The United States Food and Drug Administration (FDA) on Monday gave full approval to Moderna Inc’s COVID-19 vaccine for people 18 years and older, making it the second fully approved injection against coronavirus.
Moderna’s vaccine has been authorized for emergency use in the United States since December 2020 and will now be sold under the brand name Spikevax.
Pfizer’s COVID-19 vaccine and BioNTech, which uses similar technology, received full approval in the United States for people 16 and older last year, after also first obtaining emergency clearance.
Nearly 75 million people have already received the two-dose schedule of the vaccine. Modern in the United States, according to data from the Centers for Disease Control and Prevention.
“The public can be assured that Spikevax meets the high standards of safety, efficacy, and manufacturing quality that the FDA requires of any vaccine approved for use in the United States.”, stated Dr. Janet Woodcock, FDA deputy commissioner, in a statement.
The vaccine Modern It is authorized for use in more than 70 countries, including Canada and the European Union.
In June 2021, the company applied for authorization of its vaccine for use in 12- to 17-year-olds, but the FDA has not yet responded.
Both the vaccine Modern like the one from Pfizer-BioNTech have been linked to rare cases of heart inflammation called myocarditis, especially among young men.
Some studies have suggested that the vaccine Modern is more likely to cause this side effect than Pfizer-BioNTech.
In October, Modern said that the FDA was evaluating the risk of myocarditis after vaccination and that the review was delaying the authorization of its vaccine in adolescents.
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