mNEXSPIKE becomes Moderna's third FDA-approved product

The US Food and Drug Administration (FDA) has approved mNEXSPIKE (mRNA-1283), a new vaccine against COVID-19, US mRNA specialist Moderna (Nasdaq: MRNA) announced on Saturday, amidst emerging coronavirus variants.
The vaccine is authorized for use in all adults 65 and older, as well as individuals aged 12-64 years with at least one or more underlying risk factor as defined by the Centers for Disease Control and Prevention (CDC).

"The FDA approval of our third product, mNEXSPIKE, adds an important new tool to help protect people at high risk of severe disease from COVID-19," said Stéphane Bancel, chief executive of Moderna. "COVID-19 remains a serious public health threat, with more than 47,000 Americans dying from the virus last year alone. We appreciate the FDA's timely review and thank the entire Moderna team for their hard work and continued commitment to public health," he noted.

The news comes just days after Moderna announced that, in consultation with the FDA, the company has voluntarily withdrawn the pending Biologics License Application (BLA) for mRNA-1083, its flu/COVID combination vaccine candidate for adults aged 50 years and older.