June 28, 2022 – Some important questions remain after the recent authorizations of two COVID-19 vaccines for infants, toddlers, and young children through 5 years of age. If you're a parent or health care provider perplexed by all the nuances, you're not alone.
To answer some of those questions, infectious disease experts shared what they know during a media briefing today sponsored by the Infectious Diseases Society of America.
The FDA authorized the Moderna and Pfizer vaccines on the same day, June 17. But that doesn’t mean they're the same: They are dosed differently, on different schedules, and for slightly different age ranges.
"There will be opportunities for confusion there," said C. Buddy Creech, MD, president of the Pediatric Infectious Diseases Society.
Along with Jason G. Newland, MD, of the Washington University School of Medicine in St. Louis, Creech addressed other concerns, including:
- What did studies for the newly authorized COVID-19 vaccines in children 6 months old and older show, and why did results take so long?
- Are vaccines really necessary if it appeared the youngest children were largely spared from the effects of COVID-19 early on in the pandemic?
- Why did officials authorize two doses for the Moderna and three doses for the Pfizer vaccines?
- Should parents wait if their child will move to an older vaccine dose group soon?
- Why are some pharmacies and other retail settings reluctant or unwilling to vaccinate these youngest children?
What Studies Showed
Regarding the data reviewed by the FDA, the CDC, and their independent advisory groups, "we know that three doses of the Pfizer vaccine, at a tenth of the [adult] dose, and two doses of the Moderna vaccine, at a quarter of the dose, result in immune responses that are on par, if not sometimes better than, what we see in young adults receiving the full dose of vaccine," said Creech, who is also director of the Vanderbilt Vaccine Research Program in Nashville.
"That's really important because it shows us that children respond very well to the vaccine," he said. “And in fact, that's what we saw. We saw protection against both the Delta and the Omicron variants during those waves when the clinical trials were underway."
Many parents anxious to vaccinate their youngest children wondered why emergency use authorization took longer in this age group.
"We wanted to make sure that we could find the smallest dose necessary to make the best immune response possible," Creech said. Finding the optimal dose takes time "because we're evaluating safety and revaluating how well the immune response handles that vaccine."
In terms of safety, children ages 6 months up to 4 years in the Pfizer research and ages 6 months through 5 years in the Moderna studies showed "they respond like they do to any other childhood vaccine," Creech said.
Low-grade fever, for example, occurs in about 5% to 6% of children.
“Some children get fatigued," he said. "They take an extra-long nap the next day – which I've never heard of a parent complain about at any point." Soreness where they got the shot and some fussiness for a day or two have also been reported.
"What's most important is that we did not see any of the severe adverse events that we were specifically looking for, whether that was unusual heart inflammation, blood clots, hospitalization, or anything related to that," he said.
The evidence so far indicates “it works and that it's safe, and that should give parents and pediatricians a lot of confidence,” Creech said.
But Aren't Kids Resilient?
"At the beginning of the pandemic, we talked about how [young children] were kind of almost spared and we weren't seeing a lot of disease," said Newland, a professor of pediatrics and pediatric infectious disease at Washington University.
But, he said, "what we have seen, especially with Omicron, was a number of hospital admissions, and we had – specifically in this age group of those less than 5 – over 400 deaths."
Newland said parents wondering why they should vaccinate their young children should consider these three things:
- "Number one, it will prevent death."
- The vaccines can prevent severe disease and hospitalization. "Many of you have learned about this multi-system inflammatory syndrome in children," Newland said. "You are now impacting some potential long-term complications by being vaccinated."
- Vaccinating the youngest can help protect the whole family. “We all live in homes with loved ones or with multiple generations, and by having another individual vaccinated, we now are providing another layer of protection for those at the highest risk."
Two Doses or Three?
The first and second doses of a primary vaccine series are scheduled about 1 month apart to create a good immune response up front, Creech said. The Moderna vaccine in this age group "will probably go the way of the adult recommendations," he said, with a booster recommended about 5 or 6 months later.
"What Pfizer had to do, because their numbers didn't look as good as they wanted them to at that very tiny dose of one-tenth [the young adult dose]," was to include a third dose Into the primary series, Creech said.
If time is an issue and a child needs to be fully protected quickly, "that might give the nod to Moderna," he said. "If time is not so much of an issue or Pfizer is the one that's available, Pfizer is a great vaccine that will also result in very good immune response."
Now or Later?
A reporter asked if parents should wait if they have a child about to age into an older vaccine dosage group.
"The best vaccines to get is the one that's about to go into your shoulder, whether you're 4, almost 5, or 5, almost 6," Creech replied. "I don't think now in the middle of the pandemic is the time to wait."
He said that a child about to join older peers would likely get a booster in the future with the next appropriate dose of vaccine.
"I think we can assure parents that getting vaccinated now rather than waiting until the next age group is a very sound way to go," Creech said.
Some Pharmacies Take a Pass
Some news headlines in the past 10 days highlight that some pharmacies and other retail settings do not plan to vaccinate very young children against COVID.
"Some of it is a practical issue that many pharmacists at a commercial pharmacy may not have a lot of experience vaccinating young children less than 5," Creech said. "This is different than a simple vaccine in the deltoid [shoulder muscle] of someone shopping for groceries and then taking advantage of a vaccine clinic that's there in the store."
One of the reasons retail pharmacists have less experience is most childhood vaccines are given in a pediatrician’s or family doctor’s office. "So they have less familiarity," Creech said. Also, some of the younger children are vaccinated in the thigh, not the shoulder.
"I agree with Dr. Creech," Newland said. "There are people just aren't comfortable vaccinating young children because they don't vaccinate a lot of them and many young children won't sit still."
Parents, Talk to Your Doctor
"I think parents are starting to realize that this is not the pandemic of 2020," Creech said. "One of the ways it's changed is new variants have come along that require us to make new decisions."
He said that if people have any other questions, "I would encourage parents to have a frank conversation with your pediatrician or with your trusted medical provider to be able to think through what the questions are, what the risks are, and what the benefits are – so you can make a really good decision for your family."