What happened: The FDA said Moderna’s vaccine, called Spikevac, met the “rigorous standards for safety, effectiveness and manufacturing quality required for approval.”
- The vaccine has been approved for emergency use authorization for those 18 years old and up.
Quote: “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,” said Dr. Janet Woodcock, the acting FDA commissioner, in a statement.
- “While hundreds of millions of doses of Moderna COVID-19 vaccine have been administered to individuals under emergency use authorization, we understand that for some individuals, FDA approval of this vaccine may instill additional confidence in making the decision to get vaccinated.”