H1N1 Vaccine and Guillan-Barre syndrome

H1N1 is not the only thing that's gone viral these days. There's plenty of links and info about "H1N1 scams", and frightening write-ups, and videos about vaccine complications. This blog has also done some investigating H1N1, and the new vaccine released to help prevent it, and hope to clarify information on the H1N1 vaccine, and add perspective.

It is not a shocker that there is a great deal of confusion and/or doubt about the safety of the current vaccine being used for the H1N1 virus. After all it is new, and there has not been a long-term clinical study done in this country on it (though that is in progress and monitoring is taking places for any serious reaction to it)[H1N1 vaccine safety might be a follow-up post to this]. Part of the concern might be rooted a in a fear of getting GBS (Guillan-Barre syndrome - a neurological disorder) after being vaccinated.

In 1976, a small swine flu outbreak at Fort Dix in the U.S. sparked a national scare, and over 40 million vaccinations were delivered. One woman, Judy Roberts, was profiled on the popular show "60 Minutes". She attributed her condition to getting vaccinated, and so had others. The impact that stories of people affected by GBS, has frightened many people about taking the 2009 H1N1 vaccine, and sparked questions about its safety. These fears should not, and have not been dismissed. Below is also a modest attempt to shine more light on it as well.

GBS is rare and happens in 1 out of a 100,000. From a read of the references below, it was assessed that during the 1976 experience, an additional 1 out of 100,000 showed symptoms of GBS. Officially, research has not concluded that the 1976 vaccine was directly linked to the cause of peoples' GBS. However, there was indeed an association. It should also be kept in mind that the flu itself can stimulate an immune system response which has been also associated with GBS.

From reading literature on this, and listening to national health specialists, this message comes through as well - that todays vaccine is more purified than that 33 years ago, and there remains only minimal risk of rare side effects (see sources and quotes below). Most of the side effects are swollen arm, redness, fever, or headache.

People will make up their own minds about getting the H1N1 vaccine, but it is good to know all the risks involved. The risk of getting a rare side effect is very small, while the risk of actually catching the H1N1 flu is growing by the day. Today on CBC Radio, Dr. Faith Stratton, NL's chief medical officer of health, said that it's likely that every community in the province has someone with the virus, even though it has yet to be diagnosed as such. Last week alone, there were 97 new cases, so it is spreading quickly, and the chances of getting infected are far greater than getting a rare disease as a side effect of the vaccine.

We are in the information age and thus can be more informed in our decisions. While it is not a complete zero risk if you get the vaccine, you will be greatly protected from the H1N1 flu. Keep in mind, that, especially if you are under 65 (those born before 1957 may have some immunity to it), you do not have any antibodies in your immune system to protect you from H1N1. We have seen mainly mild cases of the disease this year, but its second wave is now upon us and getting the vaccine will help stop its spread. In whatever decision you make, here's wishing you the best of health.

See links below of some references on H1N1 vaccine & GBS, including FAQs from Public Health Agency of Canada, WHO, and Centre for Disease Control

From the World Health Organization (WHO)

Q. How can a repeat of the 1976 swine flu vaccine complications (Guillain-Barré syndrome) experienced in the United States of America be avoided?

A. Guillain-Barré Syndrome (GBS) is an acute disorder of the nervous system. It sometimes develops following a variety of infections, including influenza. Studies suggest that seasonal influenza vaccines could sometimes be associated with an increased risk of Guillain-Barré syndrome on the order of one to two cases per million vaccinated persons. During the 1976 influenza vaccination campaign, about 10 persons per million vaccinated persons developed GBS which stopped the vaccination campaign and led to the withdrawal of the vaccine.

The reason why GBS developed in association with that specific vaccine has never been firmly established. The potential for the development of a similar risk with future vaccines can never be firmly excluded. However, the influenza A (H1N1) vaccine will be manufactured according to established standards and post marketing surveillance will be conducted to monitor potential development of any serious adverse events following administration of vaccine. Safety monitoring systems are an integral part of strategies for the implementation of the new pandemic influenza vaccines.
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Public Health Agency of Canada (FAQs on H1N1)

Q How are you going to be monitoring for adverse reactions once the vaccine is in use? What sort of reactions would be of the most concern?

Once immunization begins, the Public Health Agency of Canada (PHAC) will work with provinces and territories to produce weekly reports of all reported adverse events associated with the H1N1 flu vaccine.

This reporting will be done through two existing programs – the Canadian Adverse Events Following Immunization Reporting System (CAEFISS) and the Link goes to external site Immunization Monitoring Program-Active (IMPACT).

* Link goes to external site IMPACT is made up of a network of nurses who report on immunization adverse events observed at Canada’s major teaching hospitals; and

* CAEFISS is supported by healthcare professionals who report adverse events to their provincial/territorial public health offices, who share the information with PHAC.

Adverse events can happen with any vaccine, and we expect we will see primarily mild reactions to the H1N1 flu vaccine.

The monitoring for adverse effects from the H1N1 flu vaccine will be aggressive and tailored to seek out any potentially serious adverse events. Any serious events (including those that led to hospitalization or death) will be investigated.

Serious adverse events following immunization are rare. In any immunization campaign, from regular childhood vaccines to seasonal flu shots, the average reported rate of serious adverse events is about one for every 100,000 doses of vaccine distributed.

The majority of adverse events are minor reactions – like soreness at the injection site, or a slight fever – but sometimes, more serious events are reported. Serious adverse events are reactions that cause life-threatening illness, hospitalization, disability or death, like a severe allergic reaction, paralysis, or a seizure. These events are carefully investigated to determine if they are related to the vaccine directly, or if they were caused by an underlying health condition or some other reason.

Q. What is an adverse event?

A. An adverse event is any unwanted medical reaction following immunization.

The majority of adverse events are minor reactions – like soreness at the injection site, or a slight fever – but sometimes, more serious events are reported. Serious adverse events are reactions that cause life-threatening illness, hospitalization, disability or death, like a severe allergic reaction, paralysis, or a seizure. These events are carefully investigated to determine if they are related to the vaccine directly, or if they were caused by an underlying health condition or some other reason.

Serious adverse events following immunization are rare. In any immunization campaign, from regular childhood vaccines to seasonal flu shots, the average reported rate of serious adverse events is about one case for every 100,000 doses distributed.

Careful monitoring and prompt reporting of any adverse event after immunization are an essential part of the Government of Canada's commitment to providing a safe and effective vaccine. Reporting an adverse event does not mean that the vaccine caused harm. Careful investigation is needed to determine if the events are linked or if they are coincidental.

If there is ever an indication that a vaccine, or a specific batch or lot of vaccine, is harmful to the general population, the Government of Canada has systems in place to quickly and effectively stop or alter immunization programs.
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Globe and Mail
Here's a part that many are concerned about, GBS associated with swine flu vaccination:

Q: Should I be concerned about GBS? Also why can children under 6 months not get the vaccine for H1N1?

A: GBS (Guillan Barre syndrome) was associated with the swine flu vaccine in 1976 and never since. An association does not mean that it was caused by the vaccine, only that they were associated (like saying that umbrellas are associated with rain, doesn't mean they cause rain). The association that year was a possible increase of 1 case per 100 000 people vaccinated. Please note:

1. that is pretty small;
2. the risk of getting GBS from having natural flu infection is greater than that;
3. the risk of serious complications from the flu is much greater than that; and
4. Most cases of GBS are actually caused by infections including food poisoning.

So GBS, like the adjuvant and thimerosol, are red herrings.
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Will there be a possibility of Guillain-Barré Syndrome (GBS) cases following the 2009 H1N1 vaccine? (Centre for Disease Control)

Guillain-Barré syndrome (GBS) is a rare disease in which the body damages its own nerve cells, causing muscle weakness and sometimes paralysis. It is not fully understood why some people develop GBS, but it is believed that stimulation of the body’s immune system may play a role in its development. Infection with the bacterium Campylobacter jejuni, which can cause diarrhea, is one of the most common risk factors for GBS. People can also develop GBS after having the flu or other infections (such as cytomegalovirus and Epstein Barr virus). On very rare occasions, they may develop GBS in the days or weeks following receiving a vaccination.

In 1976, there was a small risk of GBS following influenza (swine flu) vaccination (approximately 1 additional case per 100,000 people who received the swine flu vaccine). That number of GBS cases was slightly higher than what is normally seen in the population, whether or not people were vaccinated. Since then, numerous studies have been done to evaluate if other flu vaccines were associated with GBS. In most studies, no association was found, but two studies suggested that approximately 1 additional person out of 1 million vaccinated people may be at risk for GBS associated with the seasonal influenza vaccine. FDA and CDC will be closely monitoring reports of serious problems following the 2009 H1N1 influenza vaccines, including GBS.
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Dr. Donald Low, a leading Canadian Microbiologist at Mount Sinai Hospital in Toronto, was interviewed on CBC Sunday, Oct. 25, and responded directly to the questions about GBS risk, and the current H1N1 vaccine. He said that the vaccine has been tested, is safe, and that he was aware of the 1976 swine flu and claims of GBS being associated with the vaccine. He said that it has not been proven that the vaccine caused GBS.
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Other references

Dangers of the Swine Flu Vaccine: A Conspiracy Theory?
Anti-vaccination groups have been blazing blogs with dire warnings against the vaccine and twitter is chuck-full with dubious claims of conspiracy theories. Claims range from the vaccine causing neurological disorders to reduced fertility to cancer. The problem is that this fear mongering may possibly cause more harm than the virus alone could ever do.

Reasoning

To start off, it is important to point out that the fear of a flu vaccine may not be totally baseless. In 1976, there was a similar outbreak of swine flu in Fort Dix in New Jersey that killed one US soldier. As everyone panicked in fear of a new flu pandemic, president Gerald Ford ordered mass vaccination. The threat turned out to be exaggerated and the virus never spread from Fort Dix. However, 22 million Americans were vaccinated.

This was followed by a spike in reported cases of a neurological disorder called Guillain-Barré Syndrome (GBS) which led to the death of two dozen people. The flu vaccine was blamed for this and an investigation was put together whose final verdict was that there is no conclusive data whether the spread was related to the vaccine or not.

The remaining shots were destroyed and a lot of people were left distrustful of vaccines after this incident. This has caused several problems, including a sharp increase in measles in the US and UK because parents refuse to vaccinate their children out of fear of the vaccine.

Today, anti-vaccination groups are claiming that the H1N1 vaccines in the works will cause a similar increase in GBS cases, claiming vaccines are still causing the disorder all over the world.

Context
"The vaccine is produced in fertilized eggs. This method has proven to be non-carcinogenic. Modern techniques may cause cancer, but these are not tested extensively yet so we don't use them"
But before acknowledging such a piece of information, one must look at the bigger picture. Normally, the prevalence of GBS is 1-4 in every 100,000 people around the world. "Vaccination causes an increase in the rate of GBS of no more than 1-2 persons per million," Dr. Mostafa Orkhan, director of the World Health Organization's (WHO) National Influenza Center for Egypt, told IslamOnline.net.

And it is also important to keep in mind that the flu itself may cause GBS. The 1976 case was indeed unfortunate, but health officials have much more experience now than they did back then. Clinical trials are underway right now to rule out an increase in GBS and national health systems will be on the lookout for any spikes.

"GBS takes six weeks before it can be detected. That is why the clinical trials are taking a long time. We are trying to rule out any increased susceptibility to GBS," said Orkhan.

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2009 H1N1 Flu Vaccine Safety:
Frequently Asked Questions (Public Health, Butte County, California)

Q. Is there a risk of Guillain-Barre Syndrome from the H1N1 flu vaccine, as may have happened in the 1976 Swine Flu outbreak?

A In 1976, a swine flu vaccine was associated with Guillain-Barre Syndrome (GBS), a rare disorder in which a person’s immune system damages the nerve cells, causing muscle weakness and sometimes paralysis. The risk was very small (about 1 additional case per 100,000 people who received the vaccine.) Vaccine production techniques have changed since then. Today, vaccines are highly purified to eliminate any potential contaminants. In addition, scientists use only selected viral proteins in the shots, not the entire virus, as they did in the 1970s. Scientists expect the 2009 H1N1 vaccine to have a safety profile similar to seasonal flu vaccines, which have very good safety track records.

----- Other posts related to H1N1 ------

"H1N1 - Are We Ready?" - Sept. 26

Women with Unborn Children First - Oct. 20