Emergency Use Authorization Granted for 20,000 Doses of COVID-19 Preventive Antibody Agent 'Evusheld' (Update)

Administration to Immunocompromised Patients at High Risk of Severe Illness and Death

[Image source=AP Yonhap News]

[Asia Economy Reporter Kim Young-won] On the 30th, the Ministry of Food and Drug Safety (MFDS) granted emergency use authorization for 20,000 doses of Evusheld (active ingredients tixagevimab and cilgavimab), an antibody preparation developed by AstraZeneca (AZ) for the prevention of COVID-19.

According to the MFDS, Evusheld was approved after comprehensive consideration of the need for prevention in severely immunocompromised patients who are unlikely to form antibodies through vaccination, the MFDS's review of safety, efficacy, and quality, and the results of expert advisory meetings, through deliberation by the "Public Health Crisis Response Medical Product Safety Management and Supply Committee."

Earlier, on the 10th, the Korea Disease Control and Prevention Agency (KDCA) requested emergency use authorization for Evusheld from the MFDS. The MFDS reviewed clinical results, quality data, and consulted external experts before making the final decision on this day.

The United States granted emergency use authorization for Evusheld in December last year, and Europe approved it in March.

Evusheld is an antibody drug for the prevention of COVID-19. Unlike therapeutics used for patients already infected with COVID-19, it is used for pre-exposure prophylaxis. It is intended for adults without a history of infection and immunocompromised individuals aged 12 and older weighing at least 40 kg, such as those with hematologic cancers or those receiving immunosuppressants after organ transplantation, who have difficulty forming antibodies through COVID-19 vaccination. Patients with significantly weakened immunity have difficulty forming antibodies even after COVID-19 vaccination and are at higher risk of severe illness if infected with COVID-19.

The monoclonal antibodies tixagevimab and cilgavimab are packaged separately in individual ampoules and administered sequentially via intramuscular (IM) injection. Individuals who have received a COVID-19 vaccine can receive Evusheld at least two weeks after vaccination.

The most commonly observed side effect after Evusheld administration was headache at 6.6%, followed by fatigue at 4.7%, and cough at 3.5%, with most adverse reactions being mild. The MFDS considers the safety concerns to be low as the incidence of adverse drug reactions was similar between the Evusheld group and the placebo group.

An MFDS official stated, "Following this emergency use authorization, we will strengthen efforts to collect information on side effects during the use of Evusheld and implement additional safety measures."

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