Moderna submits ‘rolling’ application as part of process to obtain full FDA approval for its COVID-19 shot

Shares of Moderna Inc. gained 0.1% in premarket on Tuesday after the company said it is formally seeking full approval from the Food and Drug Administration for its COVID-19 vaccine. Moderna said it has initiated a rolling submission to the FDA; the company’s shot was the second to receive emergency use authorization in the U.S., back in December. Pfizer Inc. , which also developed an mRNA-based COVID-19 vaccine, with BioNTech SE , was the first to receive authorization. It has also submitted a rolling submission to U.S. regulators for approval. Moderna’s stock is up 77.1% for the year, while the broader S&P 500 has gained 11.9%.

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