보건복지부 영문홈페이지

South Korea to import 20,000 doses of Evusheld into Korea 
예방용 항체치료제 ‘이부실드’ 총 2만 회분 도입 결정

PRESS RELEASE
June 8, 2022

The COVID-19 Vaccination Response Promotion Group announced plans to supply and administer Evusheld, following the decision on the secondary supplementary budget (KRW 39.6 billion) for introducing Evusheld into Korea.

Evusheld is a preventive antibody treatment medication, which provides a preventive effect by directly injecting the antibody into those with compromised immunity from COVID-19 vaccinations due to other immunosuppressive treatments or severe immunodeficiency symptoms. 

A study by the US Food and Drug Administration (FDA) has demonstrated the preventive efficacy and safety of Evusheld, reporting significant reductions in infections (93%) and severe cases and death (50%). The US government approved its emergency use last December, while Europe recommended marketing approval of the drug this March. Evusheld is currently administered in several nations, including the US, France, and Singapore.

Efficacy and Safety of Evusheld

(Mechanism) A combination of two long-acting antibodies (tixagevimab and cilgavimab) are administered by intramuscular (IM) injection to provide preventive effects against COVID-19 within a few hours.

The preventive effects are maintained for a minimum period of 6 months. 

(Efficacy) The infection rate of the immunocompromised treatment group was reduced by 93% when compared to the non-treated control group, and severe cases and deaths for the trea`tment group were reduced by 50% even when infected. 

Infection prevention effect was sustained for both Omicron variants BA.1 and BA.2, with particularly stronger preventive effect for the BA.2 variant (based on research findings, including those of the US FDA and Washington University).

(Safety) No serious side effects were reported from 10,000 clinical trials. Only minor side effects were reported.

Evusheld is intended for ①blood cancer patients and ②recipients of organ transplants, who have difficulty forming antibodies from vaccinations due to previous immunosuppressive treatments, as well as ③congenital (primary) immunodeficient patients with similar symptoms. Subjects must not have any history of COVID-19 infection.

Supply volume was confirmed for 20,000 doses* after estimating the number of patients requiring the medication and based on advice from experts. 

5,000 doses are to be imported in July, with the remaining 15,000 doses planned in October.

Discussions are in progress with AstraZeneca, the manufacturer of Evusheld, on the purchase agreement for the confirmed 20,000 doses. Once signed, the drug is expected to obtain approval for emergency use from the Ministry of Food and Drug Safety and shall be promptly introduced and administered in Korea.

Due to the restricted number of subjects, injections will be administered via appointments. It was announced that Evusheld, identical to all other COVID-19 treatments, will be provided free of charge.

Medical institutions that treat severe immunocompromised patients can apply to be designated · operate as an injection administering institution. When it is determined by the medical staff that the subject requires the injection, an appointment shall be reserved and Evusheld administration applied on behalf of the subject via the COVID-19 Vaccination Management System. 

When applications are submitted by medical institutions, the public health centers in the respective jurisdictions will verify the infection history of the subjects. When confirmed to have no infection history, applications for drug allocation will be submitted to the Korea Disease Control and Prevention Agency (KDCA), which will allocate and deliver the drugs to the respective medical institutions.



Moreover, monitoring of the Evusheld-injected patients will be carried out by the medical staff to check on the health status of the patients. 

< Evusheld Application and Supply Process (draft) >

 

※ Identical to existing vaccine allocation · delivery framework

A more detailed application process and detailed explanation ‧ communications on the administration of Evusheld are planned for release at the end of June through briefing sessions for the medical sector and regional governments.



The COVID-19 Vaccination Response Promotion Group expressed their expectation that the introduction of Evusheld, as a protection measure for those who have difficulty in forming antibodies from vaccinations due to immunosuppressive treatments, can help to protect severely immunocompromised patients situated in the blind spot of the COVID-19 vaccination strategy even in the event of new variants. 

// For inquiries contact Media Relations, Ministry of Health and Welfare
044-202-2047 or fairytale@korea.kr

http://www.mohw.go.kr/react/al/sal0301vw.jsp?PAR_MENU_ID=04&MENU_ID=0403&page=1&CONT_SEQ=371717