The U.S. Food and Drug Administration is reportedly preparing to place a serious “black box” warning on COVID-19 vaccines, according to a CNN report citing people familiar with the agency’s plans.
A black box warning is the most serious safety designation the FDA can require — appearing in bold at the top of a drug or vaccine’s prescribing information to alert doctors and patients to potentially serious risks.
According to CNN, the FDA’s proposed action would highlight major risks such as serious side effects and usage restrictions that should be weighed against benefits before administering the shots.
The FDA is finalizing plans to put a “black box” warning on Covid-19 vaccines, sources tell CNN, its most serious alert meant to warn about drug risks.https://t.co/toYYb357fN
Join the conversation!
Please share your thoughts about this article below. We value your opinions, and would love to see you add to the discussion!