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COVID-19 Vaccines from Pfizer-BioNTech and Moderna: What's in Them and How Do They Work?

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CDC: COVID-19 Vaccination Info
CMS: COVID-19 Vaccine Policies, Guidance, & Provider Toolkits
NEJM: COVID-19 Vaccine FAQ

UDOH Provider Toolkit Materials on Vaccination



COVID-19 vaccines: Guidance for healthcare professionals*

With the rollout of COVID-19 vaccines well underway, it’s essential for physicians and clinicians to be aware of the rapidly evolving key risk management considerations associated with this effort. While the rollout thus far has largely bypassed smaller physician practices, these practices will become more involved as more vaccine doses become available. As such, it’s worthwhile to take the time now to think about strategies for handling the administration of the COVID-19 vaccine in your own practice setting.

Contents

  1. Patient care
    1. Communication
    2. Patient education
    3. Informed consent and refusal
    4. Tracking and follow-up
    5. Reporting
  2. Processes and training
  3. Medicolegal communications
  4. Where can I learn more?

Patient care

Communication

Consider how you might communicate important information to patients who have questions about COVID-19 vaccines, including vaccine availability. There are a variety of ways to accomplish this, so think about what would work best for your practice or facility. For example, you may wish to use your practice website, voicemail message, and/or patient portal, if you have one, to share details such as:

  • When vaccinations will be available to various patient populations according to the plans established by your state, city and/or county health department
  • Where patients can make an appointment to receive the vaccine if it is not available at your practice or facility
  • If vaccines will be available at your practice or facility, how appointment scheduling will work (e.g., “When you are eligible to receive the vaccine, we will contact you directly to schedule an appointment”)
  • Additional guidance, such as requesting that any patients who are vaccinated elsewhere let your office know so this information can be added to their medical record, or letting patients know that after they receive the vaccine, they will be monitored briefly (e.g., for 15 or 30 minutes) to be sure no adverse reaction has occurred
  • Answers to frequently asked questions about how the vaccine works, safety, etc.

As always, it’s important to keep a record of how this information was disseminated.

Patient education

Given how quickly the latest news on COVID-19 continues to evolve, it’s likely that patients will have questions about the COVID-19 vaccine. The CDC’s frequently asked questions about COVID-19 vaccination may be a helpful starting point as you think about how you would respond to patient questions such as:

  • When will I be able to get the vaccine? Who will get it first?
  • Will this vaccine give me COVID-19? / Will I test positive after receiving the vaccine?
  • What are the side effects? In the case of two-dose vaccines, are side effects equally strong after each dose, for those who experience side effects?
  • Is the vaccine safe? Was it developed too quickly?
  • I’ve heard that COVID-19 vaccines received an “emergency use authorization” from the FDA; what does this mean?
  • If I already had COVID-19, should I get the vaccine?
  • Does the vaccine provide longer-lasting immunity than being infected?
  • For vaccines that require two doses to be effective, what happens if I get only the first dose?
  • Is the vaccine recommended for children? For pregnant or breastfeeding women? For people with a history of allergic reactions?
  • Will the vaccine protect me against the new variants of COVID? Will I need to get a booster shot in the future, and if so, how will I know?
  • Once I am vaccinated, can I stop wearing a mask and social distancing and go back to “normal”?

As always, document all education given and the patient’s understanding of that education in the medical record.

A note about vaccine hesitancy

It’s worth considering how to address questions from patients who may be reluctant to receive the COVID-19 vaccine. Acknowledging such patients’ concerns with sensitivity and empathy, while also providing education about the safety and efficacy of the vaccine, will likely be a key part of these conversations.

The CDC’s resources on answering patient questions about the COVID-19 vaccine and making a strong recommendation for vaccination offer more detailed suggestions on engaging with vaccine-hesitant patients. Additionally, the FDA’s Reagan-Udall Foundation has conducted research with patients to learn which points of information are most effective to convey when addressing concerns about COVID-19 vaccination. These findings are discussed in this AMA/FDA webinar (starting at 26:00).

Informed consent and refusal

It’s critical to consider how the informed consent and refusal process will work for COVID-19 vaccination. Healthcare professionals should consider how they will discuss the potential risks and benefits of receiving – or not receiving – the vaccine, as well as possible side effects. As always, documentation of these discussions should also include a mention of whether the patient’s questions were answered, whether they expressed understanding, and finally, whether they consented or refused to proceed with the recommended treatment.

For vaccines that require a series of doses, it’s worth considering how this will affect the informed consent and refusal process. For example:

  • At or before the first vaccination, it’s important to let patients know that by receiving the first shot, they are agreeing to a series of two vaccines administered at a specific timeframe apart, per the drug manufacturer’s requirements.
    • As part of this discussion, you may want to let patients know that vaccine effectiveness data – for instance, that a given vaccine is 94% effective – assumes that the recipient received the full vaccination series. It is not yet known what level of effectiveness patients might have after just one dose of a two-dose vaccine series.
  • Patients who are receiving a two-dose vaccine series should take part in an informed consent discussion each time they get a shot.

If the patient is returning for their second dose, your documentation might note that the patient had no complications with the first vaccination; the potential risks and benefits of vaccination were reiterated and the patient expressed understanding; and the patient again agreed to proceed with the vaccination.

Finally, it’s important to note that healthcare professionals are required to provide the relevant FDA-issued Emergency Use Authorization (EUA) Fact Sheet for Patients and Caregivers to anyone who receives the vaccine, and to document that this was done.

Tracking and follow-up

If your practice or facility will be administering a vaccine that requires two doses, it’s essential to think about your processes for tracking and follow-up. For example:

  • Scheduling: For patients receiving a two-dose vaccine, you may wish to consider scheduling the appointment for the second dose when the patient comes in to receive their first dose.
  • Nonadherence/“no-shows”:

    Imagine a situation in which a patient receives the first dose of a two-dose vaccine but does not come back to receive the second dose. In such a scenario, your practice or facility may wish to consider:

    • Contacting the patient via phone, text, and/or patient portal to let them know they need to return, and reiterating why it is important to do so (e.g., the vaccine is likely to be less effective if the full two-dose series is not given). It’s also advisable to send such patients a letter via certified mail and place a copy in their medical record to document that this was done.
    • Documenting all efforts to reach the patient, as well as any additional education provided.
    • If the patient indicates they do not plan to receive the second dose of the vaccine, document their refusal as well as their reasoning for the refusal.

It’s also a good idea to consider other tracking and follow-up scenarios that may arise, such as:

  • Adverse reactions: If a patient has an adverse reaction to the first or second dose of the vaccine, how will you find out? What if the patient’s reaction is one that will necessitate future monitoring (e.g., a patient receives the vaccine and develops Guillain-Barré syndrome)?
  • COVID infections: If a patient is fully vaccinated but later becomes infected with COVID-19, how will you be sure your practice or facility is kept in the loop so you are able to report this?
  • Ongoing communication: In the event of new and important vaccine-related information, how will you reach patients to let them know? For example, what’s your communication plan in a situation where patients have received vaccine doses that are later found to have had issues with efficacy or contamination?

Reporting

Healthcare professionals should be prepared to comply with vaccine safety reporting protocols in their state, as well as being familiar with the process for reporting adverse events. Specifically:

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Processes and training

It’s essential that your practice or facility establish clear guidelines on how various vaccine-related processes will work, and that all clinicians and staff receive comprehensive training on these processes once they have been developed.

Specifically, you may want to consider how your process will look in the following areas:

  • Vaccine logistics: Consider how to best establish clear processes for the receipt, storage, reconstitution and administration of the vaccine. It’s worth noting that the PREP Act may not cover any issues having to do with improper storage of the vaccine in the office, so documenting these processes properly will be absolutely critical for any office that handles vaccinations themselves.
    • When thinking about logistics, keep in mind the complexity of COVID vaccine administration and recordkeeping, which will likely include steps such as screening patients for COVID-19 before administering their vaccine dose; being sure newly received vaccine doses are administered within the specified timeframe (e.g., within one week); and recording and reporting how many vaccine doses have been administered each day and what lot numbers those doses correspond to.
    • If your practice or facility will be storing the vaccine onsite, be sure your processes address recordkeeping (e.g., maintaining a temperature log for the vaccine storage area) and what should be done in the event that the vaccine storage area ever deviates from the recommended storage temperature.
    • Consider how your practice or facility will ensure there are adequate supplies on hand to reconstitute the vaccine and administer it (e.g., needles, syringes, alcohol wipes, band-aids, etc.).
    • Finally, it’s worth considering how your practice or facility will stay apprised of varying requirements for different vaccines, as well as any changes in CDC guidance.
  • Patient care: It’s important to develop procedural guidelines on patient selection, scheduling, documentation, informed consent and refusal, tracking and follow-up, and situations involving nonadherent patients.
  • Infection control: Think about how to reinforce existing office policies, such as wearing face masks, practicing social distancing, and maintaining strong COVID-19 infection control practices, until such time as herd immunity is reached.
  • Emergency situations: It’s essential to consider how your practice or facility would handle a situation in which an individual experiences an acute vaccine reaction. The CDC recommends making sure that all clinicians who will be administering vaccines have current CPR certification and are familiar with the practice or facility’s emergency plan for such events.

Once your practice’s policies and procedures are in place, it’s vital that all healthcare professionals and staff receive comprehensive training. As always, keep in mind that training is not a one-time event, but rather a process that should include:

  • Initial training
  • Skills verification
  • Documentation of what training was provided when, and to whom
  • Periodic monitoring to ensure adherence to established processes
  • Modification of processes as needed, which should start the training cycle over again

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Medicolegal considerations

The Public Readiness and Emergency Preparedness (PREP) Act provides broad liability protections for healthcare professionals involved in administering the COVID-19 vaccine. The U.S. Department of Health and Human Services’ Prep Act FAQs explain these liability protections in greater detail. Essentially, it appears that there should be immunity under federal law except for claims involving willful misconduct through Oct. 1, 2024.

However, although there is immunity for the administration of the vaccine, physicians and clinicians should remain vigilant about related risks that may fall outside of that immunity, such as lack of informed consent. It’s also important to understand that this is still an evolving area; there is a lack of case law related to this specific issue since COVID-19 vaccine administration only began in late 2020.

In the event that a patient does suffer certain serious physical injury from the administration or use of the COVID-19 vaccine, the Countermeasures Injury Compensation Program (CICP) as authorized by the PREP Act provides benefits to certain individuals. Patients will only have one year from the date the vaccine was received to apply for compensation through the CICP, and medical documentation of the adverse event will be very important if such a scenario occurs.

If you run your own practice, it’s important to think about how COVID-19 vaccination will work for the clinicians and staff you employ. Will all employees be required to receive the COVID-19 vaccine? If employees refuse to be vaccinated, must this refusal be accommodated (e.g. by re-assigning that person to a role where they have limited in-person contact with patients and colleagues)? As always, it’s important to be familiar with federal and state employment law when considering policies in this area. The Equal Employment Opportunity Commission (EEOC) has published guidance on COVID-19-related considerations that may be a helpful place to start.

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Where can I learn more?

External resources:

*revised from a resource guide developed by ISMIE - March 2021