Ahead of the rollout of the first COVID-19 vaccine that received emergency use authorization from the U.S. Food and Drug Administration, two Keck Medicine of USC experts held a press conference on Dec. 15 about the logistics of receiving and distributing the first round of doses of the vaccine. Krist Azizian, PharmD, MHA, chief pharmacy officer at Keck Medicine, and Neha Nanda, MD, medical director of infection prevention and antimicrobial stewardship at Keck Medicine, briefed more than a dozen local media outlets at the event.
Below are some of the questions and answers from the event, edited for length and clarity. Watch the full video here. Information is current as of 12/15/20.
How will Keck Medicine secure the vaccines?
Krist Azizian: When we look at security, we are going to be storing and securing the vaccine within refrigerators and freezers in our secured pharmacy locations with 24-hour monitoring. Additionally, we will be having security on campus, particularly throughout the vaccination process, and we’ll have security presence in the vaccine clinic as well. So, plenty of security and we’ll be keeping all eyes on the vaccines. Furthermore, the vaccines will be essentially handled, managed and prepared for administration by trained pharmacists and pharmacy technicians, so it will not be touching many hands until it actually makes it into the patient.
What are the logistics for storing the vaccines at cold temperatures?
KA: The Pfizer vaccine specifically has requirements to be stored at ultra-low temperatures, particularly minus 70 degrees. To that end, there aren’t too many health care organizations that have those readily available and on hand. So we did have to purchase six refrigerators specifically for this reason. Three refrigerators are used for ultra-low temperatures and three are routine freezers, to be able to also create capacity for both Pfizer and Moderna vaccines. We’ve been coordinating with our facilities team for securing those freezers and making sure they’re on emergency power in the event that we do have a power outage, in order to ensure the integrity of the vaccines.
Keck Medical Center of USC and USC Verdugo Hills Hospital are scheduled to receive approximately 2,500 vaccines this week. Can you tell us about the logistics of scheduling the administration of that many vaccines to people?
KA: I think one of the main challenges we have this first go-around is, because we were not one of the hubs that would receive the vaccines directly on this initial shipment, we basically have a five-day time limit from the time we receive the vaccine from our hub, which is at Los Angeles County-USC Medical Center, to the vaccine expiring. So we need to administer that many doses within a five-day time frame. We are currently anticipating picking up the vaccine sometime on Thursday. And we are then anticipating to begin vaccination and starting our vaccine clinic within three to four hours after we pick up the vaccine. At this rate, we are looking at somewhere around 400 to 500 individuals getting vaccinated a day to be able to go through that number.
The Centers for Disease Control and Prevention is recommending a tiered system for vaccine distribution, with frontline workers and first responders in that top tier. Can you tell us a little bit about the workers here that will be in that category and how we went about making those decisions?
Neha Nanda: I think one thing I want to emphasize is at a federal level, several scientific organizations have weighed in and created frameworks. And across the framework, the commonality has been that Phase 1A is where health care workers and staff and residents of long-term care facilities will be prioritized. Now within the health care workers again, there’s sub-prioritization that’s required. And there are frameworks from several scientific societies, and we have relied on ethical principles that have been laid down by the advisory committee of immunization practices that has been endorsed by CDC whereby distribution has to be equal and we have to ensure that we are truly reducing morbidity and mortality in a given individual. And I say that because of the evolving data around the vaccine as it’s becoming available.
With that, we have prioritized health care workers who are working in or caring for COVID patients and people who are at higher risk who and higher settings. For instance, if you’re doing a procedure which puts you at a higher risk you are prioritized. In addition, there are areas where we are testing patients and it is an influenza season where you’re getting a huge group of patients who need to be ruled out for COVID, so that’s another group that we have prioritized. This is where we’re going to start.
Will people who have contracted COVID-19 be able to receive the vaccine?
NN: Now, I think there are multiple studies saying that for 90 days at least you have durable immunity after you’ve contracted a COVID infection. With that in mind, at our organization, what we are recommending is if you had an acute COVID infection in the last 90 days, you don’t need to rush right now to get the vaccine.
Once we have the larger population vaccinated, what is the next step?
KA: The way things look currently and based on the information we have, barring any production issues with a vaccine from either one of the manufacturers, I think we’re looking pretty good to have our health care workforce vaccinated, probably by mid- to end of January. That would be my assumption, given everything goes as planned. And then further shipments would be available. And those will be available to start vaccinating the public. Based on everything we’ve seen and we’ve heard, it’s very possible that we’ve vaccinated or we’ve gotten to that 70% of vaccinations likely by the end of May or June. That’s the goal.
NN: The next phase of vaccinations after health care workers is going to be essential workers and people with comorbidities, nurses and people who are more than 65. And for all of the people who don’t fall in these phases, the hope is that by April, May or even sooner, anybody who needs to get a vaccine will get the vaccine. That’s the hope, if all goes as planned.
Why is there a five-day limit once you pick up the vaccine?
KA: The Pfizer vaccine requires ultra-low temperature storage. What is happening with this initial shipment is the shipment is going to specific hubs for Southern California, so they receive the vaccine directly and can move it directly into a freezer, which would give it a lifespan of six months in the freezer. When we pick up the vaccine, there’s no capability to pick that up in an ultra-low temp transporter. So our best capability is to receive the vaccine at refrigerated temperatures, which immediately puts us into that five-day shelf life.
Future shipments will be sent to us directly. And we will be able to order to our allocation and at that point we can store it immediately into ultra-low temp freezers, which will then put us on par with the hubs. The containers in which Pfizer ships the vaccine currently, the hubs are not releasing those containers and are sending it back to Pfizer because Pfizer would like them back before they ship additional doses. Therefore, it’s not an option for us at pickup.
How soon do you need to administer the second dose of the vaccine after the first is received?
NN: For Pfizer, it’s 21 days. And we know that you have some leeway of four days before or after. The other vaccine, Moderna, that going to undergo review on Thursday by the FDA. There, the time period is 28 days as we know it today.
How are patients going to be tracked to ensure there isn’t cross vaccination from the Pfizer and Moderna vaccines, from one dose to the second? And what happens if there’s cross-vaccination?
NN: A person who gets Pfizer on day one is going to get Pfizer on day 21. Someone who gets Moderna on day one is going to get Moderna on day 28. We are not going to replace one vaccine with the other. And there is a process that we are working on.
KA: Yes. Doses will be documented and clinical outcomes will be documented in our medical record. We will be essentially scheduling the second appointment with the name of the vaccine for the individuals to come, whether it’s 21 days or 28 days, and we will be running basically routine reports daily depending on whether or not we end up having vaccine clinics every single day for the next few months, to ensure that we are allocating the appropriate vaccine for administration to Employee Health. Additionally, again, our pharmacy team will be managing the dispensation of the vaccine as well as the preparation of the vaccine and will have full access to the patient’s chart record prior to administering the vaccine. So there will be double, triple and quadruple checks prior to the second dose for someone receiving the second dose.