Moderna: "Our Vaccine Effective and Safe for Children Aged 6 to 11"

Antibody Production 1.5 Times Higher Than Young Adults
Only Mild Side Effects Such as Fatigue, Headache, and Fever Reported

[Image source=AP Yonhap News]

[Asia Economy Reporter Kim Suhwan] Moderna announced that its COVID-19 vaccine showed strong immune responses in children aged 6 to 11, with only mild side effects reported, confirming its safety.

On the 25th (local time), Moderna stated that the antibody levels formed in children were similar to those found in adults during previous clinical trials.

Moderna released these preliminary results from a COVID-19 vaccine clinical trial involving 4,753 children in the specified age group.

According to the company, children participating in the trial were given two doses of the vaccine at 50 μg each?half the adult dose?administered 28 days apart, resulting in antibody levels 1.5 times higher compared to young adults.

Moderna reported that most side effects observed so far were mild symptoms such as fatigue, headache, fever, and pain at the injection site.

Rare side effects like myocarditis were not reported in this clinical trial.

Moderna did not disclose the full clinical trial data on this day. The company plans to submit the data soon to health authorities in multiple countries, including the U.S. Food and Drug Administration (FDA) and European agencies.

However, foreign media pointed out that the size of Moderna’s clinical trial was too small to detect rare side effects.

Experts especially warned that since Moderna’s vaccine dose (100 μg) is three times that of Pfizer’s vaccine (30 μg), the probability of rare side effects such as myocarditis could be higher.

Sweden recently paused the use of Moderna’s vaccine, citing concerns that it might cause rare side effects in young adults.

Earlier, in July, the FDA recommended that Moderna and Pfizer increase the size of their pediatric clinical trials to better identify rare side effects.

Moderna’s announcement came one day before the FDA’s external advisory committee was scheduled to discuss the emergency use authorization of Pfizer-BioNTech’s COVID-19 vaccine for children aged 5 to 11.

Pfizer had already received emergency use authorization for adolescents aged 12 and older in May.

Meanwhile, Moderna has yet to receive approval for emergency use in the 12 to 17 age group, which it applied for in June. Currently, in the United States, Moderna’s vaccine is authorized for emergency use only in individuals aged 18 and older.

This content was produced with the assistance of AI translation services.