Moderna Pharmaceuticals announced that it has begun studying its COVID-19 vaccine in children aged six months to 11 years, this being the latest effort to widen the coronavirus vaccination rollout beyond adults.
The American pharmaceutical and biotechnology company based said that the first children in the U.S. and Canada have received doses in the study.
“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 Chief Executive Stéphane Bancel said.
Federal health officials have suggested that if studies are positive, junior-high and senior-high students could get access to vaccines in the fall, followed by children of elementary-school age in early 2022.
Pfizer and Moderna last year started clinical trials testing their vaccines in adolescents aged 12 years and older. Both trials have fully enrolled subjects and the results are pending. Johnson & Johnson is also planning to start pediatric testing of its vaccine.
The first part of the trial will test different dose levels of the vaccine in children. Researchers will examine the safety and immune response to the various doses to determine which to carry into the second part of the study.
In the study’s second part, other study subjects will be randomly assigned to receive two doses of either Moderna’s vaccine or a placebo, 28 days apart. Researchers will track the safety, tolerability and effectiveness of the vaccine.
“They will determine the effectiveness of the vaccine in children either by using an immune-response marker known as a correlate of protection—if one is determined—or by comparing their immune responses to those seen in young adults,” Moderna said.
Moderna didn’t give a timetable for completing the study.
(With input from Moderna and Agencies)
