Interim results of a Phase 2/3 trial showed Moderna’s Covid-19 vaccine was well-tolerated and generated a robust immune response in children ages 6 to 11, the company said Monday.
The trial included more than 4,700 participants between the ages of 6 and 11, and looked at two 50-microgram doses of Moderna’s vaccine given 28 days apart. This is smaller than the 100-microgram dose given to adults. The company compared the antibody response in younger children to the response in young adults in the company’s Phase 3 trial, and found a “strong immune response in this cohort of children one month after the second dose.”
The data have not yet been peer-reviewed or published.
The vaccine’s safety and tolerability were generally consistent with the Phase 3 study of the vaccine in adolescents and adults, the company said. “The majority of adverse events were mild or moderate in severity,” the company said in a news release. “The most common solicited adverse events were fatigue, headache, fever, and injection site pain.”
Moderna said it will submit these data to the US Food and Drug Administration, European Medicines Agency and other global regulators “in the near term.”
Moderna’s vaccine is currently authorized for people age 18 and older. The company requested emergency use authorization for its vaccine for people ages 12 to 17 in June, but FDA authorization has not yet been extended to that age group.
The company said it is continuing to monitor study participants, and to study younger age groups that are a part of the trial.
What’s next for vaccine for younger children
Younger children may be eligible to be vaccinated against Covid-19 within a couple weeks. Another vaccine company, Pfizer, has already sought emergency use authorization for its vaccine for people ages 5 to 11.
FDA’s independent vaccine advisory board will meet Tuesday to discuss whether Pfizer and BioNTech’s Covid-19 vaccine should be authorized for younger children. If authorized, it would become the first vaccine available for younger children.
Pfizer’s vaccine is already authorized for children 12 to 15 and is approved for people age 16 and older.
If the FDA committee votes in its favor, the FDA will then make the final decision about whether to authorize it.
Then, the US Centers for Disease Control and Prevention’s independent advisory committee meets November 2 and 3, and will vote on whether to recommend it. Finally, CDC Director Dr. Rochelle Walensky will decide whether to accept or modify the committee’s recommendation.
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