DNA Contamination in Vaccines Inevitable

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Vaccines and Related Biological Products Advisory Committee Meeting
September 19th, 2012
Cell Lines Derived from Human Tumors for Vaccine Manufacture
Link to PDF:
This is a discussion about a few troubling key points within this document.
First up in section 4.1.1 the following information:
“Adventitious agents are defined as microorganisms that are not intended to be present in a biological product and include bacteria, fungi, mycoplasma / spiroplasma, mycobacteria, rickettsia, protozoan parasites, transmissible spongiform encephalopathy agents, and viruses.”
At what point in the history of vaccines did they determine what an advantageous agent was and could be? How long did it take them to realize that these things may be present in a vaccine?
Second up section 4.1.1
“The use of human tumor-derived cell lines poses added safety concerns regarding the potential presence of unexpected and unknown viruses. These include viruses that may be present in the cell line due to their existence in the patient tissue such as oncogenic, latent DNA viruses (e.g., adenovirus is, hepadenoviruses, herpesviruses, papillomaviruses, polyomaviruses) and 2) endogenous retroviruses (ERVs), which exist normally in a quiescent state in the host cell DNA of all species, but can become activated and produce virus particles in tumor cell lines. Furthermore many tumor-derived cell lines support infection and replication of a wide variety of viruses and therefore may be more susceptible to infectious viruses present in the host (e.g., some RNA viruses such as LCMV) or through contaminated human or animal-derived reagent used during cell-line derivation and passage history. There may be additional concerns in the case of virus-like particles (VLPs) such as co-packaging of “unwanted” oncogenic RNAs or DNAs that may be transferred to the recipient by vaccination.”
It is important to remember that it was the polio vaccine that introduced the Simian Virus 40 to the human population. SV40 has since been found in human tumors. The following article lists four current such cases of adventitious agents that were discovered in vaccinations. Of particular concern is the reverse transcriptase that was found in all lots of the MMR vaccine that was tested. Keep in mind that they can only test for viruses that are known.
Last up in section 4.2.1
“Small amounts of residual cell substrate DNA unavoidably occur in all viral vaccines as well as other biologics produced using cell substrates. There are several potential ways DNA could be a risk factor. DNA can be oncogenic or infectious; in addition, it can cause insertion mutagenesis through integration into the host genome.”
Remember section 13.1 of every vaccine insert says has not been evaluated for carcinogenic or mutagenic effects, or effects on fertility.
It is important to note that complete removal of DNA from vaccines is not possible. In appendix 4 of the document they state “the value of 100pg of host cell DNA per vaccine dose remained the recommended standard for a decade. However, the issue was revisited in 1997 for several reasons. First, vaccine manufacturers could not always meet this level of residual cell substrate DNA for some viral vaccines, such as with certain enveloped viruses…. The outcome of the 1997 who meeting was that the amount of residual cell substrate DNA allowed per dose in a vaccine produced in a continuous cell line and one administered by the parenteral route was raised from 100pg to 10ng.”
You see, they lowered the standards of safety because the manufacturer was unable to maintain this crucial level of safety. Not exactly reassuring and perhaps a bit careless. Currently the vaccines that contain residual human DNA and protein are:
Chicken Pox
DTaP, Hib, Polio (Pentacel)
Keep all of these things in mind the next time you hear the party mantra that vaccines are “safe and effective”.
What in particular bothers you the most about this information?
Soundchoice investigation on DNA mutagenesis.