[Asia Economy Reporter Kim Young-won] The Ministry of Food and Drug Safety announced on the 25th that it has approved Pfizer's initial COVID-19 vaccine for infants and toddlers aged 6 months to 4 years, "Comirnaty 0.1 mg/mL (active ingredient: tozinameran)."
The efficacy and effectiveness are for the prevention of COVID-19 in children aged 6 months to 4 years, and the dosage and administration are 0.2 mL (3 μg) administered three times (the second dose 3 weeks after the first, and the third dose at least 8 weeks after the second). This vaccine has received conditional approval and emergency use authorization in the European Union (EU), the United States, and other regions, and is being used for vaccination of infants and toddlers aged 6 months to 4 years.
The Ministry of Food and Drug Safety, after comprehensively reviewing the safety, efficacy, and quality evaluation results of Comirnaty 0.1 mg/mL and expert consultations, decided to grant product approval on the condition that long-term storage test data for the expiration period be submitted after approval.
In clinical trials of Comirnaty 0.1 mg/mL conducted in the United States involving 4,526 children aged 6 months to 4 years, the overall safety of the vaccine group (3,013 subjects) who received three doses was similar to that of the placebo group (1,513 subjects).
The most frequently reported adverse events after vaccination in children aged 2 to 4 years were injection site pain, fatigue, injection site redness, diarrhea, and fever, while in those aged 6 months to under 2 years, they included irritability, drowsiness, decreased appetite, injection site tenderness, injection site redness, and fever. Most cases were mild to moderate in severity, with no occurrences of death, myocarditis and pericarditis, drug-related anaphylaxis, or multisystem inflammatory syndrome.
Additionally, when comparing the immune response between infants and toddlers aged 6 months to 4 years who received the primary series of Comirnaty 0.1 mg/mL (three doses) and adolescents and young adults aged 16 to 25 who received the primary series of Comirnaty (two doses), the immune response at one month after the primary series showed that both the neutralizing antibody titers and seroresponse rates (the proportion of subjects with at least a fourfold increase in antibody titers compared to pre-vaccination) demonstrated proven effectiveness.
The "COVID-19 Therapeutics and Vaccine Safety and Effectiveness Verification Advisory Group," composed of infectious disease specialists and vaccine experts, concluded that the vaccine showed immunogenicity after three doses in children aged 6 months to 4 years and recognized its effectiveness for approval. They also judged that the safety profile was acceptable, allowing recognition of both effectiveness and safety for approval.
A Ministry of Food and Drug Safety official stated, "After approval, we will cooperate with relevant government agencies to strengthen the surveillance system for adverse events following vaccination and do our best to ensure thorough monitoring and prompt response so that the public can receive vaccinations with confidence."
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