Moderna's COVID-19 "Spikevax" vaccine gets full US approval

The US Food and Drug Administration (FDA) announced Monday that it has granted full approval to Moderna's Covid-19 "Spikevax" vaccine, which had previously received an emergency use authorization in the United States, News.Az reports citing France24.

"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 full approval of the Moderna vaccine is for individuals aged 18 or older.

A Pfizer vaccine for individuals aged 16 or older received full FDA approval at the end of August.

Woodcock said she hoped FDA approval of the Moderna vaccine "may instill additional confidence in making the decision to get vaccinated."

Moderna CEO Stephane Bancel called the FDA move a "momentous milestone" for the company.

"Our Covid-19 vaccine has been administered to hundreds of millions of people around the world, protecting people from Covid-19 infection, hospitalization and death," Bancel said in a statement.

News.Az

You Might Also Like