primary vaccination with a different COVID-19 vaccine.
Nearly 75 million people in the United States have completed their initial series with the Moderna vaccine, and about 38.5 million people have gotten a Moderna booster shot, the latest CDC data shows.
“The FDA’s medical and scientific experts conducted a thorough evaluation of the scientific data and information included in the application pertaining to the safety, effectiveness and manufacturing quality of Spikevax. This includes the agency’s independent verification of analyses submitted by the company, our own analyses of the data, along with a detailed assessment of the manufacturing processes, test methods and manufacturing facilities,” says Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.
“Safe and effective vaccines are our best defense against the COVID-19 pandemic, including currently circulating variants. The public can be assured that this vaccine was approved in keeping with the FDA’s rigorous scientific standards,” Marks adds.
Under the approval, Moderna must conduct post-marketing studies to further assess the risks of two heart conditions — myocarditis and pericarditis — following vaccination with Spikevax.
And though there is no FDA requirement to do so, Moderna will also conduct other post-marketing safety studies, including one to evaluate pregnancy and infant outcomes after women receive Spikevax during pregnancy.
Find a Vaccine
According to the CDC, vaccines are now widely available. In many cases, you do not need an appointment.
- The federal government is providing the vaccine free of charge to everyone ages 5 years of age and older living in the United States, regardless of their immigration or health insurance status.
- 90% of people in the United States live within 5 miles of a COVID-19 vaccine location.
- Learn how to find a COVID-19 vaccine for you or your child.