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Melanie: This Weill Cornell Medicine podcast is dated September 29th, 2021.

Welcome to Back To Health, your source for the latest in health, wellness, and medical care, keeping you informed so you can make informed healthcare choices for yourself and your whole family.

Back To Health features conversations about trending health topics and medical breakthroughs from our team of world-renowned physicians at Weill Cornell Medicine. I'm Melanie Cole. And today, we're working to promote the COVID-19 vaccine confidence. Joining me in this thought leader conversation Is Dr. Kevin Holcomb, he's the Associate Dean of Admissions and the Vice Chair of Gynecology and a professor of Clinical Obstetrics and Gynecology at Weill Cornell Medicine; and Dr. Kem Babagbemi, she's an Assistant Professor of Clinical Radiology at Weill Cornell Medicine and an assistant attending radiologist at New York Presbyterian Weill Cornell Medical Center. She's also the Vice Chair of Diversity, Equity and Inclusion for Radiology.

Doctors, thank you so much for joining us today. What a great topic. It's so important for people to hear the information you're going to give us today. And Dr. Babagbemi, I'd like to start with you. Can you tell us a little bit about the Delta variant of concern and help us to understand the latest data on this and the difference of why this is so much more contagious in terms of infectivity?

Dr Kemi Babagbemi: Hi, Melanie. Thanks for having me on. So the SARS-CoV-2 virus, which is the virus that causes COVID-19, just as other viruses do, divides very rapidly and replicates enough as it infects the host, i.e., us. And as viruses divide, they accumulate errors over time and these errors are mutations. And some of these mutations over time create later versions of the virus that could vary slightly from the original virus. And over time, the mutations could allow the virus to become more efficient at infecting us.

So the strains we have currently are being named after the Greek alphabet. So the first variant of concern after the original virus was called Alpha. And then, of course, it was beta, gamma and now we have Delta, which according to the CDC is now accounting for more than 80% of the cases we're having in the United States.

Melanie: Wow. Well, it's certainly is just unprecedented in these times right now. And Dr. Babagbemi, sticking with you for a second. While the first COVID-19 was affecting mostly older individuals, now we're seeing a little bit of a different shift with this Delta. In what age groups have we been seeing this?

Dr Kemi Babagbemi: Yeah. I'll let Dr. Holcomb also chime in on this, but I think we're seeing the infections mostly in people that aren't vaccinated. So in places where the disease is very prevalent, a lot more people are going to be infected. And because one of the groups includes younger people, it seems that an increased number of cases are now being seen in younger people, including children who can't be vaccinated, those particularly below the ages of 12. So, the course of the past few weeks, the cases have been slightly increased in children. But it's far more than what we saw in the early version when we have the first surge.

Dr Kevin Holcomb: I agree with what Dr. Babagbemi says, the other thing I just want to point out is that another significance of the Delta variant, these changes that happen over time is that it can also affect how well the vaccines are able to recognize the virus. In a lot of ways, a vaccine is giving a mugshot to your body about this invader that it has to recognize. And these mistakes, I liken it to a crook, let's say, putting on a fake mustache or a hat or something else that would change its visibility to your body's surveillance systems, the immune system.

The good news about the Delta variant is that our current vaccines seem to be still very effective at being able to identify this virus, even though the variant has put on a mustache. Our T-cells, not B cells, still seem able to recognize it because the vaccines still prevent severe disease, hospitalizations, and deaths. Although what we're seeing is that it appears to be more likely to cause mild cases of breakthrough infections in people who are vaccinated. So that's the other part of the Delta I just wanted to bring up. It is more infectious, but it also seems to be able to escape our immune response to certain degree for mild disease.

Melanie: Well, Dr. Holcomb, can you tell us for whom the vaccine is approved of as of now?

Dr Kevin Holcomb: Sure. I remember back in 2020, I really did not expect this to happen in the timeframe that it did, but it was such a pleasant surprise. In December of 2020, the Emergency Use Authorization was approved for both Pfizer and Moderna, slightly different ages between the two of them based on the studies that were done to prove how effective and safe they were.

For Pfizer, their vaccine was approved for 16 years and older. Whereas for Moderna, it was 18 years and older. But the studies kept on going on after that initial Emergency Use Authorization. And Pfizer's EUA was expanded in August of 2021. So that is now available for children 12 to 15 years of age under the Emergency Use Authorization. So right now, it's really anybody over 12 who doesn't have a contraindication, a reason that they shouldn't be taking the vaccine.

The studies continue going on in younger and younger groups. In fact, Pfizer has already submitted their paperwork for Emergency Use Authorization for anyone five years and older, so that five to 12 age group. And it hasn't received emergency use authorization, but it's highly anticipated that's going to occur somewhere probably by the end of this next month, somewhere around Halloween is what I've read.

Dr Kemi Babagbemi: So as the mother of two children aged ten and seven, this is the most exciting news for me for Halloween. So we're looking forward to Halloween costumes hopefully with first doses of the vaccination.

Dr Kevin Holcomb: And I also want to mention there's actually very few reasons you can't take a COVID vaccine. Actually, the strongest contraindication is if you've been allergic to the vaccine. If you've gotten one dose and you had a severe reaction, you shouldn't get the second. But, other than that, there are some people who are allergic to things like polyethylene glycol. And it's a rare thing, but sometimes used as a laxative for like bowel preps for colonoscopy. It's a very commonly used thing, so you kind of know if you are allergic to that. Or there's some cross-reaction to some sweeteners, polysorbates. And so they're very rare contraindications. So this is available to the vast majority of Americans.

Dr Kemi Babagbemi: One thing I wanted to add in terms of allergies is that even if you're allergic to the vaccines that contain those chemicals that Dr. Holcomb is talking about, you can see your allergist, because you might be eligible for a different kind of vaccination. So I know people who have taken one dose at first, because of a severe allergy were approved by their allergists to take a different kind of vaccination if necessary.

Melanie: That's great information. Really important for people to hear. So Dr. Holcomb, now the American College of Obstetrics and Gynecology is supporting the vaccine as well. And I know that there had been people who questioned whether or not pregnant women should get this vaccine. Can you speak to that please?

Dr Kevin Holcomb: Sure. You're right. Starting in July, the American College of Obstetrics and Gynecology changed its wording towards this. Prior to that, they were saying we should not withhold vaccination from women who are pregnant or planning to become pregnant. And then they have a full-throated strong recommendation for vaccination.

And I just want to explain that interestingly, the American College of Obstetrics and Gynecology, we call it ACOG, ACOG actually pushed hard for pregnant women to be included on the initial studies of vaccines, the Pfizer and Moderna trials. The FDA said, "No, that's not what we typically do. We don't usually start off testing new drugs on pregnant women." ACOG wanted it because we knew already that pregnant women were at increased risk for bad outcomes from COVID. It was seen in Wuhan. It was seen in Europe. It's been seen here. Pregnant women are more likely to end up on a ventilator. Although the overall risk is low, there are higher risk of them dying.

But pregnant women were not on those initial trials. And so the full-throated support for their being vaccinated really couldn't be based on the data of those trials. But what it's based on now is the post-approval surveillance programs. So there are a number of programs that have been following tens of thousands of women who were pregnant at the time of their vaccination or became pregnant soon after being vaccinated. And every month, every week now, it seems that there's a new publication showing the safety in those patients that we have not seen any signals suggesting that there's a higher rate of spontaneous abortion or low birth weights or anomalies or anything like that.

So, knowing that the risk is higher in this population and the growing body of literature showing that this vaccine is safe and effective, what we've seen is an evolution of the strength of the recommendation coming from these groups. And I don't think it can get any stronger than it is now.

Melanie: Absolutely. And Dr. Babagbemi, you mentioned as a mother that if this comes around in October and your kids can get vaccinated, you're happy about this, what would you like to tell parents? I have two children myself, but they're 18 and 21, almost 19. Ah, it goes fast. I'll tell you. But we got them vaccinated the second these vaccines were available. What would you like to tell parents and anybody who's nervous at the thought of getting this vaccine? Because this is really becoming an overload on the hospital systems. It is really causing stress around the country. What would you like to tell parents and anyone who's nervous about getting this vaccine?

Dr Kemi Babagbemi: So at this point, I think over 6 billion doses have been given worldwide and we sort of know what real-world these vaccines are doing. But we also know that these vaccines were very, very well tested. No steps were skipped in the process, even though a lot of the processes were expedited.

I was actually one of the participants in the phase III trial for one of the vaccines. So I can vouch for the fact that everything was rigorously tested, and they've been found to be extremely safe. The side effects that occur with the vaccine are incredibly rare and I feel very confident given everything I know about the vaccines to give it to my children.

I'm a firm believer in vaccinations. And so this one would not be any different to me because my natural instinct as a mom, as any other parents would want, is to keep my children safe. So if you have any questions, I would say to parents about the vaccination, your pediatrician is an expert on vaccination. So you should feel free to ask them any and all questions. But by far, these are very safe vaccines, very well tested. And I have no qualms about giving them to my children. And my children, actually, they're waiting for their vaccinations.

Dr Kevin Holcomb: I would just like to add to what Dr. Babagbemi was saying. not only are these approved vaccines has been tested and that you get what's called efficacy. It's a well-designed study. It shows the efficacy. But what we really want is real-world experience effectiveness. And so what we have at this time Is that, along with these large well-designed trials, we have as she mentioned in this country hundreds of millions of doses that have been given. And so we have a good idea about what the side effect profile is.

I hear a lot of people expressing concern to say, "Well, I want to wait for more information." And I don't think they realize that most vaccines or other drugs that get approved, get approved based on the studies that were done without this huge real-world experience. And we have these surveillance systems that have been able to pick up side effects that are extremely rare. And we've halted, for example, the J&J vaccine was halted for a while because of a very rare side effect. So I feel very confident that the surveillance systems that are in place are sensitive. And they pick up very, very rare abnormalities and toxicities.

And so people should feel very confident, not just in the well-designed clinical trials, but in the real-world experience of what's going on in the country. And in the end, the effectiveness is not in question. You look and see who's in the hospital, who's dying of COVID now. It's largely unvaccinated people. You can't question the protective impact of this vaccine. And so for those who are hesitant, just make sure your hesitancy is based on facts and not belief. And I think it's really important at this time that we make a distinction between those two.

Dr Kemi Babagbemi: So I wanted to add, when he says a large number in the hospital, he's saying 97% nationally is what we're seeing, unvaccinated people in the hospital. So the data to me is quite clear on who's at risk here.

Melanie: Well, it certainly is. So well said, both of you. And Dr. Holcomb, when we're speaking about vaccination and the importance of it, the elephant in the room really is masking. And we know that the World Health Organization is now telling even vaccinated people to wear masks in crowds, indoors in some states. Can you tell us why masks work? You're an obstetrician-gynecologist, probably been wearing a mask for years. And can you tell us please why it's important right now while we're trying to get the majority of the population vaccinated, why it's still important that we protect ourselves with masks?

Dr Kevin Holcomb: Sure. One, I just want to say that the beneficial impact of masking is also not debated. If you look at areas that have used these mitigation strategies compared to counties that have not, whether it's in school or in restaurants, you see the impact, you see higher rates of transmission in areas that don't have mask mandates and avail themselves with this pretty simple mitigation strategy.

Why it works, it's pretty simple. This is a respiratory spread of a virus. It spreads by droplets. If you can imagine when you sneeze how far those droplets can go, even though wearing a mask can't stop spread completely, it cuts down significantly on the distance that these droplets are spreading. So it's just intuitive that wearing a mask would decrease transmission.

So for me, I'm not surprised at all to see the efficacy of masking. And as you mentioned, I wear a mask in the operating room now almost all day long. The idea that this is somehow dangerous to your health, it goes counter to the experience of surgeons like myself who have worn masks, you know, since time immemorial. So I think there's no doubt that it's beneficial. There's really no proof or biologic plausibility to a downside to masking.

I also want to mention that some vaccines protect you from infection. They offer what's called sterilizing immunity, meaning you got the vaccine, you can't get infected with this thing. That's not what we're seeing with the COVID-19 vaccine. People who have been vaccinated can still get an infection. It's much lower than unvaccinated. Unvaccinated people are probably five times more likely to get infected with COVID-19. So even if you've been fully vaccinated, it's possible you could have an asymptomatic COVID-19 infection. So we all, whether vaccinated or not, when we're in public or we're in close proximity to one another, we should be masking. We should take advantage of this very effective mitigation strategy.

Dr Kemi Babagbemi: I wanted to add to what Dr. Holcomb was saying, that when I try and explain to people why we still need to mask, I tell them about layers of protection. And when he talks about mitigation strategies, he's talking about all the different layers of protection you have to put in place so they don't get severely ill from COVID-19.

So one of those layers is going to be masking. Another layer would be social distancing or avoiding crowds. And vaccination is the most powerful layer of protection we have. So it would be similar to going out in the rain. You have your umbrella, you have your rain coat and your rain boots as different layers of protection. But of course, it doesn't mean you won't get wet. So if there's a heavy downpour, some of that is going to get through. And that's the way to think about what we're trying to do with getting you all these different layers of protection. All of them add onto each other to sort of prevent you from getting sick until of course the whole world is vaccinated.

Melanie: This is such a great episode and so informative. You both are really, really excellent educators. I'd like to give you each a chance for a final thought. And Dr. Holcomb, I'd like you to speak about any myths that you have heard as far as infertility and this COVID-19 vaccine, because I think that that's important and we're hearing about that. And it seems ridiculous to me, but would you please speak to that and any final thoughts you have that you would like to make clear about the importance of masking and the vaccination and keeping each other safe and the medically vulnerable safe?

Dr Kevin Holcomb: Sure. And thank you for reminding me about the infertility question because Dr. Babagbemi and myself, we've been doing community outreach and vaccine education for a while now. And I have to say in the beginning, I was surprised when I started hearing about this infertility question. Having studied the data as it was coming out in real time, I knew that there was no data suggesting an impact on infertility. But I have to say, I understand now why some people got this idea.

There was an ex employee of Pfizer, a researcher actually, who made some very spurious claims that vaccination would lead to infertility. And there was a scientific explanation that is, I don't want to get into the weeds, but there was actually no proof of this being the case. But once that hit the internet, It really circulated around the globe and to the point where many Americans believe it's true.

And all I can say in just a nutshell is that there actually is no evidence whatsoever that vaccination impedes fertility. What we have seen is that COVID-19 infection can have an impact on fertility. We've seen that COVID-19 infection can decrease sperm count and quality. We've seen women who were pregnant infected with COVID-19 and have high fevers and things, lose pregnancies at a higher rate.

But there's a bunch of studies coming out now and I'm very reassured. I just read one recently that was done in an vitro fertilization clinic. So if there was a concern that pregnancies were not able to take hold because of vaccinations, they looked at hundreds of women who had undergone in vitro fertilization. And they compared those who had no antibodies, those who were vaccinated and had antibodies, and those who had antibodies from a natural infection from COVID-19 and they showed the implantation rate and success rate was exactly the same.

There was a study from the University of Miami on the male side looking at sperm quality in people who had been vaccinated and not vaccinated. Not only did they not see a decrease in sperm count and quality after vaccination. For some reason, they actually saw an increase in the count in the men after being vaccinated.

So there is a lot to confuse people going on right now, and there's a lot circulating around the Twitter and Facebook and Instagram sphere. But I would just ask those that are not being vaccinated because they believe this, and that's not a small number, please go back and check to make sure that the source data that you're basing this belief on exists, because I think it's going to be very easy for you to find that those claims lead to nothing. There's nothing behind them.

Melanie: Beautifully said again. And Dr. Babagbemi, last word to you. I'd like you to really emphasize the importance of getting vaccination as the best way that we, as a caring society, can go about protecting each other and ourselves, and really why it's so important that we all do this together. Please wrap this up for us.

Dr Kemi Babagbemi: Sure. Two points I'd like to make clear is that all the current spread and transmission we're seeing of this virus right now is being largely driven by unvaccinated people. So even though, as Dr. Holcomb mentioned earlier, that there can be a few cases where vaccinated people can get infected, their infections tend to be milder or asymptomatic. And they also appear to be less contagious, so they're less likely to spread it to other people.

So if you are unvaccinated, you are at high risk of getting really ill and possibly getting severe illness that could lead to hospitalization and, in some instances, death. We've lost over 600,000, almost 700,000 people to this terrible disease. And luckily for us, we now have vaccines and vaccines that are well-tested and continue to work well against the most prevalent Delta variant right now. So no matter which vaccine you choose to take, all of them can prevent severe illness, hospitalization, and death. And so I encourage you to take the chance to do this, not only for yourself, but also your community.

And one more point to the parents, please, hopefully as this vaccine becomes approved for the children under age 12, please take this time to talk to your pediatricians and consider this one of the other vaccinations like you've gotten since birth for your children. I think it's all for one and one for all in the situation we're in together.

Melanie: We are. Thank you both so much. I can hear the passion in your voices and I feel it as well. And it's so important that people hear what you're saying. And listeners, please share this show with your friends and family on your social channels, because we're learning from the experts at Weill Cornell Medicine together.

And patients, please schedule your vaccine if you have not already. You can do it via Weill Cornell Connect. And of course, Weill Cornell Medicine continues to see our patients in person as well as through video visits. And you can be confident of the safety of your appointments at Weill Cornell Medicine.

Doctors, thank you again for joining us and sharing your expertise.

That concludes today's episode of Back To Health. We'd like to invite our audience to download subscribe, rate, and review Back To Health on Apple Podcast, Spotify and Google Podcast. For more health tips, go to weillcornell.org and search podcasts. And parents, don't forget to check out our Kids Health Cast.

Thanks so much for listening. I'm Melanie Cole

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