COVID-19 vaccines transition to the 'National Immunization Program'

Two items from Moderna Korea and Pfizer have been approved for lot release

Supplied in a 'Pre-filled Syringe' format, where a single dose is pre-loaded into the syringe

Product photo of 'Spikevax Pre-filled Syringe Injection'

The government has officially transitioned the national COVID-19 vaccination program, which operated temporarily during the pandemic, into the 'National Immunization Program' for regular, stable management.

In line with this, two updated vaccines targeting the latest XFG variant for the 2026-2027 season have received national lot release approval, completing preparations for supply.

According to the Ministry of Food and Drug Safety (MFDS), a total of seven SARS-CoV-2 mRNA vaccine items, including five manufacturing lots (0.5ml) of Moderna Korea's 'Spikevax Pre-filled Syringe Injection' and two manufacturing lots (0.3ml) of Pfizer Korea's 'Comirnaty Pre-filled Syringe Injection', obtained national lot release approval on the 17th. National lot release is a system in which the government verifies vaccine quality one more time by manufacturing unit (lot) before market release.

The new XFG vaccines to be supplied this time total 4.84 million doses and will be deployed in the 2026-2027 season national COVID-19 vaccination program starting on the 12th of next month.

The two newly approved products are SARS-CoV-2 messenger ribonucleic acid (mRNA) vaccines updated to match the circulating variant. Unlike the existing multi-dose vial format, they are supplied in a 'Pre-filled Syringe' format, where a single dose is pre-loaded into the syringe.

It prevents dispensing errors in clinical settings and improves vaccination convenience, as it can be administered immediately without separate dilution or aliquoting.

'Spikevax Pre-filled Syringe Injection' is a vaccine administered as a single intramuscular injection (0.5ml) for adolescents and adults aged 12 and older. With SARS-CoV-2 spike protein mRNA as its main active ingredient, it induces neutralizing antibodies and cellular immune responses. It can be administered regardless of prior vaccination history, and vaccination is recommended at least 3 months after the most recent COVID-19 vaccine dose.

'Comirnaty Pre-filled Syringe Injection' is administered as a single recommended dose of 0.3ml via intramuscular injection without dilution for adolescents and adults aged 12 and older. It generates neutralizing antibodies through mRNA corresponding to the spike antigen and provides an antigen response optimized for the latest variant. For individuals previously vaccinated, it must be administered at least 3 months after the last vaccination date.

The essential immunization program is intended for high-risk groups with a high risk of severe illness and death. Free vaccination is provided once a year (twice for immunocompromised individuals), mainly for adults aged 65 and older, immunocompromised individuals, and those admitted to or residing in infection-vulnerable facilities such as nursing homes.

Vaccination begins on October 12 for those aged 70 and older (born on or before December 31, 1956), immunocompromised individuals aged 12 and older, and those admitted to or residing in infection-vulnerable facilities, and on October 15 for those aged 65 to 69 (born between January 1, 1957, and December 31, 1961).

Vaccination is available at nationwide entrusted medical institutions and public health centers until June 30, 2027, regardless of residential address, and can be co-administered with the influenza (flu) vaccine. Individuals must present an ID card or verification documents at the time of vaccination. For hematopoietic stem cell transplant patients whose existing immunity is lost after transplantation, revaccination is supported starting from 3 to 6 months post-transplant up to a maximum of 3 years.

The Korea Disease Control and Prevention Agency (KDCA) explained that the COVID-19 vaccination transitioned from a temporary system to an essential immunization system reflecting World Health Organization (WHO) recommendations and policy directions of major countries, as damage to high-risk groups continues, with the proportion of those aged 65 and older among hospitalized patients reaching about 63%.

KDCA Commissioner Lim Seung-kwan stated. "Because new variants of the COVID-19 virus occur every year that evade existing immunity, it is important for high-risk groups to receive the vaccine annually," urging, "In particular, we ask adults aged 65 and older to receive the vaccine at the same time as the influenza vaccine for a safe winter."