On April 27, 2007, Novartis Vaccines announced that Optaflu, the first cell culture-derived influenza vaccine, would be approved in the E.U. Now, instead of making flu shots from eggs, your next flu shot may be grown in dog kidney cells.

How the “regular” flu shot is made
Each year, between January and March, an FDA advisory panel selects the three influenza strains that are 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 prior to distributing the viruses to the manufacturers for production.

The annual flu shot contains three separate strains: two influenza A strains and one strain of influenza B. Most commonly, two of the strains are the same viruses that had been in the preceding year’s shot. A third, new strain, is selected each year and then modified in the lab before it is added to the new seasonal shot.

The next few manufacturing steps are tricky. Vaccine production is a slow, cumbersome process utilizing 500,000 fertilized chicken eggs per day for up to eight months turning hundreds of millions of eggs into “mini-incubators” for the cultured viruses. When the fertilized egg embryo is 11-days old, eggs are selected, labeled and injected with a drop of viral-containing solution. Several days later, the gooey viral suspension is centrifuged—sometimes more than once—to remove as much chicken blood and tissue solution as possible. Residual egg protein frequently remains within the final product and is the reason why persons with an egg allergy are advised against receiving the flu shot.

The entire process, from egg selection to viral harvest, can take six to nine months.(1) The potential for a pandemic raises the potential need for billions of flu shots in a short period of time. Months of lead time using eggs will hinder the response of unanticipated demands.

New Cell Lines…are they really new?
First described in the mid-1990s and still in the experimental stages, the new technology has drawn all major players in the vaccine industry into attempts to develop cell culture technology for flu shots. The methodology can be rapidly expanded in times when the government thinks there is an emergency need for any vaccine that is made from eggs.

Although new for flu shots, cell-culture technology is hardly new. It has been used since the 1950s for the production of polio, measles, mumps, and tetanus vaccines. Cell-line technology has not been used for flu shots primarily for logistical reasons: It would require a complete retooling of existing production facilities. None of the manufacturers have been willing to invest the hundreds of millions of dollars and the five to seven years required to build new vaccine plants. But with the threat of a pandemic, and the government providing tens of billions of dollars to produce a bird flu vaccine, the funding for the capital improvements allowed manufacturers to rapidly proceed.

Flu Cell Culture Technology: The Next Frontier Overview
Cell culture-derived influenza vaccines, referred to as "flu cell culture" vaccines are make from animal cells rather than chicken eggs for the production of vaccines. Flu cell culture enables batches of vaccine to be produced in less than six weeks.

One substrate under consideration is in the newly released Novartis vaccine. This flu cell line, called Madin-Darby (MDCK), has been extracted from the kidneys of a healthy female cocker spaniel. The cells have been transformed in the perpetually dividing cells, called “immortalized cells.” Solvay Pharmaceuticals, a Dutch company, has been working with this cell-culture to produce influenza vaccines since the early 1990s, where the cells have been approved for use in the Netherlands.

An independent company, Protein Sciences Corporation, has been working to develop a patented influenza vaccine that will be produced from insect cells. This vaccine strategy, known commercially as FluBlok®, isolates a purified concentration of the (H) antigen from the vaccine-bound flu virus and inserts it into a second virus called a baculovirus. The (H)-containing baculovirus is inserted into caterpillar cells growing in culture. Several clinical trials involving the bug-created vaccine have shown that the antigens elicit a strong antibody response in humans.(2)

The FDA is fully aware that the new cell substrates made from animal tissues come with risks that in many ways are no different from the risks associated with using eggs. The cells can become contaminated with adventitious viruses that are potentially deadly. An FDA memo acknowledges the risks:

“The experience in the early 1960s with SV40 contamination of poliovirus and adenovirus vaccines and the continuing questions regarding whether SV40 could be responsible for some human neoplasms [cancers] underscores the importance of keeping viral vaccines free of adventitious agents [viral contaminants]. This is particularly important when there is a theoretical potential for contamination of a vaccine with viruses that might be associated with neoplasia [cancer]…It is unclear whether cell substrates have a greater or lower risk [of contamination] than other types of cells…However, if their growth in tissue culture is not well controlled, there may exist additional opportunities for contamination of cells with a longer lifespan.” (3)

And it gets worse. The same FDA memo goes on to say:

“In addition to the possibility of contamination of cell substrates…the use of immortalized, neoplastic human cells to develop [vaccines] raises theoretical concerns with regard to possible contamination with TSE/BSE agents.”(4)

TSE is short for Transmissible Spongiform Encephalopathy, a condition that includes a group of rare degenerative brain disorders characterized by tiny holes in the brain tissues, giving a “spongy” appearance when viewed under a microscope. When this condition occurs in cows it is called Bovine Spongiform Encephalopathy, commonly known as “mad cow disease.” In a study published in 2004, researchers found that any cell line could potentially support the propagation of TSE agents.(5)

Clearly, CBER, a division of the FDA, is aware and disquieted over the carcinogenic potential of animal cells and wants manufacturers to take every available precautionary step to eliminate the cells from the vaccine final product. The FDA admits serious concerns about contamination of all types of cell lines. The question that begs an answer is, knowing the cancer-causing potential of the cell lines and the cancer-causing risks of contaminants in the cell lines, why is this technology being promoted? Or better, why is the FDA allowing its use at all?

Despite substantial evidence—and even admissions of concern—the FDA appears to be flagrantly ignoring the potential for harm to vaccine recipients through this technology and is recklessly approving the use of these products for the manufacture of the pandemic vaccine.

Avoiding the flu and staying healthy may start with avoiding the flu shot.
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REFERENCES
(1) “WHO manual on animal influenza diagnosis and surveillance,” World Health Organization, 1 September 2004.
(2) “Influenza Vaccines under development,” from Protein Sciences Corporation.
(3) “Designer” Cells as Substrates for the Manufacture of Viral Vaccines,” FDA Docket briefing.
(4) Ibid.
(5) Vorberg, I., et. al. “Susceptibility of common fibroblast cell lines to transmissible spongiform encephalopathy agents,” Journal of Infectious Diseases. PMID: 14745700