There is promising news for parents eager to protect their kids against COVID, and teachers who recently welcomed them back to school.

Following its clinical trial of more than 2,200 children, Pfizer released data showing its COVID vaccine is safe and effective in kids ages 5 to 11. This age group received 10 micrograms – one-third of the dose for adults and adolescents, who receive 30 micrograms.

At this lower dose, the vaccine produced “mostly minor side effects” and the “same type of strong immune response,” similar to that in older populations at a higher dose, the company said.

Dr. Eugene Daugherty

As in adults, the vaccine would be given to younger children in two shots, delivered at least three weeks apart. Both doses are necessary to get full immunity.

The urgency to get younger children vaccinated was only heightened by a recent study that said kids make up more than 25% of COVID cases in the United States.

“What we’re seeing, especially in patients under 12, is an increase in cases partially because of the delta variant, which is more contagious, and the fact that they’re obviously not vaccinated yet,” said Dr. Eugene Daugherty, medical director of Novant Health Hemby Children’s Hospital.

What’s next?

Pfizer will detail its clinical trial data in a formal application to the Food and Drug Administration (FDA). And hopes to do so by the end of September, Pfizer’s senior vice president of vaccine clinical research and development, Dr. Bill Gruber, told reporters.

The vaccine will be evaluated and considered for emergency use authorization (EUA). EUA 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.

How long does it take to receive EUA?

The approval process can take weeks or months, so it’s hard to say. The FDA must sign off on the vaccine before it becomes available.

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.

What about kids younger than 5?

Pfizer is still studying its COVID vaccine in children under 5 years old. A tenth of the adult dose – 3 micrograms – appears “sufficient” so far, experts said.

Moderna and Johnson & Johnson, the other COVID-19 vaccines approved for use in the U.S., are also studying their vaccines in children but have not yet released the findings.

What can we do in the meantime?

Dr. Catherine Ohmstede

Getting vaccinated is the best way to protect vulnerable populations and unvaccinated kids who aren’t yet eligible, said Dr. Catherine Ohmstede, a Novant Health pediatrician. “It’s time for us all to do our part to keep our friends and family safe, end this latest pandemic surge and provide the life we want for our children.”

Pfizer’s COVID vaccine (fully approved by the FDA for people 16 and above) already carries the “emergency status” for children 12 to 15. Pediatricians and public health experts agree the vaccine is safe for this age group and by far, the best way to protect them.

Keep in mind: Getting vaccinated is strongly recommended – even if you’ve had COVID. Here’s why.

Also recommended is protecting yourself – and your family – from the flu.

Dr. Charles Bregier

October is the ideal month to get vaccinated, said Dr. Charles Bregier, Novant Health medical director of corporate health.

“It’s the perfect storm brewing out there. If COVID remains bad and it’s a bad flu season, it could completely overwhelm our nation’s health care system,” Bregier said.

And the more people who get the flu shot, the more effective it is overall. The same goes for the COVID vaccines.

Most children can begin flu vaccinations once they are 6 months old. Not only does it reduce the risk of flu illness and hospitalization for the child, it helps prevent spreading the flu to siblings or babies who are too young to receive it – and other at-risk family members.

And no need to plan your flu shot around the COVID vaccine. They can be safely administered at the same visit, the CDC confirmed.

Novant Health
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