The FDA issues an emergency authorization for kids and the COVID vaccine. Does the rush to vaccinate children come with a different set of risks and benefits than with adults?
Dr. H. Cody Meissner, pediatric infectious diseases expert at Tufts Medical Center.
Dr. Nicola Klein, senior research scientist at the Kaiser Permanente Northern California Division of Research. Director of the Kaiser Permanente Vaccine Study Center.
MEGHNA CHAKRABARTI: The FDA has granted emergency use authorization for the Pfizer-BioNTech COVID-19 vaccine for children between the ages of 12 to 15. It means they can now receive the vaccine. Acting FDA Commissioner Dr. Janet Woodcock made the announcement yesterday:
[ARCHIVAL TAPE] WOODCOCK: We know this is a big step for our country. Vaccinating a younger population brings us closer to returning to a sense of normalcy and to ending the pandemic. Now, parents and guardians can rest assured that in making our decision, the agency undertook a rigorous and thorough review of all available scientific data. As we have with all the COVID-19 vaccine authorizations.
CHAKRABARTI: The FDA authorization, again, is for emergency use. And the Biden administration has made vaccinating children a key priority in the next phase of pandemic control. But is there a COVID emergency among young children? On the one hand, of the more than 560,000 COVID deaths in this country, approximately 300 of them have been in children under the age of 17. That's five-one-hundredths of 1%, according to the CDC.
But on the other hand, cases are on the rise. The American Academy of Pediatrics recently said that kids accounted for 24% of new infections. So today, we're going to try to sort through and understand the data and talk about how to think about the risks and benefits when it comes to kids and the COVID vaccine.
… And we're going to begin with Dr. Nicola Klein, director of the Kaiser Permanente Vaccine Study Center. She served as Kaiser's principal investigator for the Pfizer vaccine trials for adolescents 12 to 15 years old. Dr. Klein, welcome to On Point.
NICOLA KLEIN: Good morning.
CHAKRABARTI: So, first of all, tell us. The trial that you ran was with about 1,100 adolescents, if I understand that correctly. Is that right?
KLEIN: No, actually, it was the overall trial had just over 2,200. 1,100 of the adolescents received the vaccine and 1,100 received the placebo or the salt water.
CHAKRABARTI: Understood. OK, great. Thank you. So today you're going to have to forgive me because I'm going to ask a lot of basic questions because I think parents out there – I think there's no question that's too basic for folks who really want to try and understand the next steps here regarding vaccination. So, what did you find then?
KLEIN: Well, we did not enroll all 2,200. We enrolled within Kaiser and Northern California just a fraction of those, portion of those adolescents. And … as you've heard, all that data is coming from Pfizer because they are the leads of the study and that's how clinical trials operate, the data actually goes to what's called the sponsor or the one who actually manufactures the vaccine. And I think … they made publicly available that the vaccine had similar side effects to what we've seen in 16- to 25-year-olds – little bit older kids and young adults. And that the vaccine, there was no cases of COVID in the vaccinated, 12- to 15-year-olds.
CHAKRABARTI: So, Pfizer's reporting that as 100% effectiveness in the adolescents who received the vaccine, is that right?
KLEIN: That is what's being reported, yes.
CHAKRABARTI: OK, so my first question here is: We had actually this discussion last year with several vaccine clinical trial experts who were talking us through how these trials would be done in adults, and under these highly unusual circumstances. Because most people are used to these trials taking years. But they've been happening very quickly here. And one of the things that we were told about the adult trials is that there was so much COVID out there, that prevalence of the disease was so high in adults that, you know, people were getting exposed, and you could get a really good assessment of a vaccine's efficacy. Is that true for adolescents as well? Is there enough COVID out there in this age group to say that's truly 100% – the vaccine is 100% effective?
KLEIN: Well, so I think that's a great question, and I think when, again, when the trial was designed – and this just to clarify that the adolescents, the 12- to 15-year-olds, the study was really an extension of the current Pfizer’s adult study. It was an extension. So, it’s conducted in the same way as the adult study was. And as I understand the thinking of it, it wasn't clear how much disease there would be in adolescents, the 12- to 15-year-olds. But because there was enough disease, they were actually able to make an estimate … efficacy of the vaccine at 100%. And what that really means is there were no cases in the vaccinated, and there were some cases in those placebo recipients, so those who received the saltwater. I think it’s fair to say that when the vaccine is more widely used, that it will not very likely be 100% because there's no such thing really as a vaccine that is 100% effective.
CHAKRABARTI: And … in the placebo group, the adolescents that ended up contracting COVID … did any of them end up in the hospital? Do we know?
KLEIN: So, I don't think that has been made publicly available by Pfizer, that information. So, I have to defer to answering that question.
CHAKRABARTI: OK, and so then in the adolescents that you enrolled at Kaiser, what are the findings that you can tell us that you directly saw?
KLEIN: So, the way clinical trials work is that … there's a lot of people that are enrolled in a study, and all of that data gets pooled together from all the different clinical trial sites. … I can't provide data on what exactly happened in our recipients, because, as you remember, I mentioned that all the participants received the vaccine or placebo. But we don't – I don't know who received vaccine or placebo. The recipients – the kids – don't know who receive vaccine or placebo. The parents don't know. So, nobody knows. So, I actually can't tell you because that's part of the design of the study is that we don't know who received it. And in fact, we still don't know. They're still — the 12- to 15-year-old adolescents — are still blinded.
CHAKRABARTI: Yeah, understood. So, the double blind, in a sense, is an important way … to have trust in the study’s outcomes. But I guess what I'm wondering is then … I was looking at the FDA's – the information that they have released publicly. And they said that there were four serious adverse events in some of the adolescents that received the vaccine. Not causal, though. They emphasized that, but they didn't say what the adverse events were. Can you tell us, do you know?
KLEIN: I don't know. But what I can tell you is that having serious adverse events in clinical trials, that always happens because, you know, people have medical events that happen in a clinical trial and it happens. And this may or may not be related. These sound like these were not related, and that is actually not unusual. A serious adverse event just means that they may have been hospitalized for some reason.
They may have had to have an emergency room visit for some reason. And so that hospitalization, maybe – for example, may be unrelated to the conduct of the trial. And sometimes they are, sometimes they aren’t. But this time it sounds like they weren't. And that actually is not at all that unusual. But that's also why it's so important to have a blinded study because oftentimes you have placebo recipients who have serious adverse events as well. And so, you have to kind of look to see how that looks between the two groups. And is there actually a difference between the two groups?
CHAKRABARTI: Let's take a step back here for a moment … What was the duration, actually the time period of this study? Can you tell us that?
KLEIN: So, the overall studies actually designed to be for two years. That being said, and that's not unusual for a vaccine clinical trial, but because of the emergency use authorization in all the different age groups, people have been becoming unblinded and becoming vaccinated as the vaccine had been made available. So, we started recruiting and started enrolling adolescents in this trial in late 2020, early 2021. Earlier this year, January, I believe it was. But the participants will stay in the study for two years, even after they find out. Even if they get unblinded and receive vaccine, they get followed for safety and also for disease. Well, mostly for COVID disease afterwards as well.
CHAKRABARTI: So, is it fair to say, though, that since this is basically the first five to six months of this study, that there are questions about long-term effectiveness, about durability of the vaccine, about potential long-term side effects that we simply don't have the answers to yet?
KLEIN: Well, I think I'll take those two separate things. So, first of all, I think there are questions about the durability of the vaccine because questions like that just need time to last. So, I think that how long the vaccines will last – and this really applies to all ages, you know, to adults and also the older adolescents and everyone – is how long will this vaccine and all the COVID vaccines last? Because so far, we have, as you mentioned, about six months of following … monitoring people in the real world how well it's working. And so far, it's very positive. But I think that that is an open question, is how long they will last.
And I think those are things that we're going to have to just follow over time. Now, in terms of the safety, I think that that is, again: We haven't had the same time to pass. But really, most vaccine safety events occur relatively quickly after events. And we do monitor for many outcomes. … There's a very robust vaccine safety monitoring system in this country. And that has been ongoing since December, since we started working, looking at vaccines, giving vaccines to the public. But I do think that, you know, there's really never been long-term vaccine side effects shown after five months. But we will continue to monitor for sure, and that will be something ongoing.
CHAKRABARTI: This is On Point, I'm Meghna Chakrabarti, and today we're talking about the FDA's granting yesterday of the emergency use authorization for Pfizer's COVID vaccine on adolescents 12 to 15 years old. And … we’re getting some [social media comments] in already all across the spectrum. Mary says, I'll get my children vaccinated as soon as it's approved for their age group. Or as Thomas is saying, I will do nothing. I won't take the vaccine myself. I surely wouldn't impose it on my children.
I'm joined today by Dr. Nicola Klein. She's director of the Kaiser Permanente Vaccine Study Center, and was principal investigator for the Pfizer vaccine trials on adolescents between 12 to 15 years old. She joins us from Palo Alto, California. Let me bring into the conversation now Dr. H. Cody Meissner, pediatric infectious disease expert at Tufts Medical Center and a member of the FDA's Vaccines and Related Biological Products Advisory Committee, or VRBPAC. Dr. Meissner, welcome to On Point.
H. CODY MEISSNER: Thank you so much, Meghna. I appreciate the invitation.
CHAKRABARTI: First of all, let's just give listeners some background on your input on the adult EUAs that were given, just so folks know. If I remember correctly, for at least one of the COVID vaccines, you had abstained because of your questions about safety data on 16-year-olds. Can you just briefly tell us that story, so listeners remember?
MEISSNER: Yes. When the Pfizer protocols first came to the FDA for consideration, they had enrolled approximately 44,000 individuals. These were individuals, 16 years of age or older. Half got a placebo or the salt water, and half got the study vaccine. And as it turned out, it was a pretty small number of 16- and 17-year-old adolescents who actually received the vaccine. I think it was less than 100. And much as I want this vaccine for the United States, I was a little bit concerned about the very limited data that was available regarding 16- and 17-year-old adolescents.
CHAKRABARTI: OK, well, so now we have this ongoing – I'm going to call it an ongoing trial, because as Dr. Klein noted, it's a two-year trial and we're in the first five or six months of it. And 1,100 adolescents were in the non-placebo group. Is that a large enough group to change your opinion about the vaccine?
MEISSNER: Well, let me start off by saying, first of all, Dr. Klein has made so many contributions to our immunization program, and she's a very highly respected investigator for many different clinical trials. And so, it's a pleasure to have an opportunity to talk on the same program with her. But …
KLEIN: Thank you.
MEISSNER: … The point is that for adults, the benefits of vaccination are enormous. As you correctly pointed out at the start of the show, there are almost 600,000 deaths that have occurred in the United States. But if we break down those deaths by age, there were approximately 300 under 18 years of age. So, as you noted, it's a tiny, tiny percentage. So, the question becomes: When do the conditions for an EUA become satisfied for children?
And let me just briefly make three points about the criteria that the FDA has proposed for authorization. First of all, the intervention must address a serious or life-threatening condition. Well, that's certainly true for adults, but serious disease in children – it happens, but it's not very common. It's a tiny, tiny percent of what happens in adults. Secondly, the known and potential benefits of the intervention are to be balanced against the known and potential harms of the vaccine. We don't have a clue. 1,100 people between 12 and 16 years of age in a randomized trial is not very much. And we don't – for example, look at the clotting disorder that occurs in young women and that occurs at a rate of about 5 to 10 per 1 million.
CHAKRABARTI: Just to help listeners, this is for the … J&J vaccine that caused that pause.
MEISSNER: Thank you. Yes. And so that caused a pause of every vaccine. Now, we have a very small number of children. And I think Dr. Klein acknowledged that we simply don't know too much about the safety of this vaccine. I would also say that they said that there were no cases of COVID in the adolescents. Well, I don't know what a case was. The CDC defines a case as a positive test for COVID-19. It doesn't define a positive case as a person who's sick. So, it's really somewhat misleading.
CHAKRABARTI: Well, so, Dr. Klein, we’ll come back to you in just one second for your response. But, Dr. Meissner, for the sake of clarity, let me ask you: Do you think the FDA should not have granted the EUA then, for Pfizer's vaccine in this age group?
MEISSNER: I have not seen the data, Meghna, and I would not want to second guess the folks at the FDA. They are extraordinary people who are very concerned about both safety and efficacy. And I defer to their judgment. I'm talking about, I guess, a little bit more about children who are under 12 years of age. And, you know, one of the arguments that's been made is, ‘Well, we need to generate herd immunity by immunizing children.’ Well, in point of fact, 20% to 30% of Americans are refusing the vaccine, so we're unlikely to get to a point of herd immunity even if we immunize adults.
And the data from Israel has shown that the infection rates in children and adolescents dropped precipitously when adults are fully vaccinated. So, I think we're going to see even less and less disease in children as we ramp up our immunization of adults. We need a vaccine for children. I don't want to be misquoted. It's important, but we need a safe vaccine, and we don't know that today.
CHAKRABARTI: Right. So, Dr. Klein, Dr. Meissner's concerns as he's laid out, I've actually seen in some other places, too. Just in the past few days, there was an opinion piece — let's call it that — in the British Medical Journal published by a couple of physicians, Dr. Vinay Prasad, Stefan Baral and Wesley Pegden. And they said that unlike for adults, the rarity of severe COVID-19 outcomes for children means that the trials cannot demonstrate that the balance of the benefits of vaccination against the potential adverse effects are favorable to the children themselves. And therefore, they said the criteria for the EUA don't appear to be meant for children. Your response to that?
KLEIN: Well, again, I think I also want to acknowledge Dr. Cody’s very long and very strong record on being part of this field for many years and really his own contributions. And he's really been a leader in vaccines and infectious disease in children. And, you know, I think like him, I don't necessarily want to second guess that. I don't want to second guess the FDA or actually look into the mind of … what these other authors are saying.
You know, I think that the concern was that there would not be, that it would not be able to demonstrate that there's a benefit to children because of enrolling 2,200 in this trial – that it wouldn't be enough to demonstrate benefit. That because it is, as I think we're all acknowledging, it is a small size, especially to demonstrate that a vaccine is effective or has good efficacy.
That being said, I think there was enough disease actually, and that the trial was able to demonstrate that it was effective. And again, like I said, in the real world going to be 100%. But it did show that is a benefit in terms of preventing a positive test result, to speak to that earlier. The cases in the study were defined as if someone had some symptoms, they had to be swabbed and that if they were tested and they were tested positive, that was the case.
I think the points are all legitimate – that everyone's making – in the sense of let's think about the disease in children. And it certainly is much, much, much, much less in terms of severe disease than adults. But I do think we need to think about the broader picture of … in terms of disruption to their life and in terms of the local herd immunity that you might get from a whole community when you have vaccinated adolescents, that maybe you could have actual pockets when you have … the adults and the children in the community that will potentially stop transmission as well locally.
CHAKRABARTI: So, Dr. Meissner, did you want to respond to that? Because I'm seeing that, you know, the Biden administration, the FDA, other pediatricians who've been quoted make a similar point to Dr. Klein that there are sort of communitywide benefits that would come with vaccination of younger and younger cohorts.
MEISSNER: Well, we don't know that. And it is certainly possible. But remember, COVID is a disease that's passed from adults to adults. This is not a disease that spread to a large extent by children to adults. It's very different than influenza. And I think that's oftentimes forgotten. Children are the primary vectors or the vehicle by which influenza spreads within a community. That's not the case with COVID-19, at least based on the available data. So, I think to argue that including children as part of the herd immunity is a little bit risky. We certainly want to vaccinate children. There's no question about it. But at what cost? I want to be sure that the vaccine isn't worse than the burden of disease in this age group. And we simply don't know that.
CHAKRABARTI: How long generally for other vaccines has it taken to know that? And I ask that because, again, I'm trying to ground our listeners’ learning in, you know, what we know from other examples. I was looking at a meta-analysis of clinical trials for HPV vaccines, for example. Again, vaccines are given to adolescents now.
Now, these were clinical trials, I believe, for full authorization, not EUA, to be clear. But those trials went on for four years in 14 to 16 countries enrolling, you know, 2,000 to 3,000 adolescents per trial. I mean, that's the more typical sort of suite of tests that go on before full approval and when people can feel confident. Am I wrong about that?
MEISSNER: … There has never been another vaccine in the United States that has become widely available under an EUA. This is the first time. The only possible exception was the anthrax vaccine, which was licensed, but it had outdated and there was an EUA pass so that it could be given to military personnel. But we've never been in this situation before. All other vaccines have gone through a BLA, and there isn't a defined period of time. I think Dr. [Doran] Fink [of the FDA] suggests at least six months of safety data.
But you raised the question: Could there be vaccine-enhanced disease the second year around when there's waning immunity and these children get exposed to the virus? I don't think so. I think that the remarkable safety profile we've seen in adults will carry over to children, but we don't know that. And before we begin to vaccinate millions of children, I would like to be very confident that it's the right thing to do.
CHAKRABARTI: Yeah. Dr. Klein, I know I've got to let you go in a couple of minutes, but I want to be sure to get some of the listener questions here, because folks are just authentically asking about things that they have heard. So, I don't know what the answers are to these, but …
KLEIN: Can I just comment on one aspect? I'd just like to clarify a little bit. You commented on the HPV vaccines, for example, taking three or four years. Now, to be clear … the reason they take so long is to actually get enough disease to see if the vaccine is preventing the disease. And that's the reason for the length of time.
CHAKRABARTI: But isn't that the same thing then with COVID?
KLEIN: And yes, and that's my point, is that because there's so much disease, we could actually find that they work so well, that they've worked because there's been so much disease. But yes, please go ahead.
CHAKRABARTI: Sorry, forgive my own confusion here. But I thought that in younger and adolescents and younger children there, did we say earlier that there was enough COVID out there or not?
KLEIN: Well, there is. There was enough COVID to show that it had effectiveness. But I think the point that … is a legitimate point that Dr. Meissner is making and that many people have made is that there's not nearly anywhere near the severe disease that we see in adults. But children get COVID, and adolescents do get COVID, but it's typically a more mild disease.
CHAKRABARTI: OK, so let me just ask a couple of the questions here that are coming in from listeners. Paul McCarthy says, please address concerns surrounding infertility. Norma Wu says, what effect would the vaccine have on puberty if it's given at the onset of puberty? Dr. Klein, do we know the answers to those questions?
KLEIN: I don't think we know any answers to those questions. I think that those are questions that – there's always questions that come up when there's new vaccines, and then there's always questions that we don't have the answers to when a new vaccine comes out. … I know that there's been a lot of talk on social media about issues relating to fertility and things of that matter, but I don't think we have any information.
CHAKRABARTI: OK, so I have you for 30 more seconds, Dr. Klein. Parents are listening right now. I mean, what would you tell them? What advice would you give them at the moment?
KLEIN: Well, I agree the studies were ... on the smaller side. But I also think we can actually take a lot of comfort in a lot of information from the data that has come out from the older adolescents and young adults. And what all the information that we are seeing, more and more in terms of what we're finding regarding the safety in the older adolescents, young adult population. And I'm a pediatrician, so I'm not going to say that a 12-year-old is the same as a 20-year-old. And I think that's a fair statement. But I do think that I take a lot of comfort and I would have no hesitation vaccinating my own child.
CHAKRABARTI: Well, Dr. Klein, director of the Kaiser Permanente Vaccine Study Center, thank you so much for joining us today.
KLEIN: You're very welcome.
CHAKRABARTI: This is On Point. I’m Meghna Chakrabarti. And today we are talking about the FDA's granting of an emergency use authorization for the Pfizer COVID vaccine for adolescents between the age of 12 and 15. That happened yesterday. The Biden administration says it's a priority to get children vaccinated in the next phase of pandemic control. But there are a lot of questions and still uncertainties as we all try to understand next steps and think through what this means for kids and COVID.
I'm joined today by Dr. H. Cody Meissner, a pediatric infectious disease expert at Tufts Medical Center. Dr. Meissner's also a member of the FDA's Vaccines and Related Biological Products Advisory Committee, or VRBPAC. And I'd like to now welcome into the conversation, Dr. Monica Gandhi. Joining us from San Francisco, Dr. Gandhi is a professor of medicine and the associate division chief of the Division of HIV, Infectious Diseases and Global Medicine at the University of California, San Francisco. Dr. Gandhi, welcome to you.
DR. MONICA GANDHI: Thank you.
CHAKRABARTI: So, first of all, let me just get your quick response to the FDA granting the EUA. I've actually been quite surprised that both Dr. Meissner and Dr. Klein wouldn't really give me a straightforward response on whether they thought it was the right thing to do. But I'm going to ask you the same question anyway. Should the FDA have done that yesterday?
GANDHI: Yeah, it's a great question to ask. I like to ask people directly whether they would have done it yesterday. You know, I would say that … this was done in a small group of children 12 to 15. And the concern - both of them raised, I think - is that 1,131 children getting the shot is a low number to ascertain, for example, safety events.
And then they both said, and I think this is where your answer’s coming, or at least Dr. Klein said, that we've had so much experience with the vaccine in the real world setting – a billion people have been given the COVID-19 vaccine as of a couple of days ago by the World Health Organization – that people are going from safety events and extrapolating from 16-year-olds and 17-year-olds who have gotten it from the real world and not seen major safety events. So, should they have granted it? I have another concern about it, but yes, I think it was OK to grant.
CHAKRABARTI: OK, so tell me what your concern is.
GANDHI: So, I have two concerns about – and I'm not sure if I'm concerned about the EUA. I’m concerned about the dialog that has emerged, which is that … and it was quite immediate – is that the only way for children to get back to normal; the only way ... for them to go back and see their friends and go to school is this is a huge advance ‘to get children back to normal.’ And my concern again is that we have in general, because children are so much lower risk as we've all brought up, children under 20 are not only lower risk of spreading the disease; they are not the super spreaders.
In fact, it’s adults spreading it to them. And children and young adults are very low risk for severe disease, about one in a million chance of death for a child under 19 from COVID as opposed to 600 deaths [per million] in the U.S. from adults. But we have already the mental health effects of school closures, and keeping schools closed this long – we have already, in a way, sacrificed children's mental health for the concern about COVID-19 among adults. And so now we’re making this … that the only way for children to get back to normal is if they get the vaccine. I have that concern and then the global concern which we can talk about later.
CHAKRABARTI: So, hang on to the global concern for one second. But I do just want to talk a little bit more about what you just said. It is quite interesting – You're right – the immediacy of tying adolescent vaccination to ‘getting back to normal.’ I was looking at the New York Times story on this today. And in the top half of the story, The Times says, ‘Doing so (meaning getting adolescents vaccinated) will be critical for further reducing transmission of the virus, smoothly reopening middle and high schools and regaining some sense of national normalcy.’ That's not a quote. They're not quoting any particular expert. They're just asserting that. Is that the kind of thing you're talking about?
GANDHI: Yeah. I mean, that is very concerning to me. What you just summarized is the dialog around children.
CHAKRABARTI: I mean, it's a paragraph in this Times story. Go ahead.
GANDHI: Right. And of course, The New York Times … has really informed a lot of our response in the country. But yes, it's exactly right that what you just said is that school study after school study – and we all know this – has shown us that safety in children being in schools is intact with other mitigation procedures. And the ultimate mitigation procedure for an adult to be safe is them getting vaccinated. So that's why teachers were prioritized for vaccinations. The ultimate safety for children not getting COVID is their parents getting vaccinated before they go back to school.
And then [what] Dr. Meissner said that is very important from Israel: With every 20-point increase in vaccination in adults, the risk of transmission in children halves by their data. What does that mean? That means that children are going to be safe in the fall, not if they're vaccinated or not, but from what people are misunderstanding the term herd immunity. Herd immunity means that my immunity as an adult protects children's immunity if they are not vaccinated. So, the lower and lower cases go, children are protected like they were in 2019 from the low cases in the community.
CHAKRABARTI: OK, so let me just jump in here, and I want to ask something of both of you. And Dr. Meissner, you've been listening patiently, so I'm going to first turn to you here because we've got some listeners, who to the point that Dr. Gandhi was just making, they have a rebuttal. For example, Amanda’s saying the problem with the point is that in order for children to be protected, adults actually need to get vaccinated. And pointing to the still high prevalence of vaccine hesitancy in this country among adults. So, if we don't actually get enough adults vaccinated, will we see the same Israel-like, outcome for children here in the United States? Amanda’s asserting that we won't. Dr. Meissner, your response to that?
MEISSNER: Well, I think that Dr. Gandhi has made a very important point here. We caused enormous harm to our schoolchildren. Last March, just about every school in the United States was shut down. And the consequences of that are enormous. We're going to be living with that for close to a generation. People have a very hard time – or young children have a very hard time making up a lost year of school. And it's particularly harmful for students and children who live in a minority community because their families are much less likely to be able to send their children to a private school or to get a tutor.
So, the consequences of a lost year is, I think, going to be staggering for the United States. So really what we did – because children don't get sick very often, that's the point. And I think we made children pay this extreme price of closing the schools in order to protect the teachers. People didn't really think too much about the consequences, but the consequences, I think, are going to become enormously apparent.
And now … I think we're doing this once again to children by vaccinating them without knowing what the safety is. We are asking children to accept the vaccine, to get immunized, to protect the adults. That isn't necessary. Children just very rarely get sick. If we can develop a safe and effective vaccine – And I think the efficacy is not the issue; the issue is safety – If we can get a safe vaccine for children, that's wonderful. And that's why I'm so supportive of what Dr. Klein is doing. It's so important. But we need larger numbers. We should approve this vaccine for children under a biological license application, not under an EUA.
CHAKRABARTI: Hmm. OK, Dr. Gandhi, if I understand correctly, in states that do require, say, immunizations for attendance in public schools, it's those only four vaccines, per Dr. Meissner's points, that are fully approved, if I can use that language through the FDA, not … emergency use authorizations. So, I mean, would it be – it seems unlikely that we would see states or localities say you have to have the COVID vaccine to go back to school? I mean, I'm not even sure if it was safe to conjecture that? Maybe not.
GANDHI: What you just read from The New York Times, again, indicates that. For example, there was some comments last week about the outdoor camp guidelines by the CDC that they were requiring masking for children outside and also the vaccinated counselors had to be masked outside, even though that belied the recommendations that you don't have to mask outside if you're vaccinated.
And then there was an article that said, OK, well, the CDC said, yes, you don't have to mask outside if you are vaccinated as a 12- to 15-year-old. So, you have just put, you know, it's not mandated. But the normalcy aspect, right, has been linked to vaccinating at 12 to 15. So, to be clear, Amanda’s point was actually really important… the vaccine hesitancy in adults. Israel is only at 63%, first dose vaccine above 16 [years of age]. They're not at 70; they're not at 85.
Just like all of us, it takes the time to vaccinate everyone. They’re at 63%, and they had 61 cases yesterday in a country of 9 million people. That's 0.6-over-100,000. So, they're reaching herd immunity, you know, even with vaccinating the over-16s. So luckily, I don't think we're going to need … everyone to get vaccinated.
I will now make a confession. I'm vaccinating my 13-year-old to protect the herd because I am also concerned about Amanda's point. And I feel the safety is likely good from the one billion people who have been vaccinated. I'm trying to make a larger point that what Dr. Meissner saying for children to be vaccinated, to protect adults, the way the CDC works is that … their mandates on their website is you have to have a disease that is severe in children to have a mandated vaccine.
Those so far are measles, mumps, diphtheria, pertussis and rubella. And COVID-19 would not count because it's a severe disease in adults, not in children. So, we are asking children to be vaccinated to protect the herd. And I will actually do my part for the herd, but I think it's disappointing that children are going to be limited. I hope they're not in the fall based on what you just read to me from the New York Times.
CHAKRABARTI: Yeah. So, you're saying that we're asking children to do this in order to protect the herd. But I'm also hearing both of you say it's not necessary. If we could get more adults vaccinated, it wouldn't be necessary to ask them.
GANDHI: Epidemiology from Israel shows that they're only at 63% first dose, and they have gotten the rates so low without vaccinating those less than 16. This actually ties into the discussion about herd immunity, which is also going awry in the press in my opinion. They're mistaking it with eradication. You protect others. Herd immunity just means getting a certain proportion of the population vaccinated so that they protect those who are not immune, which would be children here. And it doesn't look like it's going to need to be that high.
CHAKRABARTI: OK, Dr. Meissner, we're rapidly running out of time. And I just want to play a clip from another pediatrician. This is Dr. Richard Chung. He's a pediatrician at Duke University. And he actually enrolled his son … in the clinical trial for the Pfizer COVID vaccine. And you know, he's a pediatrician, sees first-hand experience in talking with parents about their questions. And he understands, Dr. Chung says, where parental concern is coming from.
[TAPE] DR. CHUNG: Whenever I hear hesitancy or sense that from a parent, first of all, I actually really respect that because what I see in that is a parent who is just trying to do the right thing. You know? They care about their kid so much that they really are wrestling with a decision. And that's everything to do with personal ideologies and worldviews and values and perspectives. And so, it's really critical as a health care provider to sit with them and understand first.
CHAKRABARTI: Dr. Meissner, I wonder what you make of that because there have been recent polls. There's one from the Kaiser Family Foundation just out a couple of days ago that finds that for parents of children between the ages of 12 to 15, 70% of them in this poll said they would either wait or not get their kids vaccinated at all or do it only, regarding COVID, only if their school requires it. So, there's a lot of parental concern and questions out there. And just your response to that?
MEISSNER: I completely understand their position. And I think, again, it's important to remember that we're talking about a vaccine that's very different from the fully licensed vaccines. They have been around – most of them – for decades. There's no question about the safety and the benefit that's derived, for example, from the HPV vaccine. That is beyond discussion. That's not the case with the COVID-19 vaccines.
And you see it plays into something that worries me a great deal. If we roll this vaccine out to millions of children. And there is a reaction, such as we saw with this unusual clotting and thrombosis syndrome in in young women, then that is going to impact the whole immunization program, not only COVID-19. It will affect measles, mumps, rubella. The anti-vaccine community will jump on that very, very quickly. And so, I think the potential harm from not fully understanding the safety of these vaccines is pretty high. I think it will be safe. I think we will be recommending it for children. But I want to know a little bit more before I would urge the FDA to take that position.
CHAKRABARTI: You want to see the safety data, essentially, and that's going to take some time. Look, Dr. Gandhi, we have one minute left, and I know you wanted to make … a global point. And if I might just hazard a guess, is it that the doses that would go to children here in the United States might be better used to help get adults vaccinated worldwide?
GANDHI: Well, yes, so it is a 30-microgram dose. It's the same dose for adults as in these 12- to 15-year-olds. India is on fire. India has terrible rates of death and cases. And I would recommend the U.S. donating these doses, while we're waiting on more safety data, to India to help bring down the pandemic, since they are 3,000-times more likely to die from COVID if you’re an adult than a child.
From The Reading List
New York Times: "The F.D.A. authorizes the Pfizer-BioNTech vaccine for children 12 to 15." — "The Food and Drug Administration on Monday authorized use of the Pfizer-BioNTech Covid-19 vaccine for 12- to 15-year-olds in the United States, a crucial step in the nation’s steady recovery from the pandemic and a boon to tens of millions of American families eager for a return to normalcy."
Undark: "Do Kids Really Need to Be Vaccinated for Covid? Yes. No. Maybe." — "At the end of last month, Pfizer announced plans to submit important news to federal regulators. The drugmaker had recruited over 2,000 adolescents aged 12 to 15 for a clinical trial of its Covid-19 vaccine, and the results were promising: Among the young people receiving the vaccine, there were zero reports of Covid-19."
BMJ Opinion: "Covid vaccines for children should not get emergency use authorization" — "The rapid development of highly effective covid-19 vaccines is a triumph of science and, with equitable implementation strategies, represents humanity’s path out of this pandemic."
This program aired on May 11, 2021.