FDA fully approves Moderna’s COVID vaccine, pressures Pfizer to apply for emergency authorization of vaccine for kids younger than 5

The U.S. Food & Drug Administration on Monday granted its full approval to Moderna’s COVID-19 vaccine for adults ages 18 and older. Additionally, the agency is reportedly pressuring Pfizer-BioNTech to apply for emergency use authorization for its vaccine to be given to children under 5.

Moderna’s vaccine, called Spikevax, is the second mRNA vaccine to be fully approved for U.S. adults, following the full approval for Pfizer’s vaccine, Comirnaty, in August. The FDA said that Spikevax had met the agency’s “rigorous standards for safety, effectiveness and manufacturing quality required for approval.”

“The FDA’s approval of Spikevax is a significant step in the fight against the COVID-19 pandemic, marking the second vaccine approved to prevent COVID-19. The public can be assured that Spikevax meets the FDA’s high standards for safety, effectiveness and manufacturing quality required of any vaccine approved for use in the United States,” acting FDA Commissioner Janet Woodcock said.- READ MORE