Moderna opts to withdraw BLA for mRNA-1083
US biotech Moderna (Nasdaq: MRNA) today announced that in consultation with the US Food and Drug Administration (FDA), the company has voluntarily withdrawn the pending Biologics License Application (BLA) for mRNA-1083, its flu/COVID combination vaccine candidate for adults aged 50 years and older.
Moderna, whose shares fell more than 5% to $26.58 on the news, said it plans to resubmit the BLA later this year, after vaccine efficacy data from the ongoing Phase III trial of its investigational seasonal influenza vaccine, mRNA-1010, are available. Moderna continues to expect interim data from the mRNA-1010 trial to be available this summer.
While the submission had a target review date in November, the company recently pushed back the mRNA-based jab's timeline after the FDA said that it required Phase III flu efficacy data.
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