Is the H1N1 swine flu vaccine safe?

In 1976, the United States started one of the most massive vaccination campaigns in modern history to avert the emergence of a swine flu pandemic. It was also one of the biggest public health clusterfoots in history.
H1N1/Swine Flu Virus

H1N1/Swine Flu Virus

After all was said and done in 1976, 46 million people were vaccinated against the swine flu virus and 4,000 people developed Guillain-Barre syndrome (GBS), a neurological disease that can lead to paralysis or even death. To be fair, the "GBS and mortality" rate attributed to the swine flu vaccine was less than .01% but try telling that to the people who got paralyzed or died.

What was disturbing in 1976 and today is the speed by which the H1N1 vaccine was developed and rushed to market. Certainly medical and scientific advances today could explain the speed by which the current vaccine has been developed but the lack of a detailed public explanation how this was accomplished is not inspiring confidence. As a result a Consumer Reports poll shows that only 35% will surely get the H1N1 flu shot. Whatever the news is - good or bad, people would like to know the story behind the outbreaks and vaccine approval process.

CBS 60 Minutes Episode the 1976 Swine Flu Epidemic
by Dianequiose-4

Earlier in this year's outbreak the CDC was publishing information on swine flu including hot spots, primary causes of death and so forth. They also stopped testing suspected cases to positively identify H1N1. All very good information but the CDC stopped issuing the daily and weekly updates that had specific epidemiological details. While I am not prone to conspiracy theories, I am beginning to wonder why CDC stopped publishing the crucial information.

I think the public would like to know where the outbreaks have been occurring, how many confirmed cases there are, what is the demographic and epidemiological data, and what were the actual causes of death among swine flu victims. Was swine flu the primary cause of death or did a secondary infection such as pneumonia kill the victims?

There is also a veil of obfuscation on how the clinical trials were conducted and the results thereof. Having looked around, I can't find the details much less who led the clinical trials, how they were conducted and the processes by which swine flu vaccines were fast tracked and approved. Who were the drug companies involved? Who were the principal investigators? Did the principal investigators stand to financially gain from the results of their work? Was there a potential conflict of interests? Was there close and direct government oversight of the process?

Thimerosal is a vaccine preservative that is alleged to be linked to autism though there have been no conclusive studies to suggest support the link. I have spoken to families that are concerned about thimerosal preserved vaccines and they have a right to know if the H1N1 vaccines are ALL preserved with thimerosal. There have been reports that some batches of vaccines are preserved with thimerosal and some that don't have the mercury-based preservative. Will people have the option of taking one over the other?

If there is any one time or reason that the government needs to be 100% transparent to the country, it is now and it should be about everything related to swine flu. Everybody seems to be saying TRUST THE GOVERNMENT but it's hard to trust the H1N1 vaccination campaign if all swine flu information is not fully disclosed to the public. Given the full information, I believe people will make the right decisions for themselves and their families.

On the other side of the equation, there has been information given by medical professionals. A good basic FAQ can be found in WebMD's site. What the FAQ doesn't answer are the specifics of who conducted the clinical trials and who financially benefits. The WebMD article also tries to answer some questions about the 1976 episode. Another reader sent in very good virology links.

The other important point to make is so far despite all the deaths from H1N1, it seems that the H1N1 flu is no more virulent or deadlier than the common flu.

Final point - I am not advocating that people should not take the H1N1 flu shot. I am advocating for full disclosure about everything about the vaccine --- who conducted the clinical trials; who's making money on this; options for mercury free vacines; where the disease hot spots are; etc... I am NOT looking for 3 paragraph press reports from Novartis or the CDC. I want the the FULL information. As a reader points out, there are hundreds of press reports of a Novartis clinical trial on 100 patients. That's not what I am looking for. I want to know who conducted them, the protocols, the source of the virus sample, dosing, etc...

It's about informed consent. I am not a fan of blind consent.

So if anyone out there has some links to data and clinical trial studies and results, please leave them on the comments section.

The last thing we want is another 60 Minutes story rerun of the same mistakes of 1976 in 2009.

.

Posted By: Yobie Benjamin (Email) | October 20 2009 at 08:15 AM

Listed Under: Health Care
Is the H1N1 swine flu vaccine safe?
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DrJake
10/2/2009 8:10:27 AM

For me, the vaccine issue is more of a question of can we as individuals make our own choices in this world? Can I as a man think deeply about an unclear situation (vaccines and H1N1) and choose what I feel is best for me and my family?

The big question is where are the studies documenting the safety of vaccines in Healthy Children? Seriously. Where are all of the safety studies of flu vaccines and children? We're going to be vaccinating millions of them and there are legitimate safety concerns. Nobody is promising families that this vaccination program is safe or won't harm their kids. Flu shots = money, not safety. Additionally, none of the patient inserts from the vaccine manufacturers claim the vaccine will prevent us from getting the H1N1 Swine Flu. Parents will be able to read this for themselves and see that there are no claims for either safety or effectiveness in the handout. This is not a conspiracy. Families want and need to know this information.

Many Physicians are opposing swine flu vaccination. Flu shots = money, not safety. Don't believe the hype! -Dr. Jake http://wp.me/pC1DX-2S

Recommend: (39)(12)[Report Abuse] Permalink Permalink

jaakers
10/2/2009 9:19:13 AM

There is ALOT of misinformation in this article.. Let me highlight some of these points:

"After all was said and done in 1976, 46 million people were vaccinated against the swine flu virus and 4,000 people developed Guillain-Barre syndrome (GBS), a neurological disease that can lead to paralysis or even death. To be fair, the "GBS and mortality" rate attributed to the swine flu vaccine was less than .01% but try telling that to the people who got paralyzed or died."

While it is true that in 1976 the vaccine caused GBS in VERY few patients, the vaccine used in 1976 was made differently than vaccines are now. Influenza vaccine was made using a live virus in 1976, and this process is not the case in flu shots (however, FluMist contains a live virus). The H1N1 Swine Flu vaccine is just as safe as EVERY other seasonal flu shot. If this article is targeting the Swine Flu vaccine, then it is targeting ALL seasonal flu shots.

Furthermore, you also run a risk of getting GBS from an influenza infection, so either way, you are risking it. No influenza shot since 1976 has been associated with GBS.

"What was disturbing in 1976 and today is the speed by which the H1N1 vaccine was developed and rushed to market. Certainly medical and scientific advances today could explain the speed by which the current vaccine has been developed but the lack of a detailed public explanation how this was accomplished is not inspiring confidence."

The H1N1 vaccine was only made about a month faster than a typical seasonal flu shot. The vaccine was made exactly the same way as a seasonal flu shot, except with a different virus strain. The process and the vaccine are exactly the same. The CDC has explained this MANY times over in various media outlets. Almost every news article about the H1N1 vaccine has stated that the H1N1 vaccine is identical in formulation as a seasonal flu shot. The ONLY difference is the virus strain.

"Earlier in this year's outbreak the CDC was publishing information on swine flu including hot spots, primary causes of death and so forth. They also stopped testing suspected cases to positively identify H1N1. All very good information but the CDC stopped issuing the daily and weekly updates that had specific epidemiological details. While I am not prone to conspiracy theories, I am beginning to wonder why CDC stopped publishing the crucial information."

Once again, the CDC has explained why this data is no longer published. It is impossible to keep an accurate tally of influenza cases because they are so widespread and because the symptoms are generally mild. What this means is that most people do not seek treatment. Anyone who does not seek treatment can not be a reported case. Furthermore, keeping up up to the minute reporting on a virus that is so wide spread consumes resources, time, and money that would be better spent on planning how to respond to the virus, as opposed to posting useless, inaccurate information.

Recommend: (74)(44)[Report Abuse] Permalink Permalink

ybenjamin
10/2/2009 11:30:37 AM

jaakers - I never engage comment writers but you're an exception. If you have information on what you say, PLEASE PLEASE provide a bibliography or URL links to your statements.

I disagree that up to the minute tracking and provision of such information is a waste of time. It is precisely the information citizens need. You may not want the information but I am sure that a significant number of people WANT TO KNOW. Obfuscation of information is not a business plan. Transparency is far more important as we contemplate whether to vaccinate people en masse.

To be clear I am not against vaccination but I am deeply troubled by the lack of transparency and information from HHS or the CDC. It's not enough for me to accept - "Trust us, we're the government." I want to know everything as the government is asking people to make a decision that directly affects them and their families.

You seem to know what you're talking about *so share it*. I can at least say that there is evidence that government is capable of making monumental mistakes like in 1976. What is the assurance that such mistakes are not being made? Information is power. Obfuscation and lack of information leads to fear and uncertainty.

Tell us where all your information is coming from. It would help all of us.

Cheers,


Recommend: (44)(9)[Report Abuse] Permalink Permalink

NSwan
10/3/2009 6:50:11 AM

My husband almost died from Guillian Barre after his first flu shot. It took him six weeks to learn to stand up and a lot longer to walk again. Six weeks of hospitalization almost bankrupted us.

If the flu shot is so safe, why did our government, who has sovereign immunity, rush to also give immunity to the flu vaccine companies?

Our government, who has shown itself to overreact and to make bad decisions so special interests can profit, now wants us to trust them.

Flu vaccines are being made overseas. Think about the lead tainted childrens toys and wallboard that was made in China and sold in the US. Do you want to trust the quality control of other countries who may or may not be trustworthy.

After all the furor over the possible side affects from the flu vaccine, the government response was that it would monitor and tabulated the side effects. We have become the guinea pigs for a vaccine program and the medical industry.

Considering all this and my personal experience with the failure of our governments misguided intents, and considering that no one will be held accountable, from the store clerk who gives the shot to the government who demanded it, I'd rather take my chances with the flu than be a guinea pig for the swine flu shot.

Recommend: (47)(13)[Report Abuse] Permalink Permalink

wickedgood
10/6/2009 2:25:10 PM

I have not gotten a flu vaccine in at least 17 years as a personal choice. I've not gotten the flu in this time. I'm very distressed this year that New York State has mandated the flu vaccine for all health care providers in this, and all subsequent years. I will be personally effected by this, and compliance will be enforced by threat of loss of privileges or job. November 30th is the final date for compliance, and many of my colleagues are equally concerned. This goes way beyond a media blitz. In my opinion, it's a violation of personal freedom.

Recommend: (53)(8)[Report Abuse] Permalink Permalink

spaz
10/20/2009 11:41:37 AM

"Having looked around, I can't find the details much less who led the clinical trials, how they were conducted and the processes by which swine flu vaccines were fast tracked and approved. Who were the drug companies involved? Who were the principal investigators?" -- Looked around where, in your garage? Holy crap dude, try a new little thing called Google and all of the information is there from CDC trials to Novartis trials. Pages and pages and pages. See, you actually need to click on the articles and READ them. Try it, you may find this other new fangled thing called research to be very enlightening. By all means you should from your own opinions based on the results of trials but to say you can't find data is either dishonest or incredibly lazy. Your choice.

Recommend: (16)(13)[Report Abuse] Permalink Permalink

dirtydem
10/20/2009 12:06:07 PM

Swine flu was produced by a corporate hog farm, now the government should have to pay to protect us with tax money..

Recommend: (6)(22)[Report Abuse] Permalink Permalink

bashofan
10/20/2009 12:19:08 PM

DrJake:

NIH has details on results of H1N1 vaccine trials in healthy children (similar to those of seasonal flu vaccine).

There's a ton of information for anyone who cares to read it. Here's the clinical protocol (NCT00944073) at clinicaltrials.gov:

http://clinicaltrials.gov/show/NCT00944073


bashofan
10/20/2009 12:27:46 PM

DrJake: "none of the patient inserts from the vaccine manufacturers claim the vaccine will prevent us from getting the H1N1 Swine Flu"

Influenza vaccines don't prevent flu. They help the body form an immune response, which in many people prevents flu from becoming entrenched in the body sufficient to make the person sick, and in many other people they give the body's immune response a head start so that symptoms are lessened--you get sick, but less severely and for a shorter duration.


sfguy118
10/20/2009 12:27:58 PM

I dunno about this swine flu hysteria.
I've been talking to friends in Salt Lake City - apparently is everwhere over there...
They say it IS super contagious....everyone is getting it. But it lasts about 2 days. Game over. Not even very sick - more like 'stay home and play video games for a day or so and drink lots of ginger-ale' type sick.
I know people have died from this and all, but I'm just not buying the hype...