Pfizer vaccine available in Korea for ages 12 or older

The MFDS approves changes, Verifying safety of the relevant age group

Pfizer's COVID-19 vaccine has become available in Korea for people over 12 years of age.

 

The MFDS announced on the 16th that it has approved the change of Comirnaty, which can be used to prevent COVID-19 among people aged 12 and older.

 

The dosage and indications of the vaccine can be diluted once with 0.3ml and inoculated additionally after three weeks, just like the existing 16 years old or older.

 

Pfizer vaccines have also been approved in the United States (May 10, Europe (June 2), Canada (May 5) and Japan (May 31).

 

The MFDS determined that the overall safety was similar to that of those aged 16 or older and was in good condition.

 

In the age of 12–15 years of age, the cases of adverse effects following the inoculation of Comirnaty were similar to those aged 16 and older, with no significant adverse effects.

 

Common adverse effects were injection pain, fatigue, headache, muscle pain, chills, joint pain, and fever, most of the symptoms were mild to moderate and disappeared within days of vaccination.

 

The effectiveness of the 12- to 15-year-olds was sufficient after evaluating the effects of COVID-19 prevention and immune responses.

 

As a result of evaluating the preventive effect of 1,983 people (1,005 vaccine groups and 978 placebo groups) who were not infected with COVID-19 until the 7th after the 2nd vaccination, 0 people in the vaccine group and 16 people in the placebo group showed 100% prevention effect.

 

The virus neutralization test was evaluated on 360 people (12–15 years of age 190, 16–25 years of age 170) who were confirmed not to have been infected with COVID-19 until one month after the second inoculation, and the virus neutralization test met the criteria for ages 16–25 years of age.

 

When comparing immune responses at one month after two inoculations, it met 1.5 times the noninferiority standard.

 

Pfizer vaccines have become available in Korea for people aged 12 and older, but the KDCA has not yet included the age group in the list.

 

Attention is focusing on whether it will be included in the vaccination list after discussions.