U.S – Moderna has applied for full approval of its Covid vaccine, a move that will see the drug maker attain rights to market the shots directly to consumers.
The Moderna vaccine was granted emergency use approval by the FDA in December. The application by Moderna follows Pfizer’s application to have their vaccine granted a biologics license for use in people 16 and older in the U.S.
Emergency use approval gives conditional approval based on two months of safety data whereas a biologics license application or a request for full approval requires at least six months of data.
Since its inception into the market, over 100 million doses of the mRNA vaccine have 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.”
Moderna’s full approval request comes as more than 50% of the U.S. population has received at least one dose of a vaccine, but the pace of vaccinations has dropped sharply since mid-April. A recent poll from the Kaiser Family Foundation showed signs that some hesitant people have been persuaded to get inoculated.
Former FDA commissioner Dr. Robert Califf, noted that 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.
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. The approval could also help raise public confidence in the vaccine.
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.
In addition to seeking full approval, the company has also made a request for the FDA to expand the emergency use of its Covid vaccine for adolescents as young as 17. The company conducted a study that found its shots to be 100% effective in kids aged 12 to 17.