Is the patient’s informed consent required prior to administering a COVID-19 vaccine?
There is no requirement to obtain the patient’s signature on an “informed consent” form prior to administering the COVID-19 vaccine. Instead, health care providers must give the vaccine recipient a fact sheet for patients that is written by the vaccine manufacturer — see Pfizer’s Fact Sheet and Moderna’s Fact Sheet. The fact sheet takes the place of the “Vaccine Information Statement” (VIS) that is given to patients for vaccines that have gone through the complete Food and Drug Administration (FDA) approval process. (It is anticipated that a VIS will be available for COVID-19 vaccines when they receive full FDA approval.)
The health care provider should give the patient the fact sheet prior to administering the vaccine and allow enough time for the patient to read it prior to administration. The patient is not required to sign a form acknowledging receipt of the fact sheet, although a health care provider may implement this step if desired. Some providers who use an electronic vaccine administration appointment system have required vaccine recipients to check a box online attesting that they have read the fact sheet before the person is able to schedule an online appointment. This process is not required, however. The patient’s agreement to take the vaccine is implied by the fact that they voluntarily came to the vaccine administration site and submitted their arm for vaccination. This is called “implied consent.”
Background information: The currently available COVID-19 vaccines have been authorized by the FDA pursuant to an Emergency Use Authorization (EUA). Informed consent is not required for a product distributed pursuant to an EUA. Instead, patients are given a “Fact Sheet for Patients” written by the vaccine manufacturer and approved by the FDA. This fact sheet is intended to provide patients the information that is currently known about the product that is relevant in making a decision about whether to take it. See FDA guidance at www.fda.gov/media/97321/download (pages 24 and 45) for information about consent and fact sheets. The legal theory is that informed consent can’t be given for an EUA product because it is recognized and acknowledged that there is still unknown information about it – the product hasn’t been as thoroughly tested and studied as we would ideally prefer. For example, we don’t yet know how long immunity lasts after the COVID-19 vaccine is given, whether there are side effects that appear months or years after administration, or if there are groups of individuals for whom the vaccine is ineffective. With only 40,000 individuals in a phase 3 clinical trial, and with data collected and analyzed only on certain characteristics, we may still be unaware of some information about the vaccine. This is where the Public Readiness and Emergency Preparedness Act comes into play (for details, see FAQ below).
Related issues: Some providers have chosen to develop forms to use when vaccinating patients for COVID-19. For example, they may develop a simple form that does one or more of the following:
- Asks the patient to sign to acknowledge receipt of the manufacturer’s fact sheet
- Asks the patient to sign to evidence consent to be vaccinated
- Informs the vaccine recipient that the fact they were vaccinated will be reported to the county/state/federal governments
- Informs the vaccine recipient that if they are pregnant/nursing they should consult their prenatal care provider prior to getting a vaccine
- Asks for medical information about the recipient, such as allergies and recent positive COVID-19 tests
To be clear, use of such forms is not required by law. Some providers may obtain/provide the above information orally instead or choose to skip some of these steps entirely. (12/29)
Are there any liability protections for providers?
The Public Readiness and Emergency Preparedness (PREP) Act authorizes the U.S. Department of Health and Human Services Secretary to issue a declaration (which he has done here) to provide immunity from liability (protection from lawsuits) for the manufacture, distribution, administration, or use of “medical countermeasures,” except for claims involving willful misconduct. A medical countermeasure is a drug, device, or biological product that is manufactured, used, designed, developed, modified, licensed or procured to diagnose, mitigate, prevent, treat, or cure a pandemic or epidemic. To be a covered countermeasure, a product must be approved, cleared, or authorized for emergency use by the FDA or licensed under the Public Health Service Act. As mentioned above, the currently available COVID-19 vaccines received EUA.
This immunity from liability covers claims under tort or contract law, as well as claims related to compliance with state/local laws. Any lawsuit alleging an exception to PREP immunity must be brought before a special three-judge court in U.S. District Court in Washington, D.C. To win, the patient must prove that willful misconduct was the proximate cause of death or serious injury by clear and convincing evidence. The PREP Act also establishes a program to compensate individuals for serious physical injury or death caused by a covered countermeasure. (1/4)
Is a physician order required to administer a COVID-19 vaccine?
An order by a person legally authorized to prescribe is required [42 C.F.R. Section 482.23(c) and Title 22, California Code of Regulations, Section 70263(g)]. Most hospitals are asking an employee health physician, chief medical officer, or employee health physician to write standing orders. Also, the U.S. Department of Health and Human Services allows pharmacists to order (and administer) COVID-19 vaccines; this guidance preempts state law and confers immunity from liability under the federal PREP Act.
California has also issued a waiver allowing pharmacists to initiate and administer COVID-19 vaccines (and to initiate and administer epinephrine or diphenhydramine by injection for the treatment of a severe allergic reaction). After Jan. 1, 2021, the waiver will not be needed for a physician to initiate a COVID-19 vaccine, as Business and Professions Code Section 4052.8 will allow this permanently. (12/16)
Which types of health care professionals can administer a COVID-19 vaccine?
The COVID-19 vaccine may be administered by physicians, pharmacists, allopathic and osteopathic physicians, naturopathic doctors, registered nurses, nurse practitioners, clinical nurse specialists, nurse anesthetists, nurse midwives, public health nurses, vocational nurses, physician assistants, medical assistants (as allowed per law and regulation under supervision), psychiatric technicians, and respiratory care practitioners.
The Board of Registered Nursing has stated that nursing students are also permitted to administer COVID-19 vaccines (see BRN chart showing the types of services a student nurse can provide).
In addition, the U.S. Department of Health and Human Services has allowed pharmacists, pharmacy interns and technicians to administer COVID-19 vaccines; these guidance documents preempt state law and qualify these providers for immunity from any related claims under the Public Readiness and Emergency Preparedness Act.
For more information, see the Centers for Disease Control and Prevention’s vaccine administration tutorial. (1/4)
As vaccines begin to receive approval, what should hospitals expect for vaccinating their staff and others?
Hospitals will play a pivotal role in administering the vaccine during the first phase, referred to as Phase 1-A by the California Department of Public Health (CDPH), when front-line health care workers will be prioritized. This is in part because the Pfizer vaccine candidate – which received emergency use authorization on December 11 – requires storage at an ultra-low temperature (-80 degrees Celsius) or repacking with dry ice, both of which many settings do not have access to, and given the large amounts shipped (975 doses are in a shipment). Hospitals will offer the vaccine to their employees and staff, and many hospitals are volunteering to serve as closed points of dispensing for skilled-nursing facility staff, paramedics, and other health care workers who are expected to be prioritized. To help hospitals get ready, CHA has prepared a COVID-19: Vaccination Primer for California Hospitals, summarizing the latest information from the CDPH and the steps that hospitals will need to take to participate as vaccinators. (12/14)