Pfizer COVID-19 Vaccine 250,000 Doses, National Release Approval Completed

Pfizer COVID-19 Vaccine [Image Source=Reuters Yonhap News]

[Asia Economy Reporter Lee Chun-hee] On the 24th, 250,000 doses (500,000 injections) of Pfizer's COVID-19 vaccine 'Comirnaty' that arrived in Korea were granted national batch release approval.

The Ministry of Food and Drug Safety announced on the 28th that it would grant national batch release approval for approximately 250,000 doses of Comirnaty requested by Pfizer Korea. This quantity arrived at Incheon International Airport on the 24th and represents half of the 500,000 doses scheduled for introduction this month. Notably, this vaccine supply was secured separately by the government through an individual contract with Pfizer, apart from the doses introduced earlier via the global vaccine procurement project 'COVAX Facility.'

The COVID-19 Vaccination Response Promotion Team announced on the 15th that the 500,000 doses of Pfizer vaccine arriving this month would be administered starting in April to elderly people aged 75 and over (3.64 million people) and residents and workers in elderly care facilities (158,000 people). To this end, 3 million doses (6 million injections) are expected to be sequentially delivered by June.

'National batch release approval' is a system where the government conducts an additional quality check on vaccines before distribution by comprehensively evaluating the 'inspection test' for each manufacturing lot and the 'data review' of manufacturing and testing results submitted by the manufacturer as per the approved standards. Previously, on the 17th of last month, AstraZeneca's COVID-19 vaccine 'Korea AstraZeneca COVID-19 Vaccine Injection' was the first COVID-19 vaccine to receive national batch release approval.

A shipment of 250,000 doses of Pfizer's COVID-19 vaccine from the United States, intended for vaccination of seniors aged 75 and older, arrived at the Incheon International Airport cargo terminal on the 24th. Vaccine transport vehicles are moving to 46 regional vaccination centers nationwide. Photo by Mun Ho-nam munonam@

To expedite the batch release approval of Comirnaty, the Ministry of Food and Drug Safety has been preparing the national batch release approval process since November last year by verifying test method data from the manufacturer, establishing test methods, and swiftly introducing necessary equipment such as ultra-performance liquid chromatography. Additionally, to facilitate smooth testing, an RNA analysis laboratory was newly established, and ultra-low temperature freezers for storing samples for national batch release approval were additionally secured.

In particular, considering the characteristics of Comirnaty as a messenger ribonucleic acid (mRNA) vaccine, efficacy was assessed through potency tests, confirmation tests, and content tests to measure the amount of genetic material expressing the effect and the lipid nanoparticle components surrounding it. For safety, purity tests and endotoxin tests were conducted to confirm the product was not contaminated. Furthermore, in terms of quality, consistency was verified through the review of quality test data issued by the manufacturer's quality assurance officer.

mRNA vaccines are vaccines made by encapsulating genetic material mRNA containing COVID-19 antigen protein information in lipid nanoparticles (LNP). After administration, the injected mRNA expresses the antigen protein, inducing an immune response in the human body.

More detailed information on national batch release approval of COVID-19 vaccines can be checked in real-time on the Ministry of Food and Drug Safety’s official website under ‘COVID-19 Vaccine and Therapeutics Information.’

This content was produced with the assistance of AI translation services.