FDA reviewers say Moderna vaccine safe for kids ahead of approval meetings
Vials of Moderna and Pfizer BioNTech COVID-19 vaccine are pictured in the Meuhedet Clinic in Jerusalem on January 3. File Photo by Debbie Hill/UPI | License Photo
The analysis was made in briefing documents published Friday ahead of meetings next week to decide whether to give approval to Moderna and Pfizer’s vaccine regimens for children under 6 years old.
“Available data support the effectiveness of the Moderna COVID-19 vaccine in preventing symptomatic COVID-19 in pediatric age groups from 6 months through 17 years of age,” the reviewers said in the document.
The reviewers said the data shows the vaccine has a “robust effectiveness against COVID-19 caused by the ancestral strain, Alpha, and Delta variants and more modest effectiveness against COVID-19 caused by the Omicron variant.”
“While no severe COVID-19 cases were reported among participants 6 months through 17 years in clinical studies, vaccine efficacy against severe disease and hospitalizations is expected to be higher compared to vaccine efficacy against non-severe COVID-19 as observed in the adult clinical trial and in real-world studies,” the reviewers said.
The FDA reviewers noted there were uncertainties related to the benefits of Moderna’s vaccine in children, including the duration of vaccine effectiveness and the need for booster shots.
If the FDA advisory committees recommend approving the vaccine for young children, authorization from the agency and approval from the Centers for Disease Control and Prevention are expected to come quickly. Currently, no vaccines have been approved for children ages 5 and under.
Last month, Pfizer and partner BioNTech said late-stage studies have shown that three smaller doses of their COVID-19 vaccine in children younger than 5 are about 80% effective in protecting them from the virus.
Pfizer and BioNTech initially planned a two-dose regimen for children younger than 5, but added the third dose when just two failed to offer the expected level of protection against the coronavirus.
Moderna’s regimen for young children includes two doses.