Moderna applies for full FDA approval

A medical worker from Parrish Medical Center holds a vial of the Moderna COVID-19 vaccine at a drive through vaccination clinic for employees of Port Canaveral, workers at local hotels and restaurants, and residents of the Port Canaveral community.

Paul Hennessy | LightRocket | Getty Images

Moderna on Tuesday asked the Food and Drug Administration for full U.S. approval of its Covid-19 vaccine — the second drugmaker in the U.S. to seek a biologics license that will allow it to market the shots 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 compiled by 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 (BLA) of our COVID-19 vaccine,” Moderna CEO Stephane Bancel said in a press release. “We look forward to working with the FDA and will continue to submit data from our Phase 3 study and complete the rolling submission.”

Shares of Moderna were essentially flat in premarket trading.

The FDA approval process is likely to take months.

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.

Once companies submit applications to the FDA, agency scientists painstakingly look through the clinical trial data, including for any discrepancies or safety concerns, said Dr. Paul Offit, a voting member of the agency’s Vaccines and Related Biological Products Advisory Committee. “They want to make sure that the company has fairly and accurately displayed all those data,” he said.

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 permitted under an EUA.

Moderna is the second company to seek full U.S. approval of its Covid vaccine. On May 7, Pfizer and partner BioNTech said they started the process of seeking full approval for their vaccine for use in people 16 and older in the U.S.

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, has been found to be more than 90% effective at protecting against Covid and more than 95% effective against severe disease up to six months after the second dose. The company said in an earnings report on May 6 that it planned to begin the process of seeking full FDA approval soon.

In addition to seeking full approval, the company is also expected to ask the FDA to expand the emergency use of its Covid vaccine for adolescents as young as 17. The company said last week its shots were found to be 100% effective in a study of kids ages 12 to 17.

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