（按FDA規則，需要二個月的臨試三期數據才能獲得EUA，而正式批準至少要六個月以上的數據。）
So far, Moderna and Pfizer have both filed for full FDA approval, however.
FDA approval of a drug, which requires a rigorous and structured process, means that data on the drug’s effects have been reviewed by the Center for Drug Evaluation and Research, which rules on whether the drug's provided benefits "outweigh its known and potential risks for the intended population," according to the agency's website.
Moderna announced earlier this month that it had begun a “rolling submission” to the FDA of data from its studies of the two-dose mRNA vaccine.
“We are pleased to announce this important step in the U.S. regulatory process for a Biologics License Application (BLA) of our COVID-19 vaccine,” Moderna CEO Stephane Bancel said in a press release. “We look forward to working with the FDA and will continue to submit data from our Phase 3 study and complete the rolling submission.”
Large-scale studies of the shots continued after Moderna’s emergency authorization. The FDA will scrutinize the information to see if the vaccine meets stringent criteria for full licensure.
Both authorization and approval are rigorous processes that look at the safety and efficacy of a vaccine, Moss said. A key difference between the two is that at least two months of follow-up data from phase 3 clinical trials are considered for authorization, versus at least six months for approval.
The FDA will take several months to review the full set of data before granting approval, which several experts told ABC News was very likely. For Moss, with nearly 300 million doses administered in the U.S., "there's nothing about that review process that's going to reveal anything we don't know."
