According to a peer reviewed study published in the New England Journal of Medicine on Wednesday, Moderna's coronaviruses vaccine is safe and effective at preventing Covid-19 in children aged six to 11.
The data from the U.S. and Canadian trial showed that the vaccine produced a strong immune response in line with adults ages 18 to 25 years old.
The trial evaluated the effect of two 50 BCg (micrograms) doses of the vaccine, half the strength used for adults.
The study found that the first shot had an efficacy of 81% at preventing Covid-19 illness after 14 days.
The vaccine has an acceptable safety profile for children, with most side effects being mild.
The researchers said fatigue, headaches and injection-site pain were the most common side effects.
After two shots against omicron, efficacy was restored. The researchers were not able to evaluate efficacy after two doses because of the low number of Covid-19 cases among double vaccine participants. The shots have not been tested against omicron because the study was conducted at a time when the delta variant was dominant.
The FDA. The FDA is expected to convene a panel of experts in the coming months to discuss Moderna's request for emergency authorization to use its shot in children ages six to 11 years. In Australia, Canada, the U.K., and the EU, the shot has been approved for use in this age group.
Moderna is seeking emergency authorization for its Covid-19 vaccine in children as young as six months after its clinical trial found two low doses were safe and generated no side effects. The shot will be available to children under the age of five.
Moderna asked the FDA to allow covid vaccines for young kids.
Moderna wants the FDA to allow covid vaccine in children as young as 6 months.
Live updates on the coronaviruses.