The FDA on Friday issued an emergency-use authorisation (EUA) for Moderna's mRNA-1273, triggering the rollout of a second COVID-19 vaccine in the US. The decision comes a day after near unanimous backing by an FDA advisory panel, and about a week after Pfizer and BioNTech's vaccine BNT162b2 snagged the first EUA and began shipping across the country.
"Through the FDA's open and transparent scientific review process, two COVID-19 vaccines have been authorised in an expedited timeframe while adhering to…rigorous standards for safety, effectiveness, and manufacturing quality," stated FDA Commissioner Stephen Hahn. "With the availability of two vaccines now for the prevention of COVID-19, the FDA has taken another crucial step in the fight against this global pandemic," he added.
The decision sets into motion the federal government's plan to distribute approximately 5.9 million doses of Moderna's vaccine to states, territories and major cities across the US next week. In addition to mRNA-1273, the US also plans to send out 2 million doses of Pfizer/BioNTech's vaccine after 2.9 million doses were cleared for shipment in the first week of its national rollout, according to Gen. Gustave Perna who oversees logistics for Operation Warp Speed. "It will be a very similar cadence that was executed this week with Pfizer, where we're hitting initial sites on Monday, [followed] on Tuesday and Wednesday," Perna remarked.
Moderna estimates that about 20 million doses of mRNA-1273 will be delivered to the US government by the end of this month. The company added that it expects to have between 100 million and 125 million doses available globally in the first quarter of 2021, with 85 million to 100 million of those available in the US.
The EUA for Moderna's vaccine, which is given in two doses administered four weeks apart, is for the prevention of COVID-19 in individuals 18 years and older. FDA briefing documents released a few days before the approval confirmed that the efficacy of mRNA-1273 at preventing coronavirus infections stood at 94.1%, which was consistent with results seen in the interim analysis conducted on 196 cases from an ongoing Phase III study. Moderna says it will continue to gather additional data and plans to file a biologics license application for mRNA-1273 with the FDA in 2021 requesting full licensure.
Earlier this month, the US government announced that it exercised its option to purchase another 100 million doses of Moderna's vaccine, on top of an initial order for 100 million doses agreed to in August in a deal worth up to $1.5 billion. FDA's decision could help pave the way for other countries that are considering the Moderna vaccine, which also happens to be the first-ever regulatory clearance for the company.
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