[Asia Economy Reporter Lee Chun-hee] The second advisory results on the antibody treatment for COVID-19 being developed by Celltrion will be disclosed on the 27th. A verification advisory committee meeting regarding the AstraZeneca vaccine will also be held on the 31st.
The Ministry of Food and Drug Safety (MFDS) explained on the 21st the progress of the approval process for the COVID-19 treatment 'Rekkironaju' and the vaccine 'AstraZeneca COVID-19 Vaccine.' Before approving COVID-19 vaccines and treatments, the MFDS conducts a three-tier advisory review process including ▲Verification Advisory Committee ▲Central Pharmaceutical Affairs Deliberation Committee ▲Final Inspection Committee.
At the Verification Advisory Committee meeting held before the Pharmaceutical Affairs Deliberation Committee's consultation, Rekkironaju's efficacy was recognized, but it was judged that additional verification was necessary, and consequently, conditional approval was recommended to the MFDS.
The MFDS has requested the submission of some quality data that has not yet been submitted as of the 20th, and plans to proceed with the review as soon as the data is submitted. Afterward, the MFDS will comprehensively review the results and hold a consultation on the safety, efficacy, and considerations for approval of the application item at the Pharmaceutical Affairs Deliberation Committee, the MFDS's statutory advisory body, on the 27th, and plans to disclose the results on the same day.
The MFDS also explained that it has completed on-site inspections of the manufacturing sites and clinical trial institutions (medical institutions) related to Rekkironaju, which Celltrion applied for approval.
COVID-19 vaccine and syringe placed in front of the AstraZeneca logo [Image source=Reuters Yonhap News]
The MFDS plans to hold a Verification Advisory Committee meeting on the AstraZeneca COVID-19 vaccine on the 31st.
Currently, the MFDS has additionally requested data necessary for the review of the AstraZeneca vaccine on the 15th, and plans to focus on reviewing preventive efficacy, the validity of the requested dosage and administration, safety, and quality aspects for national batch release approval as soon as the data is submitted. Subsequently, a 'COVID-19 Vaccine Safety and Efficacy Verification Advisory Committee' meeting involving external experts will be held on the 31st, and the results will be disclosed the following day.
Previously, the MFDS completed on-site inspections of the manufacturing sites related to the vaccine.
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