Moderna says its COVID-19 vaccine is safe and protects children ages 6 to 11

Biotech company Moderna Inc. announced that its COVID-19 vaccine elicited a strong immune response and was generally well tolerated in children ages six to 11, and that it plans to submit the data to global regulators soon.

Moderna reported that its two-dose vaccine generated virus-neutralizing antibodies in children and its safety was comparable to that seen before in clinical trials with adolescents and adults. The company cited provisional data that has not yet been peer-reviewed.

It was unclear when US regulators will analyze the results. Moderna’s vaccine for COVID-19 is licensed for adults 18 years of age and older and is awaiting a response to a request made in June for use in people 12 to 17 years of age.

Moderna is behind rivals Pfizer Inc and BioNTech SE, whose vaccine has been licensed for ages 12 and up since May. A panel of outside advisers from the US Food and Drug Administration (FDA) will meet Tuesday to decide whether to recommend Pfizer’s vaccine in children ages five to 11.

Moderna reported that in its testing of 4,753 participants, the side effects were mostly mild to moderate in severity. The most common side effects were fatigue, headache, fever, and injection site pain.

The company’s statement did not reveal any new information about cases of cardiac inflammation called myocarditis, a known side effect of mRNA vaccines.

The injections were doses of 50 micrograms, half the concentration used in the series of primary vaccines for adults and the same as the booster dose authorized for adults. It is higher than the 10 microgram dose that Pfizer is planning for its vaccine in children.

Both the Moderna vaccine and the Pfizer-BioNTech have been linked to myocarditis in young men.

Some studies have suggested that the incidence rate in Moderna vaccine recipients may be higher than Pfizer recipients, perhaps due to the stronger dose of the vaccine.

Sweden has stopped the use of the Moderna vaccine for younger groups of people due to the increased risk of myocarditis.

While children rarely become seriously ill or die from COVID-19, some develop unusual complications, and cases of COVID-19 in unvaccinated children have increased due to the highly contagious Delta variant.