FDA and Pfizer Step Away From COVID-19 Vaccine Expedited Review

February 17, 2022

The US Food and Drug Administration (FDA) and Pfizer are backing down from initial plans to fast-track approval of their COVID-19 vaccine for use in children under the age of 5. The FDA states that they will wait until after data comes in regarding the vaccines efficacy after the second dose.

According to STAT News, “The companies said on Feb. 1 that they were asked by the FDA to submit an application for the use of a two-dose vaccine in children 6 months to 4 years old. Data on a third shot would be submitted to regulators when they became available in the spring. Some outside experts have characterized this strategy as aggressive and unusual, and have worried it could backfire by making some parents less inclined to vaccinate their kids.”