CHAPTER 11

• Jurisdiction: United States

CHAPTER 11 HOW ARE VACCINE RISKS COMMUNICATED?

The vaccine maker has two audiences: prescribers and patients. It can receive Food and Drug Administration approval of its Biologics License Application, the equivalent of the New Drug Application, or its request for Emergency Use Authorization, a temporary balancing of safety and risk information against the potential for harm that comes with speed of public distribution of a new medical product.

Once the FDA accepts the marketing claims that are proposed to be made for the vaccine, and the BLA or EUA are issued by FDA, then the marketer may often communicate risk information through four vehicles:

• leaflets,
• consent forms,
• educating health professionals, and
• presentations to the targeted or general news media.

The words, the visual contrast, and the language used are all part of the evaluation of whether this product's warnings were...