Pfizer COVID-19 Vaccine Now Available for Ages 12-15 in South Korea

MFDS Expands Pfizer Vaccine Eligibility to Children Aged 12 and Older

[Image source=Yonhap News]

[Asia Economy Reporter Kim Ji-hee] The Ministry of Food and Drug Safety has approved on the 16th a change to allow the use of Pfizer Korea's COVID-19 vaccine, "Comirnaty," for individuals aged 12 and older.

With this change, those aged 12 to 15 who can receive the Pfizer vaccine will be administered the vaccine diluted to 0.3 mL per dose, the same as those aged 16 and older, with one dose followed by an additional dose after three weeks. Comirnaty was approved for use in individuals aged 12 and older in the United States, Canada, and Japan in May, and in Europe in June.

The Ministry of Food and Drug Safety judged that the safety of this vaccine in the 12 to 15 age group is generally similar and favorable compared to those aged 16 and older. Adverse events observed after Comirnaty vaccination in this age group were similar to those in individuals aged 16 and older, with no serious adverse events reported. Commonly reported adverse events included injection site pain, fatigue, headache, muscle pain, chills, joint pain, and fever. Most were mild to moderate in severity and resolved within a few days after vaccination.

The effectiveness for the 12 to 15 age group was considered sufficient based on COVID-19 prevention efficacy and immune response evaluation. First, in an evaluation of prevention efficacy among 1,983 individuals (1,005 in the vaccine group and 978 in the placebo group) who were not infected with COVID-19 up to 7 days after the second dose, zero cases of COVID-19 were confirmed in the vaccine group, while 16 cases occurred in the placebo group, demonstrating 100% prevention efficacy after two doses.

Regarding immune response, neutralizing antibody titers were evaluated in 360 individuals (190 aged 12 to 15 and 170 aged 16 to 25) who were confirmed not to have been infected with COVID-19 up to one month after the second dose, and the results met the evaluation criteria.

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