So why the difference? And what should parents of 11-year-olds do, especially if the child is turning 12?
“We think we’ve optimized the immune response and minimized reactions,” Pfizer senior vice president Dr. William Gruber told the FDA’s vaccine advisors Tuesday about the company’s Covid-19 vaccine for young children.
It’s not about the size of the child. Rather, it is that young children are still developing, and the immune system tends to weaken with age.
“Children have a really strong immune response,” said Dr. Kari Simonsen, who is leading the Pfizer vaccine trial at Children’s Hospital and Medical Center in Omaha, Nebraska. “In some cases, they can actually create stronger responses to small amounts of vaccine antigen.”
For some vaccines, the adult and child doses may be the same, but in other cases, such as with the hepatitis A vaccine, adults receive a higher dose than children.
“As we’re fond of saying in pediatrics: Children are not little adults. Children are children,” says interim pediatrician at Texas Children’s Hospital, Dr. James Versalovic said. “Their bodies are evolving and will react differently, and we need to treat them differently.”
It was an idea as Pfizer tested vaccines in young children.
“After adolescence we took a step back, and we looked at dosage, because we thought we might be able to use a lower dose and be able to get the same immune response,” says Dr. Bob Frenk. said, director of the Vaccine Research Center at Cincinnati Children’s Hospital.
After testing, “we found a similarly good immune response to the 30-microgram dose and had fewer side effects.”
At the higher doses tested in trials, the scientist noticed a few more minor side effects, nothing serious. With the 10 microgram dose, the researchers saw fewer issues with chills and fever in the 16 to 25 year olds tested.
The low dose should also reduce the theoretical risk of myocarditis, an inflammation of the heart muscle seen in a small number of people after receiving the Pfizer and Moderna vaccines. The trial saw no cases of myocarditis in young children, but did not test enough children to show whether they were also at risk. Scientists will keep a close watch on matters.
“It’s reassuring to me that we’re giving a low dose,” said Dr. Paul Offitt, a member of the independent FDA Vaccine Committee who directs the Vaccine Education Center at Children’s Hospital of Philadelphia.
Should a child around 12 years old wait for a larger dose?
“If I had a family member in that situation, I would advise them to only take the dosage that is authorized for their current age,” Wiederman said. “I think we still have a reasonable risk that we will see cases rise again in the next few months.”
Pfizer’s Gruber said dosage levels for ages 12 to 15 may be reduced at some point, but there is no data yet to support such a change. Earlier research had shown that this age group had a higher antibody response with a dose of 30 micrograms.
“We’re thinking about it as a possible option, especially as we move out of the pandemic period,” Gruber said, considering a smaller dose. “The main goal right now is clearly to provide protection with a safe and effective vaccine.”
Wiedermann said doctors shouldn’t take that idea and go with it for now 12- to 15-year-olds.
“I’m telling my providers that you should always stay within the lines when you’re coloring,” Wiederman said. “The immune response to this virus is very complex. A physician may think, whether giving a higher dose or a lower dose, that they are helping a particular child, but that is not the case if it has not been studied.” Do it, because we don’t really know what the impact will be. This is not the time to mess with anything outside of what’s authorized.”
what happens next?
The FDA will consider the support of its vaccine advisors and possibly extend the emergency use authorization to children ages 5 to 11 over the next few days.
Next, the CDC’s independent vaccine advisory committee meets on November 2, and will vote on whether to recommend it for use.
Ultimately, CDC Director Dr. Rochelle Valensky will decide whether to accept or revise the CDC committee’s recommendation. Once a recommendation is finalized, young children can begin getting vaccinated immediately.
Some 28 million children will be eligible for the Covid-19 vaccine, and plans to help them get it are already underway. Experts have said that by vaccinating this group, the country can move closer to ending the epidemic.
“If we can create a situation where more of these kids aren’t getting infected, we should be able to reduce this epidemic, which is what we really hope to do even when faced with cold weather and other concerns.” Let’s see if we can see another surge,” said National Institutes of Health director Dr. Francis Collins said Tuesday on ABC’s Good Morning America. “We don’t want that, and it will be an important step towards putting our country in a really better place.”
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