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Will a RNA SARS-CoV-2 vaccine candidate be approved for use in the United States or European Union before 2022?

The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus is a novel betacoronavirus that likely emerged late last year from an animal reservoir in China. There is little to no pre-existing immunity against it in the human population. The clinical picture for the disease it causes, coronavirus disease 2019 (COVID-19), ranges from very mild to fatal. The virus is highly transmissible and has spread globally.

As of 20 March 2020, the WHO (World Health Organization) is reporting that it is tracking the development of forty-four SARS-CoV-2 candidate vaccines. Two of these candidates have entered phase one and the other forty-two remain in the pre-clinical stage. One of the candidates in phase one is a RNA vaccine candidate, as are seven of the candidates in the pre-clinical stage.

RNA vaccines are of particular interest because they can be developed and produced relatively quickly since, unlike other vaccine platforms, they do not require fermentation or culture and instead use faster synthetic processes. As a result, the first SARS-CoV-2 vaccine candidate to enter a phase one clinical trial is a RNA vaccine, mRNA-1273, which was developed by Moderna Therapeutics at record speed.

While promising, RNA-based vaccine platforms are a new development and the field is still nascent. No RNA vaccine has ever made it to market. And since no RNA vaccine has been approved to date, there is an urgent need to determine the likelihood of successful development of such a vaccine for SARS-CoV-2.

This question asks: Will a RNA SARS-CoV-2 vaccine candidate be approved for use in the United States or European Union before 2022?

Resolution will be determined via the first relevant press release made by the FDA, EMA, or European Commission regarding the approval of a RNA SARS-CoV-2 vaccine candidate. In the United States, approval means that the vaccine candidate has been licensed by the FDA. In the European Union, approval means that the EMA has recommended the vaccine candidate for approval and the European Commission has granted that approval via marketing authorization. Approval under any other emergency procedures, such as expanded access, would not count.


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