The CDC’s Immunization Practices Advisory Committee (ACIP) voted unanimously on Thursday to recommend that children between the ages of 6 and 17 receive Moderna’s vaccine against COVID-19.
With a 15-0 vote, ACIP approved a two-dose primary series of mRNA vaccine for children 6 to 11 years of age (50 mcg per dose) and adolescents 12 to 17 years of age (100 mcg per dose) . The recommendation is now awaiting approval from CDC Director Rochelle Walensky, MD, MPH.
The recommendation was highly anticipated and followed the FDA’s emergency use authorization last week. Until then, only the Pfizer / BioNTech mRNA vaccine had been authorized and recommended for these age groups.
At Thursday’s meeting, ACIP members considered the safety and efficacy data for the Moderna vaccine, which was studied primarily during the periods when SARS-CoV-2 and Delta ancestral strains predominated, in adolescents and younger children, respectively. In both groups, the vaccine was effective against serious illness and hospitalization.
“We know the benefits outweigh the risks of the COVID-19 mRNA vaccine at all ages,” Sara Oliver, MD, of the CDC’s National Center for Immunization and Respiratory Diseases, said during the meeting. “Receiving this primary series remains the safest way to prevent severe COVID-19.”
Oliver stressed that serious results with COVID-19 do not forgive children. The Omicron wave was accompanied by an increase in hospitalizations among children and noted 189 COVID-related deaths in children aged 5 to 11 years and 443 in children aged 12 to 17 years during the pandemic.
Several ACIP members raised questions about the intervals between the first and second doses of the Modern vaccine, as this approach may reduce the risk of vaccine-associated myocarditis. Some evidence suggests that the Modern vaccine carries a higher risk of myocarditis or pericarditis than the Pfizer vaccine, although CDC experts warned that these findings are inconsistent across all U.S. control systems.
Among about 55 million doses of the Pfizer vaccine given to people ages 5 to 17, the rare adverse event has been observed in at least 635 children, according to the CDC. The risk is usually highest among children aged 12 to 17 years, in boys and after the second dose. Among children aged 5 to 11 years, no signs were detected.
In a presentation on clinical considerations, Elisha Hall, PhD, of the CDC’s National Center for Immunization and Respiratory Diseases, said that while the current recommendation is a 4-week gap between the first and second dose, the CDC will recommend an 8-Week Interval for teenage men. (The CDC also recommends shorter dose ranges for immunocompromised children).
Some ACIP members expressed confusion about the labels of Moderna vaccine products in each age group. The authorized product for children 6 to 11 years will have the same color cap as the vaccine for children 6 months to 5 years, but a different colored border to distinguish the highest concentration. For the authorized product for children aged 12 to 17, it will have the same label as the adult vaccine, as it is the same dose.
“I’m … concerned about vaccine administration errors,” said Matthew Daley, MD, chair of the ACIP working group. Others echoed concerns about administrative errors, encouraging more resources for suppliers and more clarification on manufacturer labeling.
The safety and efficacy data of the Moderna vaccine in this younger population come from two ongoing phase II / III clinical trials (mRNA-1273-P203 study for adolescents 12 to 17 years of age and mRNA-1273-P204 study for children aged 6 to 11). The studies included about 8,000 children in total.
Among participants aged 12 to 17 years, vaccine efficacy was 93.3% (95% CI 47.9–99.9) during a time when ancestral and Alpha strains were predominant. Among the younger group, vaccine efficacy was 76.8% (95% CI -37.3 to 96.6) during a period in which Delta was more common.
The committee agreed the data that COVID-19 vaccines protect children from serious illness. Many children in this age group, however, remain unvaccinated. According to Oliver, approximately 30% of adolescents and 65% of younger children have not yet received a vaccine.
“We can predict that with future increases in COVID-19, unvaccinated people will continue to bear the burden of the disease,” he said.
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Amanda D’Ambrosio is a journalist on MedPage Today’s research team and company. He covers obstetrics-gynecology and other clinical news, and writes articles on the U.S. health care system. Follow