COVID-19 vaccine maker Moderna has petitioned the Food and Drug Administration for full approval of its shots for use for adults 18 and older.
“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,” said Moderna CEO Stephane Bancel. “We look forward to working with the FDA and will continue to submit data from our Phase 3 study and complete the rolling submission.”
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The company will supply the FDA with additional safety data on a rolling basis over the coming weeks. It is only the second vaccine maker, behind Pfizer, to file for a biologics license application, or full approval, for its shots. The licensing process relies on the availability of six months worth of additional safety and efficacy data.
In addition to monitoring the safety and efficacy of the two-shot vaccine in adults, the company has also begun testing the vaccine in children under 18. The company’s continuing study of around 3,700 children aged 12 to 17 found last week that the vaccine is 100% effective in protecting against infection. Additionally, it showed an efficacy of 93% after one dose. Moderna is also in the process of testing whether a third booster shot will be necessary to protect against new coronavirus variants, such as those first discovered in the United Kingdom and South Africa.
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So far, more than 124 million doses of the Moderna vaccine have been administered in the United States, according to the Centers for Disease Control and Prevention. Nearly 55 million adults have been fully vaccinated, meaning they have received both doses four weeks apart.
