Moderna Gallops on Positive Results for Flu Vaccine
Moderna (NASDAQ:MRNA) shares began Monday with stronger gains. The company said its experimental mRNA-based flu vaccine produced a stronger immune response than a currently available shot in a late-stage trial, clearing a path forward for the product and the company’s separate combination flu and COVID jab.
Moderna in May voluntarily withdrew an application seeking approval of its combination shot targeting Covid-19 and influenza, saying it had plans to resubmit it with efficacy data from the phase three trial on its stand-alone flu vaccine.
That decision came after discussions with the Food and Drug Administration, which is grappling with a massive overhaul under Health and Human Services Secretary Robert F. Kennedy Jr., a prominent vaccine skeptic.
With the new data, the company plans to resubmit the application for the combination vaccine and file for approval of its stand-alone flu shot later this year, Stephen Hoge, the company’s head of research and development, said in an interview.
If regulators approve the flu vaccine, the company can then advance the combination shot, Hoge said. He added that Moderna expects approvals for both shots next year pending reviews.
Moderna shares climbed 44 cents, or 1.6% to $27.60 in early trading Monday.
