The U.S. Food and Drug Administration and the Centers for Disease Control have given a thumbs up to begin distributing the Pfizer-BioNTech COVID-19 vaccine, through emergency use authorization to children 5 and older. A study of nearly 2,300 children found the vaccine is 90.7% effective against symptomatic infections.
As we’ve seen with all prior age groups, the clinical trial process by the FDA is rigorous and didn’t happen overnight.
Sanford Health News sat down with experts in pediatrics and infectious disease who weigh in on this latest milestone.
Trial data shows vaccine is safe, effective for 5+
“The vaccine is very good at preventing infection, is excellent at preventing severe disease or hospitalization and is outstanding at preventing death,” Dr. Lopez said.
“In kids, data shows the vaccine generated an immune response that will protect against the delta variant,” he said. “So, that’s an important piece that we learned from this trial.”
Kids in this age group will be administered only 10 micrograms, which is a third of the dose kids 12 and older receive.
Dr. Lopez said the data shows the same, effective immune response greater than natural infection.
“That’s really impactful in terms of this vaccine and how this vaccine works.”
Vaccine side effects in kids are minimal
Dr. Lopez said the vaccine’s side effects were comparable with the 16-25-year-old age group: They’re mild and they resolve within 48 hours.
He said the three most common side effects, by and large, found in clinical trials were:
- Fatigue or feeling tired
- Muscle aches
The less-common side effects found in clinical trials were:
- Joint pain
“The vast majority of all these side effects resolve within 48 hours of the second dose,” Dr. Lopez said. “So, very short-lived effects.”
There were no cases of myocarditis, a very rare inflammation of the heart, in the vaccine or placebo control groups.
Additionally, there were no cases of severe reaction or death related to the vaccine.
“The vaccine in the clinical trials had an excellent safety profile,” he added.
Why young kids need the vaccine
“The COVID vaccine is one major tool we have to protect ourselves from this virus,” Dr. Tokunbo Akande, M.D., said.
Dr. Akande is a pediatrician at Sanford Health in Bemidji, Minnesota.
“Having the ability to now extend this to the younger kids is just so exciting for me as a health care provider who sees parents and kids who have schedules disrupted following another COVID exposure.”
Kids are at risk for severe COVID illness, complications
Data released by the American Academy of Pediatrics in late October revealed about 1.9 million children ages 5-11 years have been infected, about 9% of all U.S. cases. More than 8,300 have been hospitalized and 94 have died. The death toll in the past year puts COVID-19 in the top 10 causes of death for this age group.
Of the number of kids who were infected, data shows only 42% have natural immunity for COVID-19 which means there are still a lot of children susceptible to the virus. A third of kids admitted with COVID-19 were hospitalized in the intensive care unit.
Not only are kids at risk for complications, but they continue to be a vessel in transmitting the virus.
Furthermore, experts like Joseph Segeleon, M.D., vice president and medical officer for Sanford Children’s, warn of the long-term effects of the virus in children.
With more infected children comes the risk of more long-term effects after the virus, such as “long COVID” or “long hauler syndrome,” which is any cluster of symptoms that hang around longer than six weeks.
For example, COVID-19 patients report a loss of taste or smell, long-term lung disease, lung scarring, cardiac abnormalities, brain fog and others over a long period of time.
“Anyone who is having those effects, which can happen in 5(%) to 10% of people who have COVID, would absolutely wish them away in a heartbeat,” Dr. Joseph Segeleon said.
Dr. Segeleon said the vaccine has proven its safety and eliminates the risk of long-term side effects.
Concerns linger over mental health, social development
The pandemic also has taken a toll on children’s education and their mental health, prompting the AAP, American Academy of Child and Adolescent Psychiatry and Children’s Hospital Association to declare a national emergency in children’s mental health earlier this month, according to the AAP website.
“Kids aren’t having the typical interactions as they grow which affects development,” Dr. Akande said.
Mask wearing limits the face-to-face interaction among children with something as simple as facial expression, Dr. Akande said.
“Having this younger population vaccinated, along with adults, just increases the number of protected people and pushes us closer to that herd immunity stage wherein we can let our guard down a little bit.”
Having kids vaccinated prevents the spread of infection and serious illness while it helps keep classrooms safe and operational, he said.
What this means for course of pandemic
Like any previous disease, the more children are vaccinated, the less likely it is for COVID-19 to spread or cause long-term risks and hospitalizations.
“This will be another step in moving to pre-pandemic activities in a safe manner,” Dr. Lopez said.
Not only an expert in child infectious diseases but a father of three under 5 years old, Dr. Lopez has zero reservations about the safety and efficacy of the vaccine.
“My kids don’t qualify for the vaccine yet but I’ve done so much homework that if they approve for the 6 months to 4-year-old age group, I would give it to my kids without any hesitation.”
More than one billion people have safely received the full regimen of the COVID-19 vaccine with no significant red flags or concerns with safety.
“I’m optimistic that the outcome is parents understanding more about the vaccine and parents will feel comfortable giving their kids the COVID-19 vaccine,” Dr. Lopez said. “I think it’s really important that our children are being protected with the best tool that we have.”
Appointments can be made through My Sanford Chart or by calling 1-877-701-0779. The vaccine will be available for children at Sanford Health primary care clinic locations. If you have questions about the vaccine as you look to make an informed decision for your family, contact your primary care provider.
Information in this article was accurate when it was posted. As the COVID-19 pandemic changes, scientific understanding and guidelines may have changed since the original publication date.
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