WASHINGTON — Drugmaker Moderna announced on Tuesday it has kicked off a mid-to-late stage COVID-19 vaccine trial for children under the age of 12.
The company said in a press release that the first participants in its Phase 2/3 study, called the KidCOVE study, have been given their first dose. The goal is to test if the vaccine candidate would protect children ages 6 months to less than 12 years from getting sick with COVID-19.
The study is a collaboration with the National Institute of Allergy and Infectious Diseases and the Biomedical Advanced Research and Development Authority.
“We are encouraged by the primary analysis of the Phase 3 COVE study of mRNA-1273 in adults ages 18 and above and this pediatric study will help us assess the potential safety and immunogenicity of our COVID-19 vaccine candidate in this important younger age population,” said Stéphane Bancel, Chief Executive Officer of Moderna, in a statement.
Moderna said the study will be broken up into two parts, one phase is an open-label, dose-escalation, age de-escalation. The other is a randomized, placebo-controlled expansion study.
Both phases of the study will "evaluate the safety, tolerability, reactogenicity and effectiveness of two doses of mRNA-1273 given 28 days apart" in about 6,750 child participants from the U.S. and Canada.
The children in the first portion of the study will receive one of two dose levels. The sizes of the doses depend on the age of the child. In the second portion of the study, some children will be given two Moderna vaccines or two placebos.
Moderna said that all of the participants in the study will be monitored for 12 months after receiving the second vaccine.
The U.S. Food and Drug Administration has previously granted Emergency Use Authorization to Moderna for its COVID-19 mRNA vaccine, but only for adults.
So far, there are no COVID vaccines approved for children.
The Centers for Disease Control and Prevention said that the first vaccine is 94.1% effective at "preventing laboratory-confirmed COVID-19 illness in people who received two doses who had no evidence of being previously infected."
Moderna has also received authorization for its COVID-19 vaccine from health agencies in Canada, Israel, the European Union, the United Kingdom, Switzerland, Singapore and Qatar.
For most people, the coronavirus causes mild or moderate symptoms. For some, especially older adults and people with existing health problems, it can cause more severe illness, including pneumonia and death.
The United States has more than 29 million confirmed cases of COVID-19, according to data from Johns Hopkins University.
As of Tuesday, the U.S. had more than 535,000 deaths from the virus. Worldwide, there are more than 120 million confirmed cases with more than 2.6 million deaths.