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US FDA approves Moderna’s COVID-19 vaccine
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US FDA approves Moderna’s COVID-19 vaccine

FDA approves 2nd COVID-19 vaccine in US. Moderna receives full approval from FDA.

Where: United States

The Facts

On January 31st, the US FDA approved Moderna’s mRNA COVID-19 vaccine (marketed as Spikevax) for preventing the disease in those aged 18 and older.

Moderna’s two-dose COVID-19 vaccine has been available for administration in the US under Emergency Use Authorization (EUA) since December 2020.

Acting FDA Commissioner, Janet Woodcock, noted that Spikevax met the FDA’s rigorous standards for “safety, effectiveness and manufacturing quality” required to approve any vaccine in the US.

Woodcock stated, “…we understand that for some individuals, FDA approval of this vaccine may instill additional confidence in making the decision to get vaccinated.”

Spikevax is the second COVID-19 vaccine to be approved by the FDA. According to Moderna, Spikevax has been approved by health regulators in over 70 countries, including Canada, Japan, and the UK.

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