One of Canada’s four approved vaccines is prepared to be tested on children across the country.
On Tuesday, Moderna announced the first 6,750 pediatric participants in Canada and the U.S. have been selected in a Phase 2/3 trial called the KidCOVE study in children ages 6 months to less than 12 years.
Moderna says the study is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA).
“We are pleased to begin this Phase 2/3 study of mRNA-1273 in healthy children in the U.S. and Canada and we thank NIAID and BARDA for their collaboration,” said Stéphane Bancel, Chief Executive Officer of Moderna.
“It is humbling to know that 17.8 million adults in the U.S. have received the Moderna COVID-19 Vaccine to date. 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.”
As part of the process, Moderna will evaluate the safety, tolerability, reactogenicity, and effectiveness of two doses given 28 days apart.
Moderna says in Part 1 of the study, each participant ages two years to less than 12 years may receive one of two dose levels.
Also in Part 1, each participant ages six months to less than two years may receive one of three dose levels.
Participants will be followed through 12 months after the second vaccination.
Currently, Moderna’s COVID-19 vaccine is authorized for use in individuals 18 years of age and older.
“Vaccine effectiveness will either be understood through achieving a correlate of protection, if established or through immunobridging to the young adult (ages 18-25) population,” said Moderna.
Vaccine deliveries from Moderna are expected to bring 846,000 doses in Canada through the week of March 22.
In Ontario, shipments are expected to grow from just over 160,000 through the week of March 8 to over 320,000 doses expected to arrive in the week of March 22.
With the extended intervals between the first and second doses, the National Advisory Committee on Immunization (NACI) projects 80 percent of Canadians over the age of 16 could receive a first dose of the Pfizer or Moderna shot by the end of June.
The timeline could move up even more once Johnson & Johnson vaccines arrive in Canada.