Officials with Moderna announced on Tuesday that the company has begun the process to seek full approval of its COVID-19 vaccine for people aged 18 and older.
The Food and Drug Administration issued an emergency use authorization for the company’s two-dose COVID-19 vaccine in December based on two months of safety data from the company. Full approval of the vaccine, which requires at least six months of data, would allow Moderna to market its vaccine after the pandemic is over, former FDA commissioner Dr. Robert Califf told CNBC. It would also allow the company to begin advertising its vaccine, according to the news network.
Company officials said they will submit data to the FDA on a rolling basis with a request for a priority review. This distinction would have the FDA taking action on the application within six months, according to CNN. The news network reported that the standard review process typically takes 10 months.
“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 CEO Stephane Bancel said Tuesday in a statement.
If the FDA approves Moderna’s vaccine, it would mark a first for the Massachusetts-based biotechnology company, which went public in 2018, according to Bloomberg News.
The vaccine developed by Moderna is one of three available in the U.S. amid the ongoing pandemic. Regulators have also issued emergency use authorization for a two-dose vaccine from Pfizer and BioNTech, and a single-dose vaccine from Johnson & Johnson.
Last month, officials with Pfizer and BioNTech announced that they had begun the process to get full FDA approval of their vaccine for use in people aged 16 and older.
Nationwide, just 50.5% of the total population has received at least one dose of the COVID-19 vaccines available in the U.S., according to numbers from the Centers for Disease Control and Prevention. Nearly 41% of the population -- 135 million people -- have so far been fully vaccinated.
As of Tuesday morning, 33.2 million COVID-19 cases have been reported across the country, resulting in more than 594,000 deaths, according to a tally from Johns Hopkins University. Globally, 170.7 million COVID-19 cases have been reported, resulting in 3.5 million deaths.
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