EMERGING TRENDS IN INFECTIOUS DISEASE
THE ROAD TO A COVID-19 VACCINE AUTHOR Stanley A . Gall , MD
The story of the COVID-19 virus
starting in China in December 2019 and continuing to the present time has been reviewed respectfully and features : 1
1 . Pandemic classifications 2 . Shutdown of the US and world-wide economies
3 . Recovery from initial wave of the virus ( in some countries ) with economies in various stages of recovery
4 . Occurrence of a second wave of COVID-19 spread and repeat shutdowns of many countries ’ economies
5 . The glaring need for treatment products and especially for vaccines to control the virus
There is a process in place for the development of vaccines which is controlled by the federal agency Food and Drug Administration ( FDA ) after completion of phases of development .
Initial Phase : Candidate vaccine is tested in animals for safety , immunity and effectiveness . This initial phase usually takes three to six months . The manufacturing of the vaccine must follow quality and safety policies of the FDA .
Small Phase I : Studies in humans ( 10-100 ) to evaluate safety and immune responses . This phase may take three to six months .
Phase II Studies : Formulation and dosing of the vaccine as established to prove vaccine effectiveness and safety profiling . Groups may be 100-3,000 persons and can take six to 12 months to complete .
Phase III Studies : Large groups ( 30,000 ) to determine effectiveness and safety . Manufacturing facilities are built after phase II studies have provided evidence the vaccine is safe and effective .
Realistically , approval of such a vaccine will normally take 12-18 months , or longer . If approved , it will take another year to produce and distribute adequate doses for the general population .
However , on May 15 , 2020 Operation Warp Speed ( OWS ), 2 a partnership of the Department of Health and Human Services ( HHS ), Department of Defense ( DOD ) and private industry was announced . OWS has provided support to promising vaccine candidates which would enable expeditious , parallel executions of necessary steps toward approval of safe products by the FDA .
Initiatives included the delivery of a SARS-CoV-2 vaccine beginning by the end of 2020 and available to as many as 300 million doses by mid-2021 .
OWS ’ s role is to enable , accelerate , harmonize and advise the companies developing the selected vaccines . OWS is to ensure that no technical or financial hurdles impede vaccine development or deployment .
Final candidates had to use one of four vaccine platform technologies most likely to yield a safe and effective vaccine against the COVID-19 virus .
A . The mRNA platform B . Recombinant subunit adjuvant protein platform C . The replication-defective live-vector platform D . The alternated replicating live-vector platform
( See Table 1 )
The FDA monitors the studies for vaccine effectiveness and safety . The stated goals of the FDA are to achieve the following :
1 . Minimal efficacy of 50 %
( continued on page 8 ) JANUARY 2021 7