ACIP supports Moderna’s COVID Shot for children ages 6-17

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

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

The recommendation was widely expected, and followed FDA Emergency Use Authorization Last week. Until then, only the Pfizer/BioNTech mRNA vaccine was authorized and recommended for these age groups.

At Thursday’s meeting, ACIP members reviewed Moderna’s vaccine safety and efficacy data, which were primarily studied during times when the ancestral SARS-CoV-2 and Delta strains were predominant. , respectively in adolescents and young children. In both groups, the vaccine was effective against severe illness and hospitalizations.

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

Oliver stressed that severe outcomes with COVID-19 do not spare children. The Omicron wave was accompanied by an increase in hospitalizations among children, and it reported 189 COVID-related deaths among children aged 5 to 11 and 443 among children aged 12 to 17 during the pandemic.

Several ACIP members have raised questions about the intervals between the first and second doses of the Moderna vaccine, as such an approach may reduce the risk of myocarditis associated with the vaccine. Some evidence suggests that the Moderna vaccine carries a higher risk of myocarditis or pericarditis than Pfizer’s vaccine, although CDC experts have warned that these results are not consistent across US surveillance systems.

Among nearly 55 million doses of Pfizer’s vaccine given to people between the ages of 5 and 17, the rare adverse event has been seen in at least 635 children, according to the CDC. The risk is generally higher in children aged 12 to 17, in boys and after the second dose. In children aged 5 to 11, no signal was detected.

In a presentation on clinical considerations, Elisha Hall, PhD, of the CDC’s National Center for Immunization and Respiratory Diseases, said that although the current recommendation is for a 4-week interval between the first and second dose , the CDC will likely recommend an 8-week interval for adolescent males. (The CDC also recommends shorter dose intervals for immunocompromised children.)

Some of the ACIP members expressed confusion about the product labels on Moderna’s vaccines in each age group. The product authorized for children 6 to 11 years old will have the same colored cap as the vaccine for children 6 months to 5 years old, but a different colored border to distinguish the highest concentration. For the product authorized for children aged 12 to 17, it will have the same label as the vaccine for adults, because it is the same dose.

“I am … ​​concerned about errors in vaccine administration,” said Matthew Daley, MD, chair of the ACIP task force. Others echoed concerns about administrative errors, encouraging more resources for suppliers and further clarification on labeling from the manufacturer.

Safety and efficacy data for Moderna’s vaccine in this younger population come from two ongoing Phase II/III clinical trials (study mRNA-1273-P203 for adolescents 12-17 years of age and study mRNA-1273 -P204 for children from 6 to 11 years old). The studies included nearly 8,000 children in total.

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

The committee agreed on data that COVID-19 vaccines protect children from serious illness. However, many children in this age group are still unvaccinated. About 30% of teenagers and 65% of young children have not yet received a vaccine, according to Oliver.

“We can predict that with future outbreaks of COVID-19, the unvaccinated will continue to bear the burden of disease,” she said.