign is ready to go now that the federal government has approved the swine-flu vaccine.

Health Minister Leona Aglukkaq announced Wednesday the vaccine has been approved for use in Canada, allowing provinces and territories to proceed with H1N1 flu shots as soon as possible.

"We now have a safe and effective vaccine being distributed to provinces and territories that they will be rolling out in a matter of days," Aglukkaq told a news conference.

"I encourage all Canadians to get vaccinated because it is the best way to protect our health and the health of our loved ones."

Other countries have already begun vaccinations.

In Canada, priority for the swine-flu shot has been given to pregnant women, health workers, young children, people living in remote places, and adults with chronic conditions - the groups most vulnerable to the H1N1 virus.

Local health authorities will ask people at lower risk to hold off on getting the swine-flu shot until people at higher risk get it. But Canada's chief public health officer, Dr. David Butler-Jones acknowledged the vaccinations are "not a rationing exercise" and no one will be turned away.

"We're not going to spend a lot of time trying to go through people's medical history. We want to get as many people immunized as possible," he said.

"I think Canadians have shown, time and time again, their respect for the most vulnerable."

The vaccine needed regulatory approval before the federal government could give the provinces and territories the green light to start the H1N1 flu shots.

Ottawa has agreed to shield drug companies from lawsuits over the H1N1 pandemic vaccine.

That means the federal government, not the vaccine manufacturers, would have to pay any damages awarded in court. That doesn't apply to cases of malpractice.

Quebec is the only province with a no-fault compensation plan for harmful side-effects resulting from immunizations.

Canadian clinical trials of the vaccine are still underway, the federal regulator was satisfied with the results of clinical trials in Europe.

"This authorization was arrived at independently and on the basis of sound health science," said Dr. Elwyn Griffiths, head of the Health Canada section that certifies the safety of vaccines.

"This vaccine is both safe and effective."

Butler-Jones added tests have shown people are more than 90 per cent immune to swine flu after a single shot.

Two million doses of the swine-flu vaccine had already been shipped to the provinces and territories and they had been awaiting Aglukkaq's go-ahead.

The government aims to ship about three million doses a week as the vaccine rolls off the production line.

Pharmaceutical giant GlaxoSmithKline has a contract to produce 50.4 million doses of pandemic vaccine at its facility in Ste-Foy, Que.
But there are concerns about the new vaccine, which contains adjuvants or compounds that boost the immune system's response to vaccine, allowing for smaller doses.

There's currently no licensed flu vaccine containing adjuvant in Canada, although adjuvants have been used for years in Europe in flu vaccines targeted at seniors.

There are no data on the use of so-called adjuvanted flu vaccine in pregnant women, which may add to the already high degree of reluctance many pregnant women feel about taking any medication or therapy.

There is also little data on the safety of the additives in vaccines given to children.

Though it had first said it would only buy adjuvanted vaccine, the federal government later ordered 1.8 million doses of vaccine that does not contain adjuvants for pregnant women and young children. But the doses shipped this week contain adjuvants.

The unadjuvanted vaccine is expected to be ready by early November, Aglukkaq said.

National recommendations on the use of H1N1 flu vaccine have been developed based on the latest scientific evidence. The recommendations include:

-All Canadians 10 years of age and older should receive one dose of adjuvanted vaccine.
-Children from six months and up to 10 years of age should receive the adjuvanted vaccine in two half-doses, administered at least 21 days apart
-Immunization not authorized for children six months old and younger.
-Pregnant women should receive one dose of the unadjuvanted vaccine.

In cases where the unadjuvanted vaccine is unavailable and pandemic H1N1 flu rates are high or increasing in the community, women more than 20 weeks pregnant should be offered one dose of the adjuvanted vaccine.

The H1N1 vaccine can be administered at the same time as the seasonal flu shot and other vaccines, as long as the needles go into different arms.

http://www.winnipegfreepress.com/li...wine-flu-vaccine_-shots-to-begin-in-days.html