Moderna Biotechnology said it will approach the FDA for an emergency use authorization to allow covid vaccinations to be given to very young children, including those six months old to six years old.
The vaccines produced by Moderna and Pfizer-BioNTech are only licensed for those older than 18, although the latter’s is authorized for adults as well as having emergency usage authorization for those between the ages of five and 18.
Moderna is seeking FDA approval for two doses of its mRNA covid vaccine in kids six to 12 years old based on data given to the agency, which states that shots are safe and effective among youngsters that age.
The youngest age group to be vaccinated against coronavirus has been six months old, while older groups have previously been the focus of studies.
The firm plans to submit the KidCOVE study to the FDA in support of its application. In this study, 7,000 children six months up to six years old were randomly given one of two regimens: two doses of Moderna’ COVID-19 vaccine or two doses of a placebo. TIME reports:
“The vaccine for this age group is one-quarter of the amount that is currently allowed for adults. SARS-CoV-2 antibodies were detected in children who had been vaccinated with the shot at similar levels to those produced by adults after being immunized at higher dosages, suggesting that children’s more active and efficient immune systems played a role.”
“When given alongside the investigator’s vaccine, those antibodies reduced the incidence of infection with COVID-19 virus by 43.7 percent in children six months to two years old, and 37.5% among kids aged two to six.”
“None of these children became infected or developed severe illness, or were admitted to a hospital, or died.”
According to a CDC bulletin, the new Omicron subvariant, BA.2, continues to spread and affects more people. Schools and other public places across the United States are ditching masks as a way to fight the virus.
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