Company Moderna Inc. started the Covid-19 vaccine study in children 6 months to 11 years old in the US and Canada, the latest attempt to expand the mass vaccination campaign beyond adults.
On Tuesday, March 16, it was said that for the first children to receive the dose, Moderna, in collaboration with the National Institute of Allergy and Infectious Diseases and a division of the Department of Health and Human Services are working to develop the study.
"This pediatric study will help us assess the safety and potential immunogenicity of Covid-19 vaccines in this important population of younger age," said Moderna chief executive Stéphane Bancel.
The clinical trial, called the KidCOVE study, will enroll approximately 6,750 children in the US and Canada.
The whole process is divided into two parts. In the first part, different doses of the vaccine are being tested in children. Children between the ages of 6 months and 1 year will receive two doses spaced about 28 days apart, at the level of 25 or 50 or 100 micrograms. Children between the ages of 2 and 11 will receive two doses of the vaccine about 28 days apart, at a level of 50 or 100 micrograms.
The findings of the first part will be used to determine which dose will be used in the second part. For the second part, the evidence for the study will be extended to include children given a placebo, or "vaccine," which does nothing. The children will then be followed for 12 months after their second injection.
Modern is not the only Covid-19 vaccine currently being tested in children, as the Pfizer / BioNTech Covid-19 vaccine is undergoing the same study. Johnson & Johnson has announced plans to study the vaccine in teens, ages 12 to 18.
In December, the U.S. Food and Drug Administration authorized emergency use of the Moderna vaccine for adults and the Pfizer / BioNTech vaccine for people 16 years of age and older. In February, the FDA authorized emergency use of the Johnson & Johnson vaccine for adults 18 years of age and older.
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Source: Wall Street Journal, CNN, New York Times