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When will a SARS-CoV-2 vaccine candidate be approved for use in the United States or European Union?

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.

In the United States, the U.S. Food and Drug Administration (FDA) must approve a vaccine before it can be used by the public. This approval process involves a "rigorous review of laboratory and clinical data to ensure the safety, efficacy, purity and potency" of the vaccine candidate. Typically, this process involves: successful pre-clinical testing, phase one clinical trials that demonstrate safety in humans, phase two trials that provide information on side-effects and dosage response, and phase three trials that show the efficacy of the vaccine candidate in the field. If these steps are undertaken successfully, the FDA approves the vaccine and grants a license for its use.

In the European Union, the European Medicines Agency (EMA) must recommend a vaccine for marketing authorization by the European Commission and the European Commission must then grant that authorization before the vaccine can be used by the public. The approval process is very similar to that used by the FDA, except that the EMA can only recommend authorization and cannot itself grant it.

This question asks: When will a SARS-CoV-2 vaccine candidate be approved for use in the United States or European Union?

Resolution will be determined via the first relevant press release made by the FDA, EMA, or European Commission regarding the approval of a SARS-CoV-2 vaccine candidate. In the United States, approval means that the vaccine candidate has been licensed. 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.

If this does not resolve before 08 April 2023, it resolves as >08 April 2023.


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