Emergency uses of the vaccine have not been approved or licensed by the FDA, but have been authorized by the FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019
(COVID-19). The Moderna
COVID-19 Vaccine is authorized in individuals
6 months of age and older as a primary series. The Moderna COVID-19 Vaccine, Bivalent is authorized as a booster dose in individuals
6 months through 5 years of age at least 2 months after the Moderna COVID-19 Vaccine primary series and is authorized in individuals 6 years of age and older at least 2 months after any authorized or approved vaccine.
The EUA for these products is in effect for the duration of the COVID-19 EUA declaration justifying emergency use of the product, unless the declaration is terminated or the authorization is revoked sooner.
For more information on the EUA authorized uses of the vaccine, refer to the Fact Sheets for Healthcare Providers Administering Vaccine (Vaccine Providers) and Full Prescribing Information.
Who Is Moderna?
Moderna is a biotechnology company founded in 2010 in Cambridge, Massachusetts. At Moderna, we are pioneering a class of medicines based on messenger RNA (mRNA).
Every cell in the body uses mRNA to provide
real-time instructions to make the proteins necessary to drive many aspects of biology, including in human health and disease.
We are currently developing mRNA-based vaccines and therapeutics for a variety of conditions, including COVID‑19.
What Is the Mechanism of Action of the Vaccine?
The nucleoside-modified mRNA in the Moderna COVID‑19 Vaccine is formulated in lipid particles, which enable delivery of the nucleoside‑modified mRNA into host cells to allow expression of the SARS‑CoV‑2 Spike antigen. The vaccine elicits an immune response to the Spike antigen, which protects against COVID‑19.
What Does It Mean That the Vaccine Is Based on mRNA Technology?
A vaccine based on messenger RNA (mRNA) technology does not use inactivated virus, attenuated virus, or any other kind of virus.
Moderna COVID‑19 Vaccines use mRNA to provide a blueprint for your cells to build your body’s defense against the virus.
This allows the body to generate an antibody response, and to retain the information in memory immune cells, with the goal of attacking the virus if the vaccinated individual is exposed.
Storage and HandlingLearn about storage and handling of vaccine
8:00AM - 8:00PM EST, Monday-Friday
(not including Holidays)
Visit Moderna's Medical Services Hub for more information