On April 10, 2018, Dr Anthony Fauci co-authors a viewpoint paper in JAMA Network setting the stage for novel genetic vaccines (mRNA or DNA) to shorten the time “to design, manufacture, and evaluate vaccines for clinical use…in response to newly emerging infections”.
“The time-honored approach to vaccinology,… has not adequately met” the challenge of “emerging viral diseases with pandemic potential.” So this paper looks to “exploit modern-day technological advances.”
[Reading this paper in retrospect summarises the “vaccine solution” response to Pandemic 2020.]
“Historically, the process of vaccine development through to licensure requires decades…[i]n total, 15 to 20 years would be a typical timeframe from virus discovery to vaccine availability if the process proceeds smoothly and there are no major biological or logistical challenges.”
…[H]owever, clinicians and public health officials are often faced with outbreaks of viral diseases, sometimes of a pandemic nature that would require vaccines for adequate control.”
“Rapid genetic sequencing allows both early identification of new pathogens and the identity of the genes encoding structural proteins that can form the basis for vaccine immunogen development.”
“Synthetic vaccinology and platform manufacturing are important innovations that can speed the initial vaccine immunogen design and vaccine development process, and shorten the time needed for manufacturing and initial regulatory approval to begin phase 1 testing.”
“The process of gene synthesis is now extremely rapid…[t]hese genetic vectors (DNA and mRNA) can be used directly for immunization whereby intramuscular immunization leads to muscle cells producing the viral proteins. Alternatively, the genetic vectors can be used to express recombinant protein antigens, in vitro, that can be used for immunization.”
“The term platform …in vaccine production… implies that the method for generating and presenting a vaccine immunogen can be applied across multiple pathogens.” “DNA or mRNA nucleic acid vaccines are good examples of how platform manufacturing can shorten timelines from pathogen identification to phase 1 clinical trials.” [1, 2]
“DNA vaccine delivery and immunogenicity have evolved and improved over the last 2 decades, making it a viable platform for vaccination.”
Based on NIAID experience “Once these pathogens were identified, the time from viral sequence selection to initiation of the phase 1 clinical trial was shortened from 20 months to slightly longer than 3 months.”
“Traditional approaches, such as live-attenuated virus vaccines (eg, Sabin polio) or whole-inactivated virus vaccines (eg, Salk polio) would not qualify as platform approaches because the requirements for growth in cell culture and purification are usually different among virus families. Protein-based approaches … may not be amenable to platform approaches.”
“Having a standard manufacturing approach reduces the time needed for current Good Manufacturing Procedures process development and simplifies regulatory approval because the safety database that has accumulated for a given platform can be applied to multiple vaccine products.”
Dr Fauci published another paper on “novel vaccine technologies” in Nature in November 2019…all in time for pandemic 2020.
mRNA vaccines are still in “preclinical studies” in September 2018.