FDA Approves Moderna COVID-19 Vaccine, Prepares to Consider Pfizer COVID-19 Vaccine EUA for Young Children

The U.S. Food and Drug Administration (FDA) on Monday granted approval to a second COVID-19 vaccine. The Moderna COVID-19 vaccine received FDA approval, and the approved vaccine will be marketed as “Spikevax” for the prevention of COVID-19 in individuals 18 years of age and older.

According to the FDA, Spikevax meets the FDA’s rigorous standards for safety, effectiveness, and manufacturing quality required for approval. The Moderna COVID-19 vaccine has been available under an emergency use authorization (EUA) for individuals 18 years of age and older since December 18, 2020.

Following the agency’s approval, California Health and Human Services Agency (CalHHS) Secretary Dr. Mark Ghaly and California Department of Public Health (CDPH) Director and State Public Health Officer Dr. Tomás Aragón issued a joint statement applauding the agency’s approval and urging residents to receive a COVID-19 vaccine.

In related news, the FDA announced it has set a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on February 15 to discuss the EUA request of the Pfizer-BioNTech COVID-19 vaccine for use in children six months through four years of age.

Recall, the FDA authorized the Pfizer-BioNTech COVID-19 vaccine for use in children ages five through 11 in October 2021 and recently authorized use of a single booster dose in individuals 12 through 15 years of age and older.