Moderna becomes the second COVID-19 vaccine manufacturer to receive full approval from the Food and Drug Administration (FDA).
The Moderna vaccine, which will be marketed as Spikevax, had previously been administered under FDA Emergency Use Authorization (EUA), which was granted in response to the COVID-19 pandemic.
The FDA said the Moderna vaccine underwent “rigorous scientific standards,” taking into account the company’s manufacturing processes, test methods and manufacturing facilities.
“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,” Janet Woodcock, acting FDA commissioner, said. “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. 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.”
The FDA looked at Modern’as ongoing randomized, placebo-controlled, blinded clinical trial that determined the vaccine was 98% effective in preventing “severe disease.” The trial tracked 14,287 participants who received the vaccine, and 14,164 participants who received a placebo. All participants were above the age of 18-years-old.
While the trial data was collected before the spread of the Omicron variant, it showed 93% effectiveness in preventing COVID-19, with 55 people in the controlled vaccine group contracting the disease, while 744 people in the placebo group tested positive for COVID.
The FDA also followed side effect data for those who suffered from myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of tissue surrounding the heart), finding that the instances occurred within 7 days after the second dose, with the highest risk coming from males between the ages of 18 and 24.
The FDA said Moderna’s Spikevax vaccine can be used interchangeably with the current vaccines in circulation under Emergency Use Authorization.