Quick Answers to COVID-19 Vaccine Questions

January 13, 2021

Question #1

Q: “Do health care organizations face malpractice liability for providing COVID-19 vaccine?”

A: If storage, dispensing and follow up protocols are adhered to, there would likely be limited malpractice liability to an organization.

Many states have already granted limited and temporary protections from liability for providing treatment during a public health emergency. The U.S. Department of Health and Human Services has also expanded the scope of the PREP Act (Public Readiness and Emergency Preparedness Act), which grants liability immunity to Covered Persons against any claim of loss “caused by, arising out of, relating to, or resulting from” the distribution, administration, or use of COVID-19 vaccines approved by FDA under an EUA (Emergency Use Authorization) or BLA (Biogenic License Applications). The only exception to immunity is for claims involving “willful misconduct” as defined in the PREP Act.

The Volunteer Protection Act of 1997 (VPA) provides liability protections to volunteers, including physicians, who are performing services for nonprofit organizations or government entities.

The National Vaccine Injury Compensation Program (VICP) may provide financial compensation to individuals who file a petition and are found to have been injured by a VICP-covered vaccine. Even in cases in which such a finding is not made, petitioners may receive compensation through a settlement. 

But what are some of the potential risks of not following all of the protocols?

  • If the organization doesn’t follow up, a patient could miss a second dose, contract the virus, experience an adverse event and then file suit.
  • If a patient is not adequately monitored after vaccination and he or she faints and is injured in the fall or experiences an allergic reaction.
  • If informed consent is not obtained, and the patient experiences a severe complication, interfering with their ability to work, and the patient claims they would not have agred to the injection if they had known of the potential complications.
  • If informed refusal is not obtained, and the patient then claims they were unaware of the risks of not taking the vaccine.

Medical malpractice insurance should protect an organization from whatever government liability limits don’t address. But every claim will be judged on the facts, and coverage can’t be guaranteed. This is particularly true if someone at your operation breaks the law or if required protocols have not been followed, resulting in harm to patients, including your own staff. But if you’re acting in good faith and within prescribed standards, any risk of uncovered liability should be limited.

Health care organizations should always consult their legal team but this gives you an overview of how you’re protected and where you could be vulnerable.

These are questions and concerns your Marsh & McLennan team can help you answer. They can help you better understand your options and liabilities as well as help you plan for and manage risks from choosing, storing and dispensing the COVID-19 vaccine. To learn more, contact your MMA representative today.

MMA will be providing whatever answers we can to questions our clients are asking about COVID vaccines. Watch for more answers to more urgent questions or visitmarshmma.com/vaccines.


Question #2

Q: “How do health care organizations mitigate malpractice risks associated with administering COVID-19 vaccines?”

A:  If all required protocols are strictly followed, malpractice problems will likely be limited. However, we would strongly recommend the following steps to better ensure patient safety:

  • Use a state-approved vaccination informed consent form, and document the consent discussion in the medical record.
  • Educate your staff and conduct skills verification on accepted procedures, new standards, and risk prevention methods.
  • Document these efforts in administrative training files.
  • Store and handle vaccines in strict accordance with manufacturers’ guidelines. Monitor your staff; don’t assume protocols are being followed correctly.
  • Follow basic medication administration safety protocols for vaccine administration.
  • If an error in vaccine administration does occur, conduct an analysis with your staff to determine why the error occurred and adjust any procedures as needed.
  • Respond to patients who express concerns about reactions to their vaccines. Document these discussions in the medical record. The CDC is concerned about patients who have had previous anaphylactic reactions and has recommended identifying them to mitigate any possible reactions during the first roll-out.
  • Ensure all vaccines are entered into the specific state vaccine monitoring program.
  • Have a follow-up and tracking system to ensure patients receive the second vaccination. If a patient does not return, or refuses to come back for their second dose, make sure to document the refusal and the reasons why.

    NOTE: You must talk with all patients or guardians about the consequences of not having the second dose in the proper amount of time.

  • Refusal can expose the patient to the COVID-19 virus
  • They could pose a threat to those who have not yet been vaccinated
  • They would need to quarantine themselves for an extended period

  • Document all follow-up communications with patients in the medical record.
  • Make sure you educate patients on potential side effects, including fever, pain at the injection site, muscle aches, fatigue, headaches, and chills.

These are questions and concerns your Marsh & McLennan team can help you answer. They can help you better understand your options and liabilities as well as help you plan for and manage any risks from choosing, storing and dispensing the COVID-19 vaccine. To learn more, contact your MMA representative today.

MMA will be providing whatever answers we’re able to provide to the questions our clients are asking about COVID vaccines. Watch for more answers to more urgent questions — and catch up on any urgent answers you missed at mma.marshmma.com/coronavirus-outbreak-resource-page.


Question #3

Q: “Do health care organizations decide who gets the vaccine and when?”

A: No. That decision rests entirely with federal, state and local governments. However, many of your staff should be considered frontline workers and should have immediate access to the vaccine.

The CDC provides links to each state’s vaccination program executive summary. These serve as guides for states, territories, tribal governments, and local public health programs as to how the COVID-19 vaccination has been assigned to be dispensed. (Each state and territory has more specific documents that can be found on their department of health websites.)

But basically decisions have already been made that the following groups will receive the first doses of the vaccine:

Health care personnel and other essential workers
Vaccinating health care workers — and then having employers carefully track results — will provide important information as to how well COVID-19 vaccines are working, including if health care workers become infected, regardless of whether they have symptoms.

Older adults living in nursing homes
Data collected from these nursing homes and long-term care facilities will include information about whether people received a COVID-19 vaccine, became sick with COVID-19, and needed hospital care in a hospital.

There are also key groups that should receive a vaccination as soon as more are available:

People with underlying medical conditions
It is important to understand if adults with heart conditions, obesity, and diabetes are well-protected from the coronavirus after getting vaccinated.

Racial and ethnic minority groups
Long-standing systemic health and social inequities have put many people from racial and ethnic minority groups at increased risk of getting sick and dying from COVID-19. The CDC is working to ensure that real-world vaccine effectiveness assessments include groups that are disproportionately affected by COVID-19.

These are questions and concerns your Marsh & McLennan team can help you answer. They can help you better understand your options and liabilities as well as help you plan for and manage any risks from choosing, storing and dispensing the COVID-19 vaccine. To learn more, contact your MMA representative today.

MMA will be providing whatever answers we’re able to provide to the questions our clients are asking about COVID vaccines. Watch for more answers to more urgent questions — and catch up on any Urgent Answers you missed at mma.marshmma.com/coronavirus-outbreak-resource-page.


Question #4

Q: “Can a health care employer mandate that employees take the COVID vaccine?”

A: In a word, yes. In most cases, everyone who works for you is an “employee-at-will.” That means you can let them go for any reasonable cause, at any time.

To date, no federal agency has issued specific guidance about COVID-19 mandatory vaccination programs. Employers need to look to existing legal precedence and agency regulations for guidance.

It makes sense for the health care industry to implement mandatory COVID-19 vaccination programs given their employees’ increased risk of COVID-19 exposure, and the potential severity of COVID-19 symptoms. Given that health care employees will be some of the first recipients of the vaccine, these employers should already be considering if and how they intend to handle any proposed vaccine mandate.

In its 2009 guidance on pandemic preparedness, EEOC explicitly said that employers could require employees to get the flu vaccine as long as employers provided reasonable accommodations to people with disabilities and those with religious objections, as required by the Americans with Disabilities Act (ADA) and Title VII of the Civil Rights Act of 1964 (Title VII), respectively.

The “reasonable accommodation and undue hardship” analyses are individualized assessments that take into account the employee’s disability, job conditions and the employer’s specific circumstances. In the case of an employee who cannot be vaccinated, accommodations may include telework, protective equipment such as face masks and face shields, increased social distancing measures, or a modified work schedule. Those potential accommodations may not work well for any industry that requires face-to-face interaction with coworkers or customers.

Health care personnel — which the CDC defines as those working in home health, hospitals, long-term care facilities, outpatient clinics, pharmacies, emergency medical services and other settings — can actively demonstrate how taking the vaccine provides maximum benefit with minimum harm.

If you haven’t yet covered this issue with your employees, you should do so immediately. Does your employee handbook cover this? What if they have religious, cultural or moral objections to it? And, if an employee is pregnant or even suspects they may be pregnant, you are not in a position to demand they are vaccinated.

What about any employees who are avowed “anti-vaxxers?” Currently their objections would not be considered legitimate by the courts, but you’ll at least need to acknowledge their concerns.

You’ll also need to obtain consent, find out if employees have any allergies that might cause a reaction or other medications they are taking that could cause interaction issues. Then you’ll need to monitor the employee for any side effects and document any reactions.

You can also use incentives rather than simply mandating vaccination to encourage compliance.

These are questions and concerns your Marsh & McLennan team can help you answer. They can help you better understand your options and liabilities as well as help you plan for and manage any risks from choosing, storing and dispensing the COVID-19 vaccine. To learn more, contact your MMA representative today.

MMA will be providing whatever answers we’re able to provide to the questions our clients are asking about COVID vaccines. Watch for more answers to more urgent questions — and catch up on any Urgent Answers you missed at mma.marshmma.com/coronavirus-outbreak-resource-page.


Question #5

Q: “What are the specific storage differences between the current COVID vaccines?”

 

A: If you’re taking direct responsibility for storing and administering the COVID-19 vaccine, there are a few things you’re going to need to understand.

 

Start by getting advice from the CDC on how to safely store any of the approved or soon to be approved vaccines, and best practices on handling them. You’ll find a complete training module along with reference material designed specifically for health care professionals right here.

In the meantime, here is a basic look at what you’ll need to know about storing and handling each of the three most likely vaccines to be distributed during 2020 and early 2021.

Pfizer
Vaccine must be kept at minus 94 degrees Fahrenheit (minus 70 degrees Celsius) and can last in a specialty freezer for up to six months. The specialty shippers that deliver the vaccine can hold up to five "pizza box" trays of vials and be refreshed with dry ice every five days for up to 15 days to keep the vaccine at the right frozen temperature.

However, a Pfizer scientist told the CDC that the specialty freezer is not supposed to be opened more than twice a day and needs to be closed within one minute of opening. Once it's thawed, the vaccine can be refrigerated for five days.

So, not everyone dispensing the vaccine will have the infrastructure to handle this vaccine.

Pfizer BioNTech has prepared detailed instructions you can read here.

Moderna
Vaccine is stable at regular freezer temperature — minus 4 degrees Fahrenheit (minus 20 degrees Celsius) — for up to six months. After thawing it can last in the refrigerator for 30 days. The vaccine can also be kept at room temperature for up to 12 hours. This means the vaccine doesn't need to go in and out of the refrigerator each time it's administered.

Astra Zeneca
Current information indicates that this vaccine can be safely stored in normal refrigeration conditions.

NOTE: Moderna and Pfizer are both MRNAs and require two doses – the second dose for Pfizer is 21 days after first inoculation; Moderna’s is 28 days.

Astra Zeneca and Johnson & Johnson vaccines will require less significant storage needs as well as monitoring and follow up. They are expected to provide a combined total of 150 million to 200 million doses in the first quarter of 2021 assuming they receive FDA approval. Moderna and Pfizer will total around 50 million total vaccinations (two doses).

So, should you lease refrigeration equipment? Purchase it? Who is liable if that equipment malfunctions, causing spoilage of the vaccine? And should you also contract with a vaccine storage company to ensure the vaccines can be stored safely if your storage system should fail?

NOTE: Talk with your broker about this because spoilage limits are not always obtainable with your current carrier. It may not be as easy to transfer this risk as you’d hope.

These are questions and concerns your Marsh & McLennan team can help you answer. They can help you better understand your options and liabilities as well as help you plan for and manage any risks from choosing, storing and dispensing the COVID-19 vaccine. To learn more, contact your MMA representative today.

MMA will be providing whatever answers we’re able to provide to the questions our clients are asking about COVID vaccines. Watch for more answers to more urgent questions — and catch up on any Urgent Answers you missed at mma.marshmma.com/coronavirus-outbreak-resource-page.


Question #6

Q: “If a health care employee refuses a vaccine, is the employer protected from Workers’ Compensation liability?”

A: Yes…but. Workers’ Compensation can be tricky, and can vary from state to state. For example, does a particular state’s workers’ comp act allow employers and employees to agree to terms of a workplace injury claim waiver? Does an employer have a valid basis for denial if they have proof that the employee’s issue occurred as a result of a “violation of a positive work order”? In other words, a COVID-19 vaccination mandate?

Another consideration: What happens if you allow a non-vaccinated employee to enter the workplace? Will you have liability exposure for the spread of COVID to other employees, customers, visitors and suppliers who may have contact with that employee and can prove the exposure resulted in contracting the virus?

Employers administering a COVID-19 vaccination program will likely be afforded a layer of immunity through the Public Readiness and Emergency Preparedness Act (PREP Act). This includes companies that administer vaccines or provide facilities for vaccine administration. The PREP Act grants liability immunity to Covered Persons against any claim of loss “caused by, arising out of, relating to, or resulting from” the distribution, administration, or use of COVID-19 vaccines approved by FDA under an EUA or BLA. The only exception to immunity is for claims involving “willful misconduct” as defined in the PREP Act.

So, an employer providing a COVID-19 vaccine onsite may enjoy the liability immunity protections of the PREP Act, meaning that the employer would be immune from claims of injury or loss arising from the administration of a COVID-19 vaccine, except in instances of “willful misconduct.”

These are questions and concerns your Marsh & McLennan team can help you answer. They can help you better understand your options and liabilities as well as help you plan for and manage any risks from choosing, storing and dispensing the COVID-19 vaccine. To learn more, contact your MMA representative today.

MMA will be providing whatever answers we’re able to provide to the questions our clients are asking about COVID vaccines. Watch for more answers to more urgent questions — and catch up on any Urgent Answers you missed at mma.marshmma.com/coronavirus-outbreak-resource-page.