Moderna Inc’s (MRNA.O) COVID-19 vaccine for people aged 18 and older received full approval from the United States Food and Drug Administration on Monday, making it the second fully approved vaccine for the virus in the country.
The Moderna vaccine has been approved for emergency use in the United States since December 2020, and it will now be marketed under the brand name Spikevax in the United States.
After receiving emergency approval in the United States last year, Pfizer (PFE.N) and BioNTech’s COVID-19 shot, which uses similar technology, received full approval in the country this year for people aged 16 and older.
According to data from the Centers for Disease Control and Prevention in the United States, Moderna’s two-dose vaccine has already been administered to nearly 75 million people in the United States.
According to Acting FDA Commissioner Dr. Janet Woodcock, “the public can be confident that Spikevax meets the FDA’s high standards for safety, effectiveness, and manufacturing quality, which are required of any vaccine approved for use in the United States.”
The vaccine developed by Moderna has been approved for use in more than 70 countries, including Canada and the European Union.
After submitting a request for authorization to use its vaccine in children between the ages of 12 and 17, the company has yet to receive a response from the Food and Drug Administration.
Both the Moderna and the Pfizer/BioNTech vaccines have been linked to rare cases of heart inflammation known as myocarditis, which has been found to be more common in young men than in older men.
Some studies have suggested that Moderna’s vaccine is more likely than the Pfizer/BioNTech vaccine to cause side effects.
In October, Moderna announced that the Food and Drug Administration (FDA) was evaluating the risk of myocarditis following vaccination and that the review was delaying approval of the company’s vaccine for adolescents.
