A reasonable assessment of the swine flu vaccine

Faith, Reason and Health Blog ^ | 10/29/09 | Dr. Brian Kopp

[Dr. Brian Kopp]

Wednesday, October 28, 2009

A reasonable assessment of the swine flu vaccine

Why be skeptical?

Orthodox Catholics have a strong tendency towards healthy skepticism when it comes to big government and big pharma. We've seen the democide carried out by atheistic governments against several hundred million innocent men, women, and children over the past century. We've seen the demographic winter and destruction of over a billion lives at the hands of scientism's big medicine and big pharma. Science no longer serves the God who created the laws of nature and nature itself, even if many individual scientists, doctors and biomedical researchers may be faithful pious believers.

Does that mean that we must accept at face value every claim against modern medicine or big pharma? As Catholics, Faith and Reason dictate we seek the Truth, and alleviate suffering whenever possible. It also means confronting evil and error outside and inside our ranks.

Many of the current internet rumors regarding flu vaccines are simply false. Seasonal flu vaccines are very safe (though there is valid debate over their overall effectiveness.) The current swine flu, if it had been isolated several months earlier in the 2008/2009 flu season, would have simply been added to this year's seasonal flu vaccine. Because it was too late to add it to the seasonal flu vaccine, an additional vaccine is necessary this year. The swine H1N1 vaccine is simply the seasonal flu vaccine without the three seasonal flu variants. Instead, it contains the swine flu viral antigen. There is no rational, reasonable basis to fear the current swine flu vaccine.

The infamous 1976 swine flu vaccine was linked to 25 deaths from Guillain-Barre Syndrome. It was administered to over 40 million people. In a worst case scenario, if the current swine flu vaccine was as "bad" as the 1976 vaccine, and the entire US population of 300 million was vaccinated, one could anticipate 188 vaccine related deaths. There is no rational, reasonable basis to believe the current swine flu vaccine would have any different safety profile than the seasonal flu vaccine from which it was made. In other words, there is no reason to suspect the side effects that occurred in 1976.

On the other hand, over 200 children have died so far in the USA alone from this pandemic, with total "official" death counts in the USA over 1200 and global deaths nearing 9000. These official numbers represent only those cases in which swine flu was verified by lab testing. (Only a tiny fraction of swine flu cases are currently being lab confirmed because the medical establishment knows that almost all current flu infections are swine flu.)

A recent article in The Atlantic, Does the Vaccine Matter? has caused a wave of concern. The article is grossly misleading in its analysis. There are good, reasonable, rational discussions of the errors of the article on two science blog posts, Vaccination for H1N1 "swine" flu: Do The Atlantic, Shannon Brownlee, and Jeanne Lenzer matter? and Journalists sink in The Atlantic article on vaccines.

I'm not qualified to make the kind of analysis that can be found in these two entries, but I am qualified to make an assessment of the original article and these rebuttals: The original article simply does not stand up to scrutiny.

Because I am in a high risk group (history of asthma, heart disease and diabetes), I received the seasonal flu vaccine two weeks ago. If the swine flu vaccine becomes available locally, I can see no valid reason not to receive the vaccine or have my own children vaccinated, given everything I know as a pro-life Catholic doctor.

My one concern is the use of adjuvants.

Fortunately, NO US VACCINES CURRENTLY USE ADJUVANTS! There is no squalene or other adjuvants in any approved flu vaccines being distributed in the USA, but they are being used in Canada and Europe.

On the other hand, the USA has purchased large stockpiles of adjuvants for emergency use:

HHS 2009 H1N1 Vaccine Development Activities

Fact Sheet

Overview The newly emergent 2009 H1N1 influenza virus is a novel virus with pandemic potential. Consistent with the National Strategy for Pandemic Influenza, HHS is committing funds for the production of pilot lots for clinical studies, as well as a bulk supply of antigen and adjuvant for use in a potential vaccine for the 2009 H1N1 which will become a part of the national stockpile of pre-pandemic influenza vaccines. A vaccine is made from a virus or bacteria (referred to as an antigen), which causes the human body’s immune system to develop antibodies against a specific virus or bacteria so the body can recognize and fight the virus or bacteria. Adjuvants may be added to a vaccine to help generate a stronger immune response so less vaccine is needed for the body to recognize and fight a virus or bacteria.

Vaccine Development

When the 2009 H1N1 strain was isolated and identified as a novel influenza virus, work began to prepare a virus reference strain. This is a standard practice when new influenza strains are discovered, where a clinical sample of the virus is mixed with another influenza virus that grows in eggs to develop a new virus that has some of the properties of the novel virus and the ability to grow in eggs. This work is necessary in order to create an influenza vaccine using conventional methods.

Once a virus reference strain is ready, it will be made available to influenza vaccine manufacturers in order to create a master virus seed, which prepares a virus to be used in making the vaccine.

HHS Contracting Activities

Since 2004, HHS has contracted with manufacturers that currently hold U.S. licenses for flu vaccine as part of the National Strategy for Pandemic Influenza. In May 2009, HHS issued new orders on these contracts to produce a bulk supply of vaccine antigen and adjuvant and to produce pilot (also called investigational) lots of a 2009 H1N1 vaccine. Most will be stored in bulk, and a small amount will be prepared as vaccine for use in clinical studies to evaluate vaccine safety and the dosage required for a protective effect. This research will include studies with adjuvant to determine its safety and the effect it would have on the immune system’s response.

Orders for Bulk Supply of H1N1 Influenza Vaccine Antigen and Adjuvant: May 22, 2009

Manufacturer	Bulk Vaccine Antigen	Oil-In-Water Bulk Adjuvant
Novartis	$150 million	$139 million
GlaxoSmithKline	$ 38 million	$144 million
Sanofi Pasteur	$191 million
CSL Biotherapies	$180 million
MedImmune	$ 90 million
Total	$649 million	$283 million

Orders for Bulk Supply of H1N1 Influenza Vaccine Antigen and Adjuvant: July 9, 2009

Manufacturer	Bulk Vaccine Antigen	Bulk Virus Concentrate/FFF	Oil-In-Water Bulk Adjuvant
Sanofi Pasteur	$61,425,000	0	0
GSK	$0	0	$71,400,000
Novartis	$346,334,450	0	$343,810,470
CSL	$0	0	0
MedImmune	$0	$61,008,000	0
Total	$407,759,450	$61,008,000	$415,210,470

HHS orders an additional 56 million doses of vaccine: September 21, 2009

The U.S. Department of Health and Human Services ordered an additional 56 million doses of vaccine for the 2009 H1N1 flu from MedImmune and Sanofi Pasteur. HHS used approximately $438 million in existing funds for the purchase. The additional vaccine purchase will help to ensure that anyone who wants a vaccine will be able to obtain one when the vaccine becomes available. The Advisory Committee on Immunization Practices recommended that five groups of people receive the vaccine as soon as it is available (embed link http://www.flu.gov/individualfamily/vaccination/index.html). The 2009 H1N1 flu vaccine will be available beginning in October and throughout the flu season.

Manufacturer	Total Cost
MedImmune	$295,660,000
Sanofi Pasteur	$143,483,025
Total	$438,143,025

Novartis' adjuvant is MF59. GlaxoSmithKline's adjuvant is AS03

There is some evidence that adjuvants increase certain elements of the cytokine response. See Adjuvants and Cytokines I - the Curious Case of IL-6

Controlling cytokine response was the central topic of the article I wrote for L'Osservatore Romano, "The unforgiving arithmetic of pandemic" that was published in July.

Furthermore, adjuvant use might increase spontaneous miscarriages. From Adjuvants and Cytokines I - the Curious Case of IL-6:

Let's start with the GSK one. In their document submitted to the EMEA, in response to a query about the use of their vaccine in early pregnancy, GSK argued that

the adjuvant is not expected to have adverse effects on early pregnancy primarily because the innate immune response is local to the site of injection and on injection of the adjuvanted vaccine, there is no systemic cytokine response detectable.

Since no data is presented in those documents, nor AFAIK in any peer-reviewed publications regarding the systemic cytokine response to AS03 adjuvanted vaccines, animals and humans included, and since we have already encountered some rather questionable claims from industry representatives, those remarks in the EMEA file should IMHO be considered unsupported by evidence, until they are.

BTW this may well be consistent with corporate policy. GSK also markets vaccines adjuvanted with AS04, an adjuvant that contains both alum and MPL, a 'detoxified' version of the bacterial endotoxin LPS. AS04 is used in a hepatitis B vaccine Fendrix which was approved in the EU in 2005, and the HPV vaccine Cervarix approved in 2007. In a recent presentation to the FDA seeking licensure of Cervarix in the US, company representatives first said that the vaccine was "not associated with a systemic cytokine release." (p.24 of meeting transcripts) Then, during Q&A, they modified that to "just a little bit of IL-6" (p.168) in response to questions from an advisory committee member, an Obs/Gyn doc from Mass General Hospital who said

One of the things that troubled me a little bit about the spontaneous abortion issue as an obstetrician, and that is why I asked the question about detoxification of LPS, because there are very good animal models for inducing abortion and early delivery using LPS, presumably mediated by IL-6, TNF alpha and IL-1 beta.

Until there is more safety data on these adjuvants, and proof that they are not abortifacient, I could not in good conscience recommend their use.

On the other hand, if a pandemic arose with a virulence similar to that of the 1918 Spanish Flu pandemic, the risks of refusing even an adjuvanted vaccine would be far outweighed by the risks of the pandemic.

Its worth noting that Jacinta and Francisco of Fatima, who with Sister Lucia were blessed with the apparitions of Our Lady of Fatima, died in the 1918/1919 Spanish Flu pandemic, which was due to a similar swine H1N1 flu strain. That is always in the back of my mind during this current pandemic.

(For more information on the nasal mist flu vaccine see my previous post, Disinformation: "Live virus in the nasal spray vaccine will cause a pandemic")

[Dr. Brian Kopp]

I wrote this from a pro-life, Catholic perspective as a response to the increasingly hysterical rumors on the internet regarding the swine flu vaccine.

[Maynerd]

I'm a healthcare professional. I have received the H1N1 vaccine as have the vast majority of my fellow physicians. By our nature we are a skeptical group however the benefits of vaccination clearly outweigh the risks.

H1N1 is a nasty virulent influenza. Although it's very early for "flu season", the number of patients with severe complications is much higher than the peak of a typical seasonal flu. My pulmonologist colleagues find the severity and frequency of complicated cases worrisome. These patients are not elderly but young and middle age adults.

[traderrob6]

Kind of academic isn’t it considering in a nation of 350,000,000 less than 15% CAN be immunized.

[mysterio]

hysterical rumors on the internet regarding the swine flu vaccine.

Some of the anti-vaccine nutbaggery out there is just flat out unbelievable. I've devoted a lot of time to debunking the woo woos, and it's like trying to drain the Pacific ocean with a bucket.

[onedoug]

Thanks for a professional, evidently well researched and well written update.

I think what makes especially conservatives suspicious of the H1N1 vaccine in praticular is that the obama administartion is so vocal in its administration.

Having received the seasonal vaccine, I’ve yet elected to pass on the H1N1. I personally don’t trust this sob to the point where I may even question next year’s general vaccine as well.

Yet that is, as of yet, STILL a personal decision for each of us to make, and I hope you’ll keep writing and informing us here, thus as such a great resource to FR.

Thank you again, and may God keep You and Yours....

[verga]

I noticed taht the matter of the Vaccine containing Mercury was not addressed, nor the possible link between Mercury and Autism.

[Dr. Brian Kopp]

That’s the next post I’m working on at the blog.

[DvdMom]

Smokin’ Joe I’m pinging your list , and some other freepers to a new swine flu vaccine article .

Thanks :)

[SaraJohnson]

The autism link to vaccines has been debunked in some medical research studies and affirmed in others. This is a terrible place in which to put parents. Congressional hearings laid bare the whole mess.

There is no doubt that autism is a huge problem and that the medical research community owe it their full attention in solving the puzzle. If they are going to deny it is caused by vaccines, they need to fearlessly investigate the cause. Trying to shout down people’s questions will only make people more leery of vaccines.

[SaraJohnson]

“Until there is more safety data on these adjuvants, and proof that they are not abortifacient, I could not in good conscience recommend their use.

On the other hand, if a pandemic arose with a virulence similar to that of the 1918 Spanish Flu pandemic, the risks of refusing even an adjuvanted vaccine would be far outweighed by the risks of the pandemic.”

---

That is the question all Americans need answered honestly, professionaly and clearly by the CDC in their data collection on the Swine Flu. How contageous and deadly is the Swine Flu because the answer to that question leads one to a logical decision on whether or not it makes sense to take a vaccine, take the personal action of social distancing or go along with business as usual knowing the flu is mild.

Since CDC stopped testing the general population for the Swine Flu virus in July, many MD researchers in Texas are not happy campers with the information they have from the government.

Americans (espeically MD’s) are not known for respecting the government’s direction blindly and this lack of hard data on the Swine Flu has given every kook in the US room to agitate their conspiracies. And then we have the other extreme kooks, fearful of government oppression in the name of the flu, shouting down anybody reporting the flu is dangerous. Have you observed this?

[NYer]

Catholic Ping
Please freepmail me if you want on/off this list

[Dr. Brian Kopp]

And then we have the other extreme kooks, fearful of government oppression in the name of the flu, shouting down anybody reporting the flu is dangerous. Have you observed this?

Only too often. That's why I started the Faith, Reason, and Health blog.

By the way, I just posted an entry about the possibility of a Swine H1N1 flu vaccine antigen/adjuvant bait and switch? on the blog. That is my biggest concern at present.

[neverdem]

thanks, bfl

[El Gato]

The way things are going, it may be moot. Most people won't be able to get the vaccine before they get exposed to the "wild" virus anyway.

My daughter's doctor seemed to think they had the H1N1 strain, and if they did, I've been exposed, and had nary a symptom. Of course I'm old as the hills and got that '76 vaccine, so I may have some immunity from that.

[Dr. Brian Kopp]

Anyone born prior to 1951 appears to have at least partial immunity to the current swine H1N1 strain due to something that was circulating in the 1940’s.

[SaraJohnson]

That is a great blog. I have it in my favorites.

I would appreciate it if you would address the state of the actual data available on flu activity in the general population versus the death rate. I don’t see how one can figure out if the virus is dangerous or not given data is not being collected in the general public through actual H1N1 tests.

The complaints I am hearing from doctors is that all they have to go on is what is going on in isolated practices and hospitals. It is like the blind man trying to name the elephant.

The other thing I am wondering about is what were the results of the human studies conducted on the H1N1 vaccine? The research committee at a hospital I am involved with in Texas were not happy about the vaccine’s study design but all objections were overcome with a good dose of government hysteria. “Don’t think - just do it!” This happened while the government was screeching “Don’t worry! It is a mild virus! It is less dangerous than the regular flu!”

[blu]

So how do your fellows feel about cancer patients undergoing chemo get the H1N1 vaccine?

[Alamo-Girl]

Thanks for the ping!

[Born Conservative]

Possible link between Mercury and Autism? Then explain how the autism rate has risen since all vaccines given prior to 3 years of age (since around 2005) are without Thimerosal?

[verga]

The really important word is “Possible”. There are just as many studies on both sides of the issue. I personally feel that this issue must be studied a whole lot more closely before we rush off and inoculate every child.

[Ditter]

We just came home from 3 days in Las Vegas. We are seniors and have had our seasonal flu shop but have been unable to get the H1N1 shot. If we are symptom free in 3 more days, I will feel like we dodged a bullet.

[Dr. Brian Kopp]

There are just as many studies on both sides of the issue.

Actually there really aren't just as many studies on both sides of the issue.

There is a good discussion of this controversy at Why Does the Vaccine/Autism Controversy Live On?.

[Born Conservative]

Anything is “possible”. It’s possible that obesity is caused by drinking water. Do I think it’s probable? Not at all, but I’m free to say it, even though it’s not at all likely. And if I worked at it, I could probably come up with an explanation that some people would believe (e.g. the amount of bottled sold over the past 20 years vs. the increase in obesity over that time frame). I’m also reminded of an example Rush uses: everyone who has ever eaten carrots have or will die.

This issue of a link between Thimerosal and Autism HAS been studied extensively. The problem isn’t lack of research, but rather one of so-called health professionals who push untested theories which have no basis in science, and thus create fear (Andrew Wakefield for one, linking MMR vaccine with Autism). Fear is a great motivator, such as this current pandemic of Swine Flu Hysteria.

I’m all for parents getting the facts about medical treatments, but when there is information that is presented as fact, and yet isn’t proven, that’s where the problems lie.

I’ve been giving children immunizations for over 15 years now. When I started, many of the vaccines were in multi-dose vials, and thus had preservative (Thimerosal). Yet the autism rate back then was not very high. Now all of a sudden, it’s skyrocketing, and as I said before, none of the vaccines given before 3 years of age (when Autism rears it’s ugly head) have preservative. About the only vaccine that currently does have Thimerosal is the Seasonal Flu Vaccine for ages 3 and up (although there are doses that are preservative free for that age group).

The one thing that may pan out (not extensively studied) regarding Autism is Vitamin D deficiency. Children AND adults rarely get tested for Vitamin D deficiency (although I think that will change). But think about the big push in the past 1-2 decades to cover children in sunscreen. Vitamin D is activated in the skin by sun exposure. 20 minutes of sun exposure activates about 20k units of Vitamin D. Milk is fortified with Vitamin D, but that amount is very small, compared to being in the sun. It would be interesting if we could have a study of Vitamin D levels 20 years ago vs today (not very likely, as the data simply isn’t available)

I’m saying this to point out that there has to be a reason for the rise in Autism, but the facts don’t at all point to vaccines.

[Dr. Brian Kopp]

The one thing that may pan out (not extensively studied) regarding Autism is Vitamin D deficiency. Children AND adults rarely get tested for Vitamin D deficiency (although I think that will change).

The data for a Vitamin D link is actually fairly strong, if you look deeper at the link between autism and cable TV subscription rates.

The increase in Cable TV in the late 1970's increased the time children spent indoors. The increase in video games in the 1980's, computer games, sun avoidance due to mainstream medicine's push to limit skin cancer in the late 1980's, and finally the increasing time spent viewing the internet and the explosion of "Barney" type programming aimed at toddlers, all add up to sun avoidance in the last 30 years at unprecedented levels.

Sun avoidance, of course, is causing an epidemic of Vitamin D deficiency. The low levels of Vitamin D in our diet might be enough to limit Rickets, but they're not likely enough for full immune system function (thus increasing susceptibility to influenza) or proper neurological development (thus theoretically increasing autism.) Sun avoidance by pregnant mothers may also contribute, and there is a further theory that Vitamin D may be necessary for clearance of heavy metals from the brain.

The problem with the Vitamin D deficiency theory is that it leaves trial lawyers with no one to blame.

Trial lawyers bribe "researchers" like Wakefield to publish junk science "linking" autism to vaccines because big pharma has deep pockets and distraught parents are easy to manipulate with highly emotional anecdotal claims.

And don't underestimate the role of Scientology in pushing the autism-vaccine conspiracy.

Bottom line? Barney and TeleTubbies are far more likely responsible for increases in autism than any other factor that has been blamed.

[Born Conservative]

Very interesting. I thought you were being facetious at first when I saw “the link between autism and cable TV subscription rates”.

I don’t take echinacea for colds, nor 10 different single high-dose vitamins to prevent every ailment known to man, but I do take Vitamin D regularly.

I started looking into it when I went on Rocaltrol for my kidney failure (I’m transplanted now), and it’s interesting how the importance of this vitamin has been so overlooked prior to the past few years.

I also see the doctors I work with stress to parents how important it is for them to slather on tons of sunscreen to prevent skin cancer, and I’ve often wondered the unintended consequences of this.

Lately, I’ve been working around a lot of kids with Swine Flu, and when I am, I take a 2,000 unit Vitamin D BID for a few days. I also did that when my son had Swine Flu, and my wife had a nasty cold. I have yet to have a URI since last year, even while being immunosuppressed. Did the Vitamin D work? Who knows? Considering that 20 minutes of full sun exposure equals 20,000 units of Vitamin D, the dose I’m taking isn’t excessive, and I do have my Vitamin D level checked yearly.

Neverdem has pinged some interesting Vitamin D threads.