VIDEO AND TRANSCRIPT AVAILABLE: Vaccines and Male Fertility Event for June 17, 2021

 Newswise
18-Jun-2021 8:55 AM EDT, by Newswise

Ranjith Ramasamy, M.D., reproductive fertility expert at urologist from the University of Miami Health System, will discuss COVID-19 vaccines and male fertility.  

Dr. Ramasamy and his team have recently published studies that found the COVID-19 virus can live in penile tissue for up to 7 months post infection and cause erectile dysfunction (See Newswise release here); as well as in the testicles, which has implications for fertilty and potential sexual transmission (See Newswise release here).  

Join us for an in-depth discussion on these latest findings that address vaccine hesitancy and more.  

When: Thursday, June 17, 11AM-12PM EDT 

Where: Newswise Live Zoom Room

Registration for media

Transcript:

Thom: Welcome, everyone, to this Newswise live event. We have with us Dr. Ramasamy from the University of Miami to talk about a study getting published just here at 11am today in JAMA about the COVID-19 vaccines and male fertility. Welcome, Dr. Ramasamy.

Ramasamy: Thank you, Thom. Thank you for having me and happy to join everybody today. 

Thom: Dr. Ramasamy, tell us about this study. As the vaccination efforts continue around the world, researchers are looking into more of the safety of these vaccines. What did this study examine and what did they find about male fertility and the vaccines?

Ramasamy: Sure. We wanted to explore the study because there were studies including our own, showing that actual COVID was affecting male fertility. And we found that one of the elements of safety that the companies did not do was to evaluate reproductive toxicity prior to getting the emergency use authorization. So, we actually went on to test male fertility in our study of about 45 healthy volunteers before and after the vaccine. And we evaluated the sperm parameters before and after the COVID vaccine, and we found that none of the men that participated in the study had any decline in sperm parameters. And so, therefore, we concluded that the COVID vaccines appeared to be safe for male fertility.

Thom: Excellent. Thank you, Dr. Ramasamy, for telling us about those findings. For members of the media, we'd love to open up the floor for questions. I have a few questions already that some of you have submitted by email and by the chat, and we'll go ahead with those. If you're on the call now and you'd like to ask any further questions yourself, please chat those to me. I can relay the question to Dr. Ramasamy for you. Or if you'd be interested, we can enable your audio and you're welcome to ask it yourself. Dr. Ramasamy is an MD, he's a urologist at the University of Miami Health System, where he's also Associate Professor and Director of the University of Miami Miller School of Medicine's Reproductive Urology Program. Dr. Ramasamy, as a urologist, I'm guessing that was part of what drew your attention to the virus infecting the tissues of the reproductive organs. I wonder if you can tell us more about that, and what has been found already about the effect of the virus on those tissues? And tell us how that led to digging further into this question about the vaccines potentially having some effect.

Ramasamy: Sure, we found that – we actually had two observations with the virus. Number one, we found that it was present in the testis long after the initial infection. And it was a little unclear whether they actually affected sperm parameters or not. So we went down to evaluate the effect of the virus on sperm parameters. And we found that at about three to six months, there was actually a decline in sperm parameters in the people that got infected long after that infection. But then thankfully, at six months, the sperm counts recovered in the men that were infected. So, while it was reassuring, we also saw that temporary decline and some people that just remained low, and we wanted to see if something like this would be done by the vaccine itself. We were pretty confident based on the biology of the vaccine and knowing what it was able to recreate in the body, which is just one of the components of the virus but not the entire virus. We were confident that it was not going to affect male fertility, but out of abundant caution and for public reassurance and to improve vaccine hesitancy, we went on to do the study with the COVID vaccines.

Thom: I have a question in the chat from Sonia asking if you can describe the study design.

Ramasamy: Sure. It was a prospective observational study. We followed; we obtained a sperm sample prior to the men getting vaccinated with the two doses. We only evaluated the Pfizer and the Moderna vaccines because that was the only one that was available in the beginning. And we followed them for three months, which is the usual time in which we see any sort of sperm count decline which we side with the actual virus, which is why we chose the three-month time point. And we looked at sperm analyses after the two doses were received, and we found that there was no decline in any of the men.

Thom: I have a question from Veronica Marshall at WINK. What concerns are you hearing from your male patients and what are you telling them in response to those concerns?

Ramasamy: We're hearing concerns about whether the vaccine can affect fertility. We're not just hearing it from the male patients, we're hearing it from a lot of their partners, their female partners as well. And we're hearing it from parents who are thinking about vaccinating their kids. Now that the vaccines are approved for adolescents above the age of 12, we are hearing long term concerns about fertility. And until the study came out today, we weren't able to reassure them completely. And so I think the answer is that we are able to conclude that pretty safely now based on the study results. And as a nice segue, General Miller asks if the cohort was too small? Absolutely, yes, 45 men is a small cohort. But if we had seen any sort of decline in these 45 men, I think we would have wanted to do a much larger sample size. But because we saw reassuring results in pretty much all of the men that participated in the study, including men that started with a low sperm count, so we didn't – just because you had a low sperm count, we didn't leave people out of the study, we actually included them to see if that counts would go lower. But in fact, some of the guys’ sperm counts actually increased. And we didn't see any decline even in the men that had a low sperm count, which is why I think even though the number 45 looks small, I think we're pretty confident that we can generalize this to the rest of the population.

Thom: Great, thank you. And thanks for seeing that question there. I see that you're paying attention to the chat. There was that question from Janelle Helio. Janelle, if you have any other questions, please let us know. Another question in the chat from Alex Row asking, something that prompted this study into male fertility has also been these rumours and conspiracy theories about the vaccines affecting female fertility. Are you aware of any studies about the safety of the vaccine on pregnant women in particular?

Ramasamy: No, so I'm not – I think the companies are doing their own clinical trials in including pregnant females into these studies now, and they are ongoing and I don't, I have not seen any results. But as far as, again, based on biology and based on what we know so far, both the American Society of Reproductive Medicine, ASRM, as well as the ACOG, the American College of Obstetrics and Gynaecology, has come out with pretty definitive statements saying that the vaccine is safe for both pregnant females as well as breastfeeding mothers.

Thom: Another question from the chat, what was the age demographic of the 45 men participating in the study?

Ramasamy: They were young, healthy volunteers. I have to go back and look at the exact table which I'm happy to do as we speak, but they were between ages of 18 to 50 and they were healthy and they had not previously gotten COVID. The racial ethnic makeup, again, I'm not, I'll have to go back to the table, I put the link on the chat. I'm happy to put the link again. Maybe if some of the people missed it. But they all describe the ethnic makeup is similar to what we see here in South Florida. Majority of the men will be Hispanic and Caucasians, and African Americans will make up the rest.

Thom: That's an interesting question. Thank you for that, Janelle and refer to the details of the study for exact points on that. But Dr. Ramasamy, I wonder if you have any point of view to share about keeping an eye toward that racial and ethnic diversity in studies? This has been a huge issue during the entire COVID pandemic. What kind of efforts do you see there at your hospital and with these kinds of studies to make sure that diversity and inclusion are part of the effort?

Ramasamy: No, absolutely. I mean, I think the – thankfully in South Florida, we are blessed with a racially and ethnically diverse patient population that I think if anything we have the opposite problem of including more minorities in trials than the rest of the country does. So we're obviously very cognizant of that. But I can tell you that the population that we recruited was pretty diverse and definitely includes minorities that we can translate this data to the rest of the population. And I'm fairly certain looking at vaccine hesitancy, demographics. There's a lot more hesitancy and a lot less vaccination among minorities with Hispanics and African Americans. And I'm hoping studies such as this that includes that patient population will help reassure those patients.

Thom: There's been a lot of talk about the safety and approvals coming out for children of lower and lower ages. Anything that you feel that this might be able to reassure further in the vaccine safety for any families of those children, which I think 12 and up now, and they're looking at two and up before long hopefully to get approved. What are your thoughts about how this kind of study can continue to confirm the safety for parents concerned about those issues?

Ramasamy: Absolutely. I think this is one that's on a lot of parents’ minds about the safety of the vaccines for long-term fertility issues. And I think based on what we know, based on biology, based on what we have found out with this study, we're pretty confident to say that this should not be affecting fertility. And given the fact that the virus can be present in the test is given the fact that the virus can affect fertility even in the short term. I think it is probably best to state that vaccines are not only going to protect people's fertility, but also protect people from getting COVID that can affect fertility.

Thom: Yeah, further into that, on the effect of the virus on fertility, there's another question from Veronica at WINK. To talk about your other work regarding COVID-19 in men's fertility, what's your overall takeaway after this? And I'd like to throw in there an additional point about the presence of the virus and post COVID erectile dysfunction being a potential longer-term effect. What are your thoughts about combining these different studies and taking that overall point of view?

Ramasamy: Absolutely, absolutely. No, both are very good points. And yes, we have done research on the effects of COVID as it affects male reproduction. So, in very short summary, the COVID-19 virus is actually present in the testes as well as in the penis tissue, long after the initial infection. How it's able to evade the immune system, how it's present in the testes as well as in the penis, what it does in terms of long-term effects, those are all studies that we are doing as we speak, and so we'll hopefully have answers to those in the coming months. What is very clear is that the virus is not present in the semen in men who have recovered from the infection. And so, therefore, the possibility of sexual transmission with COVID is almost negligible, almost non-existent based on all of the studies that have been published so far in recovered men. There's been one or two studies showing that it's present in men who are symptomatic, who actually have the virus and who are pretty sick, but in people who are recovered, it's not. So COVID is not a sexually transmitted disease, but it can be present in the testes in the penis long after the initial infection. It can affect the penis leading to erectile dysfunction, it can affect the testes leading to sperm parameters and fertility being affected. But all of those need further research to figure out exactly what the mechanism is, and whether the damage is permanent or is there a possibility of recovery from those.

Thom: Another question in the chat from Marlin about the increase in sperm concentration and TMNC after the vaccine administration. What are the possibilities of that and an explanation?

Ramasamy: Sure. So I think it's just regression to the mean. So I don't think we truly can advocate that COVID vaccines affect improvement in sperm counts, although we did notice that in quite a large percent of the population, obviously reassuring us even more that it not only it doesn't cause a decline, but even in some of the men, the sperm counts improved. So I don't think there's a biological explanation; there's just a statistical explanation for why we see that. But again, it's even more reassuring that we do see that.

Thom: Any other questions from the audience? Please do chat them to us. We'd be happy to take further questions. Dr. Ramasamy, thank you so much for joining us. A couple of quick notes. If you want to follow up with Dr. Ramasamy for any further questions or interview or additional info, contact Joanna Palmer. She's chatting a link now to B roll, and Joanna is the contact that can help you get in touch with Dr. Ramasamy. One more question, Shane in the chat asked what are your thoughts on the Johnson & Johnson vaccines and the new Novavax vaccines? These obviously weren't ones included in your study, but what do you think about looking into those further?

Ramasamy: Correct. So I think, based on just the biology of how these vaccines are supposed to work and what they're supposed to recreate, we're pretty confident to say that the other vaccines will probably not have effects on fertility. Clearly, we did not study them and so, therefore, I don't have any data to back those up. But the DNA vaccines were pretty similar to the RNA vaccines and in that they create parts of the virus but not the complete virus. And so, therefore, I think the effect on fertility should be minimal to none, if it's anything even.

Thom: What are your thoughts about vaccine hesitancy and how to dig further into understanding that, what additional questions about the vaccines could be studied like this one that may be geared toward reassuring those people who are hesitant?

Ramasamy: Absolutely. So we are actually conducting a nationwide survey now to figure out reasons for vaccine hesitancy. JAMA actually published a paper last week describing the demographics that have vaccine hesitancy, the age groups that are having vaccine hesitancy, the racial ethnic groups that are having vaccine hesitancy. So I think we know where the hesitancy is. We sort of know based on just observational studies, but not data driven on what the exact reasons for them are – mistrust in government, mistrust in public companies making these vaccines, fertility, side-effects, long-term safety studies not described properly, No FDA authorization, are all reasons for why vaccine hesitancy is there. But what is the primary hesitancy? What can we, as doctors and scientists, do to overcome vaccine hesitancy? I think we just still don't know those. But once we figure that out, hopefully, we'll try and address them with studies. But certainly, this study should at least, even if it's a small percentage of volunteers in the public that get over this hurdle and are able to get the vaccine, we'd certainly be very happy.

Thom: Yeah. Every little bit makes a difference as we try to get to herd immunity. Another question in the chat – any studies about non-pregnant women getting vaccinated and then their ability to get pregnant afterward?

Ramasamy: 100%. Some of my own staff members and their partners who got the vaccine went on to get pregnant afterwards. There’s obviously studies to show that but I think the risk is minimal to none.

Thom: Another question from Shane in the chat, if you were going to recommend which of the vaccines to your friend they should get, which one would be the top of your list?

Ramasamy: All the vaccines appear to be equally efficacious. They've shown to work. I think with the latest, some of the data showing that almost only unvaccinated people are going to the hospital with COVID and there's really no distinction between the types of vaccines. I think people should be able to get any vaccines they can get their hands on, and not pick and choose.

Thom: Well, there you have it, everyone. Dr. Ramasamy is not playing favourites with the vaccines. Any other questions? We'll kind of do one last call here for questions. If you registered for today's event, we are going to make sure to send you a recording and a transcript of today's event. We should have those available first thing tomorrow morning. And we'll also make sure – if you didn't register, please email us if you want to get those pieces of information, the recording and the transcript. One other question here from the chat, Dr. Ramasamy, can we draw the same conclusions in children being vaccinated as compared to adults who are part of the study?

Ramasamy: That's correct. Yes. Yeah. I think so.

Thom: So, children vaccinated should not have an effect on their fertility either. That's great. I don't see any other questions. So we'll go ahead and wrap things up. Dr. Ramasamy, thank you so much again for joining us for sharing the results of the study. Reporters, please follow up if you have any additional questions. Contact Joanna Palmer and we will send you the recording and transcript. With that I will say goodbye and stay safe, stay healthy and good luck.



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