JurisdictionUnited States

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 adequate.

Submission and FDA approval of vaccine risk labeling are part of the rapid and detailed processes for receiving an EUA for distribution of a new vaccine. How risk is going to be communicated is a critical factor for FDA decisions. To be clear, EUA is temporary during an officially recognized "emergency" such as a pandemic, and the EUA is not a final approval. EUA status of the vaccine can be withdrawn at any time.1 The FDA can insist that its directives or those of the CDC's Advisory Committee on Immunization Practices must be followed when a pharmaceutical company communicates about the vaccine.

It is standard practice in vaccination programs to require patients to sign an informed consent form. The "informed" consent includes a disclosure of potential risks, a message that is delivered to the patient in that patient's paperwork at the site of vaccine use. It is the duty of the physician or vaccine delivery entity to fully disclose risk information in the consent documents. Failure to adequately warn is a prime argument in products liability cases. Vaccines are a very special subset of products, and the communication of risk carries great weight in the regulatory agency decisions.

Can we generalize about how a vaccine maker can avoid liability for not having warned about foreseeable adverse side effects? Most claims assert that the label...

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