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Moderna has unveiled promising findings from its recent clinical trials, indicating that its vaccine is up to 44% effective against the Omicron variant in children under the age of 6. The company plans to pursue emergency use authorization from the FDA for this age group, a significant step forward in the fight against COVID-19 for our youngest ones.
Clinical Trial Overview
In a study involving around 6,700 children aged 6 months to 6 years, the Moderna vaccine was administered in two doses of 25 micrograms each, spaced 28 days apart. The results showed a 43.7% efficacy in preventing COVID-19 for children aged 6 months to 2 years, and a 37.5% efficacy for those aged 2 to 6. Importantly, none of the participants developed severe symptoms, required hospitalization, or were diagnosed with multisystem inflammatory syndrome (MIS-C). Additionally, there were no reported cases of myocarditis or pericarditis, conditions that had raised concerns in some vaccinated individuals, particularly young men, after receiving the second dose of either the Pfizer or Moderna vaccines.
Relevance of Findings
Given that the trials were conducted during the Omicron surge, these findings are particularly relevant, reflecting the increased occurrence of breakthrough infections associated with this variant. Moderna’s CEO, Alex Reed, expressed optimism about these results, stating that they represent “positive news for parents of young children.” He emphasized the urgent need for a COVID-19 vaccine for infants and young children and confirmed that the company is working diligently with the FDA and global regulators to expedite the submission of this data.
Parental Concerns
Parents have been in a state of uncertainty as the Pfizer vaccine received approval for older age groups, leaving families with young children without vaccination options during the Omicron wave. Side effects observed in the Moderna vaccine trials were similar to those seen in older demographics, with fever reported in 17% of the 6 months to 2 years age group and 14.6% in the 2 to 6 age group. For comparison, the fever rate was 23.9% among children aged 6 to 12 who received a higher dose of the vaccine. Fortunately, only a few participants experienced high fevers, and no fatalities were reported.
Future Approvals
In addition to seeking approval for the vaccine for younger children, Moderna is also requesting FDA clearance for a series of two 50 microgram doses for children aged 6 to 12 and two 100 microgram doses for adolescents aged 12 to 18, with approvals already granted in Canada, Australia, and several European nations.
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Summary
Moderna’s vaccine has shown up to 44% effectiveness against Omicron in children under 6, leading to plans for FDA emergency use authorization. The trials involved around 6,700 children and reported no severe symptoms or serious side effects. As families wait for vaccination options for younger children, Moderna is also seeking approval for older age groups.
Keyphrase: Moderna Vaccine Efficacy in Children
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