On Monday, the U.S. Food and Drug Administration (FDA) gave its full approval for the COVID-19 vaccine from the U.S. pharmaceutical company Moderna, which will be marketed under the name Spikevax.
The vaccine has been widely distributed in the United States and worldwide under FDA emergency use authorization since December 2020. It has already been approved for use in more than 70 countries, including the United Kingdom, Canada, Japan and those in the European Union.
It is the second COVID-19 vaccine that the agency has fully approved, after Pfizer’s vaccine received designation in August 2021.
In a statement, FDA acting commissioner Janet Woodcock said that full authorization of the vaccine is an important step in the fight against the pandemic . She noted that while hundreds of millions of doses of Moderna have been administered under the emergency use authorization, she understands that “for some people, FDA’s approval of this vaccine may instill additional confidence in making the decision to vaccinate.”
Woodcock said the public can be assured that the Moderna vaccine “meets FDA’s high standards of safety, efficacy and manufacturing quality required for any vaccine approved for use in the United States.”
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