In a significant development for parents, Moderna has announced promising interim results from its clinical trials regarding a COVID-19 vaccine for young children. The company is planning to request emergency use authorization from the FDA for its vaccine aimed at children aged 6 months to 6 years.
The trial involved around 6,700 children, and the results indicate that the Moderna vaccine, given in two doses of 25 micrograms spaced 28 days apart, demonstrated an effectiveness of 43.7% in preventing COVID-19 among children aged 6 months to 2 years and 37.5% in those aged 2 to 6. Notably, none of the participants experienced severe symptoms, required hospitalization, or were diagnosed with multisystem inflammatory syndrome (MIS-C). Additionally, there were no reported cases of myocarditis or pericarditis, which have been concerns associated with other vaccines.
Conducted during the omicron surge, these findings are particularly relevant, as they align with data showing that this variant has led to an increase in breakthrough infections among adults. Moderna’s CEO, Alex Carter, expressed optimism about these results, stating they are “positive news for parents of young children.” He also emphasized the urgency of making a vaccine available for infants and toddlers, pledging to collaborate closely with the FDA and international regulators to expedite the submission process.
While parents of children under 5 have faced uncertainty, particularly as the Pfizer vaccine was approved for older age groups first, this new data brings a glimmer of hope as families navigate the ongoing challenges of the pandemic.
The side effects observed were comparable to those seen in older children and adults, with a fever above 38°C reported in 17% of children aged 6 months to 2 years and 14.6% in children aged 2 to 6. In contrast, the fever rate was higher in children aged 6 to 12 years, who received larger doses of the vaccine. Importantly, there were no severe adverse reactions reported.
Moderna is also working towards obtaining FDA approval for its vaccine for children aged 6 to 12 and for adolescents aged 12 to 18, with existing approvals in Canada, Australia, and several European nations.
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