October 25, 2021
Moderna plans to ask the U.S. Food and Drug Administration to authorize its COVID-19 vaccine for children ages 6-11 in "the near term," the company said Monday.
The vaccine generates a strong protective effect and is well-tolerated within this age group, according to an interim analysis of clinical trial data from more than 4,700 children.
The study is investigating the safety and effectiveness of two 50-microgram doses administered 28 days apart. This is a smaller dose than what is given to adults.
The immune response generated by the vaccine was found to be just as robust as it is among adolescents and adults. The data has not yet been peer-reviewed or published.
The vaccine's safety profile in children ages 6-11 also was similar to that of adolescents, the company said. Most side effects were mild or moderate in severity, with fatigue, headache, fever and injection site pain being the most common.
Moderna's vaccine is currently authorized for people ages 18 and older. In June, the company sought emergency authorization for its vaccine among children ages 12-17, but the FDA has yet to extend the authorization to that age group.
Moderna said it will continue to monitor participants in the ongoing study, which includes three age groups – ages 6-11, ages 2-5 and ages 6 months to 2.
Pfizer also has requested authorization for its COVID-19 vaccine among children ages 5-11. The FDA's independent vaccine advisory committee will meet Tuesday to discuss the available data. After the vote, the FDA will make its final decision.
The Pfizer-BioNTech vaccine currently is authorized for children ages 12-15 and fully approved for people ages 16 and older. If the FDA decides to extend the emergency authorization to children ages 5-11, the COVID-19 vaccine will be the first for younger children.
Booster shots are now available for many adults. People ages 18 and older who received a Johnson & Johnson shot at least two months ago are eligible to receive a booster.
People who completed the Pfizer-BioNTech or Moderna vaccine series at least six months ago are eligible for a booster shot if they meet any of the following criteria:
•Age 65 or older
•Age 18 or older and have underlying medication conditions
•Age 18 or older and live in a long-term care facility
•Age 18 or older and live or work in high risk settings
Health officials say fully vaccinated people who do not meet the eligibility requirements are still protected against severe illness.