COVID-19 vaccines for young children with rheumatic diseases: What providers need to know
The fight against COVID-19 has shifted drastically since the beginning of 2021. The front lines are no longer nursing homes or retirement communities, but school cafeterias and daycare centers.
COVID-19 cases among children first surpassed those in seniors in March, according to CDC figures and an analysis by The Washington Post. By the end of August, cases among kids outnumbered those in all adults.
And although children are still less likely to develop severe disease than older adults, the higher figures among pediatric patients have caused hospitalizations to spike across the United States. Younger patients are also at risk for multisystem inflammatory syndrome in children, or MIS-C, a rare but severe complication among youths with COVID-19.
“The risk of COVID is high in the child population,” Sangeeta Sule, MD, PhD, chief of rheumatology at Children’s National Hospital, and associate professor of pediatrics at the George Washington University School of Medicine and Health Sciences, in Washington, DC, told Healio Rheumatology. “As you have seen, this wave of COVID seems to be affecting children at a higher rate than previous waves did, so having these children be unvaccinated puts them at risk.”
Currently, only children aged 12 years and older are eligible for any COVID-19 vaccine, but that may change in a matter of weeks. Pfizer and BioNTech, which released phase 2/3 trial data on their mRNA COVID-19 vaccine in children aged 5 to 11 years in September, announced Oct. 7 that they are seeking FDA emergency use authorization in this population.
The FDA has scheduled a committee meeting to discuss the matter Oct. 26. If approved, a CDC panel could recommend its use soon after — perhaps even by Halloween.
“Children are going back to their usual activities — they are in school, they are in sports, all activities where they are clustered together, which puts them at higher risk,” Sule added. “So, the vaccine coming out soon is really important for this age group.”
The Same, but Also Different
Among adults with rheumatic diseases, medications like rituximab (Rituxan; Genentech, Biogen), B-cell inhibitors and high-dose steroids are of high concern, as they can reduce vaccine response. Adults who are immunocompromised similarly demonstrate lower vaccine response and are at greater risk for so-called “breakthrough” COVID-19 cases even after they have been fully vaccinated.
Is this also the case for much younger patients?
“No one knows,” Randy Q. Cron, MD, PhD, professor of pediatrics and medicine, and director of pediatric rheumatology at the University of Alabama at Birmingham and Children’s of Alabama, told Healio Rheumatology. “The guidance that was put out through the American College of Rheumatology for adults with rheumatic conditions and musculoskeletal disorders is something I think we are extrapolating to kids — at least the kids who are 12 and older because that’s the only group that is available to get the vaccine at present. Although, hopefully, that will change sooner than later.”
However, according to Cron, many drugs do not necessitate any ceasing or withholding.
“For a few of them, they do — it’s all kind of laid out in the publications that they have,” he said. “It’s usually like holding a dose about a week after — for example, methotrexate — or sometimes 2 weeks. However, for the most part, for many of these drugs, they don’t even recommend changing while you get the vaccine, with the exception of rituximab and high-dose steroids.”
Despite a lack of data and certainty, Sule said she would hypothesize that the same risks that jeopardize vaccine response in adults would also apply to young children. This is because the medicines work in the same way in kids as they do adults: Repressing the immune system to fight off the rheumatologic disease.
“Any time you do that you dampen the immune response, so they may not generate a full immunologic response to the vaccine,” Sule said. “Like I said, the studies aren’t there yet, but I would hypothesize that it would be the same.”
There are, however, risks unique to the pediatric population. Specifically, there is signal among young adolescent males who receive the mRNA vaccine — either the Pfizer or Moderna formulation — of possible increased myocarditis.
“That seems to be different,” Sule said. “It seems to apply more to male young adults, or the adolescent age population, but overall the CDC says the risk of that is so small, and those kids did recover, so the benefits of the vaccine outweigh that small risk.”
Cron agreed, estimating the risk for pericarditis or myocarditis among young adults who receive the COVID-19 vaccine at about 1 in 10,000, “or slightly less.” In addition, he said most cases tend to resolve on their own. Meanwhile, COVID-19, which carries with it several other complications, can also lead to heart problems, he added.
“Myocarditis and pericarditis do occur, but they are rare and getting COVID is a much higher risk,” Cron said. “In fact, getting COVID can affect your heart, too. Also, most cases of inflammation are self-resolved. They may have chest pains, for example, or they may even have fluid around their heart, and they may need treatment or hospitalization, but most of it self-resolves over a few days.”
Another unique aspect of vaccinating pediatric patients against COVID-19 would be the sheer number of other vaccines children typically receive, according to Sule. These include routine vaccines children receive over the course of a normal childhood, as well as the influenza and seasonal vaccines.
At present, the CDC has yet to specify whether the COVID-19 vaccine would interact with any of those vaccines. It also hasn’t released any warnings suggesting there is a counterindication. Sule recommended that providers discuss these issues with patients’ families to ease any concerns they may have about timing.
“It seems to be safe to give the COVID vaccine with other vaccines, but that would be a talk to have with the pediatrician and with the family about how to time those vaccines — routine vaccines, plus COVID, plus flu, plus all the other seasonal vaccines as well,” Sule said.
Just the Right Dose
Another aspect of the vaccine that providers should be prepared to discuss with families is the dosage. The trial conducted by Pfizer for its COVID-19 vaccine in young children used a two-dose regimen — given 21 days apart — with each dose measuring 10 micrograms, smaller than the 30-microgram shots approved for those 12 years and older.
According to L. Nandini Moorthy, MD, MS, FAAP, professor of pediatrics at Rutgers University and chief of pediatric rheumatology services at Bristol-Myers Squibb Children’s Hospital at Robert Wood Johnson University Hospital, in New Brunswick, New Jersey, providers must ensure children receive the appropriate dose for their weight and size.
“We need to review safety data and ensure that the trials have considered their size and safety while testing a specific dosage,” Moorthy said. “Additionally, we consider their disease activity, medications they are on and the extent of immunosuppression.”
Based on the Pfizer trial data, children aged 5 to 11 years mounted a strong immune response with the reduced doses 1 month after their second shot, Moorthy said. The most common side effects were fatigue, fever and muscle aches.
“Once the FDA approves the Pfizer-BioNTech vaccine for children 5 to 11, it would be given on the same schedule, but the youngsters would receive a lower dose than adolescents and adults,” Moorthy added.
Butting Heads against Hesitancy
Cron spends a “big chunk” of his time these days talking about the COVID-19 vaccine with his patients and their families, he said.
Most of the time, these discussions are with families who are eager for their children to receive their doses. In some cases, family members are waiting for a green light from their child’s rheumatologist regarding how and when to withhold certain immunosuppressive medications.
“It’s great when families come in and tell me that, yes, the 14-year-old has already had two doses, or they just got their first dose and they’re waiting to get their second,” Cron said. “That brightens my day. And then there are some families that just wait to see me, or see their providers, because in a lot of ways the pediatric rheumatologist is as important to these families, if not more, than even a general pediatrician. So, they are waiting for us to kind of give the OK to get the vaccine. In our institution, we can actually provide it that day.”
However, there are some families who are not just hesitant about the vaccine, but actively against it — both for themselves and their children.
“There is the chunk of families for whom it doesn’t matter what you tell them, they’re not going to do it,” Cron said. “And it’s really not the kids. It’s usually the parents. It’s very similar with the anti-mask stuff — the kids, for the most part, don’t care. But it’s the parents that get upset about their child being required to wear a mask at various school systems.”
“There are just some families who are just not going to do it, so I don’t bang my head against the wall too long, because they are my patient and I want to do what’s right for their arthritis, too,” he added. “You can tell pretty early on that some of them get a little testy, that they don’t even want to talk about it.”
According to Moorthy, it is important to tailor vaccination-acceptance-boosting messages, and messaging platforms to a particular community’s root causes of hesitancy. It is also important, she said, to provide patients and families with reliable and culturally-sensitive resources.
“The ideal way is to engage the family in honest discussions, respond to their questions in a non-judgmental manner, build trust and focus on protection of the child and community,” Moorthy said. “Finally, it is important to reassure your patients and their families to the extent the data allow, and to be unequivocal in your articulation of your recommendations.”
For Sule, it’s about listening to parents and guardians. Some parents worry the vaccine was developed “too quickly,” while others are concerned the vaccine will cause a flare of the child’s rheumatologic disease.
“Just laying out the data that is out there about those concerns can help,” she said. “The flare data isn’t available for kids yet, but there is some data for adults. There is always a risk for mild flare anytime you stimulate the immune system with any vaccine, but in this situation, COVID is such an aggressive, life-threatening infection that I think the benefits of the vaccine outweigh the risks.”
Meanwhile, for those parents who are waiting, perhaps not so patiently, for the vaccine’s umbrella of protection to expand to their 5- to 11-year-olds, the answer for now remains “hang on.”
“We get those kinds of questions all the time, and we just say, ‘Hang on’,” Cron said. “We tell people to continue doing the smart things, like wear your mask and social distance, try to not go to large indoor gatherings, and all the basic stuff.”
It is also important to stress how much “all the basic stuff” has been working, Cron added. Last winter, Cron and his colleagues saw “essentially no” cases of influenza or RSV in their hospital, he said.
“Which is crazy,” Cron said. “But I think it was largely because of those measures — masking, social distancing and avoiding large indoor gatherings. It showed that those basic methods work. And that’s what we tell people until the vaccines become available for that age group.”
Sule has also received her fair share of calls from parents or guardians asking, “When can we come get it?”
“Most of the calls have been from the parents who are eager to get their kids vaccinated,” she said. “Because the kids are in school and doing things with other kids, most of the parents are eager to get their kids vaccinated. Hopefully it will be released soon to the 5- to 12-year-old population, and we are encouraging our rheumatologic kids to get it, because as we have mentioned, many of these children are taking immune-suppressing medicine, which puts them at risk for any infection, including COVID.”
For more information:
Randy Q. Cron, MD, PhD, can be reached at 1601 4th Avenue South, Birmingham, AL 35233.
L. Nandini Moorthy, MD, MS, FAAP, can be reached at 89 French Street, First Floor, New Brunswick, NJ 08901.
Sangeeta Sule, MD, PhD, can be reached at 111 Michigan Avenue NW, Washington, DC 20010.