There is increasing evidence that, with best intent, current biological technology cannot supply the world's six billion humans, and animal populations, with vaccines against emerging diseases at a rate that can contend with a disease's rapid appearance and change, eg, before the disease has come and gone. In view of Replikins Ltd's demonstration that Replikins chemically synthesized vaccines produced in seven days can be effective, the company proposed these new vaccines as a solution to the problem of these emerging diseases. Furthermore, it established WorldVaccines, Ltd to test and distribute synthetic Replikins vaccines.
As the first batches of the biological H1N1 (Swine Flu) vaccines reach consumers worldwide, seven months after the flu outbreak, this small biotech firm in Boston has created the first truly synthetic influenza vaccine that targets the broad range of A influenza viruses including H1N1, H5N1, H9N2, and H3N2, which was shown to be effective against the H5N1 (Avian Flu) virus. TransFlu is the first truly synthetic cross-strain pan-influenza vaccine.
In an independent study published in the peer-reviewed journal Avian Diseases, the synthetic Replikins TransFlu vaccine was shown to be effective in decreasing infectivity and completely blocking excretion of LPAI H5N1 virus in chickens, permitting for the first time the possibility of blocking animal virus reservoir development, a major precursor of human disease.
Both TransFlu and Taura Syndrome Virus vaccines were manufactured in seven days; kilogram amounts could be made in a few weeks, rather than six to 12 months needed for biological vaccine production. The cost to produce the synthetic vaccine is also far less than the cost of current biological production methods. Given the demonstrated effectiveness and rapid availability, it appears inevitable that synthetic Replikins vaccines will eventually replace biological vaccines.
Further, until now, all influenza vaccines have been produced in biologically living cells. Whether whole virus or recombinant virus sections are reproduced in eggs, kidney, hamster, E.coli, or other cells, these living cells provide the obligatory contamination in the vaccine of thousands of unwanted immunogenic proteins, the potential for other virus contamination (viruses only reproduce in living cells), and the need for potentially toxic preservatives.
Over the last decade, Dr Samuel and Dr Elenore Bogoch have been developing vaccine-manufacturing methods that are non-biological, based on software algorithms designed to study virus structure, and organic chemistry. The new, completely synthetic Replikins Vaccine Technology (1-4) targets a group of genomic peptides that they discovered and named Replikins. These genomic peptides were found to be conserved in viruses cross-strain over decades, and to be related to rapid replication and epidemic outbreaks.
The centrality of the Replikins to influenza has been confirmed recently by the data of two independent groups, Harvard-CDC and Scripps-Crucell. Their findings demonstrate that inhibitory antibody lands on and binds selectively to the very peptides that the Drs. Bogoch have previously identified as Replikins.
Three months to one year in advance of an outbreak, the related Replikins FluForecast software warns of the oncoming emergent disease. This technology was recently validated when it successfully identified, a year in advance, the current H1N1 outbreak. The technology also defines the Replikins that need to be synthesized in the vaccine. Thus the Replikins structures, which make up both the newly discovered infectivity and lethality genes within the virus genome, provide the keys to both advance warning and synthetic vaccine production.