Moderna on Thursday announced it requested permission from the Food and Drug Administration to expand the emergency use of its COVID-19 vaccine to adolescents — a move that, if approved, could pave the way for many middle and high school students to become inoculated before the upcoming school year.
“We have already filed for authorization with Health Canada and the European Medicines Agency and we will file with regulatory agencies around the world for this important younger age population,” Moderna CEO Stéphane Bancel said. “We remain committed to helping to end the COVID-19 pandemic.”
The initial race to inoculate the public against coronavirus primarily focused on those at particular risk from the disease, including the elderly and those with underlying medical conditions. While younger citizens are less likely to develop a severe case of the illness, medical experts have said vaccinating them against the virus is still key to achieving herd immunity.
Moderna’s vaccine is already being used in the United States, the European Union and Canada for people over 18 years. Approval from the FDA would allow for the two-dose treatment to also be administered to those between the ages of 12 and 17.
The Massachusetts-based pharmaceutical company in May said its shot was “100%” effective within the age bracket, citing a preliminary study of more than 3,700 adolescents. No cases of COVID-19 cropped up in the group of fully vaccinated volunteers while four cases were observed in the placebo group.
The company added that no significant safety concerns have been identified, and the side effects experienced by children have been similar to those exhibited by adults. The most common effects, which typically manifest after the second dose, include headache, fatigue, muscle pain and chills.
If approved by the FDA, Moderna’s vaccine will become the second in the United States available to to adolescents after Pfizer’s two-dose jab, which was approved for emergency use for the younger age group back in May.
The other COVID-19 vaccine available for use in the United States, made by Johnson & Johnson, is currently authorized for for people ages 18 and older.