Batch of Canadian H1N1 vaccine recalled for severe reactions

[alexmst]

[Update on The world's largest ongoing medical experiment....]

http://www.healthzone.ca/health/new...n1-vaccine-recalled-for-severe-reactions?bn=1


Joanna Smith
OTTAWA BUREAU

OTTAWA – A batch of swine flu vaccine is being pulled back for investigation after it appeared to cause higher rates of severe allergic reactions than other lots.

GlaxoSmithKline Inc., which is producing the Canadian order of H1N1 influenza vaccine at its plant in Ste-Foy, Que., said it asked provincial and territorial health authorities Wednesday to stop using doses from a specific lot shipment distributed late last month.

"(GlaxoSmithKline) is taking this cautionary action because (the Public Health Agency of Canada) has received a higher than expected number of reports of anaphylaxis in this lot number compared to other lots," company spokeswoman Megan Spoore said in a statement. "On an ongoing basis (GlaxoSmithKline) is working with Health Canada to ensure that each vaccine lot released to the provinces and territories consistently meets quality and safety standards."

The batch under investigation by the federal government and GlaxoSmithKline bears the lot number A80CA007A brand name Arepanrix, which is the version that contains adjuvant, a chemical additive that stretches supply and boosts immunity.

Manitoba health officials say they have noticed severe allergic reactions from the batch in question at a rate of one in 20,000, which is much higher than the normal rate of one in 100,000.

A spokesman for the Ontario health ministry said 1,500 doses of this vaccine were distributed to Ontario and sent to two public health units: Perth Health Unit and Renfrew Health Unit.

"This vaccine was not administered to any persons and is being withheld until the analysis is complete," David Jensen wrote in an email Friday.

Meanwhile, federal Health Minister Leona Aglukkaq announced during Question Period in the House of Commons Friday that provinces and territories can expect to receive 4.8 million doses of the H1N1 vaccine by the end of next week.

Ontario is expected to receive 1.86 million of those doses.

That would bring the total number of doses shipped across the country by Nov. 29 to 15.3 million.

The Public Health Agency of Canada has released its first weekly surveillance report for the H1N1 influenza pandemic vaccine since the immunization campaign began three weeks ago and the data show that from Oct. 21 to Nov. 7 – when 6.6 million doses had been shipped across the country – only 36 people experienced serious adverse events including life-threatening allergic reactions called anaphylaxis and febrile convulsions brought on by high fever.

That number includes one death from anaphylaxis that is currently being investigated and which a spokeswoman for the Quebec health ministry has confirmed was an octogenarian who died in that province two weeks ago.

"With any vaccination campaign, we expect to see some cases of serious adverse events," Dr. David Butler-Jones, Canada's chief public health officer, said at a news conference Tuesday.

"They are very rare, but they are part of all mass vaccination campaigns and we expect to see a small number of them."

The rate of serious adverse events is so far 0.54 per 100,000 doses distributed, which Butler-Jones noted is less than what is generally expected for the seasonal flu vaccine.

An additional 598 milder adverse reactions were reported during the same time period. The majority of those involved nausea, dizziness, headache, fever, vomiting and swelling or soreness at the site of the injection.

There were also several reports of allergic reactions with a range of symptoms, from hives and skin rashes to tingling lips or tongue and difficulty breathing. Most of those occurred within minutes after people received their shot in the arm and staff at the flu clinics treated them right away.

With files from The Canadian Press

 

[alexmst]

How they larded H1N1 facts with fear
November 20, 2009

Joseph Hall
HEALTH REPORTER

http://www.healthzone.ca/health/newsfeatures/swineflu/article/728283

Months of dire swine flu warnings were a dangerous, disruptive cry of "wolf" for an ailment Canadian health officials knew would be a mild, manageable beast.

That's the pointedly caustic judgement of Dr. Richard Schabas, a one-time provincial health officer who says flu experts knew in July that H1N1 would hold little threat for Canadians this fall.

Schabas, now Medical Officer of Health for Hastings and Prince Edward Counties, says many of his colleagues fed a credulous media with worst-case warnings while downplaying the flu strain's relative weakness.

"I think the media has to get its head around just how massive an overplay this was. I am quite sure that there has been more high-level coverage of this than all other health stories combined."

By the time this second H1N1 wave peters out in December, it will have killed between 200 and 300 Canadians – making it one-tenth as lethal as the seasonal flus that strike the country annually.

What's more, Schabas says, evidence from the southern hemisphere, where the flu is a spring and summer scourge, conclusively anticipated this comparatively low death toll.

In particular, H1N1's May and June run through Australia, which mirrors Canada in its health care capabilities, showed the virus was a temperate one.

"By their measures, things like physicians' visits and the like, this was no different than a usual flu year," says Schabas of the Australian experience. "In fact, it was milder."

But even after its terrifying Mexican debut in April, where it was blamed for hundreds of deaths, health officials knew that H1N1 had no apocalyptic potential.

"Within about a week of the first stories out of Mexico, it was becoming clear that the death toll (there) was in the order of hundreds, not tens of thousands," Schabas says.

"And a mild pandemic in Mexico would be expected to kill 30,000 people."

Schabas says accumulating evidence of the ailment's mildness indicated conclusively by early July that it posed no pestilential threat.

Schabas also contends there was no evidence the virus was capable of rapid mutation, of morphing into a more lethal strain.

That the disease appeared to be targeting the young was worrisome to many and gave credence to the ominous public health pronouncements.

But this too was a canard, says Schabas, who argues that young people are always more apt to catch influenzas and that the incidence of H1N1 appeared higher among them largely because many elderly people had pre-existing immunity and didn't get sick.

As with almost any flu, however, young people's robust immune systems are able to fight off the infection in the vast majority of cases, Schabas says.

And the tragic death of 13-year-old Toronto hockey player Evan Frustaglio, which galvanized the nation's attention on the disease, did not warrant the ensuing panic.

While mortality rates among people 20 and younger in Canada will be slightly higher than in a normal flu season, the actual number of deaths among healthy youngsters will be in the range of just seven, Schabas says.

"The risk of a young person being killed by a car in Ontario ... is 100 or more times higher than the risk of being killed by H1N1."

Finally, Schabas argues, public health officials have cried wolf many times in the recent past, with bird flu, West Nile and flesh-eating disease warnings. Even SARS killed just 800 people worldwide, he says, when deaths in the tens of millions were being forecast. Such "fear mongering" undermines their credibility.

Schabas says there is a growing medical consensus that some apocalyptic plague is lurking out there – in a Chinese poultry farm or an African jungle – just itching to swoop down on humanity. But all such fears have proven false in the past and are unlikely to be warranted in the future.

"For the past five or six years, lots of public health officials, nationally, provincially, internationally, have been warning people about the dreaded bird flu pandemic. It hasn't happened, it hasn't killed anybody in the Western hemisphere."

A proper media role, Schabas says, is to remind health officials of their past pronouncements and to throw a blanket of scepticism over future pandemic fires.

And any hyperventilating coverage of an H1N1 "third wave" – predicted for the spring – would be a sham, Schabas says.

"They (health officials) sound like burnt-out surfers sitting on a beach, watching the waves go in and out and arguing the next one will be better".

 

[Medman52]

"I think the media has to get its head around just how massive an overplay this was.

I have always maintained, one way to stay healthy (physically and mentally) is to stop watching and listening to news programs. Or at least take with a healthy "grain of salt".

 

[lynxguru]

Severe Reaction

A neighbor's daughter became seriously ill this week hours after being vaccinated. Still is quite ill.

 

[Cycleguy007]

More Media Hype!

OTTAWA – A batch of swine flu vaccine is being pulled back for investigation after it appeared to cause higher rates of severe allergic reactions than other lots.

"This vaccine was not administered to any persons and is being withheld until the analysis is complete," David Jensen wrote in an email Friday.

Why even write the story? Or why not lead OFF with this little tidbit! The media "reporting" IMHO sucks! THEY are responsible for most of the hype surrounding this and every other news story these days!

I have always maintained, one way to stay healthy (physically and mentally) is to stop watching and listening to news programs. Or at least take with a healthy "grain of salt".

Totally agree with this statement Medman!

As well as eating properly and exercising daily and maintaining proper hygiene of course. ;-)

 

[The Oracle]

I can't pick up a paper these days without seeing some sort of story on H1N1. It's sickening (no pun intended). There's so many other newsworthy stories out there to report.

 

[Malibook]

By the time this second H1N1 wave peters out in December, it will have killed between 200 and 300 Canadians – making it one-tenth as lethal as the seasonal flus that strike the country annually.

If this is true, the vaccine was way too late and likely saved very few lives.
I was on the fence before but now at this point there is no way I am getting the vaccine.
Perhaps it will be required one day but apparently not today.

 

[landscaper]

If this is true, the vaccine was way too late and likely saved very few lives.
I was on the fence before but now at this point there is no way I am getting the vaccine.
Perhaps it will be required one day but apparently not today.

This is Schabass's theory no more provable than the one that says the flu will reappear in the spring/summer. Who is correct will be seen at thtat point. The rest of the article is correctr in my opinion.

Assorted people and govt groups and lobbies ramped up the panic on this way past the reasonable point. The media needing a headline cooperated in their ussual " its not our fault we just report it method".

This version of the flu is a mild form deaths to this point are at about 10% of the seasonal flu level. A quick check of the Australian results would have confirmed that .

There was a companion article by Dr Low of Mt Sinai hospital a virologist of note. His responce was that it is better to be a little over the top than not prepared at all. Again there are some points in the article I agree with , yes inform the people get together with the public health personal and INFORM THE PEOPLE. Scaring the hell out of everybody is not informing them.

 

[Rantsalot]

...

Oh wow. You mean the media is causing and infusing hysteria again.....LOL

You don't say.

 

[blackrock13]

If this is true, the vaccine was way too late and likely saved very few lives.
I was on the fence before but now at this point there is no way I am getting the vaccine.
Perhaps it will be required one day but apparently not today.

yet how will it effect the next wave and it will come. 50% of the population has been inoculated by weeks end and that's good thing.

"This vaccine was not administered to any persons and is being withheld until the analysis is complete," David Jensen wrote in an email Friday.

i didn't understand this statement either CG.

 

[alexmst]

yet how will it effect the next wave and it will come. 50% of the population has been inoculated by weeks end and that's good thing.

"This vaccine was not administered to any persons and is being withheld until the analysis is complete," David Jensen wrote in an email Friday.

i didn't understand this statement either CG.

The bad batch was distributed and administered to people in Manitoba. It was distributed but not yet administered to people in Ontario.

 

[jiiimmm]

i just got my H1N1 shot today, I'll let you know how it goes.