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 Tuesday asked the Food and Drug Administration for full US approval of its Covid-19 vaccine – the second US drug company to apply for a biologics license that allows it to market the syringes directly to consumers.
The mRNA vaccine is currently on the US market under an emergency approval, the 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 shots have been administered.
“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 will likely take months.
Moderna will continue to provide the FDA with ongoing data in support of the BLA in the coming weeks, the company said on Tuesday.
Once companies have filed applications with the FDA, the agency’s scientists carefully review the clinical trial data, including any discrepancies 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. May 7th, Pfizer and partners BioNTech said they had started the process of getting their vaccine fully approved for use in people aged 16 and over 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, was found Be more than 90% effective against Covid and more than 95% effective against serious illness up to six months after the second dose. The company said in a earnings report on May 6th that it was planning to begin the full FDA approval process 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 for young people aged 17 and over. The company announced last week that its shots were 100% effective in a study of children ages 12-17.