FDA Weighs 'Black Box' Warning for COVID-19 Vaccines

• The US FDA is reportedly considering adding a "black box" warning, its strongest safety alert, to Covid-19 vaccines.
• A "black box" warning highlights serious risks, including life-threatening or disabling reactions, to be weighed against a treatment's benefits.
• The plan is not final, and it is unclear if the warning would cover all Covid-19 vaccines or specific age groups.
• Moderna and Pfizer have reaffirmed the safety and efficacy of their Covid-19 vaccines in response to the reports.
• The FDA is investigating potential links between Covid-19 vaccines and deaths, with myocarditis (heart inflammation) noted as a risk, particularly in young males.

Why It Matters: FDA considering strongest safety warning for Covid-19 vaccines could reshape public trust.