A photo of a healthcare worker holding a vial of Spikevax in clear rubber gloved hands.

ACIP supports Moderna’s COVID shot for children aged 6-17

The CDC’s Advisory Committee on Immunization Practices (ACIP) voted unanimously on Thursday to recommend that children ages 6-17 receive Moderna’s COVID-19 vaccine.

With a vote of 15-0, ACIP approved a primary series of two doses of the mRNA vaccine for children aged 6-11 years (50 mcg per dose) and adolescents aged 12-17 years (100 mcg per dose). The recommendation now awaits approval from CDC Director Rochelle Walensky, MD, MPH.

The recommendation was largely expected and followed FDA’s Emergency Use Authorization last week. Until then, only the Pfizer/BioNTech mRNA vaccine had been approved and recommended for these age groups.

At Thursday’s meeting, ACIP members discussed safety and efficacy data on Moderna’s vaccine, which has been studied primarily during periods when the ancestral SARS-CoV-2 and Delta strains predominate, in teens and younger children, respectively. In both groups, the vaccine was effective against serious illnesses and hospitalizations.

“We know the benefits outweigh the risks of the mRNA COVID-19 vaccine across all ages,” Sara Oliver, MD, of the CDC’s National Center for Immunization and Respiratory Diseases, said at the meeting. “Receiving this primary series remains the safest way to prevent severe COVID-19.”

Oliver emphasized that serious consequences with COVID-19 do not spare children. The Omicron wave has been accompanied by an increase in hospitalizations among children, and she pointed to 189 COVID-related deaths in children aged 5-11 and 443 in children aged 12-17 over the course of the pandemic.

Several ACIP members raised questions about the intervals between the first and second doses of Moderna vaccine, as such an approach may reduce the risk of myocarditis associated with the vaccine. There is some evidence that the Moderna vaccine poses a higher risk of myocarditis or pericarditis than Pfizer’s vaccine, although CDC experts cautioned that these findings are not consistent across all U.S. monitoring systems.

Of the nearly 55 million doses of Pfizer vaccine administered to individuals ages 5-17, the rare side effect has been observed in at least 635 children, the CDC said. The risk is generally higher in children aged 12-17 years, in boys and after the second dose. No signals were detected in children aged 5-11 years.

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 for a 4-week period between the first and second dose, the CDC likely has an 8-week interval. for adolescent men. (The CDC also recommends shorter dose intervals for children who are immunocompromised.)

Some ACIP members expressed confusion about the product labels on Moderna’s vaccines in each age group. The product approved for children aged 6-11 years will have the same color cap as the vaccine for children aged 6 months to 5 years, but a different color fringe to distinguish the higher concentration. For the product that is approved for children aged 12-17, it will have the same label as the adult vaccine because it is the same dose.

“I am concerned about vaccine administration errors,” said Matthew Daley, MD, chair of the ACIP working group. Others expressed concern about administrative blunders, encouraging more resources for providers and further clarification of manufacturer labeling.

Safety and efficacy data for Moderna vaccine in this younger population came from two ongoing phase II/III clinical studies (study mRNA-1273-P203 for adolescents aged 12-17 years and study mRNA-1273-P204 for children aged 6 to 17 years). -11 years). The studies involved a total of nearly 8,000 children.

Among participants aged 12-17 years, vaccine efficacy was 93.3% (95% CI 47.9-99.9) at a time when the ancestral and alpha strains predominated. In the younger group, vaccine efficacy was 76.8% (95% CI -37.3 to 96.6) over a period when Delta was most prevalent.

The committee agreed on the data that COVID-19 vaccines protect children from serious illness. However, many children in this age group remain unvaccinated. According to Oliver, about 30% of teenagers and 65% of younger children have yet to receive a vaccine.

“We can predict that with future COVID-19 spikes, the unvaccinated people will continue to carry the disease burden,” she said.

  • Amanda D’Ambrosio is a reporter on the MedPage Today enterprise and research team. She covers obstetrics-gynecology and other clinical news, and writes articles about the US health care system. Follow

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