(Washington) Moderna on Monday announced positive results for the Govt-19 vaccine for children between the ages of 6 and 11, and the company plans to submit it to regulators around the world “in the short term” for approval.
Clinical trials with more than 4,700 participants once demonstrated “strong” antibody levels a month after the second dose, demonstrating strong immunity in this group of children, Moderna said in a statement.
The vaccine has a “positive safety profile” and is “generally well tolerated,” the company added. The most common side effects are fatigue, headache, fever and pain at the injection site.
“We look forward to submitting the data to global regulatory agencies,” Moderna boss Stephen Boncel said in a statement.
The dose for children has been adjusted to 50 micrograms compared to 100 micrograms per injection for older adults. This 50 microgram dose is the one selected for the adult booster dose, which is approved in the United States.
These results mean that two vaccines may be available for young children in the future.
The U.S. Pharmaceutical Association (FDA) on Tuesday read out an application to approve the Pfizer vaccine for children between the ages of 5 and 11.
Moderna also conducts parallel clinical trials for young children aged 6 months to 5 years.