Transcription:

Prakash Chandran (Host): This Southwest General Health Talk COVID-19 podcast was recorded on May 25th, 2021. For many, lingering questions about the safety and effectiveness of the COVID-19 vaccine may be the very thing preventing them from receiving it. So, whether you have someone in your life that you want to help clear up any misperceptions or have questions yourself, here's the truth on some of the biggest vaccine myths.

Joining us today is Stacey Zorska, the Director of Pharmacy at Southwest General Health Center. This is the Southwest General Health Talk. My name is Prakash Chandran. So, first of all, Stacey, it's great to have you here today. Let's get right into it. I know that there is so much apprehension and concern about this vaccine. I'm sure you've heard a lot about this. And the very first thing, the thing that I hear the most often is that this COVID-19 vaccine was rushed and because it was rushed, it may not be as safe. Can you speak to this?

Stacey Zorska, Pharm. D, MHA (Guest): Sure. Thank you. It's very good to be here today as well. I've been working very closely with our COVID vaccine program here at Southwest for the past six or seven months. And I have heard that question before. I would tell anybody who's apprehensive about getting the vaccine that while it may seem to be rushed, the amount of research and all of the clinical trials that we would do for any other vaccine, were done in this case. The key difference is the amount of money available to fund the vaccine and get the research done quickly, was supported by the federal government and that allowed the vaccine manufacturers to do the same type of research that they would normally do, in a much faster timeline. But the vaccines have been studied and they are safe and effective.

Host: Okay. So, I have a couple questions that I want to ask you based on that. So, one of the first things that you're saying is part of the reasons vaccines take so long is typically because they don't have the funding to perform the research necessary to get them out there. Is that correct?

Stacey: That's true. Most vaccine research is funded by the pharmaceutical companies themselves, with some supportive grants from the federal government, but certainly not to the level that we saw here with billions of dollars being made available to the manufacturers and kind of a safety net program for the manufacturers to do the research that was supported by the government.

Host: Okay. So, you've assured us that they go through all of the same rigor and testing that a normal vaccine would. We know that the FDA gave an emergency use authorization and I've heard some people say, well, FDA didn't give official approval. So, can you speak to us about the differences between the emergency use authorization and full FDA approval?

Stacey: Yes. Actually many, many drugs have gotten emergency use authorization prior to FDA full approval. Most of those drugs are in the oncology or the cancer area, because initial research presented to the FDA looks so good that they don't want to withhold the treatment, particularly in cancer. Same thing here with the vaccine. The initial data looked really, really good, so they didn't want to hold up the approval. But they wanted the manufacturers to continue to do studies. And that's really what an emergency use authorization is. Full FDA approval, which actually some of the vaccine manufacturers for COVID vaccine have actually now applied for full approval; that's usually a longer process. And because the benefits of the vaccine outweigh the risks of the vaccine, the FDA granted emergency use authorization, just so we could start getting the vaccine in the arms of people faster.

Host: That makes a lot of sense. And just speaking to the efficacy and the fact that these vaccines were doing so well, I've heard that the FDA standard for approval is only 50% efficacy. And these vaccines are obviously coming in much higher than that. Is that true?

Stacey: That is true. And there've been some years, believe it or not, where we do our best guess on the flu vaccine and what needs to be in the flu vaccine and because of the types of flu that are seen in the community, the vaccine is sometimes only 40% effective, but yeah, 50% is the baseline threshold for most vaccines. And I don't think a lot of people know that. So, we're seeing efficacy rates with all three, you know, 80% and up, which is phenomenal sometimes up to 90, 95%.

Host: Yeah, absolutely. One of the last things that I would love for you to address is around the mRNA vaccines. You know, I've heard that the mRNA technology has been around for a very long time, but one of the concerns that I've heard is that while it's been around for a while, this vaccine, the Pfizer and Moderna, are the first vaccines that it's ever been used in. So, the concern is, hey, if this has been around for so long, why has this not been released with other vaccines? Is this something that you can speak to?

Stacey: That is a very good question. I know it's newer technology and these are the first vaccines offered with an mRNA component. I believe the technology is just so new and it was able to be developed relatively, actually very quickly that I would expect in the future, we will see additional vaccines using mRNA technology or possibly even other treatments for various diseases.

Host: Got it. So, another concern I hear a lot is people are concerned that they can get COVID from the vaccine itself. Is it a live virus that's in the vaccine? Can you speak a little bit around the dynamics of how it works?

Stacey: It is not a live virus in the vaccine. What the researchers did, is they took a little bit of the molecule of COVID, one of what they call the spike proteins and embedded it into a vaccine. It's not the active form of COVID or does not cause COVID-19. But by putting that in the vaccine, it allows your body to develop your own immune response to the virus. So, it allows your body to do the work and give you protection against getting COVID.

Host: Yes, that makes a lot of sense. So, the vaccines are effectively giving your body a set of instructions on how to combat the COVID-19 virus when it comes into contact with it. Is that correct?

Stacey: That is correct.

Host: Okay. So, there's been some concerns because the set of instructions is being basically injected into your body, I've also heard concerns around the vaccine altering your DNA itself. Can you talk about the dynamics of what alters DNA and what people should and should not be concerned about there?

Stacey: Yeah, the vaccine certainly does not alter your DNA. And it's specifically the Pfizer and Moderna vaccines were developed using this mRNA technology. Matter of fact, the message that your body receives from the vaccine to develop antibodies, actually leaves your body within a couple of days. So, you are definitely not altering your DNA structure. That is certainly a myth. It doesn't work that way. It just gives your body a message to kick the immune system into high gear and develop antibodies and it leaves.

Host: Okay, understood. So, I want to shift topics to something that I know concerns a lot of people and that I'm personally going through right now. My wife is pregnant and a lot of what I've been hearing is that there's no longitudinal data around the efficacy of these vaccines and what might happen over time. How could there be? Right? This was something that was a rushed. What might you say to parents or people that want to start trying soon; what might you say to them around how this vaccine affects them?

Stacey: That's a very good question. I can tell you that during the initial clinical trials, there were at least a few situations where women became pregnant during the study, meaning they were part of the clinical trial, they received vaccine and they got pregnant. So, obviously those folks are still, many of them could still be pregnant or about to deliver now, because all of the clinical trial patients are being followed for a long period of time. The American College of Obstetrics and Gynecologists, they say that most pregnant women, or those that are thinking about becoming pregnant should get the vaccine. If anybody is truly concerned about the effects of the vaccine during pregnancy, certainly address those concerns with her OB GYN.

There is also a rumor out there or a false hood, I should say that the vaccines cause infertility. And that is not the case either, because like I said, in the very early clinical trials, there were women who became pregnant during the trial. Speaking from our own experience here at Southwest General, we've had many employees who have received the vaccine while pregnant, or have gotten pregnant after they have been vaccinated. Personally, I feel very comfortable with the safety and efficacy of the vaccine and would recommend it to anyone that is pregnant or wanting to become pregnant. But again, if a woman has any concerns they should also talk with their OB.

Host: And what about the parents with young children right now? Is it prudent for them to get them vaccinated, especially because they're healthy and young and it's shown really not to affect a younger demographic.

Stacey: That's a very good question. We know that at least at the beginning of the pandemic, children were perceived as kind of the carriers of the virus to other family members. Speaking from my own experience, both of my daughters that are 12 and 16 have gotten their first dose of a vaccine. And my 16 year old has received her second. I feel very comfortable with the safety and the efficacy of the vaccine. And I think it's again, if somebody has concerns, they should talk with their pediatrician or their family medicine physician. But the studies that were done with the Pfizer vaccine, cause that's the vaccine that's available for children 12 and up, showed 100% efficacy against getting COVID and you can't beat a hundred percent. I would also add that as we vaccinated more and more adults, there had been in the pediatric population, an uptick in hospitalizations and cases. So, we want to get the kids back in school. We'd all love to be able to remove our masks. And I really think that pediatric vaccination is the way to make that happen.

Host: Yeah, that makes a lot of sense. I think that there's still going to be some parents though that might be concerned about the side effects that a child might experience because, you know, we know that for example, that second shot causes that stronger immune response in adults. Is it the same for children?

Stacey: Yes. That's a very good question. What we've seen in the clinical trials is that the second dose does have a more profound response in kids. And that makes a lot of sense because their immune systems are pretty strong. We found that folks that didn't have a really strong response to the second dose were either immunocompromised or elderly. So, their immune system wasn't quite as strong, but yes, I would actually just kind of plan on it, particularly after the second dose to have the child I'll call it, lay low for about 24 hours after, because chances are better than not that they're gonna have maybe a low grade fever, a headache, kind of some aches and chills, but know that, that means that their body's developing a really good immune response and that those side effects will go away about 24 to 48 hours after they start.

Host: Okay. That's good to know. So, I want to talk about the vaccines themselves and which ones are currently available. I know that the Johnson and Johnson was suspended for a short period of time due to the blood clots. So, is that now available again? And should people be considering getting that one or should they be only focused on the two dose Pfizer and Moderna vaccines? Maybe speak to those dynamics a little bit.

Stacey: So yes, the Johnson and Johnson vaccine is available again. When the FDA and the CDC, when they reviewed the data, they determined that the benefit of the vaccine still outweighed the risk of blood clots and the percent of people that got that type of specific blood clot, in the study population, meaning those that had received the Johnson and Johnson vaccine, was comparable to that in the population who had not gotten the vaccine. But the risk is there, for sure. So, I would say that any vaccine that you can get, is the right vaccine to get. Meaning they are all three Johnson and Johnson, Pfizer and Moderna, equally effective at preventing the really bad stuff.

That means death, hospital admission, long-term side effects of COVID. They all work against the bad outcomes that we've seen here in the hospital in our COVID patients. If somebody is truly concerned about a blood clot risk, maybe they've had a history of blood clots or something to that effect; they could talk with their physician or their pharmacist could advise them as well. And we have plenty of vaccine options available.

Host: Yeah, that's reassuring to hear. And as you mentioned, the population of people that it affected in comparison was very small. So, the benefits of getting a vaccine, far outweighs of course getting COVID and potentially having something happen, wouldn't you say?

Stacey: Absolutely.

Host: You know, one of the final things that I wanted to ask you was around the two dose shot. I think there is a lot of curiosity around whether two doses are actually necessary because that first dose gives you enough coverage. For example, I'm actually supposed to get my second shot in literally one hour and I have a lot of friends that have said to me, hey, Prakash, you're young, you're healthy; you don't even need to get that second shot. Why suffer the side effects? You already have 75 to 80% coverage. What might you say to those people?

Stacey: Well, what I would say to that is, are you happy with a C, meaning 75% or would you rather get an A+ and get to 95, 96%?

Host: Well said. Yeah, definitely, the A + to feel very protected.

Stacey: Absolutely.

Host: Still though, I'm sure you hear a lot of people say that. And so I think that the takeaway there is that while it does protect you, it only protects you so much and it's better to be safe. Even if there's going to be a little side effects, which is okay, that means that your body is building up that immune response to fight it off. But it's better to be safe than to be sorry, later.

Stacey: Absolutely. And again, unfortunately here at the hospital, we've seen some of really, really bad outcomes to COVID. And if you have the chance of getting to about a 95% protection against COVID, why wouldn't you go all the way and get there?

Host: Totally makes sense to me. So, just as we close here, you're the closest to everything that's going on with regards to COVID-19, people that are affected by it. What is one thing that you wish the general public knew about COVID-19, the vaccines or otherwise?

Stacey: I wish everybody understood truly how safe and effective the vaccines are. I also wish folks understood that COVID is not a disease that you want to get. It affects indiscriminately. It doesn't matter if you're young, if you're healthy, if you're a marathon runner. I have seen horrible, horrible outcomes, death in young people that were otherwise very, very healthy. And now, we have the opportunity to prevent those deaths. So please, please take the vaccine.

Host: Well, Stacey, I think that is a very powerful message to leave on. I really appreciate your time today. Thank you so much for educating us.

Stacey: You're welcome. Thank you for having me.

Host: That's Stacey Zorska, the Director of pharmacy at Southwest General Health Center. To learn more about Southwest General Health Center Services, visit swgeneral.com or call (440) 816-5050. We hope you found this podcast to be helpful. Please share it on your social channels and check out the entire podcast library for topics of interest to you. Thanks so much again for listening. My name is Prakash and we'll talk next time.