Why kids younger than 5 should get COVID vaccinations

Host Amber Smith: Upstate Medical University in Syracuse, New York invites you to be "The Informed Patient" with the podcast that features experts from Central New York's only academic medical center. I'm your host, Amber Smith. Parents have a lot of questions about COVID vaccines for their children who are under the age of 5. Here with me with some answers is Dr. Jana Shaw. She's a professor of pediatrics at Upstate specializing in infectious disease. Welcome back to "The Informed. Patient," Dr. Shaw.

Jana Shaw, MD: Thank you for having me, Amber. Great to be here with you.

Host Amber Smith: Now probably the most important question is, how do we know these vaccines are safe?

Jana Shaw, MD: Very important question. Safety is one of the most important concerns parents have, and understandably. They want to make sure that whatever they put in their children's bodies is safe. We do know vaccines are safe, in general and specifically for COVID vaccines because we have a very robust vaccine safety monitoring system in the United States.

The vaccines are tested during clinical trials, and the testing itself and monitoring is very rigorous. In addition, the vaccines continue to be monitored for safety once they are authorized or licensed. So vaccine safety monitoring does not end once we use vaccines in the general public. Same process we follow for vaccine authorization or licensure in children. During the clinical trials, vaccine safety data is collected, carefully monitored and documented. And even after vaccines are authorized, children continue to be monitored to ensure that the vaccines they've received, including COVID vaccines, that they remain safe.

So in short the answer is how do we know? We know because we look and measure and document safety. And if we identify any concerning signals, we pause. We quickly evaluate and we use scientific epidemiological methods to establish causality, right? Because, because something happens after vaccination doesn't mean it happened because of vaccination. So association does not imply causation. Hence, if there are any serious concerns or signals that come up, we pause, use scientific methods to investigate, and if we find out that there is a problem, we stop using vaccines. And we have lots of good examples from the past where there were some safety concerns, the rotavirus vaccine, for example, where vaccination was passed and production was stopped. And we stopped using the vaccine because there was an issue. But similarly, there might be concerns that arise, and we establish the concerns are not related to vaccination, we lift pause and we continue to vaccinate.

Host Amber Smith: So by the time the FDA has approved this vaccine, it's already been used in numerous children. It's been tested out and, and made sure that it's safe. It's not coming straight from a lab to a person. It's already been tested in people, right?

Jana Shaw, MD: Oh absolutely. So the difference between the safety we know from clinical trials and the safety we know from population level monitoring is that for the COVID vaccines for children -- and we are talking about the little ones, the 6 months to 5 years of age or so -- there were over 8,000 children enrolled in those clinical trials. So we do have vaccine safety information for those children, and a vaccine safety focus on the same areas that it did for adults. So for example, we always look at what we call systemic reactions, essentially after vaccination. How many children did get fever? How many children did feel tired? How many children had headaches and so on, so forth. And we also look at local reactions. How many children had pain at a site? How many had swelling? And we ask them every day, we call them, we document, we measure. This is a very rigorous, robust process to ensure that the vaccines are well tolerated and they are safe.

Host Amber Smith: Now it was more than a year ago that vaccines were approved for adults. Why did it take so much longer for the under 5 year olds?

Jana Shaw, MD: Well it's because we always start with the populations who are at the highest needs for vaccination, right? So with COVID in the beginning of the pandemic, we thought that the elderly and adults with underlying medical conditions such as hypertension, diabetes, and so on and so forth were at the greatest risk of dying. So the vaccine development and testing was focused on adults. But over time and especially with Omicron, we recognized that COVID is a big deal for children too. So as we have slowly lowered the age of clinical testing to the younger age groups and children. It took us a while to get there because the approach was cautious was deliberate and was based on the epidemiology of the disease and the urgency with which Omicron spread throughout the U.S. And by epidemiology, I mean monitoring for frequency of this infection in the population.

Host Amber Smith: So why should kids get vaccinated?

Jana Shaw, MD: It's really important to remind ourselves that COVID can be serious even in young children. Historically, we thought of COVID as disease of elderly and people with underlying medical condition, but as we learn more and as Omicron swept through the country, we recognized that children were particularly vulnerable to Omicron. Number of them ended up in the hospital and number of them ended up with some serious complications of the infection known as MIS-C, which stands multi inflammatory syndrome in children. So we know Omicron can be serious for children, and the infection can me have very unpredictable manifestation. Therefore it's of paramount importance that all children are protected against severe disease. And vaccination is the only way to do it. We have since the pandemic started, we have since removed masking, social distancing. People now gather in public spaces. So the risk of exposure to the virus is much greater than it was during times where we were either working remotely, children were at school remotely, or had to wear a mask. That level of protection is now removed. So vaccination is single most important intervention that parents can do to protect their children.

Host Amber Smith: Is this vaccine, for the children under 5, is it the same vaccine that adults are taking, just less of it?

Jana Shaw, MD: Absolutely. Yes. So it is the same vaccine. Both Moderna and Pfizer were authorized. For Pfizer, the dose of the vaccine is tiny. It's only 3 micrograms, which is very small amount of what we call antigen, that information that goes into our bodies to instruct the immune system to build protection. With Moderna, again, it's the same vaccine as well, just with a reduced dose.

Host Amber Smith: This is Upstate's "The Informed Patient" podcast. I'm your host, Amber Smith talking with Dr. Jana Shaw. She's a pediatric infectious disease expert at Upstate, and we're talking about the new COVID vaccination recommendations for children under age 5.

You mentioned Pfizer and Moderna. Both of those are mRNA vaccines. Adults also, originally, had an alternative vaccine option. Is that available for children as well?

Jana Shaw, MD: So I believe you're referring to Johnson & Johnson vaccine. That is not available for children. And just for the listeners, mRNA vaccines, Pfizer and Moderna, are the preferred vaccines, mostly because there were concerns about severe serious reaction following vaccination with Johnson & Johnson vaccine and clotting disorder. Particular women were at higher risk for this severe complication, and because we monitor vaccine safety carefully, we picked up the signal. We established it was related to vaccination, and we therefore prefer that people use mRNA vaccine, and not Johnson & Johnson. For children that option is not available.

Host Amber Smith: So how should a parent choose, or do they get to choose between Pfizer and Moderna?

Jana Shaw, MD: Very difficult question. Sometimes having choices can be challenging, right? With Pfizer, it is a three dose vaccine, so it will take a while for the child to be fully protected because it really, you have to sort of maintain the intervals between the doses. Moderna is a two-dose vaccine. So if parents who are eager to get their children protected faster, they may choose to use Moderna. Where only two doses are required. If they would prefer maybe higher level of protection, and wait a little longer for the full protection, they could choose Pfizer.

Host Amber Smith: Is one better than the other for a child with a chronic health condition?

Jana Shaw, MD: There are no differential recommendations for Moderna or Pfizer. The vaccines were tested in children with underlying conditions and also in children with different ethnic and racial backgrounds. So we know the vaccines do perform really well, regardless of whether the child is otherwise healthy or may have asthma or other medical issues. And the vaccines were tested in different races as well.

Host Amber Smith: Now these are shots that we're talking about. Is there another option for inhaling through the nose, or is it only available as a shot?

Jana Shaw, MD: It is only available as a shot. We don't have nasal vaccine. As you noted, you know, influenza, for example, we have a flu nasal vaccine, but that option is not available for COVID, not only not for children, but not for adults as well.

Host Amber Smith: Can these vaccines be given when the child comes for other childhood vaccinations?

Jana Shaw, MD: Yes. Co-administration is approved. They can be safely given with other vaccines.Parents should just check with their pediatrician to make sure the vaccines are available on site. Sometimes pediatricians' offices may choose to schedule COVID vaccine clinic because we are trying not to waste COVID 19 vaccines. The vaccines are packed in numbers of 10. So if you open one, and you only use one, then you would waste nine doses. So pediatricians and providers try to be really careful and thoughtful about usage, and they may choose to schedule vaccine clinic where multiple children will come so we don't waste any vaccine. So please check with your pediatrician's office what practice is available.

Host Amber Smith: I think some parents feel like, you know, the pandemic's over, so maybe they don't need to vaccinate their child, or maybe the child's already been exposed and they're safe. Do they still need to be vaccinated?

Jana Shaw, MD: Yes, the answer is yes. And you are right, a lot of children, especially during Omicron wave, got infected. In fact, some of the data suggests that three out of four children were infected during Omicron. The challenge with natural infection is that the protection doesn't last long, and we know people can get reinfected upon exposure, especially as the COVID variants escape natural immunity. So because natural immunity doesn't last long, and breakthrough infections continue to occur, it's really important that children are vaccinated, because vaccines provide a reliable level of protection.

Host Amber Smith: Should a child get vaccinated if they already had COVID?

Jana Shaw, MD: The answer is yes. We know that COVID infection provides you with certain degree of protection, but the protection is limited. We know probably three months after your infection, you are again at risk of being reinfected, and you may develop a severe disease. So, and in fact, I know personally several people who had repeatedly been infected with COVID. So we know that immune protection from natural infection wanes over time. It wanes very quickly. And therefore vaccination is probably the best next strategy for you rather than being exposed to the virus, because the vaccine protection lasts longer.

And in fact, in people who had natural infection and got vaccinated, they had even higher level of antibodies, which are the molecules that protect you from severe disease. So we know that vaccination following natural infection is safe because the clinical trials, including the childhood trials, the Pfizer, has shown and shared data with us about safety and immunity following vaccination in children who had COVID.

Host Amber Smith: So I wanted to ask you more about what the COVID vaccine does for children under the age of 5. We're not really sure for how long it will protect them after they are vaccinated, right?

Jana Shaw, MD: Correct. Yes. So we have to wait long enough to measure the level of protection, the length of protection. We can probably extrapolate from adult studies because the level of protection for children, the antibody levels, is very similar to adults. So assuming that the pharmacodynamics and the antibody decline over time will be similar for children, it's quite likely that children will be protected for at least six months and probably longer, following vaccination, against a severe disease, hospitalization and death. And that is with Omicron, because we should remind ourselves that vaccines for the little ones -- 6 months through 5 years of age -- were tested during Omicron phase. So the antibody levels we measured, or the manufacturers measured, really are antibody levels that are comparable to adults. They're high, to protect those children against severe disease for months to come.

Host Amber Smith: So the vaccine should protect them from getting seriously ill or hospitalized, if they do become infected. Does it do anything to prevent them from spreading the coronavirus If they're infected?

Jana Shaw, MD: Yes, it does. I will use adult data here because I don't have children's data, but in adults we know that adults who are vaccinated, they are not only less likely to get infected, but once they are, if they have breakthrough infection, which typically is mild, they are less likely to transmit the infection to those around them, and they're less likely to become seriously ill. So there are numerous benefits to vaccination -- reduction of risk for infection, reduced risk for spread, and highly reduced risk for severe disease and death.

Host Amber Smith: When I hear you describe that it should protect for at least six months it makes me wonder if this is gonna be like a flu shot that you need to get every year. Does that look like what is going to happen?

Jana Shaw, MD: It's quite likely, Amber. I think those are important questions, and people really want to know how often will we have to get vaccinated. Honestly, the true answer is we don't know today. But what I can tell you with certainty, that scientists and researchers, they continue to monitor antibody levels in people who were vaccinated so we can safely determine how frequently people will need to be vaccinated. The antibody level itself is only one arm of that decision tree, because we also will have to monitor the emergence of variants. And, as you know, and I'm sure listeners have heard, Omicron has managed to escape natural immunity from prior variants and also has been escaping the vaccine induced immunity, so we are seeing more people getting breakthrough infection. But thankfully the vaccines continue to perform extremely well and protect people against severe disease.

Host Amber Smith: Do you recommend that parents get their children vaccinated now, or should they wait until the fall before they go back to school?

Jana Shaw, MD: You know, it really depends on your level of risk. I'm so risk-averse as a parent. And I have three children who are fully vaccinated, not only with all childhood vaccine, but also with COVID vaccines, including boosters. So for me, I couldn't wait to get my children vaccinated because I did not want them to be infected. You know, COVID is one of the viruses that, especially for children, it can be very unpredictable. We have healthy children who end up in the hospital with MIS-C, which is a very serious inflammatory condition in children. So it's really challenging to predict which child will just have a cold or no disease with COVID and a child that will end up in a hospital. So for me, being able to vaccinate as soon as I can, is really the approach I take. And I would recommend that parents consider that as a strategy to keep their children safe because we know COVID vaccines are extremely safe. So not vaccinating might be a dangerous choice.

Host Amber Smith: Do you have general advice for what parents can expect? Are their children likely to be tired after they get vaccinated, or will there be soreness at the injection site?

we know what reactions one can expect, and I would also note here that parents are most welcome to actually look at the data themselves. ACIP, which is A C I P, abbreviations for the Advisory Committee for Immunization Practices -- it's the body that advises CDC (Centers for Disease Control and Prevention) on vaccines -- has a recording that's publicly available from their June 17th meeting where the information about reactions is carefully summarized and shared. So if you want detailed information, please log in and watch the video from the public meeting.

Jana Shaw, MD: But to answer your question, there are, yes, there are reactions, both local and systemic that parents can expect in children. And depending on the child's age, they differ. So let's look at let's say children 6 months to 23 months of age. Those children were more likely to have irritability and be sleepy. Children older, 2 to 5 years of age, complain of headache and fatigue. Small proportion of children had fevers. None of those fevers needed a doctor's visit or hospitalization, but those children had low grade fevers and needed maybe Tylenol or Motrin to help them with that. The important thing to mention is that those reactions are short-lived, couple days, one to two days. They respond to Tylenol, or Motrin. They go away, and they don't come back. And, they are comparable to reactions that parents have experienced with their children after other childhood vaccines. So they are no different, compared to the reactions their children had after vaccination with other childhood vaccines.

Host Amber Smith: Is there anything else to know about this vaccine?

Jana Shaw, MD: Yes, I think to remember thatin the past there was concern about myocarditis, which is an inflammation following vaccination that has been documented as a signal for young adults, young males, particularly. We continue to monitor this reaction. With younger age groups, for those 5 to 11, there really has not been increased riskfor myocarditis. So again, the vaccines continued to work really well. The clinical trials were not powered enough to detect this risk for children 6 months to 5 years of age, but the vaccine will continue to be monitored. But the expectation is that the risk is going to be even lower than observed in young adults because the doses are so small, compared to the adult doses.

Host Amber Smith: Well, Dr. Shaw, I really appreciate you making time for this interview. Thank you.

Jana Shaw, MD: Thank you for having me.

Host Amber Smith: My guest has been pediatric infectious disease specialist, Dr. Jana Shaw. "The Informed Patient" is a podcast covering health, science and medicine brought to you by Upstate Medical University in Syracuse, New York, and produced by Jim Howe. Find our archive of previous episodes at Upstate.edu/Informed. This is your host, Amber Smith, thanking you for listening.