Swine Flu: Looking More Closely At Celvapan Vaccine.

(Vero cells)

The H1N1, swine flu vaccine, which will be offered to most people in the UK is pandemrix from GlaxoSmithKline. The viral antigen for this vaccine is grown in eggs and for those people who have an allergy to eggs or chicken protein, the alternative is the celvapan vaccine from Baxter International. Baxter has been involved in a few scandals over recent years. In 1996 haemophilia components were contaminated with HIV virus and injected into tens of thousands of people, including thousands of children. Even when the contamination became known, Baxter continued to release the contaminated clotting substance. As of March 2008, Baxter's heparin had been linked to hundreds of serious and sometimes life-threatening reactions, including at least 4 deaths.

In February 2009, Baxter released contaminated flu virus material from a plant in Orth-Donau, Austria.

The contaminated product, a mix of human H3N2 seasonal flu viruses and unlabelled avian H5N1 viruses, was supplied to an Austrian research company. The Austrian firm, Avir Green Hills Biotechnology, then sent portions of it to sub-contractors in the Czech Republic, Slovenia and Germany.

The contamination incident, which is being investigated by four European countries, came to light when the subcontractor in the Czech Republic inoculated ferrets with the material and they died. Ferrets shouldn’t die from exposure to human H3N2 flu viruses.The H5N1 component of the product was found to be live. The accidental release of a mix of live H5N1 and H3N2 viruses could have had dire consequences.

Celvapan H1N1 is the first cell-cultured and non-adjuvanted vaccine to be authorised by the European Commission, to be marketed within the European Union.

So, having a wee shuftie at the patients' information leaflet, produced by Baxter:

"What Celvapan contains
Active substance:
Whole virion influenza vaccine, inactivated, containing antigen of pandemic strain*:
A/California/07/2009 (H1N1) 7.5 micrograms** per 0.5 ml dose
* propagated in Vero cells (continuous cell line of mammalian origin)"

Vero cells are lineages of cells used in cell cultures. The lineage was developed in 1962 by two scientists at a university in Japan. The Vero lineage is continuous, which means it can be replicated through many cycles of division without becoming senescent (liable to the process of aging that normal cells go through). For this reason they are referred to as, "immortalised."

What is coming through that needle?

The problem of pathogenic vaccine contamination.

by Benjamin McRearden

www.tetrahedron.org

excerpt— There is another very important issue reported in studies that is evidently being largely ignored as regards long-term vaccine effects and safety. There is obvious evidence that in the lab, continuous immortal cell lines react differently between one type of animal species and another (21, 23). As an example, tissue from one species will allow the immortal cell to induce a cancerous change more quickly, in comparison to tissue from a different species. These results then beg the following questions. How extensively have these continuous cell lines been tested on human tissues, and would the results vary from one type of tissue to another? And what happens over the long term if an immortal cell from a vaccine culture makes its way into the final vaccine product, does it keep dividing in the human body? Another scenario might suggest the tumor-promoting portion of its DNA inserting into a viral genome, which then gets injected into the body what happens at that point?.......

................As one researcher states, Using neoplastic cell lines as substrates for vaccine development could inadvertently result in viral-viral or viral-cellular interactions whose biological consequences are unclear viral-viral and viral-cellular interactions can result in the generation of new retroviruses with pathological consequences (30). We note the term "neoplastic" means the quality of having an abnormal growth characteristic.

There is an even stronger statement dating back to 1990. A scientist in the field writes, "The present concern is for safety of vaccines made using transformed or neoplastic mammalian cells that may contain endogenous contaminating viruses or integrated gene sequences from oncogenic viruses.

Vero cells are susceptible to a broad range of viruses and are widely used to develop vaccines against associated diseases. The array of viruses that Vero cells are susceptible to is broad and includes polioviruses, simian virus 5 (SV5), simian virus 40 (SV40), rubeola, rubellavirus, reoviruses, simian adenoviruses, Getah, Ndumu, Pixuna, Ross River, Semliki Forest, Paramaribo, Kokobera, Modoc, Murutucu, Germiston, Guaroa, Pongola, and Tacaribe

Picking out SV40, simian virus 40, for special attention. This virus contaminated both the Inactivated Polio Vaccine, created by Dr Jonas Salk, and the Oral, or "Live," polio vaccine, created by Dr Albert Sabin. Although a Federal law was passed in the USA in 1961, requiring that no vaccine contained this virus, it did not require that seed material be discarded and it has been alleged that oral polio vaccine containing the virus was administered up to the 1990s.

SV40 is a persistent infection in Vero cells.

A letter from the FDA in 2001 to vaccine manufacturers said that use of immortalised cell lines was a cause for concern and that all product should be free of intact Vero cells. Yet, it seems that there are very basic safety questions not resolved by the manufacturers.

Cell replication/division: how SV40 can disrupt this process and cause cancer.

Cells of all multicellular organisms replicate during creation and maturation and for growth and repair of tissues. When cells are injured or damaged in this process, tumour-suppressor genes promote cell cycle arrest to stop these damaged cells proliferating out of control and forming tumours. P53 and retinoblastoma (Rb) are tumour-suppressor genes, which are inactivated by SV40, allowing damaged cells to proliferate.

SV40 is a type of polyoma virus: poly means many; oma means tumour. This designates its ability to form many types of tumour.

The celvapan patient infromation leaflet instructs that you should not receive celvapan if you have had a sudden, life-threatening allergic reaction to any of the ingredients or any substance of which there may be traces in the vaccine. One of those substances is formaldehyde, which is used to split and inactivate the influenza virus. Formaldehyde was also used in the injected form of polio vaccine used between 1955 and 1961, but this vaccine was contaminated with SV40.

SV40 - Polio vaccine contamination

Soon after its discovery, SV40 was identified in the injected form of the polio vaccine produced between 1955 and 1961. This is believed to be due to kidney cells from infected monkeys being used to amplify the vaccine virus during production. Both the Sabin vaccine (oral, live virus) and the Salk vaccine (injectable, killed virus) were affected; the technique used to inactivate the polio virus in the Salk vaccine, by means of formaldehyde, did not reliably kill SV40. (SV40 Foundation)

Finally, testing of the vaccine.

Normal clinical trials, as outlined by the NHS. There are 4 phases to ensure that a vaccine is safe and effective.

1) Safety: on a small number of healthy adult volunteers (10-12) to test safety of doses and to monitor for side-effects.
2) Safety and immune response: several hundred people in the age groups for whom the vaccine is intended. Often carried out in several different countries.
3) Safety, immune response and efficacy: first step towards its use in public health. Several thousand people tested in relevant age groups. If the vaccine passes all safety and efficacy requirements, the manufacturer can then apply for a licence to produce and distribute the vaccine.
4) Post-licencing evaluation. Ongoing surveillance to monitor for rare side-effects.

Testing of celvapan H1N1 vaccine:

Earlier this year, Baxter conducted tests with a "mock-up," vaccine, using a different strain. (Not H1N1) on several thousand people.

For celvapan H1N1, post-licencing, Baxter conducted randomized trials in 400 healthy adults, aged 18 and over and in 400 children and adolescents. Baxter said that once countries initiated vaccination programmes using celvapan, they would initiate a large-scale observational study of 9,000 people in different age groups.

So, instead of testing for safety and efficacy before the vaccine was distributed and administered, Baxter will carry out the most important phase of testing after countries have initiated vaccination programmes.

The guinea pigs for this vaccine will not be the usual volunteers who sign up for testing before use on the public. The guinea pigs will be those people queuing up to receive this vaccine, assuming that if the government has given its approval, it must be safe. And remember, because this is a vaccine introduced as a contingency in a pandemic situation, the vaccine manufacturers have immunity from liability.

References:

Toronto Sun-Baxter product contained live bird flu virus

Baxter-celvapan patient information leaflet

About.com-Vero cells

http://en.wikipedia.org/wiki/Vero_cell

Informed Choice-SV40 in polio vaccines

PubMed-contamination of Vero cells with SV40

Karl Loren-cell replication/division

http://www.sv40foundation.org/How-causes.html

Encyclopedia II-SV40 polio vaccine contamination

NHS-Immunisation Safety/Clinical trials

Baxter's press release October 7th 2009

Deaths In Sweden Linked To Swine Flu Vaccine

http://www.thelocal.se/22846/20091024/

Health investigators are under more pressure as two elderly women are reported to have died, days after receiving the swine flu vaccine. It brings the total number of deaths linked to the vaccine in Sweden to four.

The two latest deaths were reported to the Swedish Medical Products Agency (Läkemedelsverket) on Friday.

A 74-year-old woman from Solleftea in northern Sweden died four days after receiving the swine flu vaccine.

The woman, who suffered from heart and lung disease, was classified as a high-risk patient.

“Naturally a report will be undertaken,” said Dr. Markus Kallionen in a press statement released by Västernorrland County Council.

“We must take this case seriously and investigate what has happened.”

A further case of a 90-year-old woman who also died after receiving the vaccine has been reported by newspaper Expressen.

Läkemedelsverket are currently investigating circumstances surrounding the deaths of two high-risk patients, a 50-year-old man with a serious heart condition and woman with an acute muscle disease.

“It’s important to says that they had complicated illnesses,“ Gunilla Sjölin Forslund from Läkemedelsverket told news agency TT.

“We still do not know if the deaths are connected to the vaccine.”

It will be interesting to follow this report and to find out if a causal link is established with the vaccine. All four of those people died quite soon after receiving the vaccine. All four also had serious underlying medical conditions. So, coincidence may come into play here. However, if a link is established with the vaccine, it raises the question of why the swine flu vaccine is being given in the first instance to vulnerable people, those who have an existing health issue.

One thing is certain. The vaccine manufacturers can't have it both ways: they can't claim that vulnerable people should have this vaccine and then claim that perhaps the vaccine itself is OK but those people had serious underlying health conditions if the vaccine is shown to have played a part in their deaths.

Swine Flu Vaccination Starts in Britain

Sky News 21/10/09

"Doctors have started the task of vaccinating millions of vulnerable patients against swine flu.

From Monday, GPs will receive their initial deliveries, though it could take up to four weeks to distribute the 4.5m doses around the country.

More will follow as it is delivered by the manufacturers.

Nine million patients who are at risk of serious complications if they catch the virus will be given priority for the vaccine.

At the front of the queue are those aged six months to 65 years who have underlying health problems such as asthma."

Next will be pregnant women, those living with patients with weakened immune systems, and finally the over-65s with underlying health problems."

The swine flu vaccination being introduced in Britain is Pandemrix from GlaxoSmithKline. This is from the GSK information for patients leaflet:

Pandemrix is a "split virion, inactivated, adjuvanted," vaccine, which means that only structural proteins from the virus are present and it is not infectious. (Flumist from Immumed, contains a live attenuated virus, which carries the risk of reverting to live in transmission.)

Ingredients:

Active substance:
Split influenza virus, inactivated, containing antigen* equivalent to:
A/California/7/2009 (H1N1)v-like strain (X-179A)
3.75 micrograms** per 0.5 ml dose
* propagated in eggs
** expressed in microgram haemagglutinin
This vaccine complies with the WHO recommendation and EU decision
for the pandemic.

• Adjuvant:
The vaccine contains an ‘adjuvant’ AS03 to stimulate a better response.
This adjuvant contains squalene (10.69 milligrams), DL-α-tocopherol
(11.86 milligrams) and polysorbate 80 (4.86 milligrams).

Other ingredients:
The other ingredients are: polysorbate 80, octoxynol 10,
thiomersal, sodium chloride, disodium hydrogen phosphate,
potassium dihydrogen phosphate, potassium chloride,
magnesium chloride, water for injections

You should not receive Pandemrix:

• if you have previously had a sudden life-threatening allergic reaction to
any ingredient of Pandemrix (these are listed at the end of the leaflet) or
to any of the substances that may be present in trace amounts as follows:
egg and chicken protein, ovalbumin, formaldehyde, gentamicin sulphate
(antibiotic) or sodium deoxycholate. Signs of an allergic reaction may
include itchy skin rash, shortness of breath and swelling of the face or
tongue. However, in a pandemic situation, it may be appropriate for
you to have the vaccine provided that appropriate medical treatment is
immediately available in case of an allergic reaction.

Side effects:

Very common (affects more than 1 user in 10)

• Headache
• Tiredness
• Pain, redness, swelling or a hard lump at the injection site
• Fever
• Aching muscles, joint pain

Common (affects 1 to 10 users in 100)

• Warmth, itching or bruising at the injection site
• Increased sweating, shivering, flu-like symptoms
• Swollen glands in the neck, armpit or groin

Uncommon (affects 1 to 10 users in 1,000)

• Tingling or numbness of the hands or feet
• Sleepiness
• Dizziness
• Diarrhoea, vomiting, stomach pain, feeling sick
• Itching, rash
• Generally feeling unwell
• Sleeplessness

Rare (affects 1 to 10 users in 10,000)

Allergic reactions leading to a dangerous decrease of blood pressure,
which, if untreated, may lead to shock. Doctors are aware of this
possibility and have emergency treatment available for use in such cases.
• Fits
• Severe stabbing or throbbing pain along one or more nerves
• Low blood platelet count which can result in bleeding or bruising

Very rare (affects less than 1 user in 10,000)

Vasculitis (inflammation of the blood vessels which can cause skin
rashes, joint pain and kidney problems)
• Neurological disorders such as encephalomyelitis (inflammation of the
central nervous system), neuritis (inflammation of nerves) and a type of
paralysis known a Guillain-Barré Syndrome

Squalene as an adjuvant.

According to Dr Russell Blaylock, a former neurosurgeon, squalene is added to boost the immune response to vaccines. The normal route by which an infectious agent enters the body is via the nose or the gut and this triggers a coordinated response from the immune system. When the infectious agent is injected into deep muscle, there is a need to include adjuvants to incite a response and this actually produces an abnormal response. Squalene is present in the body as a precursor to all the body's steroids. When injected into deep muscle, the immune system produces antibodies to squalene and attacks all the squalene in the body. 95% of vets returning from the Gulf, diagnosed with Gulf War Syndrome were reported to have tested positive for squalene antibodies.

Thiomersal as an adjuvant.

Thiomersal, or sodium ethylmercurithiosalicylate, commonly known in the United States as thimerosal, is an organomercury compound (approx. 49% mercury by weight) used as an antiseptic and anti-fungal agent, used as a preservative in vaccines.

Thiomersal is very toxic by inhalation, ingestion, and in contact with skin. In the United States, countries in the European Union and a few other affluent countries, thiomersal is no longer used as a preservative in routine childhood vaccinations. In the U.S., the only exceptions among vaccines routinely recommended for children are some formulations of the inactivated influenza vaccine for children older than two years.

Finally, from the American Journal Of Pathology

"The Endogenous Adjuvant Squalene Can Induce A Chronic T-Cell-Mediated Arthritis In Rats."

"Squalene is a cholesterol precursor, which stimulates the immune system nonspecifically. We demonstrate that one intradermal injection of this adjuvant lipid can induce joint-specific inflammation in arthritis-prone DA rats."

Read the entire article on the above link.

Swine flu vaccine is more deadly than flu shot.