Moderna COVID-19 vaccine granted emergency use authorization
The U.S. Food and Drug Administration announced late Friday evening the emergency use authorization of the second vaccine for the novel coronavirus (COVID-19), biotechnology company Moderna’s mRNA-1273, according to a statement made by the agency.
The emergency use authorization allows the Moderna COVID-19 vaccine to be distributed in the United States for use in individuals 18 years of age and older. The vaccine contains messenger RNA (mRNA), which is genetic material. The vaccine contains a small piece of the SARS-CoV-2 virus’s mRNA that instructs cells in the body to make the virus’s distinctive spike protein. After a person receives this vaccine, their body produces copies of the spike protein, which does not cause disease, but triggers the immune system to learn to react defensively, producing an immune response against SARS-CoV-2, the virus that causes COVID-19.
The vaccine is administered as a series of two doses, one month apart. The available safety data include an analysis of 30,351 participants enrolled in an ongoing randomized, placebo-controlled study conducted in the U.S. These participants, 15,185 of whom received the vaccine and 15,166 of whom received saline placebo, were followed for a median of more than two months after receiving the second dose. The most reported side effects, which typically lasted several days, were pain at the injection site, tiredness, headache, muscle pain, chills, joint pain, swollen lymph nodes in the same arm as the injection, nausea and vomiting, and fever. More people experienced side effects after the second dose, the statement said.
Moderna’s vaccine is the second COVID-19 vaccination to receive emergency authorization from the FDA. The Pfizer and BioNTech messenger RNA (mRNA)-based vaccine candidate, BNT162b2, was authorized on December 11.