Moderna’s COVID-19 Vaccine Could Be Granted FDA Emergency Use Authorization in December, Says CEO

Moderna, Inc.’s (Cambridge, MA, USA) experimental COVID-19 vaccine could be granted Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA) in December based on positive interim results likely to be announced in November from a large clinical trial. However, if the study took longer to show sufficient interim results, then government authorization of Moderna’s COVID-19 vaccine would be granted early next year.

Speaking during The Wall Street Journal’s annual Tech Live conference, Moderna CEO Stéphane Bancel highlighted the challenges of creating a safe and well-received COVID-19 vaccine. Earlier, at a conference hosted by the Financial Times (FT), Bancel had said that Moderna’s COVID-19 vaccine was unlikely to be ready for widespread public distribution until the spring of next year. The company did not plan to seek EUA for its COVID-19 vaccine for frontline medical workers and other at-risk individuals until November 25 at the earliest. Bancel had said that if the vaccine was proved to be safe and effective, an approval for EUA by the FDA cannot be expected until late March or early April.

According to the WSJ report, the first interim analysis of the vaccine’s efficacy would happen when 53 people in the entire study show symptoms of COVID-19. That first analysis was likely to occur in November, although “it’s hard to predict exactly which week because it depends on the cases, the number of people getting sick,” the WSJ report quoted Bancel as saying. Bancel also warned that ramping up production of the COVID-19 vaccine would pose a challenge. “If one ingredient is missing, we cannot make the vaccine,” the WSJ quoted him as saying.

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