Johnson & Johnson has applied to the Food and Drug Administration (FDA) for an emergency use authorization for its one-dose Coronavirus (COVID-19) vaccine, setting in motion a process that is all but sure to see a third such vaccine authorized.
FDA scientists will now pour over the data generated in the various clinical trials J&J has conducted on the vaccine. Before the vaccine can be authorized, an advisory committee of outside experts, known as the Vaccines and Related Biological Products Advisory Committee, will meet and review the data. The FDA does not have to follow its recommendation but the agency generally does. It will likely take about three weeks for this process to play out.
J&J revealed in late January that its vaccine was 66% effective at preventing moderate and severe Covid infections, with moderate infections defined as a positive Covid test plus one symptom of serious illness (shortness of breath, a chest scan showing pneumonia) or two more mild symptoms, including fever, chills, loss of taste or smell, or muscle pain.
This story was originally posted on Johnson & Johnson media release:
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