Vaccines don’t have to prevent infection or transmission to be cleared in the United States, the country’s top regulatory agency said in a new document.
“It is important to note that FDA’s authorization and licensure standards for vaccines do not require demonstration of the prevention of infection or transmission,” Dr. Peter Marks, a top official at the U.S. Food and Drug Administration (FDA), said in the document.
Marks was writing as he rejected nearly all recommendations from a group of experts that advised the FDA to update the labels for the Pfizer and Moderna COVID-19 vaccines.
Vaccines are traditionally known as drugs that prevent an illness. The U.S. Centers for Disease Control and Prevention (CDC) for years said a vaccine is a product that “produces immunity” while vaccination is an injection of an infectious organism “in order to prevent the disease.” The agency changed its definitions after people correctly noted that COVID-19 vaccines do not prevent infection….