FDA Grants Moderna Full Approval to its COVID-19 Vaccine
The Food and Drug Administration has granted Moderna’s Covid-19 vaccine full approval for use in people aged 18 and older on Monday. Moderna’s COVID-19 vaccine was available in the U.S. under Emergency Use Authorization (EUA) from December 18, 2020.
Moderna company announces in a press release, “Today announced the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for SPIKEVAX (COVID-19 Vaccine, mRNA) to prevent COVID-19 in individuals 18 years of age and older.”
Moderna is the second to be granted full approval for use in the United States.
The approval was “based on a comprehensive submission package including efficacy and safety data approximately six months after the second dose,” according to the announcement.
