Moderna Inc. (MRNA) said Tuesday that it has initiated the rolling submission process with the U.S. Food and Drug Administration for a Biologics License Application for the licensure of its mRNA COVID-19 vaccine to prevent COVID-19 in individuals 18 years of age and older.
The vaccine is currently available in the U.S. under an Emergency Use Authorization, which was granted on December 18, 2020.
The company noted that it will continue to submit data to support the Biologics License Application or BLA to the FDA on a rolling basis over the coming weeks with a request for a Priority Review.
According to the U.S. Centers for Disease Control and Prevention, as of Tuesday more than 124 million doses of the Moderna COVID-19 vaccine have been administered in the U.S.
Moderna has also received emergency or other conditional, interim or provisional authorization for use of its COVID-19 vaccine from health agencies in Canada, Israel, the European Union, the United Kingdom, Switzerland, Singapore, Qatar, Taiwan, the Philippines, Thailand, Brunei, Paraguay, Japan, South Korea, and an Emergency Use Listing from the World Health Organization (WHO).
Last month, Moderna said that its COVID-19 vaccine was highly effective at preventing COVID-19 in adolescents in its phase II/III study. The company planned to submit data to regulators globally in early June.
For comments and feedback contact: editorial@rttnews.com
Business News