Moderna on Monday announced positive results for its COVID-19 vaccine in children ages 6 to 11, data the company plans to submit to regulators around the world “in the near term” for clearance.
Clinical trials with more than 4,700 participants “demonstrate a strong immune response in this group of children one month after the second dose,” with “robust” antibody levels detected, Moderna said in a statement.
The vaccine also has a “favorable safety profile” and was “generally well tolerated,” the company added. The most common side effects were fatigue, headache, fever, and pain at the injection site.
“We look forward to submitting the data to global regulatory agencies,” Moderna boss Stéphane Bancel said in the statement.
The dose for children has been adjusted to 50 micrograms, compared to 100 micrograms for injections for older age groups. This 50 microgram strength is also the one chosen for the adult booster dose, which has just been approved in the United States.
These results mean that two vaccines may be available for young children in the near future.
The Food and Drug Administration (FDA), the agency authorizing or not the drugs in the United States, must indeed meet on Tuesday to study the request for authorization of Pfizer’s vaccine in children from 5 to 11 years old.
Moderna is also carrying out parallel clinical trials on even younger children, between 6 months and 5 years old.
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