On Monday morning, Moderna (MRNA -0.34%) released encouraging interim results from a pivotal study with its coronavirus vaccine candidate, mRNA-1273. The company reported its vaccine appears 94.5% effective after 90 of the first 95 trial volunteers to test positive for COVID-19 were in the placebo group.
Moderna also reported 11 severe cases of COVID-19 at the first interim analysis and that none of them occurred among patients vaccinated with mRNA-1273.
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Moderna's interim results appear competitive with those recently reported by Pfizer (PFE -1.05%) and BioNTech (BNTX 0.07%) for a similar coronavirus vaccine candidate, BNT162b2. Pfizer and BioNTech are still measuring data on the prevention of severe COVID-19 cases.
Both vaccine candidates deliver a strand of messenger-RNA that instructs human cells to produce harmless pieces of SARS-CoV-2, the virus responsible for COVID-19. Last week, Pfizer said its vaccine candidate appeared at least 90% effective at seven days after the second and final dose.
Independent data safety and monitoring boards tasked with maintaining the integrity of these trials will continue measuring differences between active and placebo groups at least until they satisfy the Food and Drug Administration's guidelines for Emergency Use Authorization (EUA) of a coronavirus vaccine candidate. The agency wants to see safety data that extends two months from the final injection for a majority of patients enrolled.
Moderna intends to submit a request for EUA of mRNA-1273 to the FDA in the coming weeks but wasn't specific on the timing. Pfizer and BioNTech expect to have safety data ready for the FDA this week.
