A statement released by the biotechnology company said the study is meant to cover 6,750 “healthy children in the US and Canada.”
“This pediatric study will help us assess the potential safety and immunogenicity of our COVID-19 vaccine candidate in this important younger age population,” Moderna said in the statement issued March 16, 2021.
This pediatric study will evaluate the safety, tolerability, reactogenicity and effectiveness of two doses of the Moderna vaccine.
The doses are given 28 days apart.
Done in three parts, this particular phase of the study involves the placebo-controlled expansion portion.
Participants will be under monitoring for the next 12 months after receiving the second dose.
The US FDA in December granted Emergency Use Authorization (EUA) for the use of Moderna on the adult population 18 years and older.
The bulk of studies and efforts to vaccinate have been focused on the adults, a section of the population that have a higher risk of acquiring severe COVID.
The Philippine government, while negotiating to secure Moderna for its own population, only aims to vaccinate adults.
There is enough interest elsewhere in protecting the pediatric population, though, since this will allow for a bigger section of the population to develop immunity to the virus.
Moderna has already received authorization from health agencies in Canada, Israel, the European Union, the United Kingdom, Switzerland, Singapore and Qatar.