Announcement comes as rival Pfizer awaits approval for its pediatric vaccine in both U.S. and Canada
Moderna said Monday that a low dose of its COVID-19 vaccine is safe and generates an immune response in six- to 11-year-olds, as the manufacturer joins its rival Pfizer in moving toward expanding shots to children.
Pfizer-BioNTech's kid-size vaccine doses are closer to widespread use. They are undergoing evaluation by the Food and Drug Administration (FDA) for youngsters in nearly the same age group, five to 11, and could be available in the U.S. by early November. It is also awaiting approval from Health Canada for use to vaccinate Canadian kids.
Pfizer's vaccine is already authorized for anyone 12 or older in both the U.S. and in Canada.
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Both Pfizer and Moderna have been studying lower doses for younger children.
Researchers tested two Moderna shots for the six- to 11-year-olds, given a month apart, that each contained half the dose given to adults. Preliminary results showed vaccinated children developed virus-fighting antibodies similar to levels that young adults produce after full-strength shots, Moderna said in a news release (new window) on Monday.
The study involved 4,753 children aged six 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.
The study was too small to spot any extremely rare side effects, such as heart inflammation that has occurred in a small number of cases after either the Moderna or Pfizer shots — which are both mRNA vaccines — mostly among young men.
Moderna released no further details and hasn't submitted its data to a scientific journal but said 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.
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The FDA hasn't yet ruled on the company's application to expand its vaccinations to 12- to 17-year-olds in the U.S., although some countries, including Canada (new window), have cleared Moderna's shots for adolescents.
But the U.S. is expected to begin vaccinating children under 12 sometime next month, if the FDA clears low doses of the Pfizer vaccine for five- to 11-year-olds. Pfizer reported last week that its kid-size doses (new window)proved nearly 91 per cent effective at preventing symptomatic COVID-19 in that age group, even as the extra-contagious delta variant was spreading widely.
FDA's advisers will weigh Pfizer's evidence in a public meeting Tuesday. If the agency authorizes Pfizer's kid shots, the Centers for Disease Control and Prevention is set the following week to recommend who should receive them.
The Associated Press with files from CBC News