Modern has started its testing COVID-19 vaccine on young children, the company announced Tuesday. The study, called KidCOVE, tests Moderna’s vaccine candidate in children from 6 months to less than 12 years old.
“It is humbling to know that 53 million doses have been administered to people in the US,” Moderna CEO Stéphane Bancel said in a statement. “We are encouraged by the primary analysis of the Phase 3 COVE study of mRNA-1273 in adults 18 and older, and this pediatric study will help us determine the potential safety and immunogenicity of our COVID-19 vaccine candidate in this important younger determine age population. “
Modern plans to enroll approximately 6,750 participants in children in the U.S. and Canada for the two-part study. In Part 1, each participant from 2 years to less than 12 years of age can receive one of two dose levels, while each participant can be six months to less than 2 years old, receiving one of three dose levels.
After 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 12 months after the second vaccination. The efficacy of the vaccine, as well as its safety and reactogenicity (possible side effects such as 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, assist in the implementation. of the study. .
Moderna announced in December that it had launched a similar trial in which 3,000 adolescents aged 12 to 18 were under 18 years old.
On CBS News’ “Face the Nation” earlier this month, moderator Margaret Brennan dr. Anthony Fauci asked about vaccinations for high school students.
“We plan for high school students to most likely be vaccinated by the fall period, perhaps not the first day, but certainly in the early part of the fall for the fall period,” Fauci said. “Primary school children, we are doing these so-called age-old studies to make sure they are safe and immunogenic. They are likely to be vaccinated by the first term of 2022.”
CBS News’s David Begnaud recently met two sisters, Dylan and Blair Davis, who are participating in Moderna’s adolescent vaccine trials in Houston, Texas. Their mother, dr. Mendy Jeter, said she wants to protect her daughters.
“It will protect us. It will protect their grandparents and anyone else,” she said.
Therefore, the girls’ parents, who are both doctors, did at least three vaccination trials. “I wanted them to be an example, set an example and say, ‘Hey, this vaccine is safe.’ “We actually trust as doctors that our children get this chance,” Jeter said.
“If our children can help get this trial approved for other teens, I think it will make everyone feel better and be in a safer place,” she added.
Vaccinations by Johnson & Johnson, Pfizer-BioNTech and Moderna are currently used in the USA. The Moderna shots were first sent to the Food and Drug Administration in December. authorized their emergency use for people 18 years or older. Johnson & Johnson’s vaccine is currently also only allowed for ages 18 and older, while Pfizer’s from 16 years and older can be used.
The Moderna and Pfizer vaccines have had similar, very high efficacy in adult studies. Both vaccines require two doses, while Johnson & Johnson has only one shot.
The US has now transferred 100 million doses of COVID-19 vaccine, according to figures published Friday by the Centers for Disease Control and Prevention. President Biden set a goal of 100 million vaccinations in his first 100 days in office, which the country is on course to reach well ahead of schedule. He also said he would order all countries to be eligible for the COVID vaccine by May 1.