Lot release for Pfizer's COVID-19 vaccine was completed

for 250,000 people

Inoculation to the elderly 75 years or older from April 1st

The MFDS announced that it has released a national lot of 250,000 people (500,000 batches) of Comirnaty that Pfizer Korea has applied for on the 28th (Sun).

 

The national lot release is a system that the state confirms once more the quality of the vaccine is assessed comprehensively by evaluating the results of the 'validation test' for each vaccine manufacturing unit (lot) and the 'data review' that produced and submitted the test results as permitted by the manufacturer to determine the quality of the vaccine before distribution to the market.

 

The MFDS established the test method through verification of the manufacturer's test method data from November last year for the rapid release of the national lot of Comirnaty, and thorough introduction of equipment necessary for the test such as ultra-high performance liquid chromatography, etc.

 

It explained that it has been preparing a national lot release.

 

In addition, it added that the MFDS has newly established an RNA analysis room and secured an additional cryogenic freezer to store samples for national lot release to ensure that the test can proceed smoothly.

 

The MFDS confirmed the effectiveness, safety, and quality through a verification test of about 500,000 batches of Comirnaty and a review of data on manufacturing and testing.

 

The MFDS verified the effectiveness by conducting potency tests, confirmation tests, and content tests to measure the amount of the genetic material showing the effect and the amount of lipid nanoparticles surrounding the genetic material.

 

It also revealed that the product was not contaminated by conducting a purity test and an endotoxin test.

 

In addition, quality consistency was confirmed by reviewing the quality test data issued by the manufacturer's quality assurance manager.

 

Comirnaty is an RNA vaccine.

 

It is a vaccine made by wrapping genetic material (mRNA) containing COVID-19 antigen protein information with Lipid Nano Particles (LNP).

 

It has a mechanism to induce an immune response.

 

An official from the MFDS said, "We will do our best to ensure that the Korean people can receive the vaccine with confidence by thoroughly verifying COVID-19 vaccine introduced in Korea by maximizing the relevant infrastructure such as experts and equipment necessary for the release of the national lot." This lot released Pfizer COVID-19 vaccine is planned to be inoculated to elderly people aged 75 or older starting April 1.