FDA

FDA Advisers Approve Pfizer, Moderna Vaccines for Kids 6 Months to 5 Years Old

The FDA and CDC still needs to give full approval for the age group to become eligible

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Alyssa Allen and her family of four have waited patiently for this moment. The FDA began to green-light the COVID-19 vaccine for infants, toddlers and children five and under.

Allen’s daughter Hallie is 3 years old, the only one in the family not protected.

“The big word is 'finally,' my family has been waiting what feels like forever to get our youngest child vaccinated. We were ecstatic when we could get it as adults,” said Allen on Wednesday.

An FDA Vaccines Advisory Committee reviewed hours worth of data from Pfizer and Moderna Wednesday that showed high efficacy at preventing hospitalization and death. Data also showed minimal side effects from the shot and no severe complications. The committee voted unanimously 21-0 to approve both vaccines for children six months to five years old.

Moderna’s vaccine would be administered in two doses, each one is one-quarter the dose of the adult version. Pfizer’s vaccine is a three-dose series, each dose about one-tenth of the adult shot.

Local pediatricians encourage parents to vaccinate their young children as soon as they are eligible, saying the benefits vastly outweigh the risks.

“Vaccinating your young child really does mitigate the risk of more serious complications from contracting COVID. Children who contract COVID, there is a much higher risk of long-term COVID, hospitalization, even death, as compared to the vaccinated group,” said Dr. Danielle Squires, a pediatrician with Kings Bay Pediatrics in Pinecrest.

The FDA Committee acknowledged millions of children have contracted COVID and recovered fully in the United States. But they also considered the most troubling data: Nationwide, 147 children ages four and younger have died of COVID in the first five months of this year, according to the U.S. Centers for Disease Control and Prevention. That’s far beyond the number of kids in the same age group that died of the flue from 2018 to 2020, which sits at no more than 87.

“This is a tremendous burden. Having cared for many children that have been in the ICU on ventilators with COVID and several who have died of COVID, we need to be able to prevent COVID-19,” said one doctor on the FDA panel.

Florida Surgeon General Dr. Joseph Ladapo opposes the FDA Committee’s move.

“From what I’ve seen there’s insufficient data to inform benefits and risks in children,” said Dr. Ladapo.

Many South Florida pediatricians and infectious disease doctors disagree with him.

“This is a group we haven’t been able to fully protect, so I’m looking forward to vaccinating, it’s also a group that’s the last ones left, so sometimes the little ones are actually bringing home COVID to their parents and grandparents,” said Dr. Squires.

Meanwhile, Allen says if the shot is approved by the CDC, she will be on the phone to make an appointment for her 3-year-old daughter next week.

“It’s a sense of safety and assurance, Iike you can finally start breathing again,”said Allen.

The FDA and CDC could give full approval as early as this weekend, which could make the vaccines available by next week.

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