"Expanding Vaccinations from Children and Adolescents to Infants and Toddlers..."

Moderna Applies for Vaccine Approval for Infants Over 6 Months
Novavax Available for Adolescents Aged 12-17

[Asia Economy Reporter Jo In-kyung] As the proportion of COVID-19 cases among children and adolescents under 18 increases, the government has added vaccines available for adolescents. It has also begun reviewing vaccines for infants and toddlers, who were not previously eligible for vaccination.

On the 2nd, the Ministry of Food and Drug Safety (MFDS) announced that it has started the product approval review for Pfizer Korea's COVID-19 vaccine for infants and toddlers (6 months to 4 years old). This follows Pfizer Korea's application for import product approval submitted to the MFDS on the 31st of last month.

The newly applied vaccine, 'Comirnaty 0.1 mg/mL (for 6 months to 4 years old),' is designed to prevent COVID-19 infection and contains the same active ingredient as Pfizer's adult vaccine previously approved by the MFDS.

In addition to Pfizer's vaccine, the MFDS is also reviewing whether Moderna's COVID-19 vaccine can be administered from 6 months of age. Moderna applied for product approval for its COVID-19 vaccine for those aged 6 months and older on June 3rd.

Regarding the implementation of vaccination for infants and toddlers, the Korea Disease Control and Prevention Agency (KDCA) stated, "It can be reviewed if necessary," adding, "We will continue to review based on the MFDS approval results, quarantine situation, vaccine efficacy and safety, and vaccine supply status."

Starting from the 5th, the vaccination age for another COVID-19 vaccine, Novavax, will be expanded from 18 years and older to 12 years and older, increasing the vaccine options available to adolescents. Until now, adolescents could only be vaccinated with the Pfizer vaccine.

The MFDS approved Novavax vaccination for ages 12 to 17 on the 12th of last month. The COVID-19 Vaccination Promotion Task Force decided to expand the vaccination age after expert advisory meetings and the Vaccination Expert Committee review, based on efficacy and safety studies and international trends.

According to the task force, the Novavax vaccine showed 79.5% effectiveness in preventing infection among 12 to 17-year-olds. The neutralizing antibody titer in this age group was 1.46 times higher than that of 18 to 25-year-olds, meeting the non-inferiority criteria. Additionally, adverse reactions in 12 to 17-year-olds vaccinated with Novavax were similar to those in adults 18 and older, mostly mild to moderate, and symptoms disappeared within a few days after vaccination.

However, as of now, the first-dose vaccination rate among domestic adolescents aged 12 to 17 is 68.9%, the second dose rate is 66.2%, and the third dose rate is low at 11.0%. Among children aged 5 to 11, the first-dose rate is only 1.7%, and the second-dose rate is 1.2%.

In the last week of August, the number of new confirmed cases per 100,000 population was 271 for those aged 6 and under, and 255 for those aged 7 to 18, which was higher than other age groups such as 19 to 39 (231), 75 and older (209), 60 to 74 (197), and 40 to 59 (183).

Among confirmed COVID-19 reinfection (second infection) cases so far, those aged 0 to 17 accounted for 40.72% of the total, which is significantly higher than 18 to 29 (17.02%), 30 to 39 (13.05%), 40 to 49 (10.80%), 50 to 59 (6.59%), 60 to 74 (8.27%), and 75 and older (3.64%).

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