Children six months to six years old have the same levels of antibodies produced by adults who have received the vaccine.
Moderna said in a statement that the results of the KidCOVE study will be submitted to the FDA for emergency use authorization in the last group of children to be eligible for the vaccine.
The study randomly assigned 7,000 children six months to six years old two doses of the vaccine or placebo. One-quarter of that currently approved for adults is for this age group. Children who have received the shot have similar levels of anti-SRS-CoV-2 to adults who have received higher doses of the vaccine. Children six months to two years old were protected from getting the Omicron variant of the COVID-19 virus with an efficacy of 43.7%, and children two to six years old were protected with an efficacy of 37.5%. None of the children in the study were hospitalized or died.
Moderna's vaccine is only approved for people over 18 years old, while Pfizer-BioNTech's vaccine is only approved for adults. Moderna could be in a better position to distribute its vaccine to younger children because of these results. Moderna is asking the FDA to authorize two doses of its vaccine for children six to 12 years old based on data provided to the agency that the shots are safe and effective.
The companies and the agency decided to delay reviewing the application until April, when additional data will be available, after Pfizer-BioNTech submitted a request for FDA authorization for its vaccine for the youngest age group. The two-dose regimen didn't prove to be as effective in protecting the youngest children from disease as health officials had hoped.
Ensuring the shots for children under six are both safe and effective is important as the new Omicron subvariant, BA.2, continues to cause more infections, and virus control measures like mask-wearing are being dropped.
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