Pfizer Korea Pharmaceutical’s early COVID-19 virus vaccine for infants (6 months to 4 years old) ‘Cominati Inj. 0.1mg/mL (for 6 months to 4 years old) (Tojinameran)’ was approved on the 25th.
This item has the same active ingredient as the recently approved ‘Cominati Inj’, ‘Cominati Inj 0.1mg/mL’, and ‘Cominati Inj 0.1mg/mL (for 5-11 years old)’.
Efficacy and effect is prevention of COVID-19 in children aged 6 months to 4 years, and the usage and dosage are 0.2mL (3μg) administered 3 times (2nd administration following 3 weeks, 3rd administration following at least 8 weeks).
The Ministry of Food and Drug Safety reflected the opinions of the expert advisory group in a comprehensive evaluation prior to reviewing the item approval for Kominati Inj. 0.1mg/mL (for 6 months to 4 years old).
An interprofessional advisory group composed of infectious disease specialists and vaccine experts said, “Immunogenicity was confirmed following 3 administrations from 6 months to 4 years old, so the effectiveness for approval is acceptable, and the safety profile is at an acceptable level.” Its effectiveness and safety for the drug are acceptable.”
On the other hand, this vaccine is currently being approved for conditional permission and emergency use in the EU (October 20, 2022) and the United States (June 17, 2022), and is used for vaccination for the purpose of preventing corona in infants aged 6 months to 4 years.