ISIS Report 07/10/09
Flu vaccines are increasingly manufactured in cell lines that are actually or potentially oncogenic, and FDA guidelines allow high levels of contamination and no spot checks are carried out Dr. Sherri J Tenpenny
Much concern has been generated over the new swine flu H1N1 vaccines that are being rushed to market. Clinical trials have been short – less than three weeks – and there is also the possibility of adding toxic oil-in-water adjuvants at the last minute to stretch the vaccine supply (see [1] Fast- tracked Swine Flu Vaccine under Fire, SiS 43). Those are not the only concerns. The new manufacturing process for flu shots, called cell-line technologies, are little understood and have the potential for serious, long term consequences.
Manufacturing the “regular,” annual flu shot
Each year, between January and March, an FDA advisory panel selects the three influenza strains expected to be in circulation during the upcoming flu season. Admitting that the process is an “educated guess,” the CDC sends the selected seed virus to the FDA for approval, and is then distributed to manufacturers for vaccine production.
The annual flu shot contains three viral strains: two type influenza A viruses and one type influenza B. Most commonly, two of the viruses are the same viruses included in the preceding year’s shot. The third virus is typically a new strain in circulation. This is the purported reason for giving the shot each year. The new strain is modified through a laboratory process called reassortment to ensure that it can readily grow in eggs. Once the modification is complete, all three viruses proceed through tricky manufacturing steps for what goes in that vial.
The cumbersome flu shot production process uses up to 500 000 fertilized chicken eggs per day for up to eight months. Hundreds of millions of fertilized eggs become “mini- incubators” for cultured viruses. When the chick embryos are 11-days old, the amniotic membrane (the egg white) is manually injected with a drop of viral-containing solution. Several days later, the gooey viral suspension is centrifuged to remove as much chicken blood and tissue from the solution as possible. Residual egg protein remains within the final vaccine solution and is the reason why persons with an egg allergy are advised against receiving the flu shot.
The entire process, from viral selection to viral harvest, can take up to nine months [2]. With the potential for a pandemic and the Director General of the WHO, Margaret Chan, requesting up to 4.9 billion of flu shots to vaccinate the world [3], the slow lead time and labor-intensive production process cannot meet the demand for massive quantities of pandemic flu vaccine.
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