Moderna Requests Approval for COVID-19 Vaccine for Children Under 5 Years Old

[Image source=Reuters Yonhap News]

[Asia Economy Reporter Cho Hyun-ui] Moderna has requested emergency use authorization from U.S. health authorities for a COVID-19 vaccine for children under 5 years old. This is the first case of requesting approval from the U.S. Food and Drug Administration (FDA) for a COVID-19 vaccine targeting infants and toddlers aged 6 months to 5 years.

On the 28th (local time), the New York Times (NYT) and others reported this citing a senior official. Moderna plans to complete the submission of related data by the 9th of next month.

The dosage for infants and toddlers under 5 years old is 25㎍ (micrograms), one-quarter of the adult dose, administered twice. Moderna stated, "Children who received this dosage showed immune responses similar to adults aged 18 to 25 who received 100㎍," adding, "They exhibited strong neutralizing antibody responses and favorable safety."

Clinical results showed a 51% preventive effect against symptomatic infection in children under 2 years old, and a 37% effect in children aged 2 to 5 years.

Moderna explained, "Although it seems less effective compared to previously approved adult vaccines, this data was obtained during the spread of the highly contagious Omicron variant." They noted that the estimated efficacy is similar to that of adult vaccines against the Omicron variant.

Pfizer is also expected to request emergency use authorization for a COVID-19 vaccine for children aged 6 months to 4 years before June.

Unlike Moderna, Pfizer is expected to apply for approval with a standard vaccination regimen of three doses, each 3㎍?one-tenth of the adult dose.

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