COVID-19 vaccines for children 6 months to 5 years of age are now ready to go. Centers for Disease Control Prevention (CDC) Director Rochelle, Walensky, MD, has endorsed a unanimous recommendation by the agency’s vaccine panel today, allowing vaccinations to begin early this week.
The FDA authorized the vaccines on Friday in children as young as 6 months of age, soon after its advisory panel also unanimously recommended the shots earlier this week.
“Authorization of the Moderna and Pfizer-BioNTech vaccines for children ages 6 months and older will extend the protection of immunization to the last segment of our population awaiting protection. More work remains to vaccinate older children and adolescents, as well. As of June 8, more than 23 million children ages 5 to 17 have received two doses of COVID vaccine. Another 26 million in this age group have yet to receive any doses,” the AAP said in a prepared statement.
“We must not let up in our efforts to make sure all families can benefit from the protection of these vaccines,” said AAP President Moira Szilagyi, MD, PhD, FAAP.
The CDC panel vote in favor of both mRNA COVID-19 vaccines in this age group came after 2 days of deliberation by scientists, clinicians, and other experts participating in the advisory committee.
The Moderna vaccine emergency use authorization is based on two primary doses (one-fourth the adult dose) separated by 1 month. The Pfizer vaccine is authorized as a three-dose primary series (one-tenth the adult dose). The authorized Pfizer vaccine dosing is 21 days between dose 1 and dose 2, followed by 60 days between dose 2 and dose 3.
This level of efficacy “is consistent with adult effectiveness against Omicron,” said Rituparna Das, MD, PhD, vice president for,vaccines at Moderna.
The antibody levels after two doses of the Moderna vaccine in the 6 month to 5 year olds was similar to levels observed in young adults 18 to 24 years. Similarly, the antibody levels after three doses of the Pfizer vaccine were similar to those seen in people ages 16 to 24 years old.
There was one seizure caused by fever reported 3 days after a first dose, a reaction that the study investigator considered related to the vaccine in the Moderna study. “Approximately 6 weeks later, the child has remained in the study and received two doses of the vaccine without [further] events.”
There were no cases of myocarditis or deaths reported in the Moderna or Pfizer studies.
Pain or tenderness at the injection site were the most common local reactions in the Pfizer study. In terms of systemic reactions, irritability and drowsiness were more common in children 6 months to under 2 years. Fatigue was most common in children ages 2 to 4 years. Most symptoms were mild and resolved within 1 to 2 days.
Fevers also were reported in the Pfizer trial, most lasting about 1 day.