FDA grants full approval of Moderna’s COVID-19 vaccine

The Food and Drug Administration on Monday granted full approval of the COVID-19 vaccine developed by Massachusetts-based biotechnology company Moderna.

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The drug, which will now be marketed as Spikevax, was approved as a primary series of two doses spaced one month apart. Officials with the FDA said in a news release that the vaccine “meets the FDA’s rigorous standards for safety, effectiveness and manufacturing quality required for approval.”

In a social media post Monday morning, Moderna officials said, “The approval was based on a comprehensive submission package including efficacy and safety data approximately six months after (the) second dose.”

The FDA authorized Moderna’s COVID-19 vaccine for emergency use in people aged 18 and older in December 2020. Since then, more than 243.4 million doses of Moderna’s COVID-19 vaccine have been administered nationwide, according to the Centers for Disease Control and Prevention.

In August 2021, officials with Moderna said they had completed the rolling submission process seeking full approval of the vaccine.

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In a statement, Dr. Janet Woodcock, acting commissioner of the FDA, called Monday’s approval “a significant step in the fight against the COVID-19 pandemic.”

“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,” she said.

Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, emphasized in a statement that “safe and effective vaccines are our best defense against the COVID-19 pandemic, including currently circulating variants.”

Monday’s announcement makes Spikevax the second COVID-19 vaccine to gain full approval from the FDA following the agency’s decision in August 2021 to grant full approval to the vaccine developed by Pfizer and BioNTech. The drug, marketed as Comirnaty, is approved for people aged 16 and older and authorized for emergency use for people between the ages of 5 and 15.

>> Related: Coronavirus: FDA grants full approval of Pfizer-BioNTech COVID-19 vaccine

As of Sunday morning, more than 75% of the U.S. population – 249.8 million people – has gotten at least one dose of any of the available COVID-19 vaccines, CDC data shows. Nearly 64% of Americans, or 211.6 million people, have been fully vaccinated, and over 41% of those who have been fully vaccinated have gotten booster shots, according to the CDC.

Officials have confirmed more than 74.3 million COVID-19 infections and reported over 884,000 deaths nationwide, according to numbers compiled by Johns Hopkins University.

More than 375.5 million COVID-19 cases have been reported worldwide, resulting in 5.6 million deaths, according to the university.