Depression And COVID-19 Vaccines: US FDA Notes ‘Imbalance’ In Novavax Trial For Adolescents

But agency assessors also said there did not appear to be a biological reason for the vaccine to cause depression when granting the emergency use authorization for use of the Novavax vaccine in 12- to 17-year-olds.

COVID-19 and depression — The FDA also noticed cases of depression reported among adolescents in the Pfizer/BioNTech and Moderna COVID-19 vaccine trials. • Source: Shutterstock

The Novavax, Inc. vaccine clinical trial in adolescents included a notable number of episodes of depression and related adverse events, which may be a sign of the pandemic’s impact on mental health rather than related to the shot or its ingredients.

In its assessment of the company’s emergency use authorization request to use the vaccine in children age 12 to 17,...