Although the U.S. Food and Drug Administration recently announced that Gardasil® indeed does contain recombinant HPV L1-specific DNA fragments, the physical condition(s) of these HPV DNA fragments in the final vaccine product has not been characterized.
The short-term and long-term impact of the residual fragments of HPV L1 gene DNA, or plasmid DNA, if chemically bound to the mineral aluminum of AAHS nanoparticles is largely unknown and warrants further investigation.
Recombinant technology has been used for many years to manufacture medicinal products. Gardasil does contain HPV L1-specific DNA fragments. This is expected, since DNA encoding the HPV L1 gene is used in the vaccine manufacturing process to produce the virus-like particles. The presence of these expected DNA fragments, which are inevitable in vaccine production, is not a risk to vaccine recipients, is not harmful, and this DNA is not a contaminant.
…all HPV-18 isolates can be classified into 3 subtypes based on alignments of the DNA sequences of the variants, (i.e. the European, the Asian-American and the African subtypes). In Europe, it has been reported that all of the HPV-18 isolates from patients are found to be of the European or Asian-American variants. In the U.S., 91% of the HPV-18 isolates from white women are reported to be of the European and Asian-American variants, and 64% of the HPV isolates from African American women belong to the African variant.
Since the prevalence of the African variants of HPV-18 among European patients is negligible, the Dutch researchers who originally developed the HPV INNO-LIPA kit naturally selected an HPV-18 probe targeting a homologous sequence shared by all European and Asian-American HPV-18 variants for the testing.
However, the HPV-18 L1 protein-coding gene chosen by the manufacturer for Gardasil® closely related to an African subtype. Failure to detect a target sequence of an African variant HPV-18 DNA in the vaccine Gardasil® with a hybridization probe specifically designed for the European and Asian-American DNA variants may simply reflect the diversity of the L1 protein amino acid sequences within the genotype of HPV-18.