Faulty Swine Flu vaccine withdrawn in Canada (only 1 batch - # A80CA007A )

[AlaskaDenise]

British drugs giant GlaxoSmithKline has has warned the Canadian medical authorities that a batch of its anti-H1N1 vaccine can trigger potentially dangerous allergic reactions. The Canadians have withdrawn the batch from use and are testing it after it produced a range of serious reactions, notably in the heart and lungs. The recall affects 172,000 dises of the Arepanrix vaccine.

“We’ve been asked by the manufacturer GSK not to use this vaccine at this time pending further investigation,” said Manitoba chief medical officer Joel Kettner.

Thirty-six Canadians, including one little boy whose face swelled up like a balloon, suffered severe allergic reactions after vaccination. 200 others died.

“It is a serious thing that has the potential to kill – but fortunately seems to be relatively rare,” said Dr Neil Rau, an infectious disease specialist.

Canada has been particularly badly hit by the flu virus, and has vaccinated around a fifth of its population, or nearly seven million people, already. GSK has sold seven point five million doses to Canada

http://www.euronews.net/2009/11/24/faulty-swine-flu-vaccine-withdrawn-in-canada/

[AlaskaDenise]

Re: Faulty Swine Flu vaccine withdrawn in Canada

170,000 Doses of Glaxo H1N1 Vaccine Pulled in Canada After Allergic Reactions

Canadian health providers have been advised not to administer about 170,000 doses from the same batch of a GlaxoSmithKline PLC H1N1 swine flu vaccine after six reports of recipients developing severe allergic reactions.

Company officials monitoring reports of side effects, including allergic reactions, associated with the vaccine alerted Canadian doctors last week and told them to avoid administering doses from the batch, according to the Associated Press.

Health officials in the United States recently announced that some people given the H1N1 vaccine have developed Guillain Barre syndrome, a potentially fatal muscle disorder that can result in paralysis. From October 6 through November 11, 2009, the Centers for Disease Control and Prevention said there were six confirmed cases of GBS in H1N1 vaccine patients. Thousands of others have suffered other adverse reactions, including skin rashes and allergic reactions, officials said.

In Canada, officials said it is likely that most of the doses in the batch linked to serious allergic reactions have already been administered. Glaxo is only looking into the reports from the single batch distributed in Canada and said no other doses of its swine flu vaccine given around the world are affected.

Glaxo sent a letter to Canadian healthcare professionals on Nov. 18 advising them not to administer doses from the targeted batch. More than seven million doses of the vaccine have been distributed in Canada, according to the AP.

http://www.attorneyatlaw.com/2009/11/170000-doses-of-glaxo-h1n1-vaccine-pulled-in-canada-after-allergic-reactions/

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[Boneset]

Re: Faulty Swine Flu vaccine withdrawn in Canada (only 1 batch)

Hi AD. Post #1. Last sentence, third paragraph '200 others died'. Surely not?

[AlaskaDenise]

Re: Faulty Swine Flu vaccine withdrawn in Canada (only 1 batch)

Company checking one batch; Canadian health agency says no cause for alarm
Posted: 11/24/2009

LONDON (AP) ? A drug company is telling Canadian doctors to stay away from a batch of swine flu vaccine while authorities check reports of severe allergic reactions.

A spokeswoman for GlaxoSmithKline says the company issued that request after word that a batch of the vaccine may have led to "a slightly increased rate" of life-threatening allergic reactions.

The Canadian health ministry says six people in Canada have had allergic reactions. The batch in question contains about 170,000 doses.

The World Health Organization's vaccine chief confirms the number of people who went into anaphylactic shock after getting the vaccine in Canada was "a bit higher than normal."

But a spokesman for Canada's health minister says there doesn't appear to be a major cause for alarm. As he put it, health officials aren't seeing anything "wild or spooky or crazy" about the vaccine. He says the reports may be a statistical anomaly.

http://www.9and10news.com/category/story/?id=186296

[AlaskaDenise]

Re: Faulty Swine Flu vaccine withdrawn in Canada (only 1 batch)

Hi AD. Post #1. Last sentence, third paragraph '200 others died'. Surely not?

That data is not being repeated in other related news stories, so I am assuming that number is NOT related to the faulty vaccine, but rather total deaths from H1N1.

.

[AlaskaDenise]

Re: Faulty Swine Flu vaccine withdrawn in Canada (only 1 batch)

Batch of swine flu vaccines studied in Canada
By MEERA SELVA (AP) – 2 hours ago

LONDON — 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.

http://www.google.com/hostednews/ap/article/ALeqM5iAS-zirig_lx530YTbjBLdH5jAYQD9C61CQG3

[Boneset]

Re: Faulty Swine Flu vaccine withdrawn in Canada (only 1 batch)

Thanks AD

[AlaskaDenise]

Re: Faulty Swine Flu vaccine withdrawn in Canada (only 1 batch)

To put the 6 cases of reactions into a proper context, see...

Causes
Anaphylaxis is a severe, whole-body allergic reaction. After an initial exposure "sensitizing dose" to a substance like bee sting toxin, the person's immune system becomes sensitized to that allergen. On a subsequent exposure "shocking dose", an allergic reaction occurs. This reaction is sudden, severe, and involves the whole body.

Hives and angioedema (swelling of the lips, eyelids, throat,or tongue) often occur. Angioedema may be severe enough to block the airway. Prolonged anaphylaxis can cause heart arrhythmia.

Anaphylaxis can occur in response to any allergen. Common triggers include insect bites or stings, food allergies, and drug allergies. Pollens and other inhaled allergens rarely cause anaphylaxis. In ophthalmology, the dye fluorescein used in some eye exams is a well-known trigger. Some people have an anaphylactic reaction with no identifiable cause, in which case the anaphylactic reaction is said to be idiopathic.

Some drugs (polymyxin, morphine, x-ray dye and others) may cause an "anaphylactoid" reaction (anaphylactic-like reaction) on the first exposure.[9] This is usually due to a toxic reaction, rather than the immune system mechanism that occurs with "true" anaphylaxis. The symptoms, risk for complications without treatment, and treatment are the same, however, for both types of reactions. Some vaccinations are also known to cause "anaphylactoid" reactions.[10] Antitoxins and antivenins may cause similar reactions. In certain individuals, strenuous physical activity can induce anaphylaxis.

Due in part to the variety of definitions, between 1% and 15% of the population of the United States can be considered "at risk" for having an anaphylactic reaction if they are exposed to one or more allergens, especially penicillin and insect stings. Most of these people successfully avoid their allergens and will never experience anaphylaxis. Of those people who actually experience anaphylaxis, up to 1% may die as a result.[3] Anaphylaxis results in approximately 1,500 deaths per year in the U.S.[4] (one out of every 1,600 of the 2.4 million deaths from all causes each year in the U.S.;[5]).

http://en.wikipedia.org/wiki/Anaphylaxis#Causes

[AlaskaDenise]

Re: Faulty Swine Flu vaccine withdrawn in Canada (only 1 batch)

Fear over H1N1 vaccine recall in Canada: What are the FDA-approved H1N1 vaccines in the U.S.?

GlaxcoSmithKline have recalled a batch of approximately 170,000 H1N1 vaccines in Canada due to a number of allergic reactions in people; although the Canadian government has stated that there is no cause for alarm, and only one batch of the H1N1 vaccine is being held back, there are conflicting reports over how serious the allergic reactions may have been. The batch in question is no longer in use, under advice health care officials in Canada received on November 18th from GlaxoSmithkline in the U.K, and other batches of the H1N1 vaccine are so far unaffected. The affected batch was released at the end of October 2009.

An associated press report stated that H1N1 vaccines in the rest of the world were unaffected by the incident. There are a number of H1N1 vaccines approved for use around the world, five of which are currently FDA-approved for use in the U.S.

H1N1 FDA- approved vaccines

Reports surrounding the H1N1 vaccine ingredients have been mixed and confusing; many pregnant women are concerned about taking the H1N1 vaccine because of reports in miscarriages and the effect of the thimerosal ingredient (a mercury preservative) found in some H1N1 vaccines. The FDA-approved H1N1 vaccines in the U.S. are:

H1N1 Monovalent Vaccine (Sanofi Pasteur, Inc.) - injectable
H1N1 Monovalent Vaccine (CSL Limited) ? injectable
H1N1 Monovalent Vaccine (Novartis Vaccines and Diagnostics Ltd) ? injectable
H1N1 Monovalent Vaccine (ID Biomedical Corporation of Quebec) ? injectable
H1N1 Monovalent Vaccine (MedImmune LLC) ? intranasal.

Warnings for pregnant and nursing mothers taking the H1N1 vaccine

Pregnant and nursing mothers should refer to the package inserts and warnings to determine the full ingredients of a particular H1N1 vaccine before making a decision to have the H1N1 vaccine.

http://www.examiner.com/x-20361-Womens-Health-Examiner~y2009m11d24-Fear-over-H1N1-vaccine-recall-in-Canada-What-are-the-FDAapproved-H1N1-vaccines-in-the-US

[cartski]

Re: Faulty Swine Flu vaccine withdrawn in Canada (only 1 batch)

Consent form in MB for the vaccine:

http://www.gov.mb.ca/health/publichealth/sri/docs/consent_form.pdf

Adverse event report form from vaccine:

http://www.gov.mb.ca/health/publichealth/sri/docs/aefi_form.pdf

Last MB news release on H1:

http://news.gov.mb.ca/news/index.html?archive=&item=7220

and note....

"As of Nov. 16 in Manitoba, there have been seven serious adverse events following immunization, which have been reported to the Public Health Agency of Canada (PHAC). Five of the serious adverse events have been confirmed as anaphylaxis, a serious and immediate allergic reaction to the vaccine. A total of 88 adverse events have been reported.

At this time, two deaths are being investigated of people who died within seven days of receiving the H1N1 flu shot. Both individuals were adults between the ages of 18 and 64. Early indications are the immunizations were not likely the cause of death in either case and the investigations are continuing."

[Pathfinder]

Re: Faulty Swine Flu vaccine withdrawn in Canada (only 1 batch)

Winnipeg Free Press - PRINT EDITION
Nothing to link deaths to vaccination: doctor

Nearly a quarter-million Manitobans immunized

By: Bruce Owen
20/11/2009


The provincial medical examiner's office is continuing to investigate two recent deaths of people who died within seven days of getting the H1N1 flu vaccine, Manitoba's chief public health officer said Thursday.But Dr. Joel Kettner said health officials believe it's likely neither died from the immunization.

"We're not going to presume, no matter what they died from, that they did not die from something related to the vaccine," Kettner said. "But from what I know about these two deaths, it doesn't look like there's anything in these stories that (points to) the vaccine."

Despite the ongoing medical investigations, one family is concerned their loved one fell ill and died four days after she and her daughter got the H1N1 vaccine.

Soo-Lee Wong, a 38-year-old diabetic, was vaccinated Nov. 5 and died in hospital Nov. 9. Her funeral was Monday.

Following the service, her brother, Steve Wong, said his sister got a fever a short time after getting the vaccination and went to an urgent care centre for help.

He said his sister was treated with Tamiflu, but became progressively sicker. Her young daughter, Angela, also fell ill and is being treated in hospital.

He said he remains in contact with the medical examiner's officer, which has so far ruled out the H1N1 shot as causing her death. Results of further tests are pending.

Wong's husband, Hoan Truong, told a TV news crew doctors believe his wife, an accounting supervisor at Manitoba Lotteries, died of a blood infection.

Kettner said he could not comment on Wong's death and her daughter's case.

He said on average 30 people die in Manitoba each day. With almost a quarter of a million Manitobans vaccinated to date, having two people die within a week of getting the shot is not alarming, he added.

"I'd be surprised if there wasn't an overlap of one week between getting the vaccine and dying of a whole variety of causes," he said. "In fact, I could even statistically probably show that based on the number of people we vaccinate every week (61,651 Manitobans in past week) how many by pure coincidence would be expected to die during that week after they got the shot."

Kettner said if the two deaths were related to the H1N1 vaccine he would announce it in the same way the province is announcing adverse or anaphylactic reactions to the H1N1 vaccine.

Globally, there have been about 40 deaths worldwide among people who have recently been vaccinated against pandemic H1N1 influenza, but there is no evidence the deaths are related to the vaccine, officials from the World Health Organization said Thursday.

At least 65 million people have been vaccinated, and it is inevitable that there will be some deaths among such a large group, said Dr. Marie-Paule Kieny, director for the Initiative for Vaccine Research at the WHO.

Although some investigations are still ongoing, she said at a news conference in Geneva, "results of the completed investigations reported to WHO have ruled out that the pandemic vaccine is the cause of death."

She said fewer than a dozen suspected cases of Guillain-Barre Syndrome have been reported following vaccination.

"Only a few of these Guillain-Barre cases may be linked to the pandemic vaccine," she said. "Illness has been transient and patients have recovered."

Guillain-Barre has been a particular concern because many cases occurred during the 1976 swine flu vaccination campaign, although none were definitively linked to the vaccine. That has led to the belief in some quarters that the vaccine is worse than the illness.

Overall, she said, the WHO has received reports of one adverse event for every 10,000 doses of vaccine. Among those reports, five out of 100 have been for serious events, for an overall rate of five serious events for every one million vaccinations.
Many of those events were allergic reactions among people with unsuspected allergies to eggs.

http://www.winnipegfreepress.com/local/nothing-to-link-deaths-to-vaccination-doctor-70604007.html?viewAllComments=y

[Pathfinder]

Re: Faulty Swine Flu vaccine withdrawn in Canada (only 1 batch)

Canada stops use of one batch of flu vaccine

Mon Nov 23, 2009 12:55pm EST

WINNIPEG, Manitoba (Reuters) - Some Canadian provinces have stopped using a particular batch of the H1N1 flu vaccine after six people experienced severe allergic reactions, the country's health agency said on Monday.

The Public Health Agency of Canada and vaccine manufacturer GlaxoSmithKline Plc have asked the governments of Manitoba, British Columbia, Alberta, Saskatchewan, Ontario and Prince Edward Island -- nearly half the country's 13 provinces and territories -- to stop using a batch of 172,000 doses.

Six allergic reactions from that size of a batch is a higher percentage than usual, said a spokeswoman for the Public Health Agency. Overall, the number of severe allergic reactions following H1N1 vaccinations is less than 1 per 100,000 doses, the norm for other vaccines.

All six people who experienced the allergic reactions have recovered, the spokeswoman said.

Manitoba received 63,000 doses of the vaccine batch and has only 930 left, a spokeswoman for the provincial health department said. Health officials have now placed all the remaining doses in storage.

People who were vaccinated from that batch have no reason for concern if they did not suffer an immediate allergic reaction, she said.

http://ca.reuters.com/article/domest...5AJ3GZ20091123

[cartski]

Re: Faulty Swine Flu vaccine withdrawn in Canada (only 1 batch)

Consent form in MB for the vaccine:

http://www.gov.mb.ca/health/publichealth/sri/docs/consent_form.pdf

Manitobans fill out the above form. The nurse fills in the remaining parts and puts a sticker on it. The sticker has 3 numbers on it: a batch number and separate lot numbers for the vaccine and adjuvant. The form is given to an attendant when exiting the clinic.

So unless a very prudent person wrote down the numbers on a separate piece of paper, and assuming GSK has released somewhere the recalled batches, Manitobans, at least those in Winnipeg, won't know whether or not they got the recalled vaccine.

However, the patient's name and address was taken, so presumeably we'd be notified if something really scary was going on.

J.

[AlaskaDenise]

Re: Faulty Swine Flu vaccine withdrawn in Canada (only 1 batch)

Japan to Study Glaxo?s Canadian Swine Flu Advice, Asahi Says

By Kanoko Matsuyama

Nov. 24 (Bloomberg) -- Japan?s health ministry will investigate advice by GlaxoSmithKline Plc for Canadian authorities to hold off on using a batch of its swine flu vaccine, the Asahi newspaper said.

Japanese officials will travel to Canada to study the decision by early next month, the newspaper reported, citing Japan Health Minister Akira Nagatsuma.

Glaxo said yesterday Canadian doctors should hold off on using a batch of the vaccine while the company probes reports of higher-than-expected occurrences of a side effect known as anaphylaxis. The batch of 172,000 doses of Arepanrix was linked to more cases of acute allergic reactions, including swollen tongues, throats and respiratory distress, than is expected, spokeswoman Gwenan White said.

There?s no change to Japan?s plan to import Glaxo?s flu vaccine to cover 37 million people in the year ending March, a Glaxo spokesman Yoshiaki Komatsu in Tokyo said by telephone today. A patient study under way locally hasn?t shown any serious side effects, he said.

To contact the reporter on this story: Kanoko Matsuyama in Tokyo at kmatsuyama2@bloomberg.net.

Last Updated: November 23, 2009 20:41 EST

http://www.bloomberg.com/apps/news?pid=20601082&sid=aAEUTJo_Vn88

[AlaskaDenise]

Re: Faulty Swine Flu vaccine withdrawn in Canada (only 1 batch)

GSK says still no answer on whether H1N1 vaccine batch triggers more reaction

By Helen Branswell Medical Reporter (CP) ? 1 hour ago

TORONTO ? The investigation into whether a batch of H1N1 vaccine may have triggered a higher-than-normal rate of allergic reactions hasn't yet come up with answers, vaccine manufacturer GlaxoSmithKline said Tuesday.

And health officials in Quebec said they are still trying to determine if the death of an elderly man who died of anaphylaxis after receiving a pandemic flu shot was triggered or hastened by the vaccination.

"Investigations being undertaken by GSK, Health Canada and the Public Health Agency of Canada (PHAC) have not yet been completed," GSK spokesperson Megan Spoore said in an email about the pulled batch of vaccine.

The lot, No. A80CA007A, comprised 172,000 doses of vaccine that were shipped last month to British Columbia, Alberta, Saskatchewan, Manitoba, Ontario and Prince Edward Island.

Quebec did not receive vaccine from the batch under investigation.

After discussions with Health Canada, which regulates vaccines, GSK told provinces last week not to use any more doses from this lot after it came to light that six cases of anaphylaxis had been reported in people who had H1N1 shots from the batch.

The event is raising a lot of questions. Here are some answers:

Q: What is anaphylaxis?

A: Anaphylaxis is a severe allergic reaction that in extreme cases can lead to death. Marked by sudden onset, the reaction can produce hives, cardiovascular problems and swelling of the tissues in the mouth and airways that can compromise breathing.

True anaphylaxis has to meet an internationally accepted diagnostic criterion called the Brighton collaboration case definition. It must involve at least two organ symptoms - in other words, some combination of reactions involving the skin, heart and respiratory systems.

Q: What causes anaphylaxis?

A: Anaphylaxis is an allergic response to exposure to an allergen, a non-pathogenic (i.e. not a germ or a fungus) substance that's capable of triggering a response from the immune system. For some people, pollen is an allergen. For others, peanut protein is.

Why some people are allergic to some things and others are not isn't clear. But when a person with an allergy encounters the specific allergen, his or her immune system generates a type of antibodies that trigger the release of histamines into their system, says Dr. Scott Halperin, a vaccine expert at Dalhousie University. Histamines induce the response.

Q: How is anaphylaxis treated?

A: True anaphylaxis is treated with epinephrine (adrenaline). That's the stuff in EpiPens carried by people with life-threatening allergies.

Q: Are there any doses of this suspect batch of vaccine left?

A: By the time GSK issued the halt-use order last week, all but about 20,000 doses of the batch had been used, a spokesperson for the Public Health Agency of Canada says.

Q: So that's about six cases of anaphylaxis out of about 152,000 shots given. Is that unduly high?

A: GSK said in a statement Tuesday that the expected rate of anaphylactic reactions to flu shots is in about one in 100,000.

Q: Is anaphylaxis a reaction seen with other vaccines or just flu shots.

A: "Any time you immunize somebody with something, there's always a chance of an allergic reaction," says Dr. John Treanor, an influenza vaccine expert at the University of Rochester in New York.

And if you vaccinate millions? "Some people are going to have anaphylaxis, absolutely," Treanor says.

Halperin says the rate of anaphylactic reactions will vary depending on the type of vaccine used and the age of the people the vaccine is being given to.

It can even vary by location. Australia saw higher than expected rates of anaphylaxis when it rolled out its HPV vaccine campaign - about 2.6 cases per 100,000 shots, according to one study. But those elevated rates weren't seen in North America.

Q: Why do some people have allergic reactions to vaccines?

A: "For most times people have anaphylaxis, you don't know exactly what it is. And vaccine is a complex mixture," Halperin says.

Most flu vaccine - and all the flu vaccine used in Canada - is produced in eggs. If there was residual egg protein in the vaccine it could trigger an allergic response in people with egg allergies, he says.

With the combined measles, mumps and rubella vaccine, reactions have occurred that are believed to be due to an antibiotic that is used in the production process, Halperin says.

Q: Why would one batch of vaccine produce more reactions than others?

A: Treanor says that's a difficult question to answer.

"It's hard for me to think of what the mechanism would be for a lot-specific increase in anaphylactic reactions," he says.

"The only thing that would make sense if it was really true that you were seeing with a specific batch that there were more anaphylactic reactions that there's something in that batch that's not in the other batches . . . that people tend to be allergic to."

http://www.google.com/hostednews/canadianpress/article/ALeqM5hyRQAwdPH-BPk6vy5naAkGl6ZUgw