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Moderna applies for full FDA approval

A Parrish Medical Center medical worker holds a vial of the Moderna COVID-19 vaccine at a vaccination clinic for Port Canaveral workers, local hotel and restaurant workers and residents of the Port Canaveral community.

Paul Hennessy | LightRocket | Getty Images

Moderna on Tuesday asked the Food and Drug Administration for full US approval of its Covid-19 vaccine – the second US drug maker to apply for a license for biologics that will allow it to market the vaccines directly to consumers.

The mRNA vaccine is currently available on the US market under an emergency clearance that was granted by the FDA in December. There is conditional approval based on two months of safety data. This is not the same as a biologics license application or a full authorization application that requires data for at least six months. According to the Centers for Disease Control and Prevention, over 100 million shots have been administered.

“We are pleased to announce this important step in the US regulatory process for a Biologics License Application (BLA) for our COVID-19 vaccine,” said Stephane Bancel, CEO of Moderna, 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 ongoing filing.”

The FDA approval process is expected to take months.

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

Once companies submit applications to the FDA, the agency’s scientists carefully review clinical trial data, including any inconsistencies or safety concerns, said Dr. Paul Offit, a voting member of the Agency’s Vaccines and Related Biological Products Advisory Committee. “You want to make sure that the company has displayed all of this data fairly and accurately,” he said.

Full US approval will allow Moderna’s vaccine to stay on the market once the pandemic is over and the US is no longer in a public health emergency, said former FDA commissioner Dr. Robert Califf. It also creates the conditions for the company to start promoting the recordings on television and other media platforms, which is not allowed under an EEA.

Moderna is the second company to apply for full U.S. approval of its Covid vaccine. On May 7, Pfizer and partner BioNTech announced that they had begun filing for full approval of their vaccine for people aged 16 and over in the United States

Moderna’s vaccine, which requires two doses four weeks apart, has been found to be more than 90% effective against Covid and more than 95% effective against serious illness for up to six months after the second dose. The company said in an earnings report on May 6 that it intends to begin filing for full FDA approval soon.

In addition to getting full approval, the company is expected to ask the FDA to expand emergency use of its Covid vaccine to adolescents aged 17 and over. The company announced last week that its shots were 100% effective in a study of children ages 12 to 17.

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