As Keck Medicine of USC has started distributing the Pfizer-BioNTech COVID-19 vaccine based on guidelines by the Centers for Disease Control and Prevention (CDC), two Keck Medicine experts held a press briefing on Jan. 6 to offer an update on staff vaccinations and future patient and community vaccination efforts. 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 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 1/6/21.
What is the global landscape of COVID-19 vaccination right now?
Neha Nanda: Today, if you look at it globally, we have 64 vaccines that are undergoing human clinical trials. Now in different parts of the world, there are different vaccines available. In the U.S., we have Pfizer and Moderna at this time that have received the (Emergency Use Authorization, or EUA). In the United Kingdom, there’s AstraZeneca, Moderna and Pfizer. AstraZeneca as you know doesn’t have the demanding cold chain requirements that Pfizer and Moderna have. Now in the developing world, places like India and China, they have AstraZeneca and they also have vaccines from their local groups, which have received authorizations.
Is there a possibility that we could administer only one dose of the Pfizer or Moderna vaccines?
NN: What we know about the Pfizer vaccine is that it was designed to test for efficacy after two doses, and the efficacy was 95%, which is amazing. For the Moderna vaccine, again, it was designed to measure efficacy after two doses. The efficacy is around 94%, which is amazing. Neither of the trials were designed to measure efficacy of a single dose and the way these trials are designed and the way we interpret results — that results in policy. You decide the endpoint “a priori.” So a priori, it was decided that we are going to measure the efficacy after two doses. Therefore, we will stick to the schedule that was decided on in the trial and has since then been endorsed by FDA and the EUA and CDC.
We continue to believe that at this time two doses of both vaccines will be needed. Krist (Azizian) will talk about what we have locally available. So that’s efficacy. It’s very efficacious after two doses. It’s understandable, the discussions that are ongoing about whether we can use half the dose, or just give one dose. It’s very reasonable given what’s happening. Having said that, the science is solidly grounded in what I just shared with you.
What do we know about the safety of the vaccines?
NN: Both of these vaccines are very safe, but I will say they have a higher predilection for causing anaphylaxis than the previous vaccines that we have worked with. So typically your rate of anaphylaxis is one in a million, and with these vaccine doses so far it’s one in 100,000. With that, there are contraindications and groups where we have to take precautions when we administer the first or second dose. And those have been shared by the CDC and have been embraced by all academic medical centers.
Which vaccine is Keck Medicine administering?
Krist Azizian: So at Keck Medical Center and Keck Medicine we currently only have access to the Pfizer vaccine. Essentially the Moderna vaccine is being distributed to or allocated for first responders and long term care facilities or certain acute care facilities that have skilled nursing facilities or long term care facilities. So we’ve been getting continuous allocation of our Pfizer vaccine as we continue to vaccinate our folks.
How is the vaccination process going at Keck Medicine?
KA: To date we’ve vaccinated over 4,500-plus of our health care providers and staff members. We continue to work through the different tiers of our Phase 1A, in collaboration with our Los Angeles Department of Public Health and county partners. We are exploring opportunities with them to see if we can open up vaccination to our community providers that fall within the Phase 1A categories in order to help expedite some of the vaccinations. We’ve also expanded to some of our frontline medical students and health care providers outside of the hospital, dental providers within USC, and will be opening some slots up for them to vaccinate as they as they fall in to the Phase 1A category. And then lastly, we are starting to plan for Phase 1B and vaccinating some of our patients that would fit in to the Phase 1B category, and are working closely with our county and L.A. Department of Public Health partners on when that could be made possible.
How did Keck Medicine prioritize who would receive the vaccine and when?
NN: So we started working on the process of creating phases within phase 1A very early on and we’ve made all efforts to follow various organizations, starting with National Academy of Sciences, WHO, CDC and then state authorities, the California Department of Public Health. And some of the common themes across all the frameworks have been that we want to reduce mortality and morbidity at an individual level, and also be sensitive to the fact that equity is what we live by.
Keeping that in mind all along, then we had to create our own framework because within phase 1A, we have categories: A, B, C. The way we created those categories is by prioritizing any personnel who is patient facing, whether it’s by position, whether it’s a person who is administering medications or it’s someone who’s just going to check the room or facilities. Anybody who’s patient-facing receives priority. And then depending on your patient-facing time, the categorization is created.
Will the hospital’s infection prevention protocol change once Keck Medicine has vaccinated a critical amount of staff?
NN: So at this time it is not going to change because what’s grounded in science is that it prevents clinical disease. It likely helps with transmission, but we do not know that for sure. Therefore if today, I get exposed, I have to follow all exposure protocols. We have to continue abiding by our masking, physical distancing, following PPE protocols that we worked so hard on in the last 10 months, including the screening protocols that we undergo when we enter the hospital. Nothing’s going to change for now, or in the near future.
What happens if someone is diagnosed with COVID-19 in between the first and second dose?
NN: If someone develops a COVID-19 infection between dose one and dose two, that person can present in two ways. If you’re asymptomatic, then for the sake of preventing transmission of disease we are recommending that you get your vaccination 10 days after your diagnosis — as long as you’ve been asymptomatic, because we don’t want you to spread disease. You should just be self-isolating at that time in your home. If you are symptomatic, we are still expecting the person to follow self-isolation and the person will receive dose two after 10 days have passed and the person is symptom free for 24 hours, whichever comes later.
What do we know right now about the transition to vaccinating patients?
NN: As we move towards vaccinating our patients, that’s going to be Phase 1B where we know the priority is going to be given to essential workers and people who are older than 75 years of age.
KA: We’re also working with our L.A. County partners because there are patients that would technically fall into Phase 1A as community providers, etc., that we would move forward with vaccinating as part of the initial phase, but for phase 1B, which is essentially 75 and older and other essential workers, we are planning for it and we are optimistic that we will get to them sometime in the first quarter of this year. But, we don’t have a crystal ball. And so I think what we can be is optimistic that we have ample supply coming our way. And there’s been nothing to suggest otherwise. And we are planning to make sure we have the resources and the appropriate spacing to run a vaccine clinic in anticipation of Phase 1B.
Are there any groups within the larger community that we should be a little bit more cautious or careful about vaccinating at this time?
NN: So the only reason we are being cautious about certain groups is because those were the groups that were excluded from the big clinical trials that have been done. And with those groups, let me preface, before I go into what those groups are, by saying it’s not that they can’t receive it. We’re just asking them to check with their specialist before they receive it.
So, for instance, someone who is pregnant, someone who’s lactating, someone who’s received a stem cell transplant, someone who received a solid organ transplant. It’s the timing piece that has to be taken into account, which the oncologist, or the hematologist or the obstetrician would know best. So this is the group that we want to be able to vaccinate when it comes to our patients or employees and we just want to be a little cautious.
What side effects should people expect and at what point should they speak to their doctor?
NN: The common side effects are a really sore arm. About 80% of people did get a sore arm, a lot of my peers and myself, too. In addition, feeling fatigued and drained seems to be very common. About 20% of people, which replicates what we saw in the trials, do get a fever — not very high, about 100 degrees. And the side effects are pretty comparable whether you look at the Pfizer vaccine or Moderna.
A patient should contact us when there’s shortness of breath, when there’s a severe reaction, when there’s angioedema, when there’s something that just doesn’t feel right, something that hasn’t been shared with you in the fact sheet that is shared with you when you sign up for the vaccination. That’s when you want to reach out to your primary care provider.
How do we ensure that vulnerable communities aren’t left out of vaccine distribution?
NN: What I can tell you is that the things that are under our control at our facility, we’re going to make all efforts to live by our framework. At a federal and a state level there have been conversations about targeting the socially vulnerable groups. So there’s an index, a socially vulnerable index, which means that where the index is higher, that means those communities are more prone to be hit by a disaster like a pandemic. There are considerations in making sure those groups have easy access to, by way of setting up pharmacies, by way of creating community clinics, so that those groups have access to the vaccine.
How is the health system tackling vaccine hesitancy among staff?
KA: So we are in the process of really gathering data to drill down on our various units. Our initial survey had indicated, based on I believe 2,600 responses, that about 80% of our staff were very interested in getting the vaccine, what we’re seeing now is it’s kind of declined to 70% and so we are doing a drill-down by unit to do some focused, targeted education to those specific areas that do have some concerns and hesitancy in order to see if that can move the needle a little bit.
NN: We’ve made all efforts to be consistent with our messaging and understanding that with this pandemic. One thing that’s been constant is that things keep changing and we want to be ahead of the curve in terms of messaging. That’s where we have been as proactive as we can to share the new data and the evolving data and that is reflected in our policies around vaccination.
Will the vaccine protect against the new variation of COVID that’s now circulating in the United States?
NN: The immune response that our body mounts following a natural infection or after vaccination will be able to tackle the new variant. That’s what we know today. So the variant is not something that we will have to succumb to if we have taken the vaccine and our body mounts the appropriate response.
What about vaccinating patients who have had previous anaphylaxis that’s not related to a vaccine?
NN: There are different types of reactions. The first is anaphylaxis to a COVID-19 vaccine or to an ingredient in the vaccine requires the person to consult with their allergist/immunologist before they plan for the second dose. Second, if the person has had an anaphylactic reaction to any vaccine in the past or to injectable medication in the past, we will counsel them. We encourage them to touch base with their allergist and they will be monitored for 30 minutes after the vaccine as opposed to 15 minutes, which is routine. The third category is when someone has had an anaphylactic reaction to pet dander, to a food product or something else. At this time, based on the data that’s accumulating, that group is not considered as high risk for developing anaphylactic reaction or a severe allergic reaction to the COVID-19 vaccine.
How many vaccines has Keck Medicine received and how many have been administered?
KA: We’ve administered just about 4,500 doses and we’ve received likely around 8,000 doses and that includes doses that are reserved for our second round, basically, which will start on Jan. 7.
If someone has been infected with the virus in the last three months and they display antibodies, is their place in line for the vaccine impacted and does that move them to a different priority group?
NN: Someone who has been infected in the last 90 days, if there is enough vaccination at an individual level, we will likely not be harming the person if you take the vaccine. However, if the supply is not generous, then it’s advisable to be a global citizen, like we all are citizens in that case this is a group that can delay the vaccination for at least three months if not longer. The reason for that is, we know that reinfection is extremely uncommon following natural infection in the next three to six months. Therefore, that group can wait at this time.