Dec 09, 2020 9:00 AM

Author: University of Utah Health Communications

University of Utah Health is preparing to receive and distribute COVID-19 vaccines while the Food and Drug Administration (FDA) considers Emergency Use Authorization (EUA). The vaccines will be rolled out in phases and provided based on availability.

U of U Health experts, Jeanmarie Mayer, MD, chief of the Division of Infection Prevention and Andy Pavia, MD, chief of the Division of Pediatric Infectious Diseases, answer questions about the vaccine and the health care system’s plans to distribute it.

Does a rushed vaccine make it less safe?

Pavia: The marketing of “Operation Warp Speed” gives people the sense that things are being done with speed and not with scientific rigor. That is not true. More than 40,000 people were involved in the Pfizer/BioNTech vaccine trial, and 30,000 people participated in the Moderna vaccine trial. What is typically done for any vaccine is establish efficacy and safety. In October, there was a lot of talk about political pressure, but the FDA set a transparent and thorough independent process. In early December, the FDA will review all the data with an independent advisory board called the Vaccines and Related Biological Products Advisory Committee (VRBPAC). This group consists of outside vaccine experts with no political or financial ties who have evaluated dozens of vaccines. The FDA will post all the materials they reviewed online so other vaccine experts can review the data.

Preliminary data shows these are efficacious vaccines. The effectiveness is about 95%. That compares to some of the very best vaccines, like the measles vaccine, and is much better than the influenza vaccine. What we know about both vaccines so far is that they are as safe as most vaccines that are currently available. They do cause some mild side effects such as headaches, muscle aches, and fever. Some vaccine trial participants took Tylenol to help these symptoms, but otherwise there have been no serious safety signals.

The problem we need to be aware of with all vaccines that are studied is that those studies give us a good idea about basic safety. However, they don’t tell us what could happen at rare levels (one in half a million). We aren’t going to know that answer for months. To put it into context: COVID-19 will kill 1 in 150 people who become infected. What is not known about the vaccine yet is whether there will be side effects for one in half a million people. The benefits of preventing the disease are going to outweigh the risk of the vaccine.

When will vaccinations be distributed?

Pavia: The Pfizer/BioNTech and Moderna vaccines are currently under review by the FDA. They will be distributed once given Emergency Use Authorization (EUA).

Which vaccine will be rolled out first?

Mayer: The Pfizer/BioNTech vaccine is expected to be approved first. It is a fragile and unstable vaccine that needs to be handled carefully. Utah Department of Health (UDOH) will distribute this vaccine to hospitals and health systems who take care of the most COVID-19 patients and can manage a successful vaccine rollout. It’s anticipated that the Moderna vaccine will soon become available as well. The Moderna vaccine is less challenging to handle and store, which would be more ideal for hospitals that are smaller and in rural communities.

How is U of U Health prepared to roll out the vaccine?

Mayer: U of U Health has been working with several stakeholders and UDOH for several weeks, as well as following recommendations from the Centers for Disease Control and Prevention (CDC) and other advisory groups. U of U Health has a COVID-19 vaccine planning committee and a multi-disciplinary team that includes physicians, nursing directors, pharmacy, emergency management, ethicists, information and technology, and communications.

U of U Health has plans in place to roll out the vaccines as soon as EUA is approved by the FDA. This includes possible temporary vaccine clinics where 500-700 personnel can be vaccinated a day. It’s not known yet when U of U Health will receive the vaccine, but our teams are prepared and ready.

What measure will be taken to ensure vaccines are secure?

Mayer: The vaccine will come directly from Pfizer and go to U of U Health’s secured central pharmacy. The vaccines will then be transferred from shipping containers to minus-80-degree freezers for storage. This process must be done in 60 seconds. When EUA is granted, the vaccine will need to thaw. Once thawed, the vaccines will be placed in a fridge where they can be stored for up to five days. Pharmacy staff will be ready to handle, distribute, and track the vaccine.

Who will receive the vaccine first?

Mayer: U of U Health care personnel who have been on the frontlines taking care of COVID-19 patients will be the first to receive the vaccine. This includes individuals who are paid or unpaid that have direct contact with COVID-19 patients or indirect exposure to potential infectious materials. This group has gotten bigger over time and includes ICU, acute care, emergency department, urgent care, and COVID-19 testing staff. Our environmental services employees will also be included in this group. This will ensure our health care system stays intact and that our health care workers are able to continue to care for our most vulnerable populations.

Pavia: In the first wave of Phase 1, there are not enough vaccines to provide to all health care personnel. That’s why those on the frontlines of the COVID pandemic will be targeted first. We will later target everyone in the health care setting when more vaccines are received. We expect all health care personnel to be offered the vaccine within a six week period.

Will vaccine distribution cause staffing shortages?

Mayer: We feel we have adequate staffing to provide vaccinations. Pharmacy staff are trained and ready. We also have plans of having multiple stations during the day and working 12-hour shifts. We will need to be strategic about who is offered the vaccine. Once we get past the initial wave it will be more random on how we offer vaccines to make sure we aren’t vaccinating all individuals in the same area at the same time.  

Will the vaccine be mandatory for health care workers?

Pavia: The vaccine won’t be mandatory. Faculty and staff will be educated so that they understand the risks and benefits of the vaccines.

How do you anticipate people in the general population would get their vaccine?

Pavia: Distribution is complex and evolving. By the time spring rolls around, we may have two to four vaccines. The way they are going to be made available is still being figured out. It depends on how easy the vaccines are to transport and how easy they are to administer at community clinics or drug stores.

When will the vaccine be approved for those under age 18?

Pavia: Both Moderna and Pfizer are just beginning their trials that include ages 12-17. Once those trials are done, they will include younger ages, but safety data is needed beforehand. Teenagers are a very important group to get vaccinated. They can get quite sick (though not as frequently as adults), can have very critical illness, and are very important in the propagation of the epidemic by spreading disease. Moderna announced they will finish their study on June 30th. They will then need two to four months for authorization for use on that age group.

How will reports of people able to get COVID-19 twice impact the efficacy of the vaccine?

Pavia: The way we are going to do that is with ongoing studies that look at vaccine effectiveness over time. We do studies like that every year for influenza. At some point, we will see whether people who were previously vaccinated get infected with COVID-19. That will help us understand the duration of protection.

What is an mRNA vaccine?

Pavia: mRNA is a very different genetic code. It’s not the basic code of life that is our DNA. It’s actually the template for manufacturing proteins. It is the coding that runs a piece of machinery to build a protein. It can’t be incorporated into your DNA because mRNA is rapidly degraded. Our bodies make mRNA in our cells all the time and cycle them through. This isn’t a concern for the COVID-19 vaccines. The issue with all vaccines is that they sometimes cause side effects because they trigger the immune system to respond to things we want to fight against. We aren’t concerned about this because it’s genetic material; rather, it’s a new vaccine that we don’t have years of experience with it.

What is known about the long-term immunity of mRNA vaccines?

Pavia: We only have short-term data right now. These vaccines were first started in phase one and phase two in the spring. We are comfortable the vaccine will last for many months, but we won’t know if it will last longer until we have more time under our belt.

coronavirus COVID-19 vaccine moderna pfizer biontech

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