On Friday, December 11, the U.S. Food and Drug Administration issued the first emergency use authorization ("EUA") for a vaccine for the prevention of coronavirus disease 2019 ("COVID-19") caused by severe acute respiratory syndrome coronavirus 2 ("SARS-CoV-2") in individuals 16 years of age and older. The EUA allows the Pfizer-BioNTech COVID-19 Vaccine to be distributed in the U.S. and delivery to 145 hospitals, clinics and public health systems in all 50 states has already begun. While the distribution of the vaccine is subject to a complex set of rules, we have highlighted below some key facts for providers already in the midst of Operation Warp Speed.
Key Facts for Providers
Hospitals and other health care providers identified by their states to receive and provide the vaccine will want to be aware of a number of key facts:
- Vaccine providers are required to comply with the EUA instructions, CDC Vaccination Plan and the applicable state Playbook. The EUA Fact Sheet for providers can be found here and the CDC Vaccination Plan can be found here. The applicable state Playbooks are available online: for example, the Playbook for Indiana can be found here, Wisconsin's Playbook can be found here and the Colorado Playbook can be found here.
- Each individual presenting for the vaccine must receive the information contained in the FDA Fact Sheet for Recipients and Caregivers (found here) prior to vaccination. The Fact Sheet outlines important information for vaccine recipients, including contraindications to receiving the vaccine at this time.
- Provide a vaccination record card to each vaccine recipient, caregiver or legal representative. Because the Pfizer BioNTech COVID-19 Vaccine is administered as a series of two doses, three weeks apart, upon receipt of the first dose, individuals must be provided information for receiving their second dose on the vaccination card; best practice may be to provide a follow-up appointment card scheduling the second dose as well.
- Vaccination providers must include vaccination information in the state/local jurisdiction's Immunization Information System or another designated system. Vaccination providers must also report the following to the Vaccine Adverse Event Reporting System for the Pfizer-BioNTech COVID-19 Vaccine: all vaccine administration errors, serious adverse events, cases of Multisystem Inflammatory Syndrome and cases of COVID-19 that result in hospitalization or death.
Is Informed Consent Required?
Current federal guidance does not include a requirement for informed consent for the administration of this vaccine. While some states may have addressed the need (or lack of need) for consent expressly in their vaccine Playbooks, the failure of many to do so has led to the question of whether informed consent is required – particularly given the operational challenges of standard consent procedures during a pandemic. In the absence of clear guidance under the applicable state Playbook, providers should look to state law that addresses requirements for informed medical consent more generally.
Even in those states where informed consent is not legally required for the administration of the vaccine, the creation and implementation of a simple consent form may nonetheless be prudent. A well-crafted yet brief statement that acknowledges the patient's review of the FDA Fact Sheet for information on risks and benefits, and which briefly mentions Public Readiness and Emergency Preparedness Act immunity and the Countermeasures Injury Compensation Program, may assist to address informed consent requirements and may serve a secondary purpose of deterring future lawsuits alleging harm caused by the vaccine. Hospitals are urged to contact their legal counsel to determine the most appropriate approach for their organizations.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
