FDA Postpones COVID-19 Vaccine Approval for Young Children

While many across the United States have been patiently waiting for FDA’s approval for the Pfizer-BioNTech COVID-19 vaccine for young children ages 6 months through 4 years of age, it looks like we will have to wait a bit longer. It is unclear how long this will be postponed, but the FDA said that Pfizer needs more time to evaluate additional data regarding the vaccine in children, causing them to postpone the meeting scheduled for Tuesday, February 15.

FDA stated: “We believe additional information regarding the ongoing evaluation of a third dose should be considered as part of our decision-making for potential authorization…Given that the study is advancing at a rapid pace, the companies will wait for the three-dose data as Pfizer and BioNTech continue to believe it may provide a higher level of protection in this age group. The companies expect to have three-dose protection data available in early April.”

Source: NPR