South Korea has authorized the use of Pfizer's COVID-19 vaccination for children aged 5 to 11, according to the Ministry of Food and Drug Safety on Wednesday. The approval comes amid mounting worries about an increase in the number of illnesses in the country ahead of the start of school next week.
From the previous day, the government reported a new daily high of more than 170,000 instances of COVID-19, setting a new record. In the previous week, the Korea Disease Control and Prevention Agency revealed that about 30% of the new cases were detected in minors under the age of 18, according to the agency.
In accordance with the Ministry of Health, the vaccine, known as Comirnaty, will be provided twice, with a three-week interval between each dose. Children with severely compromised immune systems will be eligible to receive a third shot four weeks following the second dose of the vaccine.
Specifically, the ministry stated that "the approved vaccine is significant in that it is the first to prevent coronavirus infection in children and restrain the development of severe symptoms in children at a time when the number of COVID-19 cases is increasing due to the spread of the omicron variant."
The Kentucky Department of Children and Families (KDCA) will provide a detailed plan detailing when and how health officials will begin providing the vaccination to children aged 5 to 11.
The clearance came less than three weeks after Pfizer's Korean division filed a request for the product's approval on Feb. 4, according to the company's website. An international pharmaceutical company had previously submitted data of clinical studies conducted on 3,000 children aged 5 to 11 in four countries, including the United States, to the Food and Drug Administration (FDA).
As reported by the ministry, the overall safety and efficacy of the vaccine administration on children aged 5 to 11 was comparable to the safety and efficacy of vaccine administration on persons aged 16 to 25.
Discomfort and swelling at the injection site, as well as fatigue, headache, redness, muscular pain, and chills, were the most frequently reported adverse effects. According to health officials, there have been more reports of adverse effects after the second dose than after the first, although the symptoms have all resolved within three days after the second treatment.
According to the ministry, there have been no recorded fatalities, cardiac inflammatory symptoms, or anaphylactic reactions as a result of the vaccine's delivery.
Among 1,968 children who had not been infected with the coronavirus, Comirnaty was shown to be 90.7 percent effective at preventing COVID-19 symptoms, according to the Ministry of Health and Human Services.
At a press event held behind closed doors, Choi Eun-hwa, a professor at Seoul National University's College of Medicine, stated, "Although we have not yet determined on who would be the main topic for vaccination, the first group to be targeted is the high-risk group among minors."
"Children with obesity, chronic obstructive lung disease, heart illness, and diabetes are among those who fall into this category. The other target category would be youngsters who live with elderly or ill family members who have underlying disorders."
On the aim of delivering vaccinations to children, the ministry noted that because children are very active, they have a greater chance of spreading the virus at school and in their homes. As a result, immunizations must be administered to them in order to both avoid severe symptoms and to slow the spread of the virus.
According to the ministry, the vaccine has been approved for use in 62 countries, including the United States, the United Kingdom, the European Union, and Japan, for children aged 5 to 11.