Moderna’s Covid-19 “Spikevax” vaccine, which had previously acquired an emergency use license in the United States, has now received full approval from the US Food and Drug Administration (FDA).
“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 in a statement.
“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,” Woodcock said.
The Moderna vaccine has received complete approval for everyone aged 18 and up.
At the end of August, the FDA gave full approval to a Pfizer vaccine for those aged 16 and up.
The FDA’s approval of the Moderna vaccine, according to Woodcock, “may give more confidence in making the decision to get vaccinated.”
The FDA decision, according to Moderna CEO Stephane Bancel, is a “momentous milestone” for the company.
