The Food and Drug Administration (FDA) has recently undertaken a number of notable actions with respect to vaccines in response to the ongoing COVID-19 pandemic. Below is an overview of these actions and related COVID-19 vaccine information:
Full Approval of the Moderna COVID-19 Vaccine for 18+
On January 31, 2022, the FDA announced its full approval (licensing) of the Moderna COVID-19 Vaccine for individuals 18 and older. The Moderna vaccine had been administered under an Emergency Use Authorization (EUA) from the FDA since December 18, 2020. This is the second COVID-19 vaccine to be approved by the FDA following approval of Pfizer-BioNTech’s COVID-19 vaccine on August 23, 2021. Notably, the approved Moderna COVID-19 vaccine will be marketed and known as the ‘Spikevax.’
FDA Review of EUA For COVID-19 Vaccine for 6 Months – 4 Years
The FDA scheduled a virtual meeting of its Vaccines and Related Biological Products Advisory Committee for February 15, 2022, to discuss a request to amend the EUA of the Pfizer-BioNTech vaccine to allow for use in children 6 months through 4 years of age.
Vaccine Availability for Individuals Ages 5 through 15
On October 29, 2021, the FDA authorized the Pfizer-BioNTech vaccine for emergency use in children ages 5 through 11. In a press release the FDA noted that the vaccine was found to be 90.7% effective in preventing COVID-19 in children 5 through 11.
On January 3, 2022, the FDA amended the EUA for the Pfizer-BioNTech vaccine to authorize the use of a single booster dose in individuals 12 through 15 years of age and older (this follows on the initial EUA for this age group issued May 10, 2021). This recent amendment also allowed for a third primary series dose for certain immunocompromised children ages 5 through 11.
*This post was co-authored by Erin Howard, legal intern at Robinson+Cole. Erin is not yet admitted to practice law.