Moderna asking for full FDA approval of its COVID vaccine

WASHINGTON / CNBC — Moderna officials asked the Food and Drug Administration to fully approve it’s coronavirus vaccine on Tuesday, making it the second drugmaker in the U.S. to do so.

If approved, Moderna would be able to market their vaccine directly to consumers.

The mRNA vaccine is currently on the U.S. market under an emergency use authorization, which was granted by the FDA in December. It gives conditional approval based on two months of safety data. It’s not the same as a biologics license application, or a request for full approval, which requires at least six months of data.

Over 100 million of the shots have already been administered, according to data from the Centers for Disease Control and Prevention.

“We are pleased to announce this important step in the U.S. regulatory process for a Biologics License Application of our COVID-19 vaccine,” Moderna CEO Stephane Bancel said. “We look forward to working with the FDA and will continue to submit data from our Phase 3 study and complete the rolling submission.”

Moderna will continue to submit data to support the BLA to the FDA on a rolling basis over the coming weeks, the company said Tuesday.

The FDA approval process is likely to take months.

Full U.S. approval will allow Moderna’s vaccine to stay on the market once the pandemic is over and the U.S. is no longer in a public health emergency, said former FDA commissioner Dr. Robert Califf. It also sets the stage for the company to begin advertising the shots on TV and other media platforms, he said, which is not allowed under an EUA.

If the FDA grants Moderna’s request, it would be the Massachusetts-based company’s first-ever approved product.

Moderna’s vaccine, which requires two doses given four weeks apart, is more than 90% effective at protecting against COVID and more than 95% effective against severe disease up to six months after the second dose, research shows.

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