Moderna said it intends to dose a total 3,000 adolescent participants in the U.S. ages 12 to less than 18 years. Each participant will be assigned to receive a placebo or a 100 μg dose at both vaccinations, Moderna said.
“Our goal is to generate data in the spring of 2021 that will support the use of mRNA-1273 in adolescents in advance of the 2021 school year,” Moderna said in a statement.
Researchers studying the virus have noted that morbidity and mortality associated with Covid-19 infections have been significantly lower in young children and adolescents, though reports of Covid-19 symptoms and deaths have been recorded.
As of October, the American Academy of Pediatrics reported that nearly 700 000 child and adolescent Covid-19 cases had been reported in the U.S., roughly 10.7% of all cases, with more than 5,000 cumulative hospitalizations and more than 100 deaths.
Preliminary results from Moderna's current trials have shown strong efficacy against Covid-19, the disease caused by the novel coronavirus that has plagued the world for more than a year. Moderna is one of several front-runners racing to develop a viable Covid-19 vaccine, which to date has caused more than 1.57 million deaths globally.
Moderna, which reported a 100% efficacy rate against severe forms of Covid-19 from late-stage trials of its mRNA-based vaccine on Nov. 30, last month requested clearance in the U.S. and Europe for its vaccine candidate. It is expected to receive emergency approval from the European Medicines Agency on Jan. 12.
Pfizer's (PFE) - Get Report Covid-19 vaccine, meanwhile, already approved on an emergency use basis and being rolled out in other countries, will receive a final review from a Food and Drug Administration advisory committee that could authorize the first coronavirus vaccine in the U.S.
The EMA could give its own blessing to Pfizer's vaccine as soon as Dec. 29.
Shares of Moderna were down 1.35% at $154.47 in trading on Thursday.