Pfizer Vaccine for Children Aged 5-11 Approved in Korea... Vaccination Plan Expected Soon (Comprehensive)

On the 19th of last month (local time), a 6-year-old child in Namur, southern Belgium, is holding up a certificate after receiving the first dose of the Pfizer COVID-19 vaccine at a vaccination center.
[Image source=Yonhap News]

[Asia Economy Reporter Lee Chun-hee] Pfizer's COVID-19 vaccine for children aged 5 to 11 has received domestic approval. As the infection rate among children has recently increased, and with the new school term approaching next week, tension is rising in educational settings. Accordingly, health authorities are expected to announce related vaccination plans soon.

The Ministry of Food and Drug Safety approved the import license for Pfizer's COVID-19 messenger RNA (mRNA) vaccine for children aged 5 to 11, "Comirnaty 0.1 mg/mL (active ingredient: tozinameran)," on the 23rd.

Pfizer's pediatric vaccine is currently authorized or granted emergency use approval in 62 countries, including the United States, the European Union (EU), the United Kingdom, and Switzerland. Although it is manufactured with the same ingredients as the adult vaccine, there are differences in dosage and administration. The single dose volume has been reduced from 0.3 mL to 0.2 mL, and notably, the amount of the antigen component tozinameran has been reduced to one-third of the adult vaccine’s 30 μg, down to 10 μg.

The vaccination schedule remains the same, with two doses administered three weeks apart. A third dose has not been approved except for children with severe immunodeficiency, as Pfizer Korea has not applied for it. Severely immunocompromised children can receive a third dose four weeks after the second dose. Professor Choi Eun-hwa of Seoul National University Hospital’s Department of Pediatrics and Adolescents stated, "The highest priority for vaccination should be high-risk groups among children who could develop severe illness. Children with underlying conditions such as obesity, chronic lung disease, heart disease, or diabetes, or those who have close contact with or live with adults who have high-risk conditions, should also be considered for vaccination."

Pfizer-BioNTech's COVID-19 vaccine for children
[Image source=Yonhap News]

The Ministry of Food and Drug Safety used clinical trial data conducted on approximately 3,000 participants from four countries? the United States, Finland, Poland, and Spain?to evaluate the safety and efficacy of Pfizer’s pediatric vaccine. Among the trial participants, 6% (90 individuals) were Asian.

Regarding safety, the ministry assessed that the clinical trial involving 3,109 children aged 5 to 11 showed similar results to the trial involving 1,064 individuals aged 16 to 25. Common adverse events included injection site pain or redness and swelling, fatigue, headache, and muscle pain, with most symptoms being mild to moderate and resolving within three days.

However, injection site redness and swelling were found to be 9 to 16 percentage points more frequent than in the 16 to 25 age group. Professor Choi Young-jun of Korea University Anam Hospital’s Department of Pediatrics explained, "Other vaccines generally tend to cause stronger local reactions in younger children. It seems that the degree of immune system response varies by age." He added, "Most reactions were mild and disappeared within 2 to 3 days, so there should be no major concerns."

Furthermore, no cases of death, myocarditis, pericarditis, or anaphylaxis were reported, and no serious adverse drug reactions such as hospitalization or death related to the vaccine were identified.

The Central Pharmaceutical Review Committee, which advised on the approval, decided that post-approval risk management plans should include monitoring the safety of myocarditis and pericarditis preventively, even if these were not observed in clinical trials, and collecting and evaluating adverse events occurring during ongoing clinical trials and post-approval use.

Professor Choi Eun-hwa urged, "The period when adverse reactions mainly appear after vaccination is up to the second day, so parents should closely observe common adverse reactions in young children."

A nurse at a children's hospital in Columbus, Ohio, USA, is placing a bandage on the arm of 11-year-old Jackson Stuckers after he received the Pfizer-BioNTech COVID-19 vaccine.
[Photo by Yonhap News]

The Ministry of Food and Drug Safety also judged the vaccine’s preventive effect to be significant. Among those confirmed with COVID-19 seven days after the second dose, 3 out of 1,305 in the vaccine group and 16 out of 663 in the control group were infected, showing about 90.7% effectiveness. At one month after the second dose, both the neutralizing antibody rate and seroresponse rate demonstrated confirmed efficacy.

According to the Central Disease Control Headquarters, during last week (13th to 19th), out of a total of 563,791 new confirmed cases, 74,464 were aged 0 to 9 and 88,982 were aged 10 to 19, meaning that children and adolescents aged 10 and under accounted for 29.0% (163,446 cases) of the total, showing a sharp increase. The incidence rate per 100,000 population was 282.8 for ages 0 to 9 and 269.8 for ages 10 to 19, which is higher compared to other age groups.

Authorities attribute the recent rapid spread of COVID-19 mainly to the surge in infections among children and adolescents, along with increased infections in nursing hospitals and facilities. Especially for those aged 0 to 11, who are currently ineligible for COVID-19 vaccination, the increase in confirmed cases has been more pronounced recently. This approval by the Ministry of Food and Drug Safety raises the likelihood that vaccination for children aged 5 to 11 will soon be implemented domestically.

However, vaccination for the 5 to 11 age group will not begin immediately. Based on this approval, related agencies such as the Korea Disease Control and Prevention Agency must establish a separate vaccination plan before actual vaccinations can proceed. Kwon Geun-yong, head of the vaccination management team at the COVID-19 Vaccination Response Promotion Team, stated at a briefing the day before, "We are reviewing pediatric vaccination based on overseas policy trends, recommendations, various research results, and domestic expert consultations," adding, "We are monitoring the Ministry of Food and Drug Safety’s approval of the vaccine for children aged 5 to 11." He further said, "Assuming approval by the Ministry of Food and Drug Safety, we will prepare and announce the timing of introduction and detailed vaccination plans."

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