By Mary O’KEEFE

COVID-19 vaccines are now approved for children from age 6 months to 5 years. This announcement came after a Food and Drug Administration (FDA) panel unanimously voted on June 15 to authorize the use of Moderna and Pfizer/BioNTech COVID-19 vaccines for children. The Centers for Disease Control and Prevention (CDC) also approved the vaccines.

On Wednesday, the CDC held a webinar on recommendations for Pfizer-BioNTech and Moderna COVID-19 vaccines for children 6 months through 5 years of age.

“There is a perceived myth that young children have no ill effects from COVID-19,” said Sara Oliver, M.D., MPH of the CDC. Dr. Oliver is a commissioned officer in the U.S. Public Health Services and board certified in pediatrics and pediatric infectious disease. In addition, Dr. Oliver is the lead for the Advisory Committee for Immunization Practices COVID-19 Vaccines Work Group.

According to the CDC, there have been more than 2 million cases of COVID-19 among children ages 6 months to 4 years. Children in this age range are at risk of severe illness from COVID-19 and more than half of hospitalized children in this age group had no underlying conditions. Prior infection does not provide broad protection, Oliver added.

The trial for the vaccine ran from December 2021 to February 2022. During the Moderna trial there were no deaths reported in any trial participants; serious adverse events were rare overall, there were no cases of myocarditis in any trial participants and no cases of vaccine-associated anaphylaxis in any trial participants. The most common reactions were pain at the injection site and, for those 2 years old to 5 years old, there were complaints of fatigue and headache. For those 6 to 23 months, the most common reactions reported by parents were their child’s irritability and sleepiness. These symptoms occurred one-to-two days after the injection, Oliver said.

Fevers were more common after the vaccine and more often after the second dose. Most fevers were reported on days one and two after the dose was given and lasted a median of one day. However, fevers are more common with other routine vaccines given to this age group than the COVID-19 vaccine, Oliver said.

The Moderna COVID-19 vaccine will require two doses, 28 days apart.

Similar trials were done for the Pfizer vaccine. Pfizer will require three doses. Dose one and dose two are separated by 21 days; dose two and dose three are separated by at least eight weeks.

“Many parents, caregivers and clinicians have been waiting for a vaccine for younger children and this action will help protect those down to 6 months of age. As we have seen with older age groups, we expect that the vaccines for younger children will provide protection from the most severe outcomes of COVID-19, such as hospitalization and death,” said FDA Commissioner Robert M. Califf, MD. “Those trusted with the care of children can have confidence in the safety and effectiveness of these COVID-19 vaccines and can be assured that the agency was thorough in its evaluation of the data.” 

The American Academy of Pediatrics suggests parents call their child’s pediatrician or primary care doctor to talk to them about COVID-19 vaccination. Ask them questions and share any concerns.

There are some parents who have been waiting for this since vaccines were announced, others who are choosing to wait to get their child vaccinated and still others who will not get their child a COVID-19 vaccination at all. Next week CVW will speak to local pediatricians; anyone who has specific questions they would like CVW to ask can email mary@cvweekly.com by Monday, June 27.