MFDS Adds 'Rare Thrombosis' to AZ Vaccine Usage Precautions

Consultation on Safety and Measures at Central Pharmaceutical Advisory Committee Meeting on the 20th

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[Asia Economy Reporter Kim Ji-hee] The Ministry of Food and Drug Safety (MFDS) changed the precautions for use of the AstraZeneca COVID-19 vaccine on the 27th in relation to cases of thrombosis occurring after vaccination.

The main additions to the precautions for use include ▲ individuals who have experienced major venous and/or arterial thrombosis accompanied by thrombocytopenia after COVID-19 vaccination should not receive this vaccine ▲ careful administration to patients with a history of rare site thrombosis such as cerebral venous sinus thrombosis, visceral venous thrombosis, heparin-induced thrombocytopenia, or antiphospholipid syndrome, and to those with risk factors for thromboembolism and thrombocytopenia ▲ very rare cases of severe thrombosis accompanied by thrombocytopenia have been observed after vaccination ▲ attention to signs and symptoms of thromboembolism, thrombocytopenia, and coagulopathy.

Accordingly, healthcare professionals should pay close attention to signs and symptoms of thrombosis and thrombocytopenia after vaccination to enable prompt treatment of patients. The MFDS stated, "If symptoms such as severe or persistent headache, blurred vision, confusion, seizures, shortness of breath, chest pain, leg swelling, or leg pain occur after vaccination, immediate medical consultation with a healthcare professional is necessary."

Earlier, on the 8th, the MFDS distributed a safety letter containing precautions related to the unusual thrombosis accompanied by thrombocytopenia associated with the AstraZeneca COVID-19 vaccine and has been reviewing additional necessary measures.

On the 20th, the Central Pharmaceutical Review Committee received advice on the safety and necessary measures regarding the occurrence of thrombosis cases related to the AstraZeneca vaccine through a meeting. The committee, after reviewing evaluation data from overseas regulatory agencies, data submitted by the manufacturer, and domestic and international adverse reaction information, concluded that vaccination did not increase the overall risk of thrombosis, but the rare ‘unusual thrombosis accompanied by thrombocytopenia’ that occurred abroad was considered to have a possible causal relationship with the vaccine, consistent with assessments by the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK.

Accordingly, the Central Pharmaceutical Review Committee concluded that it is appropriate to add information about ‘unusual thrombosis accompanied by thrombocytopenia’ to the precautions for use.

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