Dangerous Batch of H1N1 Vaccine Found

(AP)  Canadian doctors have been advised not to use a batch of 170,000 doses of swine flu vaccine while authorities investigate reports of allergic reactions among recipients, drug maker GlaxoSmithKline PLC said Tuesday.

Authorities routinely monitor vaccines for any signals of problems, such as the allergic reactions that do occur, rarely, every year.

Company spokeswoman Gwenan White said that GlaxoSmithKline advised medical staff in Canada last week to refrain from using one batch of the vaccine while they look into reports that that it might have caused more allergic reactions than normal.

"One batch has seen a slightly increased rate of anaphylaxis," she said. Anaphylaxis is life-threatening type of allergic shock.

Six people in Canada had suffered an allergic reaction, said Tim Vail, the spokesman for Canada's health minister. The batch contained about 170,000 doses. It was not immediately clear how many had been administered, although Vail said the majority had been.

GlaxoSmithKline said it has distributed a total of 7.5 million doses of the vaccine across Canada.

"We're not seeing any thing wild or spooky or crazy about our vaccine at all," Vail said, arguing it may have been a statistical anomaly that the reactions occurred.

The vaccine chief of the World Health Organization, Marie Paule Kieny, said Monday that the number of people who went into anaphylactic shock after getting the vaccine in Canada was "a bit higher than normal" but that the numbers were still small. She said Canadian authorities are investigating the components of the vaccine to see if there might be a problem.

She said the problem has so far only been detected with one lot of the vaccine and that they haven't seen evidence of a higher rate of side effects with other lots.

GlaxoSmithKline, the world's second largest drug maker by revenue, is only investigating the one batch of its swine flu vaccine in Canada. White said no other doses of its swine flu vaccine around the world are affected.

White said London-based GlaxoSmithKline wrote to Canadian health care professionals advising them to stop using the batch on Nov. 18.

Canada is honoring the company's request, but urging people not to be alarmed. Dr. Joel Kettner, Manitoba's chief medical officer of health, said that allergic reactions sometimes occur shortly after inoculations, but haven't lasted long and have not led to long-term health problems.

The provincial Alberta government was also holding back the vaccine, although it had not seen a jump in reactions.

[thomderr1]

In most probability, people just checked "No" to most of the questions on the medical questionnaire handed to them before the injection. Why? They were more afraid of H1N1 than they were the side effects, simply because of all of the scares and scores of information about this strain of flu hitting them from all aspects of media - journalistic, internet and public health departments.

People must realize that most only read what they want to read, hear what they want to hear.

A quick reaction such as this, if there is a problem with the batch - should be lauded, not chided.

Such a response was unheard of when I had a reaction to the 1976 'Swine Flu' vaccination.

When I received my yearly vaccination this year, the nurse added insult to injury when she stated, "Oh, I read about that in my medical books!"

Fifty-two isn't that old!

[us_1776]

I would much prefer that the government tell us about this stuff than like in '76 when some people got sick from the vaccination and it was covered up.

Much better like this. Tell us what is happening. Knowledge is power.

[Zann-Zel]

I had my mind made up that my little grandson needed it - now I'm back at square one? I hate this! : (

[erasmus111]

by Zann-Zel November 24, 2009 11:12 AM EST
I had my mind made up that my little grandson needed it - now I'm back at square one? I hate this! : (


Oh please. Back to square one? I hardly think so. There are a few more cases of people having an allergic reaction which they think MIGHT be from a particular batch. And it's in CANADA. Get a grip.

[erasmus111]

I have heard that our vaccine is slightly different than yours. We used Europe's vaccine. We were able to get our vaccine sooner because it had already been tested. Of course Canada is also doing it's own testing.

[rocketjl]

Now where are all the articles about the N1H1 vacine being safe. Sounds as if they were a little premature and dangerous. Geeesch!!!!

[lmshaker]

GBS, Allergies, and Dystonia. Unreal....

Let's keep juicing people with mercury. That's a brilliant idea.

[CassieP205]

I don't think this is really too funny. There were 5X the expected allergic reactions immediately after the shot from this lot of vaccine.

I would like to know why the GSK vaccine took so long for approval by the FDA. Now, the US is supposed to be getting 7.5 million doses from GSK, to be delivered during December/January.

[CompletelyFrustrated]

It did not take long at all - they bullied through just like the Gardasil vaccine that was causing serious reactions in girls, you do not see that in the news either!

They are pushing these out without adequate testing or allergy warnings.

My MD will not give these vaccines.

[CassieP205]

CompletelyFrustrated, we're talking about two different things. First, I agree with you that the process was rushed and clinical trials were totally inadequate.

But, I was talking about something very funky happening with FDA approval. Four of the vaccine producers (Novartis, Sanofi Pasteur, MedImmune and CSL) received FDA approval for their vaccines on Sept. 15th. Glaxo did not, and the FDA refused to say why. Glaxo didn't receive FDA approval until Nov. 10th, which is why none of their vaccine will be in the US until December. Of course in Nov., there was increasing pressure for the govt. to get more doses out.

So, I'd like to ask what the FDA knew about Glaxo production back in September that they refused approval? Could political pressure have played a role in the FDA's change of mind in November?

I'd love to see Sharyl Attkisson check this out with her sources BEFORE the 7.5 Glaxo doses come to the US.

[mojo1372]

this is not the only time this has happened . there have been incidents of people getting very sick after the shots it is not happening alot and seem to be in radom locations . the seem to get respratory problems which would be part of a bad allergic reaction such as asthma even if you have never had it before bad allergies could bring it on . in israel they had 3 people die within two weeks of getting the shots . it could be any chemical make up of the shot that someone could be allergic too.it sound like something went wrong with the making of this batch

[I_am_me1953]

OOPS!

Someone is allergic to eggs?