Moderna announced Tuesday morning it has applied to the U.S. Food and Drug Administration for full approval of its COVID vaccine for people ages 18 and over.
The company is the second drugmaker in the U.S. to seek a biologics license that would allow it to market its vaccine directly to consumers. Last month, Pfizer and its partner BioNTech began the process of seeking full approval for their vaccine for use in people 16 and older in the U.S.
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, former FDA commissioner Dr. Robert Califf told CNBC. It also sets the stage for the company to begin advertising the shots on TV and other media platforms, he said, which is currently not permitted.
”We are pleased to announce this important step in the U.S. regulatory process,” Moderna CEO Stéphane Bancel said in a news 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 shot, which like rival Pfizer Inc.’s is based on messenger RNA technology, has been shown to be highly effective in preventing symptomatic COVID-19. Along with the Pfizer vaccine, it has been a linchpin of the U.S. immunization campaign. More than 124 million doses have been administered in the U.S., according to the statement.
If regulators grant Moderna’s request, it would mark the company’s first approved product. Moderna went public in 2018 as a biotech company with little revenue, but it logged $1.94 billion in sales in the first quarter of this year.
Moderna’s vaccine is one of three — along with the shots made by Pfizer/BioNTech and Johnson & Johnson — with emergency-use authorization in the U.S., a designation that can be revoked at any time and lasts only as long as the state of emergency itself.
Peter Marks, director of the FDA’s center for biologics evaluation and research, said in April the review process typically takes six months, but that U.S. regulators would attempt to move faster than that in clearing COVID vaccines and therapies.
The Associated Press contributed to this report.
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