BENGALURU — Moderna Inc’s COVID-19 vaccine appeared to be set for regulatory authorization this week after U.S. Food and Drug Administration staff members did not raise any major new concerns about it in documents released on Tuesday.
The FDA reviewers said a two-dose regimen of Moderna’s vaccine was highly effective in preventing confirmed cases of COVID-19 and did not raise any specific safety issues with using the vaccine in adults over the age of 18.
The comments were made in documents prepared for Thursday’s meeting of outside experts, who will discuss whether to endorse a U.S. emergency use authorization (EUA) for the Moderna shot.
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