Now, Moderna has announced that its COVID-19 vaccine is effective in adolescents aged 12-17 and has showed no new or major safety problems in a clinical trial.
The study, known as the TeenCOVE study, enrolled more than 3,700 participants ages 12 to less than 18 years. Two-thirds of the participants got the vaccine and one-third got a placebo.
Two weeks after the second dose, the study revealed there were no cases of COVID-19 in the vaccine group compared to 4 cases in the placebo group. The researchers, therefore, concluded that the vaccine had an efficacy of 100%.
The researchers further found no new safety issues with only headaches, fatigue, body aches and chills stated as the side effects.
“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,” Stéphane Bancel, Chief Executive Officer of Moderna said in a press release.
“We will submit these results to the U.S. FDA and regulators globally in early June and request authorization. We remain committed to doing our part to help end the COVID-19 pandemic.”
Waiting for FDA approval
The Moderna vaccine is already authorized for adults 18 and older. Now the firm plans to submit its new findings to the U.S. Food and Drug Administration and other regulators for emergency use authorization in early June.
The Pfizer/BioNtech vaccine, which was authorized for ages 12-15 on May 10, took only a month to be reviewed by the regulators which means Moderna's authorization could come as early as July.
Children, in general, seem to fare better than adults when infected by COVID-19, showing little or no symptoms. However, a vaccine could further protect them against more serious outcomes while also stopping them from infecting others.
It could also let them reduce the use of masks in public that is especially uncomfortable for children.
The company said it is still in the process of accumulating safety data and will continue to monitor all trial participants for 12 months after their second dose. The firm will also soon be submitting its new results for peer review.
Moderna is also currently conducting vaccine trials in children as young as 6 months of age.