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The company announced that clinical trials have shown that the vaccine has a 93 percent efficacy rate among adolescents, and has been proven to be safe. Moderna officials said that they plan to apply for federal approval from the Food and Drug Administration (FDA) to use the vaccine in that age group in June.
If approved, it would be the second COVID-19 vaccine authorized for adolescents, joining the Pfizer-BioNTech vaccine, which was given the green light for use earlier this month.
In their study, Moderna found no cases of COVID-19 in participants who received two doses of the COVID-19 vaccine, while four were reported in the placebo group.
Side effects were largely mild or moderate, the company said, with the most common symptoms being arm pain and, after the second dose, headache, fatigue, muscle aches, or chills.
In total, more than 3,700 participants between the ages of 12 and under 18 were studied. The company said it plans to submit the data to the FDA in early June for authorization.
“We are encouraged that mRNA-1273 was highly effective at preventing COVID-19 in adolescents. It is particularly exciting to see that the Moderna COVID-19 vaccine can prevent SARS-CoV-2 infection,” Moderna CEO Stéphane Bancel stated.
“We will submit these results to the US FDA and regulators globally in early June and request authorization. We remain committed to doing our part to help end the COVID-19 pandemic.”
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