Moderna Inc.’s COVID-19 (NASDAQ:MRNA)vaccine has been approved for emergency use authorization in the U.S.
The U.S. Food and Drug Administration’s (FDA) decision to grant the authorization for the vaccine’s use among adults means that two of the six vaccine candidates identified by the U.S. government’s "Operation Warp Speed" are now available for use in the general public, a feat accomplished in less than one year.
Vaccines from AstraZeneca (NASDAQ:AZN) and Johnson & Johnson (NYSE:JNJ) that have also received U.S. government funding are expected to be submitted for review next year.
Developed with the National Institutes of Health, Moderna’s vaccine, like the one produced by Pfizer, is based on messenger RNA technology that previously hadn’t been used in vaccines. For Moderna, it is also the first product from the company to be cleared by regulators for use.
On December 17, advisers to the FDA voted 20-0, with one abstention, to back the vaccine, which isn’t yet approved in any other countries and hasn’t yet been used on anyone outside of a clinical trial. Delivery of the vaccine to the U.S. government will begin immediately and an application for full approval is expected early in 2021, Moderna said in a statement.
Moderna’s vaccine, like the one from Pfizer (NYSE:PFE), is administered in a two-dose regimen. Moderna said the most common adverse reactions after receiving its shot include injection site pain, swelling, and swollen lymph nodes. Most reactions are mild or moderate.
