Soon, everyone in the United States over age 5 will be eligible to be vaccinated against COVID-19. And doctors from Cincinnati Children's Hospital Medical Center are helping families figure out what that means.
On Oct. 26, scientists on the U.S. Food and Drug Administration's advisory panel recommended that Pfizer's two-dose mRNA COVID-19 vaccine be granted emergency use authorization (EUA) for children ages 5-11 years old. The FDA accepted data from Pfizer showing that the vaccine is safe and 90% effective at preventing COVID-19 for kids in that age group.
Next, the FDA will take or reject that recommendation, and then the Centers for Disease Control and Prevention (CDC) will follow with its own recommendations, likely next week.
Currently, Pfizer's vaccine has an EUA for people ages 12 and up as well as full approval for use in people ages 16 and older. Vaccines from Moderna and Johnson & Johnson currently are approved for people ages 18 and up, though both companies are applying for additional approvals.
Cincinnati Children's Hospital was one of a handful of sites in the nation to conduct COVID-19 vaccine trials in 2020, work that has continued this year for the 5-11 age group. This week, Robert Frenck, M.D., director of the Gamble Vaccine Research Center at Cincinnati Children’s, and Mary Carol Burkhardt, M.D., associate division director for primary care at Cincinnati Children’s and medical director of the hospital’s Hopple Street Health Center, discussed with reporters what the FDA's vaccine approval means, what's happening in ongoing clinical trials and what families should know about the available vaccines.
After extensive research, both doctors recommend vaccination for both adults and children, saying that it's an important key to ending the pandemic and protecting society.
"We know thousands of children have been hospitalized and over 500 have died. And it's impossible to predict which children are going to have those more severe symptoms," Burkhardt said. "With most things in medicine, prevention really is the best answer, and so this vaccine is a way that we can actually prevent COVID disease and illness in our children."
"Right now in the community, the leading groups that are getting COVID are kids under age 18," Frenck added.
Cincinnati Children's has been vocal about the importance of COVID-19 vaccines and other protection measures such as masking and physical distancing. In August, the hospital joined other pediatric care centers in advocating for universal making and other robust precautions in schools. Earlier this year, Cincinnati Children's was one of the area's first major hospital networks to require all employees, providers, contractors and volunteers to be vaccinated against the coronavirus.
Below, we're sharing some of Frenck's and Burkhardt's answers to common questions about COVID-19 vaccines.
What does the FDA advisory panel's recommendation mean?
They lowered the authorization for emergency use down to five years of age so that the Pfizer vaccine will be available for children five years of age and above. Next, the CDC will make a recommendation about how to deploy the vaccine. I think that will be a positive response, too, in the next week. (Frenck)
When will young kids be able to gt the Pfizer vaccine?
I think the first week of November. Certainly before Thanksgiving. (Frenck)
Is the vaccine dosage for young children different from that for adults or older kids?
We did a phase one study for the dose that's needed for adults and found that the 30 microgram (µg) dose is what we needed for the adults. And that same dose was used for the 16- and 17-year-olds and then the 12- to 15-year-olds. But when we got below 12 years of age, we decided to re-look at the dose to see "Did you need the same dose for the younger kids?" We were one of five sites in the country to do the phase one (trials) for the children, and we found that the 10µg dose was sufficient. It gave the same immune response as the 30µg for the 16- to 25-year-olds, so that's why the 10µg dose was chosen. It's not that it's a weaker dose or a lesser dose; it's all the children needed to make the same immune response as the adolescents and young adults. (Frenck)
If a child is about to turn 12, should they get the smaller dose from the kids' vaccine now or wait for the larger adolescent dose?
I think that the 10µg would be fine. Honestly, 10µg probably could be used at a little bit older (age group), too, but we don't have the data to know that for sure. We are planning studies for that; that will be in a few months. (Frenck)
What concerns do parents have about getting a COVID-19 vaccine for their child?
I think what's been really challenging with COVID is there's been so much information out there in the news and on social media. I think families are looking for good, quality information that they can turn to so they can make informed choices for their children. And I think what's encouraging about the FDA's decision (on Oct. 26) is that it really comes out with a strong recommendation that the benefits of COVID-19 vaccination in this 5- to 11-year-old age range far outweigh any risks associated with the vaccine. And so I hope that brings good peace of mind to families, that the evidence really has been looked at and studied and weighed, and there's good evidence to proceed and consider this vaccination for your child. (Burkhardt)
Are COVID-19 vaccines safe for kids?
Yes, I think the vaccine is safe. You have to kind of split reactogenicity from longer-term side effects. Reactogenicity is the immediate response our bodies are having to the vaccine, and I kind of look at that as our immune (system) is making a good immune response. That's why we're having some of those reactions (pain at the site, maybe a headache, some fatigue, some people are having fever and chills), but those things last about a day or two. (Frenck)
Should parents wait a few months before vaccinating their young child?
Vaccines have to be given before an exposure, and we have COVID circulating in our community still at relatively high levels. And it's too late once your child has contracted COVID and is symptomatic from that. You certainly can get still get vaccinated after you have COVID, but really to prevent those symptoms and effects on your children, we want to vaccinate them now we don't want to wait until it's too late. I would encourage people to have an open mind, to have a discussion with their provider that they trust and ask the questions that they specifically have. Again, with vaccines, we need to give them ahead of time in order to have the most effective path forward. (Burkhardt)
(In trials), the other thing that we were able to show is that with only 2,500 children, we're able to show that the vaccine had efficacy. There was a 91% reduction in cases in kids that got the vaccine vs. those that had placebo. It took us almost 40,000 adults to be able to get enough efficacy data to be able to show the vaccine efficacious in adults — that's because of how frequently adults were getting exposed to the virus — but it only took 2,500 children. What you need to realize with that, then, is it's much more likely that the kids are getting exposed to the virus. Right now in the community, the leading groups that are getting COVID are kids under age 18. When we first started this pandemic, 70-year-olds and above were the highest incidence, but now they're the lowest incidence. A lot of it is because of the vaccine, that they've been vaccinated. There's a very high vaccination rate in 70 years old and above. The highest incidence rates, the highest likelihood of getting COVID infection now is in kids under 18. (Frenck)
Do kids really get sick from COVID-19?
While it's true that many children don't get super-sick from COVID, the hard part is we can't predict totally which kids are going to become more severely infected. We know thousands of children have been hospitalized and over 500 have died. And it's impossible to predict which children are going to have those more severe symptoms. With most things in medicine, prevention really is the best answer, and so this vaccine is a way that we can actually prevent COVID disease and illness in our children. Let's hope many of them don't get that sick, but there's a possibility they'd pass that disease on to somebody else or they're one of the unlucky ones who do have more severe illness. Additionally, there's still a lot we don't know about COVID, and we know many children have suffered with long COVID or more prolonged symptoms, and we don't know what those long-term effects are for children who are experiencing COVID symptoms for longer periods of time. As with many things, as parents, we try and prevent our children from illness and disease and unsafe situations, and that's why the vaccine is something to consider. (Burkhardt)
Does the vaccine protect kids from current and future variants of the coronavirus?
The biggest thing to know is that the mRNA vaccines have shown great efficacy against the various strains of COVID that have come out, so not only the Delta strain, but should there be another strain moving forward, there's a good likelihood that this vaccine would still be efficacious and protect children and adults from new strains that arise. I think people can feel very confident that this vaccine would still be effective. (Burkhardt)
As we were conducting these clinical trials, the Delta strain was about the only variant that was circulating in the community. While we didn't measure directly which strain it was, there was a 91% protection rate. I feel very comfortable to say that the vaccine is highly protective against Delta. (Frenck)
How do you explain to kids the importance of getting the vaccine?
Kids actually have a great understanding of how important this vaccine is. Their lives have all been affected by COVID, just as our lives as adults have. My experience with kids in the office is they know what COVID is. Families may call it different things, but kids understand that something is going on and something is making people sick. Telling kids that we now have a way to prevent that illness and we take vaccines to help keep us healthy is important. Even young children know something has been going on. I think a lot of the kids are excited about this. A lot of kids want to be vaccinated and are asking their parents. I have certainly seen that in the teenage population, that they're saying they want to be vaccinated because they want to get on with life, they want to play sports, they want to go to school, and I think this younger group will be no different. Sometimes we see fear of vaccines or getting an immunization itself. I always advise parents to be factual and brief with their children, not to prepare children weeks and weeks in advance, but tell them the day of "We're going to do this, you're strong, you can handle this, this is going to keep you healthy and it's important that we do it." Most kids have done amazing. (Burkhardt)
We've seen the same thing in the trials, with the kids being very excited. When we started immunizing the 4- and 5-year-olds, I walked in one day to one of the exam rooms and there was a young girl in there. She had a big smile on and I introduced myself and said, "So why are you here today?" She goes "I'm going to get my COVID vaccine." I said, "You are?" She says, "Yes I am!" And she was very excited and very proud, and she wore her "I got vaccinated" sticker after that. The parents can really help a lot. The children are going to follow the leads of the parents. If the parents explain why it's important... kids understand that. They know how life has been so miserable for them this last year and a half. (Frenck)
What about "natural immunity" as an excuse for not getting a COVID-19 vaccine?
"I want to build their immunity naturally" is something I hear a lot. I think what is important to know as parents is there are a lot of things we can't prevent with vaccines. There's a lot of disease and illness that we can't prevent. There's a lot of developmental delays that happen to children that we can't prevent. (But) this is a win — we have one that we can prevent. Children are still going to develop fine. They are still going to build immunity because there's things that they're going to have to build natural immunity for. But when we have one that we can prevent that we know has as serious consequences as COVID, that's one I think parents can be reassured that this is an important one to do. It's hard as a parent. You want to make those good decisions for your kid, but you don't want to miss one, either, and in retrospect say "I wish I would have gotten my child vaccinated." We have good science, as Dr. Frenck referenced, and I think parents need to look to that good, quality information to have the reassurance that this one is safe. (Burkhardt)
Will Children's administer the vaccine to kids, if it's authorized?
I think the hospital is excited and prepared for this next step. We've been working very hard to vaccinate adolescents as well as adults in the community and are ready for this next age group. Should the next steps go through with CDC approval as well, our vaccine clinics will be ready to administer this vaccine to the 5-to-11 age group, as well as our primary care office locations. (Burkhardt)
Is Cincinnati Children's conducting vaccine trials on even younger kids?
We're enrolling children down to six months of age. At Cincinnati Children's, we've tested the Pfizer trial for adults, AstraZeneca for adults, Pfizer for adolescents and younger kids, and now looking at Moderna for kids going down as young as six months of age. Currently, we're enrolling children 2- to 6-years-old, and in about a week or two, we'll be starting the six months to 2 years age group. (Frenck)
Is it safe for vaccinated kids to play with unvaccinated kids?
One of the things I've heard is "Why should I get vaccinated (if) people are still getting infected anyway?" But if you look at it this way, since January of this year, 97.5% of the COVID-related hospitalizations and 99% of the COVID-related deaths have been in unvaccinated people. So while we're having some breakthrough infections (among vaccinated people), these are mild. It's rare that it's ending up in hospitalization or anything more serious than that. It's having the more common things that people get with most coronaviruses, which is a runny nose, a little bit of a cough, maybe a little bit of fever, but they're not getting really sick (if they've gotten the vaccine). (Frenck)
I would also point out that we still need to take other protective means. That's why children are wearing masks in school, because there's often blended environments where there's children (under age) 12 that are unvaccinated. So using other means of protecting your children, wearing masks, using good hand hygiene, I think are also important in those circumstances, especially if you're interacting with unvaccinated individuals. (Burkhardt)