Science in Society Archive

CSL Pandemic Swine Flu Vaccine Safety in Question

New vaccine formulation contains thimerosal and beta-propiolactone a potent cancer causing chemical. Prof. Joe Cummins

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].

Article first published 21/09/09


  1. Ho MW and Cummins J. Fast-tracked flu vaccine under fire  Science in Society 43, 4-6, 2009.
  2. Cummins J, and Ho MW. Live attenuated swine influenza vaccine for children safety in question. Science in Society 44. 
  3. RxList The Internet Dru Index Afluria 2008,
  4. Medimmune  Medimmune licenses Reverse Genetics Technology to CSL for Use in Influenza Vaccine Production  2008
  5. International Agency for Research on Cancer  IARC Monogr.Eval.Carcinog.RisksHum.1999,71 Pt3,1103-18.
  6. Perrin P and Morgeaux S. Inactivation of DNA by beta-propiolactone. Biologicals1995, 23(3), 207-11.
  7. Segal A, Solomon JJ, Mignano J, Dino J.The isolation and characterization of 3-(2-carboxyethyl)cytosine following in vitro reaction of beta-propiolactone with calf thymus DNA. Chem Biol Interact. 1981, 35(3), 349-61.
  8. Talbot HK, Keitel W, Cate TR, Treanor J, Campbell J, Brady RC, Graham I, Dekker CL, Ho D, Winokur P, Walter E, Bennet J, Formica N, Hartel G, Skeljo M, Edwards KM. Immunogenicity, safety and consistency of new trivalent inactivated influenza vaccine. J Infect Dis. 2008, 198(5), 650-8.
  9. CSL H1N1 Influenza Vaccine Administered at Two Dose Levels in Adult and Elderly Populations 2009,
  10. “Pandemic vaccine enters clinical trials”, Cassandra Willyard, Nature Medicine 2009, 15, 978,

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Erwin Alber Comment left 5th October 2009 19:07:11
In reply to Rory: Vaccination is disease prevention only from a historical perspective, from which it can be seen as a failed attempt at disease prevention. Contrary to medical-pharmaceutical mythology, Jenner's crude cowpox vaccine failed to live up to his expectations that it would protect people against smallpox. Instead, vaccination was declared a triumph of medical science. The rest is history, the result the multi-billion global vaccine-industry, a swindle and organised criminal racket without precedent. Profits are however only one of several reasons why vaccination is still practised. Because healthy people are unprofitable and only sick people are a source of revenue, vaccines are used to promote ill-health and disorders among the popualtion. This creates a large and profitable customer base for medical services and pharmaceutical products. If vaccines cause lots of cancer, all the better for the cancer industry. Likewise, around 80% of asthma is vaccine-related, which translates into major profits from the sale of inhalers and other asthma medication. A further useful aspect of vaccination, which especially the "elites" and the governments they control are interested in, is population control and reduction. Mercury and aluminum are e.g. added to vaccines to impair children's mental functions, while the global "swine flu" vaccination programme now being implemented is not meant to prevent any so-called swine flu, but to drastically reduce the world population. Austrian investigative journalist Jane Burgermeister says that soon, up to 6 billion people may be dead due to a vaccine-induced pandemic. This represents about 90% of the world's population. The medical profession found vaccination such an attractive invention because in the eyes of the public it appeared to give the medical profession almost magical powers over life and death. Vaccination was the proverbial magical bullet. Far from preserving life, vaccines have turned out to be a curse on humankind. It is rather ironic that a medical intervention meant to save lives has now been used to plan humanity's demise.

Cynthia St Amour Comment left 16th October 2009 00:12:45
My husband and I have been trying to find out if sodium metabisulphte is used as a preservative in either the H1N1 Vaccine manufactured by Glaxo or the Seasonal Flu Vaccine 2009 Manufactured by ID Biomedical Distributed in Canada.My Husband is anaphaltic to this chemical Thanks for your help ,Cynthia

Rory Short Comment left 22nd September 2009 04:04:30
It amazes me that a vaccine producing company can embark on developing a vaccine which they decide will contain known cancer causing agents especially when there are other ways of constructing the vaccine.

amicus curiae Comment left 23rd September 2009 02:02:11
strange fact is that ONLY the first 7 days reactions have been used to say that it is ok, and has no problems than, isn't it? see an article on, where I tell of the links and deals and Anomalies in CSL in aust, and their links to other companies for vaccines. around the 28th July under the cotonews section.

joe cummins Comment left 24th September 2009 20:08:29
In reply to Dario Soldateschi: Thanks for the useful comment. Beta-propiolactone is very reacive and leaves its adducts on DNA and RNA guanine and cytosine as well as proteins. The nucleic acid adducts in inactivated virus will be released when the nuclleic acid is broken down. There are no available published reports on the beta-propiolactone modified nucleic acid guanine and cytosine in animals or human cells in culture but modified nucleic acid bases usually interfere with nucliec acid synthesis or cause mutations when incorporated into DNA. That area crys out for fuller study because so many people have been or will be vaccinated with inactivvated viruses.In general there are few long term follow up studies of cancer in those vaccinated.

Dave Conrad Comment left 6th October 2009 06:06:40
I add my testimony to what Erwin Alber is saying. For additional documentation besides that which Erwin references -- you may google the phrase - Infowars: They Want To Inject My Kid With What?

Dario Soldateschi Comment left 23rd September 2009 00:12:23
The fact that beta-propiolactone is used to inactivate the virus, does not imply that it is present in the vaccine. In fact, beta-propiolactone is very unstable and rapidly hydrolyse to an isomer of lactate and beta-propionic acid, both of which are harmless. To avoid the presence of beta-propiolactone in the final product it is sufficient to incubate the inactivated vaccine at 37°C or less until the inactivated agent is completely hydrolysed, that is what presumptively the producer daes.

Ben Comment left 24th October 2009 05:05:09 conducted a study among 300 Americans viewing a clip of the assistant surgeon general addressing concerns about the H1N1 and seasonal flu vaccines. Results found that parents with children under the age of 18 are more likely to have them vaccinated against the H1N1 virus after viewing a message from the assistant surgeon general. The majority of respondents (70%) reported that they are confident that the H1N1 vaccine is successful in preventing the H1N1 flu. More in depth results can be seen at: Thanks, Ben