Moderna's COVID-19 vaccine is safe and effective for children ages 6 to 12 years, the company announced on Monday (Oct. 25).
The findings are part of a clinical trial on the effectiveness and safety of the vaccine in around 5,700 children between the ages of 6 months and 12 years; More than 4,700 children between the ages of 6 and 12 years participated in the study and were given two doses of the vaccine 28 days apart, but at half the dose (50 µg) given to adults (100 µg).
The researchers found that the vaccine at this dose was "well tolerated," and side effects were similar to what was seen in adolescents and adults, according to a statement (opens in new tab). The majority of adverse events were mild or moderate; and the most common side effects were fatigue, headache, fever and injection site pain, the company said.
They also found that the vaccine prompted a "strong immune response" one month after the second dose; children in this age group had 1.5 times higher antibody levels than those observed in young adults, the company said.
Moderna previously submitted data to the Food and Drug Administration (FDA) to get authorization for use of its vaccine in people ages 12 to 17, but the agency hasn't yet responded to the request. The company now plans to also submit this new data to the FDA and other regulatory agencies around the world.
Meanwhile, the researchers will continue to monitor the participants for 12 months after their second dose to assess long-term protection and safety.
Currently, Moderna is approved for those who are 18 years or older, while Pfizer is approved for those 12 years and older. Pfizer has already submitted a request to the FDA to authorize its vaccine for children ages 5 to 11, Live Science previously reported.
The FDA's advisory committee will meet on Tuesday (Oct. 26) to discuss Pfizer's request.
Originally published on Live Science.