Moderna has started testing it COVID-19 vaccine on young children, the company announced Tuesday. The study, called KidCOVE, is testing Moderna’s candidate vaccination in children 6 months to 12 years old.
“It is humble to know that 53 million doses have been administered to humans in the US,” said Stéphane Bancel, CEO of Moderna, in a statement. “We are encouraged by the primary analysis of the Phase 3 COVE study of mRNA-1273 in adults 18 years and older and this pediatric study will help us assess the potential safety and immunogenicity of our COVID-19 vaccine in this important younger age population. “
Moderna plans to enroll approximately 6,750 pediatric participants in the US and Canada for the two-part study. In Part 1, any participant from 2 years to less than 12 years old can receive one of two dose levels, while any participant from 6 months to less than 2 years can receive one of three dose levels.
After analysis, the researchers will determine the dose to be used in part 2 of the study, which uses a placebo for comparison.
Children participating in the study will be followed for 12 months after receiving the second vaccination. The effectiveness 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 in the U.S. Department of Health and Human Services, help conduct the research .
Moderna announced in December that it had started a similar study of 3,000 adolescents ages 12 to 18.
On CBS News’ Face the Nation earlier this month, moderator Margaret Brennan asked Dr. Anthony Fauci on vaccinations for high school students.
“We predict that high school students will very likely be able to be vaccinated by the fall period, perhaps not the very first day, but certainly in the early fall for that fall educational period,” Fauci said. “Elementary school kids, we’re doing this so-called age de-escalation studies to make sure it’s safe and immunogenic for them. They’ll likely be able to get vaccinated in the first quarter of 2022.”
CBS News’ 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 wanted to protect her daughters.
‘It would protect us. It would protect their grandparents and everyone else, ”she said.
That’s why the girls’ parents, who are both doctors, signed up for at least three vaccine trials. “I wanted them to be an example, to give an example, by saying, ‘Hey, this vaccine is safe.’ … As doctors, we actually trust our kids to get this injection, ”said Jeter.
“If our kids can help get this trial approved for other teens, I think it will make everyone feel better and in a safer place,” she added.
Vaccines from Johnson & Johnson, Pfizer-BioNTech and Moderna are currently in use in the U.S. The Moderna shots were first shipped in December, after the Food and Drug Administration authorized their emergency use for people 18 years of age or older. Also, the Johnson & Johnson vaccine is currently only approved for children 18 and older, while the Pfizer vaccine can be used for children 16 and older.
The Moderna and Pfizer vaccines had similar, very high efficacy rates in studies in adults. Both vaccines require two doses, while Johnson & Johnson’s is just a single injection.
The US has now ruled 100 million doses of the COVID-19 vaccine, according to figures posted Friday by the Centers for Disease Control and Prevention. President Biden set a goal of 100 million vaccinations in its first 100 days in office, which is on track to reach the country well ahead of schedule. He also said he would order all states to make all American adults eligible for the COVID vaccine by May 1.