The study was posted to the website clinicaltrials.gov this past Wednesday.
Moderna, the creator of the SARS-CoV-2 vaccine mRNA-1273, has recently announced that it is planning to test their product in children. Based in Cambridge, Massachusetts, the biotechnology company has been one of the leading pioneers of a vaccine for the coronavirus disease 2019 (COVID-19), along with Pfizer and AstraZeneca. The latter two companies have been testing their therapies in children since at least October.
The phase 2/3, randomized, observer-blind, placebo-controlled study will seek 3,000 participants within the age range of 12 to 17 years old. They will be split into two groups, with one receiving the therapy, while the other receives shots of saline. Investigators will seek mainly to evaluate the safety and reactogenicity of a single dose of the vaccine in separate doses, administered 28 days apart.
Children and adolescents are typically tested for a new vaccine separately for serval reasons. Among them, children have a more active immune system, which could potentially cause stronger reactions to the therapy like fever, fatigue and muscle and joint aches. This can make parents hesitant to go back for a second dose, as they may not have been prepared for intense side effects.
“They may be more out of sorts than adults for a day or two,” William Schaffner, an infectious disease specialist and adviser to the Centers for Disease Control and Prevention said. “You really do want to know, if it’s given in adolescents, what can parents expect? You really want to be able to tell them clearly how you might feel for 24 or 48 hours after you receive the vaccine. And obviously, we really want to be able to tell parents it works.”
Last week, Moderna announced that’s its trial on 30,000 adult participants found that the vaccine was 94.1% effective and had applied to the Food and Drug Administration for an Emergency use authorization. The study on children is not yet taking volunteers, and there is not a set date as to when they will begin accepting them. It is slated to last for two years