Second COVID-19 Vaccine Gets Full Approval

January 31, 2022

Moderna’s COVID-19 vaccine has become the second to receive full approval from the U.S. Food and Drug Administration (FDA).

On Monday, the FDA announced it had given full approval to Moderna’s vaccine, which will be marketed as Spikevax for the prevention of COVID-19 in people 18 and older. The vaccine is administered as a two-dose series, one month apart.

The FDA said the approval follows a thorough evaluation of the data related to the safety, effectiveness, and manufacturing quality of the vaccine.

“While hundreds of millions of doses of Moderna COVID-19 vaccine have been administered to individuals under emergency use authorization, we understand that for some individuals, FDA approval of this vaccine may instill additional confidence in making the decision to get vaccinated,” said Acting FDA Commissioner Janet Woodcock, MD.

The vaccine is second to receive full FDA approval after Pfizer’s Comirnaty vaccine was approved during August.

Here’s what you should know:

• The name:  Moderna’s mRNA vaccine instructs the cells’ machinery to produce a harmless piece of the spike protein. This triggers the body’s immune response to create antibodies based on these spike proteins. The name ‘Spikevax’ refers to the spike protein and the shorthand for vaccine
• The approval process:  Moderna’s vaccine has been available under emergency use authorization since December 2020. The full approval enables the vaccine to be used after the pandemic ends
• Vaccines administered:  About 204 million Moderna vaccines have been administered in the U.S., including 38 million booster doses, according to data from the Centers for Disease Control and Prevention
• Quotable:  “Safe and effective vaccines are our best defense against the COVID-19 pandemic, including currently circulating variants. The public can be assured that this vaccine was approved in keeping with the FDA’s rigorous scientific standards,” said Peter Marks, MD, PhD., director of the FDA’s Center for Biologics Evaluation and Research

HAP urges members of the general public who have not received the vaccine or are eligible for a booster dose to make an appointment. The available vaccines are free, safe, and effective, and provide strong protection against severe outcomes of COVID-19.

If you have questions or concerns, don’t hesitate to contact your health care provider for more information. Vaccine appointments can be found online.