Moderna has released the results of phase II and III clinical trials of its COVID-19 vaccine in adolescents, with the US-based company claiming the vaccine is 100% effective in the age group.
According to details, Moderna’s vaccine offered 93% protection against COVID-19 in children aged 12 to 17 years after the initial dose and 100% protection after the booster dose.
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No serious safety concerns were reported over the course of phase II and III clinical trials in which more than 3,700 adolescents participated.
The most common adverse event after the first dose was pain at the site of the injection. Headache, fatigue, muscle pain, and chills were the most common adverse events after the second dose.
All participants of the clinical trials will be monitored over the next 12 months to determine the long-term protection and safety of Moderna’s COVID-19 vaccine.
While terming the results of clinical trials as encouraging, CEO Moderna Stephane Bancel said the company will now submit these findings to the Food and Drug Authority (FDA) as well as other global regulators early next month to request authorization in children aged 12 to 17 years.
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Moderna’s COVID-19 vaccine has only been authorized for use in individuals aged 18 years and above.
This year in March, Moderna had also launched clinical trials to determine the efficacy and safety of its COVID-19 vaccine among children aged six months to less than 12 years.
Earlier this month, Pfizer’s COVID-19 vaccine received regulatory approvals in the US and Canada for use in children aged 12 to 15. European Medicines Agency (EMA) is currently reviewing Pfizer’s vaccine for use in adolescents and is expected to announce its decision this Friday.
Pfizer has also been conducting clinical trials to determine the efficacy and safety of its COVID-19 vaccine among children aged six months to 11 years.
