By Gina DiPietro, Novant Health Healthy Headlines
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An endorsement from a Food and Drug Administration (FDA) advisory panel puts children ages 5 to 11 closer to eligibility for Pfizer’s COVID-19 vaccine.
It’s promising news for the nearly 6.3 million children who have tested positive for COVID since the pandemic began – and parents eager to protect them.
“I have a 10-year-old and I can’t wait until it’s time for her to get vaccinated,” said Nikki Nissen, vice president for clinical operations and chief nursing officer for the Novant Health Medical Group clinics.
While she waits on emergency use authorization (EUA), Nissen reminds people of a new state law in North Carolina, which requires that a parent or legal guardian provide written consent for anyone under 18 to receive a vaccine that only carries emergency use authorization from the FDA.
Since Pfizer’s COVID vaccine carries full FDA approval for those 16 and older, parental consent is only currently required for youngsters under age 16. Here are nine other things for parents to know right now:
Is it safe?
Data from Pfizer’s clinical trial showed its vaccine is safe and effective in children 5 to 11 – producing “mostly minor side effects” and the “same type of strong immune response,” similar to that in older populations, the company said.
Dr. David Priest
The preliminary data is “very promising’ in terms of its safety profile for children, said Dr. David Priest, Novant Health chief safety, quality and epidemiology officer.
“In the months ahead, I think we’ll also see the COVID vaccine get incorporated into the childhood vaccination schedule, and it will be a routine part of care going forward. So, we’re excited for that,” Priest said.
Pfizer’s study included more than 2,000 children and “if you look back at the history of clinical trials, that’s a pretty big number. I think it’s adequate,” Priest added. “If the vaccine is approved for kids age 5 to 11, I think parents can be confident that it’s safe and effective.”
When can my child get vaccinated?
Adolescents age 12 to 15 have been eligible for Pfizer’s vaccine since May, under a previous emergency authorization.
The FDA will meet soon to consider its use for ages 5 to 11. While it’s not bound by the advisory panel’s recommendations for EUA, if often agrees with them.
If FDA-approved, the Centers for Disease Control and Prevention (CDC) would make its own recommendations about whether this age group should become eligible. So, it’s possible kids age 5 to 11 could be inoculated before Thanksgiving.
Once the approvals are in place, Novant Health will be ready to begin administering the vaccine at walk-in clinics and pediatrician offices.
Is it the same COVID vaccine that adults and adolescents receive?
Yes, the only difference in Pfizer’s vaccine for ages 5 to 11 is a smaller dose. If approved, they will receive a 10-microgram dose. That’s one-third the 30-microgram dose that adults and adolescents receive.
As in adults, the vaccine would be given to younger children in two shots, administered at least three weeks apart. Both doses are necessary to get full immunity.
Additionally, an even smaller dose is being administered to children under 5 in its ongoing clinical trial. So far, a 3-microgram dose (one-tenth of what adults receive) appears to generate an adequate immune response, Pfizer confirmed.
If most children don’t get seriously ill from COVID, why should my child get vaccinated?
Dr. Aliza Hekman
While COVID does not typically result in serious illness in children, Aliza Hekman, a Novant Health physician assistant who specializes in infectious diseases, noted an increase in pediatric hospitalizations during the latest surge.
Another reason to vaccinate is to slow the spread of COVID in the community. This helps protect those too young to receive the vaccine and vulnerable populations who are more likely to have serious complications.
Bottom line: The more people we can vaccinate, the more lives we’re able to save.
What about parents who are still hesitant?
People age 65 and above, and those with compromised immune systems, are especially vulnerable to COVID complications, Priest said. He encourages families to focus on that.
“I tell people to consider their home situations. Who lives in the home? Immunosuppressed people? Grandparents? Someone going through chemotherapy? Getting children vaccinated is a way to protect the child and ultimately, their household,” Priest said.
Hekman, also confident the vaccine is safe, plans to vaccinate her children. “I have 3 children in the 5-11 age range that I will be getting vaccinated when they are eligible,” she said.
Parents are encouraged to speak with their pediatrician and ask questions as they make a decision.
What side effects should children anticipate?
Side effects (also referred to as expected effects) in children are similar to what adults experience after vaccination, including:
– Tiredness.
– Headache.
– Muscle pain.
– Fever or chills.
– Soreness at the injection site.
These may affect children’s daily activities but will go away within a few days. Contact your child’s pediatrician if expected effects linger.
Any there any safety concerns about administering the vaccine to children?
In rare cases, myocarditis (inflammation of the heart) has occurred after mRNA vaccines – especially in male adolescents and young adults. This will likely be addressed in the FDA review for younger children, Hekman said, who added that most cases have been mild and responded well to medicine and rest.
It’s worth nothing that “no cases of myocarditis” have been reported in clinical trials with Pfizer’s product in children ages 5 to 11, Priest said.
Myocarditis can also occur after many viral infections, including COVID-19. Benefits of the vaccine will likely be shown to outweigh the potential risks of having a rare adverse reaction to vaccination, including the possible risk of myocarditis.
Can the COVID vaccination be given at the same time as other shots?
Yes. You can receive COVID-19 vaccines the same day as other vaccines, the CDC confirmed. Keep this in mind if your child will be vaccinated against the flu. They can safely receive both in one visit.
Should I be concerned about future fertility for my child?
The mRNA technology shows cells how to make a protein – think of it as a blueprint – that triggers an immune response. And then it disappears. There is no plausible mechanism by which an mRNA vaccine could affect future fertility of children, doctors confirm.
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