How fast can SARS-CoV-2 vaccines be developed?

Recently,  Florian Krammer from Icahn School of Medicine at Mount Sinai published an article in Nature, reviewing the development of vaccines against SARS-CoV-2. In the paper, the author compares traditional vaccine-development pipelines with that of SARS-CoV-2 vaccine development.  
Traditional vaccine development can take 15 years or more, starting with a lengthy discovery phase in which vaccines are designed and exploratory preclinical experiments are conducted. This is usually followed by a phase in which more formal preclinical experiments and toxicology studies are performed and in which production processes are developed. During this process an investigational new drug (IND) application is filed and the vaccine candidate then enters phase I, II and III trials. If, when phase III trials are completed, the predetermined end points have been met, a biologics licence application (BLA) is filed, reviewed by regulatory agencies and finally the vaccine is licensed. After that point, large-scale production begins.
Vaccine development for SARS-CoV-2 is following an accelerated timeline. Because of knowledge gained from the initial development of vaccines for SARS-CoV and MERS-CoV, the discovery phase was omitted. Existing processes were adopted, and phase I/II trials were started. Phase III trials were initiated after the interim analysis of phase I/II results, with several clinical trial stages running in parallel. In the meantime, vaccine producers have started the large-scale production of several vaccine candidates, at risk. The exact pathway by which these vaccine candidates will be licensed—for example, through an initial emergency use authorization—is not yet clear.


Although vaccine development is moving forward at an unparalleled speed, there are still many open questions. It is likely that two doses of a vaccine will be required, with booster doses potentially necessary at later time points; in this case, at least 16 billion doses will be needed to meet the global demand. Many of the vaccines that are described below are being developed by entities that have never brought a vaccine to market, or use technologies that have never resulted in a licensed vaccine. Therefore, unforeseen issues with scaling could cause delays. It is also not yet clear whether bottlenecks will occur in the availability of, for example, syringes or glass vials; how vaccines will be distributed globally; and how rollout will occur within countries. Finally, for certain vaccine candidates against SARS-CoV and MERS-CoV, vaccine-enhanced disease was reported in some animal models. For SARS-CoV-2 vaccine candidates, there have so far been no signals of enhanced disease in animal models or in humans; however, such a safety signal would certainly derail the development of a vaccine candidate and would negatively affect vaccine development in general.

Reference

Krammer, Florian. "SARS-CoV-2 vaccines in development." Nature 586.7830 (2020): 516-527.


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