MFDS Grants National Release Approval for Moderna Vaccine... Supply Begins in Earnest

On the 1st, a transport vehicle carrying 55,000 doses of the Moderna vaccine entered the GC Green Cross Ochang Plant in Ochang-eup, Cheongju-si, Chungbuk.
[Photo by Lee Chunhee]

[Asia Economy Reporter Lee Chun-hee] The supply of the Moderna COVID-19 vaccine in South Korea is imminent as it has received national batch release approval from the Ministry of Food and Drug Safety (MFDS).

On the 16th, the MFDS announced that it granted national batch release approval on the 15th for approximately 55,000 doses of the "Moderna COVID-19 vaccine" applied for by GC Green Cross. National batch release approval is a system where the government comprehensively evaluates the MFDS's test results and the manufacturer's manufacturing and testing data for each manufacturing lot to verify the vaccine's quality once more before it is distributed in the market.

Since March, the MFDS has verified the manufacturer's testing methods, established its own testing protocols, and preemptively introduced necessary equipment such as imaging analysis devices to prepare for the rapid national batch release approval of the Moderna COVID-19 vaccine.

To this end, the MFDS established testing methods including in vitro translation for protein expression, ribonucleic acid (RNA) content, RNA encapsulation rate, RNA identification, purity, product-related impurities, lipid content, lipid impurities, lipid identification, lipid nanoparticle (LNP) size, and lipid nanoparticle polydispersity.

The Moderna COVID-19 vaccine was developed using a messenger ribonucleic acid (mRNA) vaccine platform. The mRNA vaccine is made by encapsulating genetic material (mRNA) containing the COVID-19 antigen protein information within LNPs. After administration, the injected mRNA expresses the antigen protein, inducing an immune response in the human body.

Regarding this, the MFDS conducted in vitro protein expression tests, identification tests, and content tests to measure the amount of genetic material expressing efficacy and the lipid nanoparticle components surrounding the genetic material. For safety, purity tests and endotoxin tests were performed to confirm the product was not contaminated. From a quality perspective, the MFDS reviewed quality test data issued by the manufacturer's quality assurance officer to verify consistency in quality.

Through this process, the MFDS decided to grant national batch release approval for approximately 55,000 doses of the Moderna COVID-19 vaccine 15 days after its domestic introduction on the 1st.

Excluding 300 doses used for national batch release approval, the remaining approximately 54,700 doses of the Moderna vaccine are scheduled to begin administration this week to healthcare workers under 30 years old (including prospective healthcare workers) at 45 tertiary hospitals through self-administration. Previously, these institutions conducted priority vaccinations in the first quarter, but due to the decision to exclude those under 30 from AstraZeneca (AZ) vaccine administration, additional vaccinations are needed for those unvaccinated or newly hired employees and trainees.

Health authorities plan to continue vaccination at designated medical institutions capable of administering mRNA vaccines such as Moderna and Pfizer, in addition to AZ and Janssen vaccines, as the supply of Moderna vaccines continues, promoting vaccination not only at vaccination centers but also at entrusted medical institutions.

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