U.S. authorizes Moderna's coronavirus vaccine for emergency use
The emergency use authorization allows the Moderna coronavirus Vaccine to be distributed in the U.S. for use in individuals 18 years of age and older.
The totality of the available data provides clear evidence that the Moderna coronavirus Vaccine may be effective in preventing coronavirus.
The data also show that the known and potential benefits outweigh the known and potential risks—supporting the company’s request for the vaccine’s use in people 18 years of age and older.
In making this determination, the FDA can assure the public and medical community that it has conducted a thorough evaluation of the available safety, effectiveness, and manufacturing quality information.
The Moderna coronavirus Vaccine contains messenger RNA (mRNA), which is genetic material. The vaccine contains a small piece of the coronavirus 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 coronavirus.
Moderna coronavirus Vaccine is administered as a series of two doses, one month apart. The available safety data to support the EUA 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 commonly 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.
Of note, more people experienced these side effects after the second dose than after the first dose, so it is important for vaccination providers and recipients to expect that there may be some side effects after either dose, but even more so after the second dose.
The effectiveness data to support the EUA include an analysis of 28,207 participants in the ongoing randomized, placebo-controlled U.S. study who did not have evidence of coronavirus infection prior to the first dose of vaccine. Among these participants, 14,134 received the vaccine and 14,073 received placebo.
After the analysis of these 196 cases was completed, one severe case in the vaccine group was identified and is awaiting confirmation.
At this time, data are not available to determine how long the vaccine will provide protection, nor is there evidence that the vaccine prevents transmission of coronavirus from person to person. ■