Moderna has been paused for youth in some countries over heart inflammation issues. At the same time, Moderna has begun testing its COVID-19 vaccine on young children, the company announced Tuesday.
The study, called KidCOVE, is testing Moderna’s vaccine candidate in children ages 6 months to less than 12 years old.
“It is humbling to know that 53 million doses have been administered to people in the U.S.,” Stéphane Bancel, chief executive officer of Moderna, said in a statement. “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.”
Moderna plans to enroll approximately 6,750 pediatric participants in the U.S. and Canada in the two-part study. In part 1, each participant ages 2 years to less than 12 years may receive one of two dose levels, while each participant ages six months to less than 2 years may receive one of three dose levels, CBS News reports.
Following analysis, researchers will determine which dose will be used in part 2 of the study, which involves a placebo for comparison.
Children participating in the study will be followed for 12 months after receiving the second vaccination. The vaccine’s effectiveness, as well as its safety and reactogenicity (potential side effects like injection-site pain, headache and fever) will be studied.
The National Institute of Allergy and Infectious Diseases (NIAID) 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, are helping conduct the study.
Moderna announced in December that it had launched a similar trial involving 3,000 adolescents ages 12 to less than 18.
Guinea pig babies for an illness that barely affects any babies. Will we look at mandates for them as well?
The Elsevier medical journal Toxicology Reports notes that “the COVID-19 attributed deaths per capita are negligible in children” while “the normalized post-inoculation deaths are small, but not negligible, in children.”
The largest medical experimentation in human history, as Dr. Robert Malone called it, continues, and is now enrolling the babies. We have no idea of longterm affects. Why is this necessary? Influenza or pneumonia are more dangerous to babies.
Listen to Dr. Ben Carson, pediatric neurosurgeon at John’s Hopkins: The risk of Covid for children is extremely small. The risk of the vaccine in children is unknown – we have no long term safety data for children. pic.twitter.com/dJuTWQVw0q
— Sarah T. 🇺🇸 (@Sarah6t) November 4, 2021
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