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.) And there is a very real possibility of genetic mutations increasing the virulence of the current swine H1N1 pandemic virus.

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 several good, reasonable, rational discussions of the errors of the article on the science blogs:

Vaccination for H1N1 "swine" flu: Do The Atlantic, Shannon Brownlee, and Jeanne Lenzer matter?

Journalists sink in The Atlantic article on vaccines

Science journalists, bloggers and the Brave New World we live in

I'm not qualified to make the kind of analysis that can be found in these 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")