A Parrish Medical Center medical worker holds a vial of the Moderna COVID-19 vaccine on a ride through the vaccination clinic for Port Canaveral workers, workers at local hotels and restaurants, and residents of the Port Canaveral community.
Paul Hennessy | LightRakete | Getty Images
Moderna on Tuesday asked the Food and Drug Administration for full US approval of its Covid-19 vaccine – the second US drug company to seek a biologics license that would allow it to market the shots directly to consumers .
The mRNA vaccine is currently on the US market under emergency approval that was granted by the FDA in December. It grants conditional approval based on two months of safety data. It is not the same as filing a biologics marketing authorization application or a full marketing authorization application that requires at least six months of data. According to the Centers for Disease Control and Prevention, over 100 million syringes have already been given.
“We are pleased to announce this important step in the US regulatory process for a Biologics License Application (BLA) of 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.”
Moderna shares were largely unchanged in pre-market trading.
The FDA approval process is expected to take months.
Moderna will continue to provide the FDA with ongoing data in support of the BLA in the coming weeks, the company announced on Tuesday.
Once companies submit applications to the FDA, the agency’s scientists carefully review the clinical trial data, including for inconsistencies or safety concerns, said Dr. Paul Offit, a voting member of the Agency’s Advisory Committee on Vaccines and Related Biological Products. “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 in 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 advertise the recordings on television and other media platforms, which an EEA does not allow.
Moderna is the second company to file for full U.S. approval of its Covid vaccine. On May 7th, Pfizer and its partner BioNTech announced that they had initiated the process of obtaining full approval for their vaccine for use in people 16 years and older in the United States
If the FDA approves Moderna’s application, it would be the Massachusetts-based company’s first approved product.
Moderna’s vaccine, which requires two doses four weeks apart, has been shown 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 a May 6 results report that it plans to begin the process of full FDA approval soon.
In addition to filing for full approval, the company is expected to urge the FDA to expand the emergency use of its Covid vaccine to adolescents aged 17 and older, children ages 12-17.