By Gina DiPietro, Novant Health Healthy Headlines
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Pfizer’s COVID-19 vaccine could be authorized for children ages 5 to 11 by Halloween or early November, top U.S. health officials confirmed. The announcement came after Pfizer released data of its clinical trial of more than 2,200 children, showing its COVID vaccine is safe and effective in this younger age group.
Dr. David Priest
“The preliminary data from Pfizer 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.”
As parents wait for emergency use authorization (EUA) from the Food and Drug Administration (FDA), questions are pouring in. Here are 9 things to know right now.
Is it FDA-approved?
The Pfizer vaccine has been approved by the FDA for people 16 and older but is still under emergency use authorization for adolescents ages 12 to 15.
For kids 5 to 11, Pfizer will detail its clinical trial data in a formal application to the FDA. The vaccine will be evaluated and considered for EUA, which provides access to medical products that may be effective in preventing or treating a disease, provided the FDA determines its potential benefits outweigh any potential risks. This process can take weeks or months.
If Pfizer’s review process follows a similar timeline to the ones for older children and adults, it’s possible kids age 5 to 11 could be inoculated before Halloween. Once the approvals are in place, Novant Health will be ready to begin administering the vaccine at walk-in clinics and pediatrician offices.
Is this the same COVID vaccine that adults and adolescents receive?
Yes, the only difference in Pfizer’s vaccine for kids age 5 to 11 is a smaller dose. Once it is FDA-approved, they will receive a 10-microgram dose. That’s one-third the 30-microgram dose that adults and adolescents receive.
Additionally, an even smaller dose is being administered to kids 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.
Is the vaccine dose for kids as effective as in adults? Is it given in two shots?
It appears so. At the lower 10-microgram dose, the vaccine produced the “same type of strong immune response,” similar to that in older populations at a higher dose, Pfizer said in its clinical trial data.
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.
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. A recent study from the American Academy of Pediatrics (AAP) showed that kids make up more than 25% of COVID cases in the United States.
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.
Are there any safety concerns about administering the vaccine to children?
Pfizer says the vaccine at a lower dose is safe for children, but full safety data won’t be available to the public until it’s officially reviewed by the FDA.
Cases of myocarditis (inflammation of the heart) have 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 important to remember that myocarditis can 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.
What about parents who are still hesitant?
Pfizer’s study included more than 2,000 kids and “if you look back at the history of clinical trials, that’s a pretty big number. I think it’s adequate,” Priest said. “If the vaccine is approved for kids age 5 to 11, I think parents can be confident that it’s safe and effective.”
He encouraged parents to speak with their pediatrician and ask questions as they make a decision.
What side effects should kids 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.
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. 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.
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