CSL Pandemic Swine Flu Vaccine Safety in Question

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http://www.i-sis.org.uk/CSLPandemicSwineFluVaccine.php

 

ISIS Report 21/09/09

CSL Pandemic Swine Flu Vaccine Safety in Question

Prof. Joe Cummins

A fully referenced version of this report has been submitted to the US FDA, CDC,

and Sir Liam son and can be downloaded. It is also posted on ISIS’

member’ website. Details here

New vaccine formulation contains thimerosal and beta-propiolactone a potent

cancer causing chemical

Pharmaceutical companies worldwide are rushing to produce their vaccines against

the current swine flu pandemic to fulfill the needs of the entire global

community, no doubt taking advantage of fast-track approval and immunity from

prosecution if serious side effects should come to light. [1] (Fast-tracked

Swine Flu Vaccine under Fire, SiS 43) as already found in clinical trials of a

live attenuated flu vaccine on children [2] Live Attenuated Swine Influenza

Vaccine for Children Safety in Question, SiS 44).

Now another serious candidate vaccine has appeared. It is produced by an

Australian based company CSL Biotherapies. The CSL global seasonal influenza

vaccine AFLURIA® is prepared from influenza virus propagated in the fluid of

embryos in chicken eggs. Following harvest, the virus is purified in a sucrose

density gradient using a continuous flow zonal centrifuge. The purified virus is

inactivated with betapropiolactone, and the virus particles are disrupted with

the detergent sodium taurodeoxycholate to produce a ‘split virion’. The

single-dose formulation is preservative-free; and thimerosal, a mercury

derivative, is not used in the manufacturing process for this formulation. The

multi-dose formulation, however, contains thimerosal, as a preservative; each

0.5 mL dose contains 24.5 mcg of mercury [3]. The pandemic H1N1 vaccine has been

prepared in the same way as the seasonal vaccine. However, CSL also licensed

reverse genetic technology (see [2])

from Medimmune company and has indicated that some vaccine may be produced

using that method [4].

Inactivation of the virus using beta-propiolactone is a common practice in virus

inactivation for vaccines. However, there is some concern about the use of beta

propiolactone because it is a potent cancer causing chemical [5]. Beta

propiolactone is a direct threat to laboratory workers preparing vaccine. The

chemical forms carboxy ethyl adducts on the nucleic acid bases guanine [6] and

cytosine [7]. Such modified nucleic acid bases may interfere with the host cell

nucleic acid synthesis and/or be incorporated into the DNA of the host cells

causing mutations. Cancer incidence has not been studied among those preparing

vaccine, nor in those vaccinated using beta propiolactone inactivated viruses.

A trivalent CSL vaccine containing inactivated H1N1 virus, inactivated H3N2

virus and inactivated influenza B virus was studied in a phase III clinical

trial on 1359 subjects between the ages of 18 and 64 years. The subjects

received a single injection containing the trivalent vaccine with, and without

thimerosol, or placebo with thimerosol. The trivalent vaccine preparations

showed ‘satisfactory’ immune responses. Reported adverse events included

erythema (skin redness), bruising and myalgia (muscle pain) mostly mild or

moderate. One subject experienced general urticaria (skin rash) and

dermatographism (ability to write on the skin) which persisted for at least one

year. The patient, who had never previously experienced a problem with

vaccination, was diagnosed as having serum sickness syndrome. In spite of the

adverse events, the trivalent inactivated influenza vaccine was judged to be

well tolerated and immunogenic [8].

CSL has begun a phase II study of the inactivated pandemic H1N1 vaccine. The

study has enrolled over 400 subjects, 200 of which are between 18 and 64 years

while the other 200 subjects are older than 65 years of age. Participants are

randomly assigned to groups, one group receiving 15 mg vaccine on day 0 and

another dose on day 21. The other group will receive 30 mg of vaccine on day 0

and day 21 of the study [9]. Following immunization, the safety of the vaccine

will be assessed by monitoring for adverse events through 21 days following the

last vaccination (day 42 after the initial vaccination). Serious adverse events

and new onset chronic medical conditions will be followed for seven months after

the first vaccination.. The phase II trial is still in progress [9].

CSL is the only company in the southern hemisphere that produces seasonal and

pandemic influenza vaccines; though a vaccine company appeared to have emerged

in China [10].

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