- The FDA said Moderna’s coronavirus vaccine for infants and toddlers was safe and effective.
- The institution is setting the stage for a review by the agency’s outside advisers.
- The analysis was released in briefing papers ahead of next week’s meeting.
The scientists of the Food and Drug Administration (FDA) reported on Friday, June 10, that the vaccine against coronavirus of Moderna for infants and toddlers was safe and effective.
The institution is preparing scenario for a review by external advisors from the agency on Wednesday, June 15, and a possible clearance by the end of next week.
The analysis was released in briefing papers ahead of next week’s meeting, when independent advisers will also consider whether to license a vaccine from Pfizer and its German partner, BioNTech, for older children. little ones.
Babies and children under 5 years old, a group of 19 millionthey remain the only group in the United States not yet eligible for a coronavirus vaccine.
Modern has asked FDA permission to use its vaccine in children 6 months to 5 years of age. The Pfizer-BioNTech application is for children ages 6 months to 4 years.
The FDA is expected to release its evaluation of the Pfizer-BioNTech vaccine in the coming days.
Effectiveness
The vaccine, according to company data and confirmed by the FDA, was only somewhat effective in preventing disease among the youngest group of recipients, reflecting the impact of the Omicron variant it is highly transmissible and has also weakened the potency of the vaccine in adults.
The Moderna vaccine was shown to be 51% effective in preventing disease in children 6 months to 2 years old, and 37% effective in children 2 to 5 years old.
The FDA said the regimen of two modern injections for younger children it met the main requirement set by regulators: to generate an immune response at least as strong as the protection afforded by young adults.
Side effects
In examining side effects, the agency said adverse reactions in younger children were generally lower compared to with those seen in adolescents and young adults, except for fever.