Getting Technical
The resulting discoveries will not only help mitigate the current pandemic , but also be of value for prevention , diagnosis , and treatment of future emerging infectious diseases .
Developing a safe and effective SARS-CoV-2 vaccine is a priority for preventing , or at least reducing future outbreaks of the virus . Taking into account that vaccine candidates for MERS-CoV , SARS- CoV-1 and other coronaviruses have previously been developed , NIAID investigators in conjunction with the world-wide scientific community are well placed to use similar approaches in the current pandemic .
NIAID will utilise its broad intramural and extramural facilities to advance vaccine candidates through phase-1 safety and dosing clinical trials . Product candidates which show the most promising results will then be advanced to Phase-2 / 2b clinical trials .
Given the urgency of the response effort to develop a safe and effective vaccine , NIAID is prioritising promising vaccine candidates that can be rapidly produced and tested . NIAID , in collaboration with the biotechnology company Moderna , is conducting a Phase-1 clinical trial of a vaccine candidate that uses a messenger RNA ( mRNA ) vaccine platform expressing a NIAID-designed recombinant spike protein of SARS-CoV-2 .
The trial is being conducted at various NIAID-funded clinical research sites . In one of these sites the first enrolled individual already began receiving vaccine treatment on March 16 , 2020 .
Preparations for a pivotal Phase 2 / 2b clinical trial of candidate mRNA-1273 are already under way . It is also imperative that preparations for the likelihood of any seasonal recurrences of SARS- CoV-2 are completed as soon as practically possible .
Given the theoretical risk of vaccine-enhanced respiratory diseases , large scale phase-2 trials are unlikely to be launched until these possibilities have been evaluated in animal models . Planning for those animal studies is already advanced , and , assuming favourable results , an initial phase-2 / 2b study would be launched late in 2020 .
This represents a historically fast timeline for the development and testing of a vaccine candidate . Additionally , these studies will provide increasing amounts of information on immunity that will help accelerate the advancement of other vaccine candidates . If the mRNA-1273 vaccine candidate shows protection against SARS-CoV-2 infection in a phase-2 / 2b trial , NIAID will work with government partners to ensure that the vaccine is manufactured in sufficient quantities to allow prompt distribution to those at highest risk of acquiring Covid infections .
Although promising vaccine candidates may show efficacy in pre-clinical studies , many do not translate into effective vaccines in clinical trials . Therefore , it is crucial to support multiple promising
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RACA Journal I January 2021 www . hvacronline . co . za