Moderna said on Monday that a low dose of its COVID-19 vaccine is safe and appears to work in 6- to 11-year-olds, as the manufacturer joins Pfizer in moving toward expanding shots to children, reports The Associated Press.
Researchers tested two shots for the 6- to 11-year-olds, given a month apart, that each contained half the dose given to adults, according to Moderna.
Preliminary results showed vaccinated children developed virus-fighting antibodies similar to levels that young adults produce after full-strength shots, the company said in a news release.
The study involved 4,753 children ages 6 to 11 who got either the vaccine or dummy shots. Moderna said that like adults, the vaccinated youngsters had temporary side effects including fatigue, headache, fever and injection site pain.
Moderna added it plans to share the interim results with the FDA and global regulators soon. The study is still going on, and the company cannot calculate the vaccine’s effectiveness in actually preventing infections in children unless there are sufficient COVID-19 cases to compare rates between vaccinated and unvaccinated participants.
FDA’s advisers will look at Pfizer’s evidence for vaccinating children on in a public meeting Tuesday. Dr. Anthony Fauci, US President Joe Biden's chief medical adviser, estimated on Sunday that children ages 5 to 11 in the United States may be able to receive their COVID-19 vaccine in the first two weeks of November if the shots are approved.
Moderna’s vaccine has been approved in the US for adults but not yet for 12- to 17-year-olds. In addition, the Centers for Disease Control and Prevention last week cleared booster shots of Moderna's vaccine, as well as the Johnson & Johnson vaccine.
The booster shots in the US are currently only approved for adults aged 65 or older and those at high risk of severe illness or occupational exposure to the virus, but a US source said last week that the US government likely will soon recommend booster shots to people as young as 40.