Moderna CEO Stéphane Bancel said Oct. 19 that the company expects interim results from its COVID-19 vaccine clinical trial in November, and the FDA could grant emergency use authorization in December if those results are positive, The Wall Street Journal reported.
The timeline is similar to Pfizer’s, which said last week that it should see data from its clinical trial indicating whether the vaccine works by the end of October and could seek FDA approval by the end of November.
Mr. Bancel said it’s hard to predict exactly which week it will receive the trial results because it depends on the cases and number of people getting sick, the Journal reported.
Mr. Bancel said at the end of September that Moderna will not seek FDA approval to use the vaccine in the general population until at least late January and that it wouldn’t seek emergency use authorization for front-line employees until at least Nov. 25.
In September, Moderna became the first company to release its trial protocol detailing how safety and efficacy will be determined after scientists asked vaccine makers to do so so that outside experts could review the protocol. Shortly after, Pfizer and AstraZeneca also released their trial protocols.
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