On Tuesday, Moderna announced that children have begun to receive vaccinations in its Phase 2/3 pediatric Covid-19 vaccine trial.
The “KidCOVE study” is a clinical trial that will include around 6,750 children in Canada and the United States. Children involved in the trial will be between 6 months and 11 years old.
The study is broken up into two parts. The first part includes giving children differing dosages of the vaccine in order to decide how much dosage should be used in the second part of the trial. The second portion will include a placebo group, as well. A press release about the study states that the effectiveness of the vaccine “will either be inferred through achieving a correlate of protection, if established, or through immunobridging to the young adult (ages 18-25) population.” After the second shot, the children will be monitored and followed up with once a year has gone by.
“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 53 million doses have been administered to people in the U.S. 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.”
The study is being carried out in conjunction 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), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services.
Other companies are also including children in trials of their vaccines. Pfizer told CNN that its Covid-19 vaccine trial is fully incorporating children between the ages of 12 and 15. The study has 2,259 participants. Pfizer says that it is unclear when data from this study will be distributed. The current Pfizer vaccine has been authorized by the U.S. Food and Drug Administration and can be used on people 16 years of age or older.
In late February, Johnson & Johnson announced that it will begin to study its vaccine in teenagers. The trial will start by looking at how the vaccine affects adolescents ages 12 to 18 and will continue down from that age group.
Johnson & Johnson CEO Alex Gorsky said that the company will probably have a vaccine open to people under the age of 18 by September.
“I think it’s likely to occur right in that timeline. The good news is, is that the FDA is already working with companies to establish the clear regulatory guidelines, so that the appropriate data can be collected,” Gorsky told David Ignatius during a Washington Post event a few weeks ago.
Gorsky reportedly added that the type of vaccine that Johnson & Johnson has distributed has already been given to younger people in the past. Pfizer and Moderna both use mRNA science whereas Johnson & Johnson uses the more standard use of a viral vectored vaccine. A similar process was used in order for Johnson & Johnson to create its Ebola vaccine, according to PBS.
Dr. Macaya Douoguih, head of clinical development & medical affairs with Johnson & Johnson’s vaccine extension Janssen, told a Centers for Disease Control and Prevention committee, “We will conduct several immunogenicity and safety studies in children from 17 years of age down to neonates … We are also anticipating a study in pregnant women in the second and third trimesters toward the end of March, early April.”
Douoguih added, “We also plan to begin a study in immunocompromised individuals in the third quarter of this year.”
The FDA has not yet issued an emergency authorization for any Covid-19 vaccines for children, with the exception of the Pfizer vaccine, which has been authorized for individuals 16 years of age or older.